A privately-owned Canadian company headquartered in Richmond, BC, bioLytical now sells and markets its INSTI® HIV-1/2 Antibody Test, including a self-test version which allows users to test in the privacy of their own homes. Its line-up of one-minute INSTI® tests can diagnose infectious diseases like COVID-19, HIV, hepatitis C, and syphilis with speedy, precise results, which have received worldwide regulatory approval, including the US FDA, Health Canada, and the CE mark in Europe.

The INSTI® platform offers vital point-of-care diagnostic tests that are both quick and extremely accurate using advanced flow-through technology, delivering a result in 60 seconds or less, bringing invaluable clinical and financial advantages to patients, healthcare providers, and public health organizations.

“From the beginning, we’ve been an industry leader in HIV diagnostics with our one-minute platform INSTI® and our flagship HIV products. The importance of an accurate and fast assay was the main reason bioLytical was founded,” says Rob Mackie, President and CEO.

“With flow-through technology, we give more results in less time with one sample. Historically, it has been a challenge to have multiple results on a lateral flow platform which, due to the way the platforms are designed, flows over your antigens, leading to a possible degradation of the sample.”

Currently, approximately 36.4 million people are living with HIV worldwide, and many don’t know they have it.

“We need people to know their status so they can connect to suitable anti-retroviral treatment, or ART, to live a quality life; the by-product is that we help to dramatically decrease new infections by significantly reducing the chances of onward transmission,” Mackie says. “That’s why testing for HIV and early detection is so important, and it has been our focus since inception.”

bioLytical’s success includes not only the world’s fastest HIV and syphilis rapid tests but also its ability to determine what diagnostics are in demand worldwide. One example is the recent surge across North America in hepatitis C infections. Since the development of affordable and effective treatment, testing for hep C has become more vital to connecting patients to care. However, more recently, treatment has become affordable for insurers and the average patient, increasing demand for an accurate and accessible hepatitis C test.

“When treatment costs tens of thousands of dollars, there is less urgency to develop a rapid test,” says Mackie. “It’s very challenging to give somebody a result if there is no easy or accessible remedy due to a lack of resources. Now that treatment is covered and reasonably priced, we can focus more on diagnostics.”

The INSTI® platform’s high-quality hepatitis C test is comparable to its industry-leading INSTI® HIV test, with over 99.96 percent accuracy. “Our research and development team has done an outstanding job fine-tuning a highly effective hep C test,” Mackie says.

At the moment, hep C testing in Canada is performed in a professional format called a POCT (point-of-care test) where a doctor, pharmacist or medical professional administers the test, but self-testing could “change this dramatically,” allowing customers to purchase a test kit at a drug store and test themselves at home.

“We are the first company in Canadian history to receive an HIV self-test approval using our INSTI® platform, and the hepatitis C test uses the same innovative technology approved for ease of use for a self-test in HIV,” says Mackie.

The company has gained professional-use approval for its hepatitis C test across Europe and expects to receive WHO prequalification soon. Mackie plans to also launch in North America this year.

While bioLytical is ready to address hep C, much as it has taken a bite out of the HIV sector, COVID-19, unfortunately, put everything on hold for close to three years. However, that delay helped the company fine-tune its marketing approach to address the right demographics of a world suffering from different diseases.

“What sets us apart from our larger competitors is that bioLytical can pivot on a moment’s notice to take advantage of opportunities that otherwise might be missed,” Mackie says. “With us being a private company, we’re growing quite rapidly, representing our region strongly. But we continue to keep ourselves nimble and agile, able to react on our feet to different healthcare challenges, such as the hep C situation.”

While bioLytical knew there was a huge opportunity with hep C, they discovered a largely untapped market in India and Africa for hepatitis B. Subsequently, the company is developing a hep B test performed on the new lateral flow platform, originally developed for COVID-19.

“It is serendipitous how things unfold. Hep B was never on our radar; it was not a focus before COVID-19,” Mackie says. “We were planning to work on a lateral-flow HIV-confirmatory test for the WHO but ended up pivoting toward COVID-19 to help our country fight the virus, as any other local company would.”

During its efforts to make a COVID-19 antibody test on the INSTI® platform, bioLytical developed a new antigen platform called iStatis which lends itself to detecting hep B antigens more effectively due to the nature of the virus.

Despite adversity, including shutting down for seven months during the height of COVID-19, the company persevered. “I think bioLytical and the HIV industry have both been fortunate, and I think it’s all because the world needs the products bioLytical develops,” says Mackie.

“We have an amazing and successful company with a great culture and family here with our employees. Now, three years later, we are three times the company, we have launched a new platform, and we feel that we can face any challenge head-on,” Mackie says.

“If we can’t figure it out on INSTI®, we’ll figure it out on iStatis. We went from having an antibody-based platform to also having an antigen-based platform, and as such, bioLytical is confident it can develop new assays for the ever-changing healthcare needs.”

Unfortunately, COVID-19 created other adverse effects, including a significant increase in HIV infections due to testing being severely hampered, something that regions worldwide are seeing the impact of this year.

Mackie says, “We are seeing infectious rates equal to the rates a decade ago—which reiterates the importance of knowing your status to connect to care and reduce onward transmission. However, to regain the progress we made won’t take as long as it took us to get there in the beginning.”

This is due in part to the pandemic introducing more people to rapid testing and the use of self-testing as a favourable option for people to investigate ways to keep themselves safe without the aid of doctors or leaders—a new tool to help manage health as the world learned more about the novel virus and what worked to help prevent and keep people safe. “Self-testing goes right along with people taking more responsibility,” he adds.

“It’s unfortunate this wasn’t adopted earlier because our health is the most important thing we have and, therefore, the great equalizer. Without health, we have nothing.”

He adds that education is also key, particularly when breaking down stigma. For years HIV was associated solely with drug use and lifestyle choices, misplacing the blame on the patient. There was little to no focus on other methods of transmission—for example, blood transfusions.

“HIV is transmitted through six bodily fluids, and an overlooked infectious place is your gums,” Mackie says. “You can get HIV by sharing a toothbrush if both partners have bleeding gums or sores, and many people don’t know that.”

While Mackie is not discounting the need for great doctors and lower wait times, self-testing allows patients to take responsibility for their health by managing it instead of immediately seeing a doctor whenever there’s an issue. Being proactive and having access to valuable information leads to making informed health decisions and providing some reassurance at the same time.

“We are excited for the months and years ahead of us,” says Mackie. “What the pandemic has taught us is how easy, accurate, and available rapid tests are to use and how important early detection is,” he says.

“With INSTI®, you can take our test and find out if you have hep C in just one minute and get connected to care. Treatment is now through oral pills, taken daily for two to six months. The medication is highly effective with a 95 percent success rate, helping patients rid the disease and lead healthy lives.”

Conversely, if you find you have hep C through symptoms, treatment may be more difficult, possibly leading to the need for lifelong dialysis, costing upwards of hundreds of thousands of dollars over a patient’s lifetime. “It is a terrible disease; left untreated, the virus can lead to severe liver disease. Often known as a silent killer, it can lead to painful suffering for those impacted by the disease.”

STIs are costly, and potentially deadly diseases are rife around the world. Africa spends tens of billions a year to treat a significant number of new cases of chlamydia and gonorrhea each year. Many global regions are seeing historical surges in STIs, such as syphilis. Mississippi alone saw an increase of over 900 percent in congenital syphilis over the past six years.

“Sexually transmitted diseases are not going away, so it is important to have proper protocols,” Mackie says. “Managing your own health is part and parcel, so we’ve put a lot of effort into our online presence, including our social media and websites, taking it upon ourselves to spread awareness for testing and infectious diseases.”

Along with a host of notable lifesaving inventions and best-in-show base platforms, bioLytical is also an industry leader, a rare achievement for a Canadian biotech company.

“We’re not buying from China and repackaging with a maple leaf, like many competitors,” Mackie says. “INSTI® and iStatis are 100 percent developed in-house, right down to our antigens. We start with a proprietary cell bank and develop our antigens here at bioLytical. We do our plastic injection here locally, so there’s no supply chain risk of disruption. That was a big thing, too.”

With the ultimate goal of everything eventually being available for self-testing, bioLytical envisions the future of health care as being in the hands of the people themselves for early diagnosis and management.

“The future is bright for us in rapid testing,” says Mackie. “With our two platforms and amazing research and development team, we’re confident that we are nimble, fast, and highly accurate, capable of reacting with agility to address some of the world’s most severe health challenges.”

The post Hands-On Healthcare<p class="company">bioLytical Laboratories</p> appeared first on Manufacturing In Focus.

Signed into law by President Joe Biden last August, the Act will see some $280 billion in new funding for the domestic research and manufacturing of semiconductors in America. The bipartisan legislative package will see greater investment in America’s semiconductor research, manufacturing and supply chains, and job creation.

For President and Chief Executive Officer Bill Stuart and the team at Photodigm, seeing the enthusiasm on the Congressman’s face and hearing the excitement in his voice during the tour was further assurance the company is on the right track.

“We were incredibly honored and grateful to have Congressman Colin Allred visit Photodigm,” Stuart said during the tour. “It’s clear that he understands the crucial importance of our innovative semiconductor chip technology and is incredibly quick to grasp the real-world challenges companies like ours face as we scale production of our leading-edge photonic chips to meet customer demand.”

100% American-owned
Stuart is quick to praise his staff past and present. Before coming on board about a year and a half ago, he spent some 30 years in technology, mainly on the software side until a decade ago, when he set up a venture fund and conducted private investing in hardware-related companies, including Photodigm.

During the COVID-19 crisis, many businesses were affected by supply chain issues and disruptions. Not a day went by without news of the worldwide computer chip shortage, and how it was causing backlogs for everything from electronic games to pickup trucks. Present-day vehicles have come to include dozens of sensor modules requiring numerous microchips, often thousands per car or truck. So no chips meant millions upon millions of dollars’ worth of vehicles sitting incomplete at factories.

As Photodigm is entirely American-owned and predominantly sourced within the United States, it didn’t face the supply chain hurdles that others did during the pandemic, a key difference. And since the company is under U.S. ownership, Photodigm can sell to the strictly regulated American defense industry, and all large manufacturing related to defense, because they are incentivized to buy American.

“It gives us a lot of flexibility, and it gives them the assurance that their intellectual property is maintained, and the differentiation is maintained,” says Stuart, adding that more companies are now doing business with the U.S. operations instead of China or Russia.

Unlike dealing with offshore entities, Photodigm clients can visit the Texas-based facility, and see for themselves how fixed-wavelength semiconductor lasers are made. “They want to get comfortable with a smaller company being part of their value chain, and it helps that we’re right here.”

Rooted in education
After two decades, Photodigm remains the only commercial semiconductor manufacturer of single spatial and longitudinal mode DBR (Distributed Bragg Reflector) laser diodes, an important consideration in a strategic sector such as this.

Today, these DBR lasers are critical for many applications, including atomic clocks, laser spectroscopy, optical metrology, and quantum sensing.

What became Photodigm in 2000 was originally a part of Southern Methodist University’s (SMU) photonics lab. In its early days, the company built niche lasers “in a custom job shop kind of way for a handful of customers,” according to Stuart, who compares it to auto maker Porsche in the 1990s, when cars were assembled using different parts.

Once Stuart came on board, big changes were introduced, including how the company scaled manufacturing. “We’ve changed that now to where we are on volume manufacturing,” he says. “Instead of making four or five units for a professor at a university, we now make 300 to 400 lasers at a time and sell those to a myriad of customers around the world. That became our focus.”

In the past year alone, Photodigm made 4,000 lasers. This year will see the production of 7,000 to 8,000, and likely 15,000 in 2024. The market is strong, and to meet demand, Photodigm will grow from a high-end custom niche builder to a company producing many more units while maintaining the same level of quality, if not better.

And because the company is scaling up production, it has lowered its unit cost and announced dramatic price reductions on some products. “We’ll continue to do that to get our technology into the hands of a lot more people who can’t afford several thousand dollars for one laser,” says Stuart.

Strength and talent
A strong and talented team helps Stuart lead Photodigm. This includes Dr. Annie Xiang, Senior Vice President of Quality Management and Customer Success. A trained electrical engineer holding a Ph.D. and an MBA, she started in fiber-optic telecom before joining Photodigm in 2012, focusing on the laser as a source component.

Her responsibilities include supervising the back-end process, testing, qualification, customer product specifications, and supporting success. “I’ve observed our company from trying to get a process to be stabilized, to the last two years of the transformation that’s grown into a full-scale manufacturing production environment. Very exciting,” she says.

Recently Xiang was recognized as one of the Top Women in Technology by the Dallas Business Journal for her role at the company—which itself was honored last year as one of the top semiconductor manufacturing solutions providers by Semiconductor Review Magazine.

Dr. Preston Young is Photodigm’s Chief Technology Officer and has been with the company for over fifteen years. He holds a Ph.D. in Electrical Engineering and holds three patents awarded, with others pending, for his contributions. Most of Dr. Young’s research focuses on the design and fabrication of resonant optical and microwave diffractive and waveguide grating structures with emphasis on their incorporation into semiconductor lasers.

Leading the company’s cutting-edge research and development projects with the United States Office of Naval Research and other key customers is Tom Clifford, Photodigm’s Vice President of Project Management, who brings extensive experience in driving strategy, reconfiguring and managing operations, and technology and management consulting.

Rounding off the team is Mandy Eaton, who joined the company last July. As Vice President of Marketing and Communications, she brings years of brand strategy, public relations, communications, strategic planning, and change-management expertise to Photodigm.

Turbo-charging its successful trajectory, the company hired 19 of its 30 staff in just the past year. Some were brought straight from trade school and high school at the technician level and were put through Photodigm’s own training curriculum, Semiconductor Manufacturing 101, and given the opportunity for growth in a good paying job.

As one would expect considering its origins in SMU, Photodigm fosters great partnerships with academia. “600 customers are universities themselves,” says Stuart. “Every major photonics physics lab in the country has our lasers in it, which is a very intentional strategy.”

Believing passionately in education, the company has invested millions of dollars in research carried out for them by universities, putting a lot of students to work. Earlier this year, Stuart was invited to a seat on the Southern Methodist University Lyle School of Engineering Industrial Advisory Board.

This prestigious Board includes executives from other leading companies, including Texas Instruments, Ericsson, Qualcomm, and BCG. “It’s an honor to be asked,” Stuart said then. “I am hoping I can contribute in a real way to such a prestigious engineering school. The collaboration of private industry with world-class universities is imperative for the development of world-class engineering leaders facing tomorrow’s challenges.”

Joe Camp, interim department chair of SMU Lyle’s Electrical and Computer Engineering Department, said at the same time how honored he was to have Stuart join the Advisory Board.

Accurate to a billionth of a meter
Unlike mainstream lasers, Photodigm’s Distributed Bragg Reflector (DBR) laser diodes are remarkably accurate. According to the company, Photodigm’s DBR lasers “are each produced as a single-frequency laser diode ranging from 700 to 1100 nanometers (nm), accurate to the nearest billionth of a meter and capable of converting electrical current into light for specific wavelengths required to stimulate unique elements in the periodic table. They are so small that 500 DBR lasers can fit on an average-sized thumbnail.”

Owing to their size, precision, and quality, DBR laser diodes are used in laser spectroscopy, cold atom optics, atomic clocks, biomedical frequency-resolved diagnostics, quantum sensing, optical metrology, and many other areas.

Some of the more unusual uses for the company’s DBRs in devices are to identify the exact color red in a painting by French Impressionist artist Claude Monet for restoration, and, in cultural forensics, to detect frauds. Photodigm’s laser diodes have also been used to remove graffiti from rock paintings in an Indigenous cultural area in West Texas, and even to determine the amount of rust on bridge I-beams to identify areas that may fail soon.

“The accuracy of our laser allows them to get down to that level of identification,” says Stuart, who is also excited about new applications on the horizon. He believes that in a few years, lasers in iPhones and Androids will do more than facial recognition, telling users about the quality and moisture content of their of skin, forehead temperature, and skin pigment as we age.

“All sorts of things are going to become diagnostic in terms of tools associated with fixed wavelength lasers,” he says, adding that one customer already uses Photodigm lasers in technology to identify and confirm the content of prescription drugs through light signatures, sending back alerts through software if there are issues.

With all the company’s innovation, President and CEO Stuart is quick to credit his enthusiastic team at Photodigm. “History shows great companies attract great people,” he says. “I’m not saying we’re a great company yet, but we are a growing company with significant growth and significant upside. All of our technicians—whether they came from fast food jobs, nail salons, or major universities as Ph.D. students—have stock in the company,” he shares.

“It’s being run like a software start-up because that’s my background, and we’re changing the way the community looks at us versus other players. We’re in a really interesting time with all the challenges going on in manufacturing and globally. It’s nice to come in, focus on something, and feel like you’re actually making a hell of a difference. I think our team is incredibly grateful for that.”

The post Light Fantastic<p class="company">Photodigm</p> appeared first on Manufacturing In Focus.

Established in 2010 by Chris Glencross, a mechanical engineering graduate with a second degree in biology, and a friend from the University of British Columbia, the name “Torvan” encapsulated their two locations—Toronto and Vancouver.

The company started as a distributor, and was thus met with the opportunity to observe what medical equipment was made and offered, how customers responded, and what could be improved upon. With the medical industry extensively regulated, having access to someone who specializes in those limits and guidelines was imperative. Doug Brown, who has been involved in the medical industry since 1985 and now Director of Sales and Marketing, acted as an in-house advisor on product development that either complied with or exceeded requirements for the medical environment.

“I had already been working in medical at this time designing and building operating rooms, and we were just looking for products to offer,” explains Glencross. “Doug and I, who had previously worked together for a multinational company, had gotten back in touch with each other. He was working for a stainless steel manufacturer, bringing them into the medical industry, and we were actually that company’s first distributor in healthcare.”

When declining margins became a problem, the team’s attention turned from selling to manufacturing. “We were engineers, and we knew how to design,” he says. “So we started designing and building our own products, and that’s when I asked Doug to come and join us.”

When stricter regulatory changes impacted the healthcare world, a market opened up for Torvan, he adds. The company caught the attention of some other large companies, started manufacturing for them, and was the first in North America to make a drying and tracking endoscope storage cabinet. While a few other companies were building cabinets for scope drying, Torvan was the first North American manufacturer to use electronics and touchscreens in North America to aid in the monitoring and auditing of scope flow at the cabinet.

“We discovered we were really good at integrating technology and redesigning to what the customer needs because we weren’t a multinational, and quite honestly, we were looking for business,” says Glencross. “It allowed us to develop our own tech ahead of other companies because we weren’t fenced in by the box of a large corporation. But in a weird way, we were being supported by one, because we were OEMing to them. This gave us a good strong financial foundation to work with, which allowed us to build a very strong technical foundation.”

The company successfully pursued OEM relationships with significant medical manufacturers and distributors with their advanced technology and modular expansion ideas, which has set it apart from most other equipment vendors and contributed to its success. Additionally, local fabricators were used in the production of fully upgradeable equipment and modular add-ons were used to boost the equipment’s capabilities rather than replace what was already being used in the facilities. Torvan was also able to further its objective of being “at the forefront of the technology curve” because its products were sold through international OEM partners.

Torvan has been working steadily over the years developing products and fine-tuning its processes, as it was continually “under the microscope” in the beginning. “We’d always had a Health Canada Medical Device Establishment License, but we also had to get an FDA Manufacturers License which was good,” adds Brown. “And then we had to get ISO13485 certification.” There was a period where Torvan was literally being audited every month by different organizations to ensure it was following all the rules and guidelines, adds Glencross.

Ultimately, however, the ongoing scrutiny helped the company’s quality and processes, especially vital when working in the medical field. “We’ve specialized where infection control and cross-contamination are issues,” says Glencross. “So endoscope areas, medical device reprocessing areas, and in 2020 we bought the assets of a company called Unilab, so we’ve been producing scientific lab furniture, and we’ve always produced pathology equipment.”

While pathology grossing stations—workstations where pathology specimens are processed for additional microscopic evaluation—are now becoming a significant area of business for Torvan, it was the company’s scope cabinets that really put it on the map.

“It took time for us to really develop them properly, which is what we did,” says Brown. “And we designed them in such a way that they were modular; nobody else was doing that. So again, [we were] ahead of the curve.”

Torvan’s comprehensive array of high-quality stainless steel scope cabinets provides benefits for easy cleaning and longevity and a smooth, quiet operation along with HEPA and channel drying. “A lot of people realized that was going to be a necessity,” says Brown. “We designed our products so we could upgrade their cabinet on site. Everything we design is scalable.”

The company’s most successful product is its endoscope cabinet. Using OEM distribution, Torvan has about 60 to 70 percent market share on its tracking cabinets in North America, and a reach as far away as Chile and the Middle East. Torvan’s latest push is its sink systems and pump systems, however. Designed for sterile processing departments, the sinks combine E-drain—the use of an electronic solenoid—bottom fill, overflow protection, and height-adjustable features with a new E-sink touchscreen central control to produce a more effective and ergonomic sink.

“These are used in areas where they’re cleaning contaminated instruments and scopes used in surgery and endoscopy,” says Brown. “They don’t want their staff reaching in like we would at home with our kitchen sink to pull the drain plug. So there’s what’s called an external drain.”

In the past, drain operation was primarily mechanical, using a lever or a pole typically located underneath the sink. Over time, these drains would regularly break, but the use of an E-drain resolves those issues. Overflow is another concern that Torvan has addressed. The E-drain sensor picks up on the potential of a sink overflowing and opens the drain, preventing a costly and potentially harmful mistake.

“Overflow protection doesn’t sound like much, but you’d be amazed,” adds Brown. “Somebody’s working away, filling up a sink, they get called away and next thing you know, it’s all over the floor.”

If an SPD (sterile processing department) goes down due to overflow issues, it adversely affects an entire hospital or clinic, adds Glencross, because you can’t sterilize equipment for ERs, ORs or GI departments.

“When you’re talking about forward-thinking innovations, that’s the stuff that we do,” he says. “Now our sinks have touchscreens and gesture sensors on them. There are pumps being attached and devices used to automate, like filling, draining, pumping, and dosing of chemicals, done with potentially a touch of a button.”

Torvan’s innovation extends to the development and distribution of other products, including completely redesigning its lab line to make it more easily manufactured and shipped to customers using materials like phenolic board, a “big piece of epoxy” that has been pressed together with tens of thousands of tons or pressure. Resembling the top of the desk, it’s actually a solid piece of material, so even if cut or nicked, it limits the mold and bacteria growth.

“We’re [increasing our focus] using different materials for different jobs,” says Glencross. “When we design our equipment, we often design it to be built out of multiple materials.” Torvan’s packing prep tables, or wrapping tables—large, height-adjustable workstations—can be built with stainless steel or with phenolic tops, depending on the look, feel, and purpose of that particular table.

This ability to continually pivot to satisfy customer needs isn’t the only quality that puts Torvan above its competition. “What sets us apart from other companies? Probably innovation,” says Glencross. “And I know everybody says that, but we actually mean it.”

Brown agrees. “We listen to end users. In a lot of cases some of the ideas we’ve gotten in our products have come from suggestions by end users, and we bring it back and the engineers incorporate it,” he shares. “That’s extremely important—listening to who we’re working with and getting them products that work for them.”

A lot of other companies in the sector are essentially copycat companies, adds Glencross. “Admittedly, when we started, we were too, but quite honestly, nowadays, we don’t care what the competition is doing,” he says. “Because the customer will tell us what they want. We don’t have to have the competition showing us what they’re doing.

In short, Torvan isn’t driven by its rivals. The team creates new technology to carry out the tasks necessary in the constantly evolving medical business in order to satisfy the desires and wants of its clientele. “Some of our competition now are mimicking what we’re doing,” adds Brown. “But imitation is the best form of flattery.”

That being said, as Torvan looks to the future, it has its own milestones it’s looking to achieve.

“While we’re relaunching our entire lab line, we’ve got a couple of fairly intense medical products coming out in the next few years,” says Glencross. “We’re also really upping our sales game now, because quite honestly, we always sold by word of mouth. We’ve never actually had a real sales force before.”

While in the past, Torvan has worked only through distributors, it’s now expanded in the U.S., including the addition of a National Sales Manager, with the goal of continued growth while building the Torvan name. “It’s really, for us, the next evolution of the company,” says Glencross. “It’s about expanding us as a brand.”

That brand also includes an outstanding company culture that thrives on collaboration, communication and support from the top down. “We’ve got a really good bunch of people here,” says Glencross, “and our turnover is very, very low.”

And while Brown and Glencross have both previously worked for multinationals, after experiencing Torvan’s philosophy, they would never go back.

“This is a great company to work for and be part of,” says Brown. “We’ve got young engineers I’ve had the opportunity to travel with, who at one point I thought would come to work here for a couple of years, get some experience, and then move on maybe to something else, but as they got entrenched in the company and realized where we’re going and what we’re doing, they said, ‘it’s a no brainer to stick around.’”

The post Creating and Collaborating Ahead of the Curve<p class="company">Torvan Medical</p> appeared first on Manufacturing In Focus.

It took hard work and dedication for PAMA to become a leader in ethylene oxide sterilization. Development and installation, over several years, by company experts of a state-of-the-art sterilizer was completed in 2019.

Optimizing the system in 2020, around the same time as the United States Environmental Protection Agency (EPA) began reviewing EtO emissions, PAMA dramatically reduced the amount of time needed for sterilization processes. Batch load release times that previously took an entire week could now be completed in under a day, saving customers time and, best of all, money.

“The installation of our sterilization system turns around a lot of automation, so we were able to re-engineer the EtO sterilization process,” says PAMA’s Executive Director and Engineer, Rasha Al Hashimi. The company also worked with new guidelines for parametric release, which refers to sterility assurance. This helped to reduce the EtO sterilization time and concentration, which plays a major role in the process.

Innovation and success
Initially existing under a different name, PAMA Manufacturing and Sterilization began life under its new name in 2012. From its inception, PAMA committed itself to the utmost professionalism and strict guiding principles, covering corporate social responsibility, respect for the environment, and sustainability.

“From the first year, the company has provided the equipment necessary for several surgical procedures in Quebec,” says the PAMA website, adding that 2013 saw the business “focused on solidifying its corporate structure and practices.” These included establishing a Good Manufacturing Practices (GMP) structure, investing in staff training, and creating a top-notch quality management system to meet industry requirements.

The coming years saw outstanding success for PAMA, which secured a new factory location, installing a new sterilization system and “defining itself as a green company.”

Environmental initiatives
At PAMA, helping the planet has consistently been a front-and-centre, genuine commitment to making a positive difference. Every year, the company acknowledges Earth Day on its website, posting information on how PAMA is doing its part in reducing its environmental footprint.

This includes the development of the unique new process for eco-efficient ethylene oxide (EtO) sterilization by the company’s dedicated engineers in which, through sterilization, PAMA practically eliminates the presence of EtO in the air.

Using half of the amount of EtO gas in its cycle compared to the sterilization industry, EtO residue is also recycled. Transformed in ethylene glycol, it can be used for practical applications, like windshield washer fluid, or even to de-ice aircraft.

“We’re using 50 percent less of the EtO scientifically used in the sterilization cycle,” says Al Hashimi. “Consuming less material to achieve the same result is part of our sustainability as well.” As a further commitment to the environment and sustainability, PAMA’s system is powered with renewable energy from Hydro-Québec.

Another way the company lessens its environmental footprint is through its recyclable PAMA-labeled trays.

According to the peer-reviewed medical journal The Lancet, approximately 313 million surgical procedures are done worldwide every year. Many of these operations need a procedure tray, which is typically thrown out.

“We’re always working on the recycling part of our disposable medical devices,” says Al Hashimi. “Our trays labelled PAMA are recyclable. That’s one initiative that’s important for us, that those products can be recycled, and not just thrown away.”

Along with many contract manufacturing and contract sterilization services like kitting, packing, regulatory approval, assembly, labelling, validation services, and EtO sterilization, the trays that PAMA makes for customers are customizable.

“This means that each of our kits has been created for a specific healthcare professional need,” says the company. When using standard, non-customized trays, healthcare professionals often add missing components, or throw away other components, adding to global waste. “So, in addition to helping to reduce the environmental impact, the custom tray also reduces the risk of contamination,” says PAMA. “Customizable trays help prevent wasted material, as we ensure that all components of the tray are going to be used.”

Facing challenges
Soon after the WHO declared COVID-19 a global pandemic in March 2020, PAMA Manufacturing and Sterilization stepped up. Social distancing and other precautions, like masks and sanitation, were immediately implemented at the facility in Mirabel, Quebec, and the company worked with a nurse, closely following her guidelines.

Even though some raw materials were unavailable due to supply chain issues, PAMA kept going for the benefit of its many faithful customers. “We had to find other solutions,” says Al Hashimi, “but we always have backup suppliers, depending on the material we need to put into our kits.”

Like many others in the medical supply and services sector, PAMA was called upon to help during the pandemic. Shifting production, the company received a contract and worked with the authorization of the Public Health Agency of Canada on a massive order: the packaging and sterilization of five million COVID-19 testing swabs.

To meet deadlines, the company hired students and other short-term staff, keeping some on. That same year, 2020, PAMA obtained its pharmaceutical product establishment licenses (LEPP).

Making connections
PAMA takes pride in being part of the Ethylene Oxide Sterilization Association, Inc. (EOSA) and Medtech Canada, which it joined last year. Medtech Canada represents around 100 medical technology companies. “There are a lot of benefits to being part of MedTech,” says Al Hashimi. “They have a good networking ground, and there are a lot of ways for us to be up-to-date on everything regarding medical devices in Canada.”

Being a part of the EOSA since 2018—a non-profit organization with a membership that includes medical device companies, laboratories, contract sterilizers, and others promoting the use of ethylene oxide—also provides PAMA with valuable information on industry news, safety, federal and state regulatory issues, and more. “It’s beneficial because we’re up to date with everything going around the EtO sterilization industry in the United States,” she says.

Currently marketing its kits only in Canada, PAMA is looking to expand into the U.S. market. On the contract sterilization side, the company’s services are available to Canadian and American clients, with PAMA registered as a contact sterilizer. Through its staff of about 35, PAMA Manufacturing and Sterilization continues to proudly manufacture and assemble its single-use procedure kits in Canada. However, the company plans to take on more staff soon to meet growing demand, especially for its sector-leading ethylene oxide (EtO) sterilization. The company looks forward to continuing to innovate and lead the way in this growing sector.

The post Canada’s Medical Manufacturing and Sterilization Specialists<p class="company">PAMA Manufacturing and Sterilization</p> appeared first on Manufacturing In Focus.

Beating these superbugs has become a medical emergency as antibiotics are proving futile against certain microorganisms and lives hang in the balance. Many superbugs create extracellular matrixes to structure and protect the colony. These organisms typically attach themselves to calcium carbonate-based surfaces that scientists call scaffolds to form what is known as biofilms.

Most biofilms found on medical devices in hospitals have, until recently, been untreatable even with most antibiotics. However, this has been taken to another level due to antimicrobial resistance as the organisms become immune to the medicines meant to eradicate them.

Enter German-manufactured KiteLock 4%, a central venous catheter (CVC) lock solution. A CVC, placed into a large vein above the heart, is essential for life-saving medical treatment but is also at significant risk of leading to bloodstream infections.

Central venous access devices rely on a purpose-specific plastic tubing, known as a catheter, typically fed from a bag to deposit medication or deliver treatments into the bloodstreams of cancer patients, dialysis patients, COVID-19 patients, and other seriously ill people. As necessary as CVCs are in medical recovery, the possibility of complications is always high.

“What people don’t realize is that, if [a catheter] gets infected, one in four people will die from the infectious biofilm inside that catheter, not from their disease, so we must take care of that catheter, and that’s what we do with the KiteLock 4%,” says Karen Mueller, Chief Executive Officer. She explains that, while the new product makes such infections preventable, they are almost impossible to stop without it.

“Catheter infections are considered one of the top hospital-acquired infections. They are acquired in the healthcare system because catheters get contaminated by the healthcare worker and this is almost impossible to stop because bacteria live everywhere. They are deadly, they are costly, and they are preventable.”

Fortunately, since the Markham, Ontario-based company, SterileCare Inc., has brought the game-changing solution to market, the situation is changing. In the process, the company, founded 2011, is having an impact on human life. With distribution ranging across Canada, Europe, the Middle East, and Australia, it has become a manufacturer of note.

The Coordinated Accessible National (CAN) Health Network has done much to ensure that this leading manufacturer remains in Canada. To this end, CAN Health footed the bill for a six-month project that would see the full development of the product to prepare it for going to market. This was done in collaboration with Juravinski Hospital and Cancer Centre of Hamilton Health Sciences, an Ontario-based hospital, to test the KiteLock 4%. CAN Health has also made it possible for the company to work with Fraser Health’s intensive care unit in British Columbia where the product is applied to minimize vascular catheter complications.

“Coming out of COVID-19, we realized how important infection prevention is. We have a non-antibiotic antimicrobial that kills all kinds of bad bugs, including superbugs, which is our next slower moving pandemic,” says Mueller.

With a success rate of 70 to 100 percent, KiteLock 4% is bringing results to the North American health system, and the product has already made a positive impact around the world. That includes reducing blocked CVC catheters due to blood coagulation (occlusion) by well over 60 percent and CVC catheter replacement by more than 10 percent.

KiteLock 4% relies on tetrasodium ethylenediaminetetraacetic acid (EDTA). Known as disodium EDTA, the solution is typically used by cosmetic manufacturers to preserve skin care preparations and help such products perform better. Moreover, it is in a host of hair care products, soap, and even prepared store-bought food items like infant meals.

The use of EDTAs in the medical industry ranges from their use as anticoagulants in test tubes for research samples or blood testing. “When you change disodium EDTA to tetrasodium EDTA, it becomes this really effective antimicrobial that we have a patent on. Nobody knew that something so simple would be so powerful,” Mueller says.

Part of what makes biofilms so dangerous is that once the film has formed its matrix, antibiotics cannot penetrate it. That means these bacterial colonies form such a tough barrier that without obliterating the bacteria’s protective layer, infections remain inside CVCs.

Tetrasodium EDTA binds to the calcium that provides strength to the matrix of biofilms in a process called chelation, entirely destabilizing the integrity of the bacteria’s superstructure and breaking down the film. That, in turn, allows penetration into the now unprotected core of the bacterial colony.

“The way that [tetrasodium EDTA] works is that it grabs onto calcium and pulls it out of the surrounding area. Calcium is vital for blood to clot… Calcium is vital for microorganisms to survive. If you take it away, they die. Calcium is crucial in the formation of the slime called biofilm. If you take the calcium out, it cannot build up,” says Mueller. “It works because tetrasodium EDTA has a mechanism of action that applies to all of it, whereas an antibiotic’s mechanism of action is specific to one microorganism. That’s all that it can do.”

While tetrasodium EDTA has been used commercially for many years, Mueller tells me that it was Dr. Peter Kite, a well-known microbiologist from the United Kingdom, who founded KiteLock 4% for CVC protection. Part of Kite’s research involved using an endoluminal fibrin analysis system (FAS) brush, with which catheter tubes are unclogged in hospitals, to extract biofilm deposits for studies.

Kite had studied the use of tetrasodium EDTA to solve the challenges presented by film-forming organisms since the early 2000s, proving that 24-hour exposure of a diverse selection of bacterial species by the chemical resulted in a significant enough drop to render any residual presence entirely insignificant. The anticoagulation properties of tetrasodium EDTA also mean that blood cannot become overly viscous or dry inside catheters, ruling out the need for premature cleaning or replacement.

“All these superbugs, including but not limited to Methicillin-resistant Staphylococcus Aureus (MRSA) and Vancomycin Resistant Enterococcus (VRE)—all of those big deadly bugs, we kill them,” says Mueller.

Working in medical manufacturing can be challenging but working on the SterileCare Inc. team is all about flexibility. For Mueller, having happy people onboard is imperative to achieving success. “The company has always been virtual so that everybody can do what they need to do at home and work and not be stressed about anything. I am the woman who tries to make people feel good about what they do,” she says, explaining that in this way, the team’s productivity soars.

“I want people to be their best selves. Here, we have fun. Everybody’s motivated. We do good things.” The result is a collaborative group of professionals dedicated to delivering what their clients need most: peace of mind and a groundbreaking way of saving lives.

“When you’re diagnosed with cancer and you have to get chemotherapy, you are given this catheter that is going to deliver what you think is going to save your life. You have no idea that catheter can also take your life away due to possible infections,” Mueller says.

She notes that helping customers adopt this new product has been a long and arduous process. “They say, on average, it takes sixteen years from the idea to commercialization for people to understand the idea, and they are not wrong,” she says.

Mueller travels the globe to educate and inform those in the medical industry about the phenomenal contribution KiteLock 4% can bring to the field. She recently represented the company at the Infusion Nurses Society conference in Boston on April 2, where she introduced the product to medical field attendees. She also presented at the World Congress for Vascular Access in Toronto, Canada at the end of April.

The daring CEO has also won several awards, including Discovery Parks’ 2012 CEO-in-residence program entrepreneur award and Southlake Regional Health Centre’s 2017 innovation award. In addition, she was nominated for the RBC Women of Influence in 2020 and in again earlier this year. Mueller also received the Trailblazer of the Year award in 2022 from CAN Health Network as a member who has made an outstanding contribution to the medical field.

As a young trained nurse, her first introduction to losing a life was when, while treating vascular access dialysis patients as part of her everyday routine, a patient died from a catheter biofilm-related infection. The perfectly preventable death became something she bore throughout her career as a reminder of her purpose in life. After exchanging nursing for sales, she happened upon the chance to bring the KiteLock 4% to market and leaped at the opportunity to become a change maker.

Her journey would become even more personal when her daughter received open-heart surgery. “I started this company as a nurse to pay it forward, to make a difference. As much as we won’t admit it, our healthcare system is driven by finance, not by outcomes,” she says, relating how she went back to school to learn the financial aspects of manufacturing and marketing.

Today, her determination and hard work have brought her to her goal of preventing catheter-related infections and deaths. “I get to say that every day, I get to save babies—people’s lives. I am in it because of my passion for what I do—paying it forward. I think when you do that, the rest will follow,” she adds with a smile.

Soon, the product promises to be easily accessible in the United States. “In the USA, the Food and Drug Administration has never approved a product like ours in history… So we have been awarded with a breakthrough device designation for approval which means we are fast-tracked, so we have a high probability to be approved but it will take about two years,” she says.

At its core, SterileCare Inc. is focused on eliminating the life-threatening health risks and high financial costs caused by infections contracted in medical facilities. Demand for the product has the potential to be huge, according to Mueller, and the company’s growth potential is noteworthy. Over the next five years, it aims to distribute KiteLock 4% around the world. With such a powerful contribution to make to the world of human health and medical manufacturing, this nimble and collaborative company will no doubt succeed.

The post Unlocking the Secret to Beating Superbugs<p class="company">SterileCare Inc.</p> appeared first on Manufacturing In Focus.

But say the kidney’s function is impaired, whether through diabetes, high blood pressure, disease, or physical injury. In that instance, hemodialysis, also known as kidney dialysis, is needed to sustain life and to filter out poisonous wastes created during metabolism like urea and creatinine.

First performed in the early 1940s with the invention of the artificial kidney, the hemodialysis procedure has improved considerably over the decades, with unwanted elements in the blood efficiently removed. However, hemodialysis requires patients to visit a treatment centre, usually a hospital, three or even four times a week, with each session taking about four hours. Add travelling time, and some hemodialysis patients consider treatment a part-time job.

“It’s a very vigorous treatment,” says Delaram Hajipour. “But imagine if we can provide that in-home; how good that would be for patients?”

Chief Executive Officer for Vancouver-based NephroCan since 2016, Hajipour is on a mission: for NephroCan to be a leader in innovative and improved therapies to help ease some of the burden for patients who have to visit centres approximately 150 times a year for their hemodialysis treatments.

Dialysis specialists
With the tagline “Rethinking Hemodialysis,” NephroCan provides patients, medical professionals, and healthcare authorities with innovative and cost-effective hemodialysis solutions of the highest quality. Specialists in end-stage renal disease (ESRD) / end-stage kidney disease, NephroCan is committed to improving quality of life for patients by offering trusted state-of-the-art hemodialysis consumables and machinery.

ESRD is the final stage of chronic kidney disease, when the kidneys can no longer sustain life for the patient. The three types of kidney replacement therapy are hemodialysis—NephroCan’s specialty—peritoneal dialysis, which uses the lining of the abdomen to filter blood inside the body, and kidney transplants.

Unlike many companies that solely provide disposable kits or solely the machinery, NephroCan supports the entire hemodialysis process with kits, hemodialyzers, needles, hemodialysis machines, reverse osmosis machines, and even patient chairs. As Hajipour says in the company’s latest “Rethinking Hemodialysis” catalogue, “We are the first and only Canadian company with an A to Z product offering. We have everything you need for one hemodialysis treatment, so we’re a fully integrated product and services company,” she says. “That was important for us from the beginning.”

NephroCan categorizes its product offerings into groups: disposables, like its well-known NephroFilter and sodium bicarbonate; and machinery, such as its reverse osmosis machines. The company maintains comprehensive manuals for nurses to reference and provides seminars to familiarize others with their disposable products. On the machinery side, nurses receive training, NephroCan’s in-house engineers install the equipment, and local engineers are trained to perform maintenance.

To ensure successful operation, NephroCan offers full after-sales care services like in-person or remote troubleshooting, spare parts, ongoing advice, and even expertise in establishing dialysis clinics. And for both disposables and machinery, the company provides extensive post-market surveillance through an in-house nurse involved in hemodialysis care who works directly with healthcare providers and patients.

“We have 25 years of accumulated experience among our experts, and that has allowed us to have everything from our manufacturing line to the end product—even some key raw materials—in our product list,” explains Hajipour. “That naturally gives us the flexibility and agility to meet market demands and needs as they arise.”

Producing everything in-house is a key point of difference for NephroCan, enabling the company to better serve its clients.

Growing to meet demand
From its headquarters in Vancouver, BC, the capital of Silicon Valley North, NephroCan is surrounded by partners and opportunities that enable the team to advance all levels of patient care.

Beginning in 2008 as a medical consulting business (under a different name), the new venture soon realized that there was an enormous interest in medical devices manufactured by Canadian companies. Conducting a feasibility study and gaining a better knowledge of the market landscape, they created NephroCan in 2016.

As well as Vancouver, the company has strategic locations in Italy for business development and representation for certification in the European Union, and manufacturing sites in Germany and Turkey, which has a high percentage of persons with chronic kidney disease (CKD).

All of NephroCan’s manufacturing lines are designed in-house by the company. “We’re lucky, being fully integrated, because we have so many experts around us,” comments Hajipour, “and Germany is known for its medical-grade hollow fibres.” These are synthetic “hairs” about the size of a human hair, hollow inside, with tiny holes along their length, allowing permeability between waste and extra granules in the blood, which are filtered out during hemodialysis.

“Germany had that innovation and advanced technology for many years,” Hajipour notes. “They were leading the industry for that. This is why we went to Germany and acquired a plant, but Turkey was our own strategic decision.”

Green dialysis
Recognizing that some products created by the medical supply industry add to the world’s waste, NephroCan is active in sustainable practices and environmentally friendly initiatives. Times are changing, and in the industry, there is a movement toward “green dialysis,” which NephroCan believes is the future.

“Some projects are in progress or being implemented as we speak,” says Hajipour, “and one is establishing how to recycle our disposable waste material into other manufacturing resources.” This includes the body of the company’s filters. Made from durable polycarbonate (PC), a thermoplastic, it can be recycled into applications like car taillights.

Another way NephroCan helps the environment is by learning to regenerate water intake. Just one hemodialysis session requires about 120 litres of purified water—approximately 200 litres of tap water. Over a year, this amounts to about 30,000 litres of tap water used for a single patient. The company is investigating how to recover some of that water as a duty to the world we live in. NephroCan also plans to install solar panels on the roof of its factory in Turkey for sustainable energy generation.

Home hemodialysis
Not satisfied with current technologies, the team of industrial engineers, hemodialysis nurses, and nephrologists at NephroCan is looking to the future. The company’s current hemodialysis machine, NephroHDM, was developed for adult kidney replacement therapy. Equipped with a single, double, or triple blood pump, it can “accommodate even the most tailored hemodiafiltration procedures.” It also gives the team the foundation to work on a new machine suitable for home treatment, which they plan to introduce to the market in the next two to three years. Instead of spending three to four hours three times a week at a hemodialysis centre, patients will perform the procedure in the relaxed comfort of their own homes, saving time while improving their quality of life.

“We see the future of accessible renal care moving toward home dialysis,” says Hajipour. “This would make a huge difference, especially in a country the size of Canada, where people often have to travel for hours from rural areas to a treatment centre or hospital.”

Worldwide, more and more people are requiring hemodialysis. The compound annual growth rate of patients in the next 10 years is estimated to be 6.8 percent. CKD is already one of the leading causes of death in the 21^st century and is expected to become the leading cause of death by 2040, due to the increasing incidence of obesity, diabetes, hypertension, and possibly long-term effects from COVID-19.

No wonder NephroCan is focusing right now on meeting this coming crisis by expanding its product range and—especially—its home care solutions.

Going global
Presently, NephroCan is in Phase 2 of its three-Phase global strategy. Expanding into Germany, Phase 3 will see the company growing its manufacturing efforts in Canada, which will require the support of government groups.

As company CEO, Delaram Hajipour is actively streamlining NephroCan’s day-to-day operations, overseeing the leadership team, and driving strategy. A graduate of the prestigious UBC Sauder School of Business, she has been involved in several successful small-scale business ventures, including the development of intellectual property that was sold to a large international company.

Her involvement with the medical industry was inspired by her parents, both physicians. “I always knew I wanted to pursue a career that centred on my passion for medicine and healthcare, so this was my way of contributing to the industry,” she says.

Her goal remains to find new solutions that better the lives of patients. “Our vision is to create a new modality of treatment that meaningfully lessens the cost for governments and increases the quality of life for patients in the comfort of their homes, instead of going to a dialysis centre 150 times a year,” she shares.

“Many of our partners tell us how valuable and integrated our vision is, and that working with a trusted manufacturer like us that focuses on quality, value, and long-term relationships is what they are looking for. We’re open to partnerships that align with our vision of re-thinking hemodialysis and changing the paradigm of treatment.”

The post Changing the Paradigm of Dialysis Treatment<p class="company">NephroCan</p> appeared first on Manufacturing In Focus.

And it’s a focus that has worked.

As one of the largest organizations of its kind in Canada, Life Sciences BC’s membership is as broad as its reach. The organization serves as a non-physical hub to optimize connectivity, resource-sharing, partnership, and innovation for B.C.’s life sciences sector, bringing together academic and research institutions, small and medium enterprises, and global pharma manufacturers, service providers, investors, and policy makers.

President and CEO of Life Sciences BC Wendy Hurlburt defines the organization as “a hub for BC-sector stakeholders including [those in] biotech and medtech (including numerous global companies that operate in those spaces), diagnostics, digital health, and scientific suppliers.” Additionally, twenty percent of the organization’s membership comprises service providers that support the sector, including investors, lawyers, accountants, communications specialists, architects, consultants, and professionals in quality, privacy, and regulatory matters.

The organization’s members can rely on a range of valuable benefits, including networking and relationship-building opportunities, access to resources and programming, support, advocacy, and mentorship. These benefits are delivered through various means, such as events, education and programming, representation, and promotion on the LSBC website, weekly newsletters, and social media.

Bringing value
Life Sciences BC brings value to its members in many ways, but the most significant benefits come from the delivery of events and provision of resources, of which there are many. Each year, the organization hosts about twenty-five events focusing on everything from policy to investment to specialized courses like BioBasics 101: The Biology of Biotech for the Non-Scientist.

A popular offering is the Investor Readiness Program, an annual program that runs from October to March, which brings together ten early-stage small- and mid-size enterprises with an equal number of entrepreneurs-in-residence to offer education, mentorship, and coaching to help them become pitch-ready. An actual pitch opportunity takes place at the end of the process before a group of pre-qualified investors.

The Invest in BC Conference is another event that brings together stakeholders and investors in the healthcare innovation ecosystem over two days to enjoy presentations, panel discussions, pitches, and other opportunities to connect and share experiences that will provide beneficial feedback.

Career development is also an area of focus. This year marked the fourth annual Career Connect Day, a full-day event that brings together employers and prospective employees. Hurlburt explains that it “demystifies what careers look like in life sciences and offers the opportunity to hear from leaders about their career journeys, sector trends, and what skills people are looking for, and offers advice to people pursuing a career in life sciences.”

When Life Sciences BC isn’t hosting events, it represents the voice of the sector at conferences around the world. Whether a delegation is joining them or not, Hurlburt notes, “our members are always in our suitcase,” and their interests are always being advanced.

The same applies to the organization’s collaboration with government. The BC government recently released its first-ever life sciences strategy, signalling its confidence in the sector’s ability to create jobs, diversify the economy, and drive healthcare innovation. Life Sciences BC played an essential role in developing this strategy by providing valuable insights into member and sector needs.

Home to world-class science
For Hurlburt and Life Sciences BC, “it always begins with world-class science,” which leads to world-class companies.

B.C. is home to world-class academic and research institutions like the University of British Columbia, Simon Fraser University, the University of Victoria, BC Cancer, St. Paul’s Hospital, the BC Centre for Excellence in HIV/AIDS, and others who work tirelessly to achieve advances that can be commercialized—though the commercialization process can prove a challenge.

Indeed, the life sciences sector faces significant growth challenges, primarily due to the increased need for capital, talent, and infrastructure. The availability of commercial wet lab space in particular is limited, with zero vacancies in the province currently.

“You need capital, talent, infrastructure, manufacturing, labs, data, IP, and ultimately, access to markets,” says Hurlburt about the ultimate goal of the organization. “When those are in alignment, you end up creating world-class companies that end up reinvesting in the life sciences sector.”

This reinvestment leads to what Hurlburt refers to as a “double helix benefit,” where jobs are created and the economy is diversified while also producing “innovative products, solutions, and services that are so critical for our healthcare system.” Life Sciences BC is thus chasing two complementary goals simultaneously, “whether it’s the security of our health system as we experienced it over the last couple of years or the development of innovative products, solutions, and services that are going to drive better patient outcomes and help the system run effectively and efficiently,” she explains.

Building skills
As Hurlburt puts it, “One strategy to improve the function of the health and life sciences ecosystems is the reskilling, upskilling, and new-skilling of talent. While our sector is smaller than some others, we’re Canada’s third largest life sciences sector and the fastest growing.”

Creating jobs is crucial for growth but presents a unique challenge in the life sciences sector. Like other industries, the life sciences sector currently needs more talent, and this challenge is especially significant in a smaller sector with specialized talent requirements. While the sector offers the potential for an exciting and lucrative career, the need for more skilled professionals is a pressing problem that must be addressed.

Life Sciences BC is proactively addressing this issue by producing a labour market report to identify talent gaps and forecast the talent requirements for the next five years, with the aim of ensuring a steady flow of talent. Hurlburt recognizes the commendable efforts made by companies in the life sciences sector to be innovative in their talent attraction, retention, and development activities and acknowledges the government’s efforts to support the sector in this regard.

To this end, in partnership with the federal government, plans are underway to build a biomanufacturing training centre in BC to advance the sector through further talent development. The training centre is part of the provincial StrongerBC Future Ready commitment to address skills shortages and boost BC’s competitiveness.

Impact and momentum
Innovation involves risk, challenge, and, at times, failure, but the life sciences sector of British Columbia has found a way to break through barriers and develop solutions that have a resounding impact. This is especially true of the last couple of years.

While tragic for many and challenging for all, the pandemic created momentum for BC’s life sciences sector and reconfirmed the role that science plays in advancing healthcare on a global scale. Hurlburt highlighted two examples of BC innovation that changed the trajectory of the pandemic.

A BC-based company or scientist was involved in the initiation, development, or manufacture of the components of nearly every COVID-19 vaccine candidate that reached late-stage development in 2020. Similarly, a member company acquired one of the first COVID-19-positive blood samples from which antibodies were extracted, resulting in the first therapeutic treatment of the virus. However, these examples only scratch the surface of what has been achieved and what is possible.

With partnerships between industry players like adMare BioInnovations, which has received funding to develop a new wet lab facility, and Genome BC, which supports the industry via research funding and commercialization advancement programs, there is no shortage of collaboration in the interest of progress.

Rising tide
Hurlburt lives by the adage, “A rising tide lifts all boats,” and the thriving life sciences sector is a testament to the truth of this statement. Life Sciences BC adopts a collaborative approach to innovation, development, and progress, which enables its members to advance their resources and capabilities. This strategy is proving effective in achieving shared goals within the sector.

As the life sciences sector in BC rivals the pace of company creation across Canada, greater efforts must be made to remove barriers to growth. Government policies regarding taxation, research, and development could make all the difference in encouraging investment that will realize the sector’s potential. Fortunately, Life Sciences BC is actively pursuing these ends using a unique model for a unique industry—one based on global collaboration—to ensure that the life sciences sector in BC and its members are empowered to elevate the industry and are recognized as world-class innovators.

The post Advancing the Health of the Sector and the Community<p class="company">Life Sciences BC</p> appeared first on Manufacturing In Focus.

Through alliances with an increasing number of suppliers and by purchasing regional and national distributors—most notably Ingram & Bell Scientific in 1994—ESBE is dedicated to offering the scientific community high-quality goods and expert services at reasonable costs.

With an eye to environmental preservation, ESBE is also committed to collaborating with businesses that make energy-efficient machinery, develop environmentally friendly solutions for consumables and packaging, use environmentally friendly production techniques, and support Green programs in the workplace and the community.

In fact, in addition to minimizing, reusing, and recycling waste whenever possible, ESBE has solar panels installed on the roof of its head office and warehouse.

ESBE has a long and impressive history serving the Canadian scientific community. For more than five decades it has been bringing the latest innovations and technological advances, providing quality products and professional services at competitive prices.

“My dad bought the existing business of ESBE Laboratory Supplies in 1968,” says President Laurel Wiseman. “He was an engineer by trade, and he worked for a number of companies, the last one being Westinghouse.”

After he was laid off, her father went back to school and got into the law field, but he always wanted to be his own boss. When he and a colleague found ESBE for sale, it seemed a perfect opportunity. “My dad quickly realized he didn’t want to work with a partner, he wanted to work for himself. So he bought the partner out.”

Located on Bathurst Street, ESBE initially also had a retail store where it sold birthday gifts, says Wiseman.

“Then my father hired some really good people, which I think was really the key for him, particularly his first sales manager, a woman, who, for that time in the late 60s, was really quite interesting. My dad couldn’t care less what the gender was, as long as they were great at what they did.”

A medical technologist who wanted to get out of the lab, she got the business off the ground, expanded it and spent her entire working career with ESBE, says Wiseman.

“I think this speaks to the culture of being a family, and the inclusiveness of the place,” she adds. Wiseman herself joined the company in 1986 and has since expanded the business “by leaps and bounds” across both its product mix and customer base. Part of its success over half a century, she says, has been the company’s trust in and commitment to its long-serving, highly knowledgeable salespeople, earning in return loyalty and dedication. That continues unchanged.

“That speaks to who we are and the culture we are,” Wiseman says.

In terms of innovation and technology, Wiseman’s father was also innovative in his way, adds Michael Ratos, Vice President of Sales & Marketing.

“He created moulds for some of the urine tubes currently used in the market. He saw a need and he created something,” Ratos says. And when the company early embraced environmental issues, ESBE was the first to put up solar panels, long before sustainability became an industry-wide credo.

Along with its commitment to energy-saving green practices, the company’s ERP (Enterprise Resource Planning) system—the brain and nerves of a distributor—saves time and money for the company and its customers.

“A lot of our customers are in a fast-paced industry,” says Ratos. “They require things fast and our system allows us to do this.”

Some examples include Punch-Out, a digital system that enables clients to browse the company’s product catalogues online before making purchases through the client’s e-procurement system. “Currently, we’re integrating a lot of the universities and other accounts with Punch-Out,” says Ratos.

With its perspective on innovation and organizational excellence, ESBE had moved its phones to a VoIP system even before the pandemic. “We were a bit ahead of the game with that,” says Ratos.

In the same way, ESBE chooses to partner with innovative companies, including PHCbi (formerly Panasonic Healthcare Holdings Co., Ltd.), a leader in incubation and preservation, Hettich, a German company that has won numerous awards for innovation globally, and Irish company Randox, a longtime key supplier in the diagnostic division.

Then there’s Montreal-based Galenvs, the only company in Canada producing magnetic bead technology, which was highly in demand during COVID for PCR extractions.

“We’re excited to work with them because they developed everything in Canada, and with us being a Canadian company, the partnership and the synergies were there for the market,” Ratos says, adding that a lot of these companies are at the forefront of their technologies around the globe and that it’s ESBE that’s bringing them to the Canadian market.

“One of the reasons they pick us over the large multinationals is they know we’ll treat their products with respect, as opposed to the larger companies who put them into their portfolio and maybe they’ll get to it,” Wiseman says. “They know we’re going to focus on it, that our salespeople are going to focus, and they know their customers want their product. I’m honoured when they pick us versus someone else.”

ESBE continues to look for suppliers that embrace sustainability and has brought on board many that have a record of reducing a large amount of wastage in the community. “When you look into the scientific industry, there’s a lot of wastage in consumables, so we do our best to look for suppliers that reduce that as well,” Ratos says.

This results in dollars and cents for customers, and as a Canadian company, ESBE is always very sensitive to taxpayer dollar waste, says Wiseman. “If we can do something in our own way to save them money, then we’re for it.”

These are all recipes for success, but there’s more to ESBE’s story.

“The engine behind us is our people,” says Ratos. “It’s a family-style kind of operation, but we’re very corporate in how we manage our business. We treat people like they’re part of the family, but they know at the end of the day we have to produce the numbers and results for ourselves.”

Ratos adds that three legs support the organization and keep it rock-steady, the first being customer-centricity. ESBE continues to make decisions based on the customer and how every aspect impacts the customer.

“That’s important to us because that’s how we drive loyalty,” he says. “We do have a lot of loyal customers, and that customer-centricity is driven across the entire organization from our salespeople to our operation, even to our finance people.”

The second leg is supplier engagement. For instance, ESBE won’t be a company that takes on a million suppliers and loses sight of what matters to customers. “We don’t want to create too much competition among suppliers, but at the same time we want to give our customers choice,” says Ratos. “We actually reduced the number of suppliers so we could form stronger partnerships with them.”

In addition, offering too many choices can be overwhelming. ESBE handles this by reducing the number of suppliers it has to key suppliers only, and who are making quality products.

“Anything a customer buys from us, we stand behind, from a service and quality perspective,” Ratos says. “We’re one of the few companies in our industry that have in-house service, giving our customers peace of mind that whenever they buy anything from ESBE, there’s a service team that stands behind it.”

The third and last leg of the three-legged stool is operational excellence. The company’s Vice President of Operations and Regulatory Affairs, Ari Pires, does a “phenomenal” job in management, promoting customer focus, including the ERP system. Operational excellence, Ratos says, involves doing what the customer wants, delivering when they want, the accuracy rate, the timings, and reducing the number of errors.

“It’s also going that extra mile for a customer. If a customer calls and says they didn’t get their shipment, most other companies will put them into the queue and get to them whenever. Not here. We take it personally, and I think our customer loyalty reflects that.”

Part of ESBE’s dedication to providing quality products lies with its five product managers and two agents that work globally, allowing the company to source the world for products that meet customer needs. Product managers and agents bring quality products to ESBE’s table where they go through an internal vetting process, validation, and quality control before they’re sent to customers.

“Once we’re happy with a product, before launching it or introducing the market, we’ll pick customers we know very well that will help try out the products we’re going to onboard,” Ratos says. Once products pass the customer test, ESBE starts launching into the market, confident they have achieved their high standard of quality.

Ratos adds that the high-tenured service component of the organization is also a critical part of the company, bringing vital reassurance to customers.

“These guys are phenomenal,” he says. “I can’t overemphasize the quality of our service technicians and our service team in providing peace of mind for our customers.”

Ratos also praises the company’s sourcing team, which tackled numerous challenges during COVID, including the stoppage of testing kits from U.S. vendors.

“They chose not to supply Canada with critical products we needed for testing and protecting ourselves,” he says. “Our global sourcing team was able to find the product, and we were able to comply with the government requests and provide them with the kits they needed to do all the testing required during the pandemic—even the provincial and federal governments.

“It was key for us. That’s one of our biggest competencies—that we were able to help the Canadian government when they needed us. We all take pride in that.”

ESBE also helped track down cold storage units for the vaccines when they were initially developed. “Again, it just goes to show that as a Canadian company, we bend over backwards for our customers.”

In late 2020, Wiseman was interviewed by Global News following an announcement by The Honourable Anita Anand, Minister of National Defence and former Minister of Public Services and Procurement, that ESBE Scientific had been awarded a contract to supply Canada with PHCbi -86°C freezers to be used to store COVID-19 vaccines. ESBE answered the call and delivered over 30 freezers (-86°C and -30°C) to the Public Health Agency of Canada without any delay. These freezers were delivered to every Province and Territory in Canada in preparation for the COVID-19 vaccine roll-out.

As ESBE is a distributor, not a manufacturer, it scours the world for products, but there’s always the risk of doing too good a job, prompting offshore suppliers to decide to sell products direct.

“There’s always somebody looking over our shoulder,” says Wiseman. “If you don’t have a proper partnership with your major suppliers, there’s always that risk and it’s happened once or twice to us. Our job is to make sure the manufacturers understand the value we bring that they can’t do on their own if they want to go direct.”

What does ESBE hope to achieve in the upcoming years? The company is heavily focused on the clinical market and is doing an extremely good job there, says Ratos, but it’s looking forward to expanding into the academic and biotechnology markets.

“We offer great products and great service, we’ve just never gone full force into these different market segments,” he says. “Those two areas will be my next challenge and milestones.”

It’s all about meeting clients’ needs for different products, sourcing them, bringing them to market, and keeping customers happy, all of which ESBE excels at. “We’re proud to be Canadian, and proud to be female-owned,” says Ratos. “I don’t know too many companies in our industry or in the market that are female-owned.”

The company’s succession plan for the next few years includes Wiseman passing the torch to her daughter. Until then, Wiseman will continue to uphold ESBE’s commitment to quality and customer service across the board.

“It reflects the positive culture of our workplace,” she says. “Gender doesn’t matter here. We’re all colleagues working together to get the job done. But I agree with Mike that our culture is truly special and unlike any other.”

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Although competition is fierce within the industry, this sector is reaping the rewards of coming together to advance its interests in the interests of all Canadians through an active national medtech association.

With a history going back 50 years, Medtech Canada is the sole national trade association in the country focusing exclusively on the medical technology industry. Governed by a board of directors representing the unique perspectives of members nationwide, Medtech Canada represents about 120 medtech companies, from small and medium-sized Canadian-owned businesses to multinationals.

Working closely with various levels of government, health professionals, patients, and stakeholders “to deliver a patient-centred, safe, accessible, innovative, and sustainable, universal healthcare system supported using medical technology,” according to the association, Medtech Canada’s mission remains steady: developing and advancing the country’s dynamic medical technology industry.

When it was created in 1973, Medtech was originally called the Canadian Association of Manufacturers of Medical Devices (CAMMD).

“It was founded primarily to engage with the Canadian government on matters relating to the regulatory environment for medical devices,” says Gerry Frenette, Vice President of Public and Member Relations. “It was beneficial for the government and industry to be able to engage through a single body, and the association was born out of that.”

From 1987 to 2019, the Association was called MEDEC (Medical Devices Canada). In 2019, it was rebranded as Medtech Canada, “a brand identity that better reflects the evolving nature of the industry, including the growing digital health offerings from the industry,” says Frenette.

Although regulatory affairs remain an integral focus of the Association to this day—especially engagement with Health Canada—Medtech’s mandate expanded, with the Association striving on behalf of the industry “to optimize the environment in Canada for medical device / technology adoption and the growth of the industry in Canada.”

With five membership categories—full members, allied members, associate members, emerging medical technology (EMT) and honorary members—it makes sense for anyone associated with the industry to join Medtech Canada.

All membership levels (full, allied, associate, and emerging technology) receive weekly e-Pulse bulletins with valuable news and information on important industry issues, stakeholders, advocacy and other industry information, along with member savings programs, business solutions, discounts on Medtech Canada educational seminars and conferences, and much more.

Many of Medtech’s Canadian members and multinational member companies have manufacturing facilities in Canada, making every conceivable product used in the delivery of healthcare. These include pacemakers, MRIs, glucose monitors, wound care products and orthopaedic implants, to name a few.

“In addition to our medical technology company members, we also have membership categories for allied business members, which are companies that provide services to the medical technology industry, and associate members, composed of organizations that are partners to our association,” says Frenette.

Medtech’s mission is “to develop and advance Canada’s innovative medical technology industry.” Some of the many ways the Association speaks for the industry are through advocacy, regulatory affairs, education and information, and Medtech Canada committees.

By working closely with its many members through committees, Medtech learns their needs, develops positions, and promotes their interests to federal and provincial governments, health care organizations, and other stakeholders across Canada.

“We’re an advocacy association which allows members to get involved in improving the environment for the adoption of medical technologies in Canada and ensuring the business environment is conducive to a vibrant industry through engagement in areas such as regulatory and supply chain,” says Frenette.

“Medtech Canada’s staff, often in concert with our members, regularly engages with government officials to ensure that government policies and investment are taking advantage of the benefits offered by medical device technologies to ensure the health of Canadians, create health system efficiencies, and grow this sector that provides meaningful employment to thousands of Canadians.”

Medtech has addressed and provided advice for some of the regulatory issues about the nation’s medical device regulations. These include medical device funding and reimbursement, the performance of the therapeutic products directorate, and other areas.

“We pride ourselves on taking a highly collaborative approach when we engage with government,” says Frenette, “aligning many of our initiatives to help achieve the goals they’re seeking to achieve.”

Through whitepapers, position papers, and government submissions, Medtech Canada informs others about information essential to the medical technology industry in its Whitepapers, Position Papers & Government Submission section (medtechcanada.org/our-work/whitepapers-position-papers-government-submissions.html).

The past few months have seen pre-budget submissions made to Alberta, Ontario, and other provinces, along with position papers and white papers including Innovation and Medical Technology Adoption to Address Medical Services and Surgical Backlogs in Canada, Wound Care in Ontario – Call for Collaborative Action, Addressing the Global Supply Chain and Shipping Crisis, and other important subjects.

Medtech Canada’s advocacy efforts are wide-ranging, with the association working on multiple fronts. On the supply chain side, according to Frenette, Medtech continues advocating that healthcare purchasers allow for increased flexibility in contracts with medical device companies to allow for situations where manufacturers are facing significant cost increases. “We’re pleased that some purchasers have now done this,” he says, “but there’s more that can be done.”

Medtech keeps pressing for increased data from healthcare systems across Canada, which would allow medical device companies to better plan for surgical and procedural volumes. “This is crucial for our members to be able to ensure that the Canadian healthcare system will have the necessary products to enable the delivery of care,” he says.

“We’re optimistic that the recently announced 10-year funding deal between the federal government and the provinces will address this, given that the deal includes a data transparency element.”

Medtech continues to advocate that procurement in Canada be improved. This would shift purchasing away from a disproportionate focus on the lowest price to focusing on the broader value a technology brings to patients and the health care system (value-based procurement).

“Our industry provides immense opportunities to make healthcare systems more efficient and reduce burdens on a strained Canadian healthcare workforce and we’ve highlighted examples through a microsite at www.medtechinnovation.ca/medtechsolutions.”

All industries faced shortages and supply chain issues during the COVID-19 crisis, including members of Medtech Canada.

In the early days of COVID, governments and healthcare systems across the nation were woefully unprepared with regard to stockpiles of necessary pandemic-related products. Nations, including Canada, were competing with other countries for products in short supply. Still, companies and governments alike quickly mobilized and worked together to address these challenges.

“Domestic medical device manufacturers increased their production or adapted their product lines and multinationals brought pandemic product-related manufacturing to Canada—in many instances with the financial support of the government,” says Frenette.

“From a regulatory perspective, Health Canada showed tremendous nimbleness in adapting regulatory pathways for these products to help ensure sufficient supply.

“From Medtech Canada’s perspective, we worked tremendously hard to facilitate connections between companies and governments as they sought products. We helped convey information on regulatory matters, and acted to ensure that medical device company representatives had ongoing access to healthcare facilities to ensure that products were supplied and technical / clinical support was maintained.”

Today, three years after the start of the pandemic, global supply chain challenges and product shortages continue to affect the industry. Still, there is growing recognition of the vital importance of the sector, and Medtech Canada is pleased to be a part of a product shortages group at the federal level seeking to address some of these issues, according to Frenette.

“We also welcome recent investments from the federal government in transportation infrastructure to help address some of these challenges,” he adds.

To increase awareness, Medtech Canada both participates in and hosts regional events across the nation—often in partnership with its regional life science association partners—along with hosting educational webinars throughout the year, some of them open to non-members. The Association will also host its annual Medtech Conference (May 11 in the Greater Toronto Area), and a Regulatory and Quality Medtech Conference this fall.

This year marks Medtech’s 50^th

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Addressing every sector of the pharmacy market, including health systems, hospital inpatient pharmacies, outpatient pharmacies, long-term care institutions, and government pharmacies, ARxIUM offers comprehensive and scalable pharmacy solutions by rethinking and redefining how pharmacies operate within healthcare ecosystems, ultimately contributing to better patient care and improved healthcare outcomes.

ARxIUM offers customers in all pharmacy environments a comprehensive selection of pharmacy technology available by combining resources, products, and expertise in an effort to increase patient safety, boost workflow effectiveness, and lower operating costs.

With the goal of making medication dispensing easier and safer, ARxIUM RxWorks™ Pro software helps pharmacies operate more efficiently and effectively by tracking medications across the enterprise. This means the software can handle inventory management and replenishment, packing, storage, and accounting / transactions, allowing hospitals and health systems to view, track, monitor, and act upon their inventory of medications within one hospital or across the entire health system.

“It’s a very difficult operational environment for pharmacy leaders who are trained to be clinicians, not supply chain experts, to keep track of all the medications—what they have, where they’re located, how much they have on hand in terms of quantity and dollar value for each drug,” explains Nhat H. Ngo, Owner and Chief Executive Officer of ARxIUM. “It’s a real challenge every day and is too much for anyone to manage well without the right technologies. Making matters worse are the severe staffing shortages hospitals and health systems are experiencing today.”

RxWorks provides users enterprise-wide visibility to see where medications are located, enabling pharmacists and their teams to create orders to replenish inventory at any given inventory-carrying location.

“It’s a sophisticated system that’s much-needed in the health system today,” says Ngo. “Sometimes it’s a life-and-death situation if you don’t have the right medication on hand when you need it.”

He recounts a story of a set of twins who urgently needed a drug that, due to a lack of enterprise visibility, couldn’t be found within the health system. This situation required the medical team to choose an alternative medication which led to a very serious adverse patient outcome. The hospital later learned that one of its sister hospitals, just a few miles down the road and part of the same IDN (integrated delivery network), had the medication.

“If they’d had enterprise-wide medication inventory visibility, this could have been prevented.”

In short, RxWorks improves patient safety by ensuring medication availability, having the right drugs when needed while also helping to manage and deliver on the five rights of medication management.

“The five ‘rights’ are the right patient getting the right drug at the right time, at the right dose through the right route,” says Ngo. “And this system enables the inventory management required to ensure the availability of the right drug, and particularly at the right time.”

Connected to RxWorks is a system of smart conveyance solutions to support a fast-growing trend in healthcare, the growth of Consolidated Service Centers to consolidate and centralize pharmacy operations to better support the enterprise. Think of hub and spoke—such a system is particularly effective for central fill and mail order prescription fulfillment operations. The idea is when you have a large health system with multiple hospitals and clinics, you need to be able to procure drugs on a consolidated basis. “Doing so optimizes the supply chain while ensuring that medications are distributed more efficiently,” Ngo says. “But more importantly, it’s the idea that you can optimize the entire medication distribution process from beginning to end.”

If a large health system has 10 hospital sites, for example, and each location procures a very expensive drug that comes in a box of 10 vials, and each vial is $1,000, it’s $10,000 per box. Each hospital buys their own box, but not all of the vials will get used by the expiration date.

“They use maybe half, and the rest goes unused and expires, and then they buy the next batch—so a lot of waste,” Ngo says. “But if you buy at a central location—a Consolidated Service Center (CSC)—and you distribute vials to the 10 hospitals, you can monitor the usages. Hospital A gets six, hospital B gets two, hospital C gets eight, depending on their usage, rather than each hospital buying individually and wasting the rest.”

Drug expiration is a big issue as health systems are very inefficient at managing expiration dates, resulting in many wasted drugs, he adds.

With RxWorks, users connect to a smart conveyance system that operates the entire central distribution process. Not only is there visibility to the drugs, but the clinics and hospitals can create requisitions for more drugs with the CSC filling those orders. The required hardware is the combination of a conveyance system and OptiFill™, a principal high-volume vial-filling solution that can handle over 20,000 daily prescriptions at each site. While OptiFill technology plays a significant role, the ARxIUM specialized software makes it work. Referred to as PPS, it acts as the “brain” of any OptiFill system configuration, managing workflow.

“It takes in different types of drugs and fills the drugs into vials and sends them to inventory carrying locations,” Ngo says. “You can do it for inpatient CSC for self-distribution, outpatient central fill, or mail to home operations.”

At the enterprise software visibility level, you’re able to see the orders and work to fulfill them with elegant workflows embedded in RxWorks, he adds. Then the pharmacy technician acts on the orders, with the pharmacy manager approving the order and a pharmacist verifying the fulfillment, as a safety check, all in RxWorks.

How do we get more pharmacies to move to this system? Is it cost or simply creating awareness of the benefits it could bring? “I think there’s certainly awareness,” Ngo says. Called a centralized pharmacy service center, consolidated pharmacy service center, or CPSC, the concept has been talked about since 2015, but only recently gained more traction.

“I’d say in the last few years, health systems [have been] thinking about setting up the CSCs,” Ngo says. Why? The drugs are very expensive, arguably the most expensive in a hospital operating budget, and costs have been rising by double digits over the last five years. “The idea of the CSC mainly has been driven by the need to deliver on important clinical initiatives, improve efficiencies, and reduce costs,” he says.

Certainly, there’s a lot of cost pressure on a health system. 2022 was a very tough year financially for many health systems—their performance was down 38 percent relative to 2021—and the forecast for 2023 is that approximately 70 percent of health systems are either going to break even or will be operating at a loss.

“That’s where the need for ARxIUM RxWorks, OptiFill, and smart conveyance systems come in,” says Ngo, “to design, set up, and run these CSCs. Combined, our connected solutions and expertise in pharmacy workflows help health system leaders achieve their vision for a CSC.”

On the patient safety and precision side, the RIVA™ system has become the standard when it comes to robotic sterile IV compounding. A fully automated IV compounding system created for hospital pharmacies, RIVA consistently and precisely produces IV syringes and bags, solving patient and pharmacy technician safety concerns, overall pharmacy efficiency, and ongoing regulatory environment obstacles by automating a significant part of the sterile compounding process.

“We’re very proud of our RIVA system,” says Ngo. “What sets the RIVA system apart and differentiates it in the marketplace is its accuracy and reliability. RIVA has accurately and safely prepared more than 14 million doses across all installations. It’s just very reliable.”

Finally, the MedSelect™ automated dispensing cabinets (ADC) from ARxIUM—together with a wide range of additional technologies intended to expand functionality—improve fulfillment accuracy and boost overall facility efficiency, lowering medication errors, controlling costs, complying with regulatory bodies, and boosting employee productivity. “It’s for pharmacy and nursing, to make sure medications are placed throughout the hospitals so nurses can take care of their patients by having access to the drugs when they’re needed,” Ngo says.

Think of ADCs as an ATM, says Ngo, where a nurse puts in their ID to access the medications. “You click on the patient whose drugs are due at noon, and cabinet drawers open and the bins open,” he says. “The nurse takes the medications and administers those medications to the patient.”

These ADCs can be placed on the surgery floor, in the ICU, and in the ER. “It’s another way to deliver on the five rights of medication management, having the right drugs available to the right patient,” says Ngo.

Holistically it all works together, from the supply chain to the RxWorks software and the smart conveyance CSC solutions that receive the drugs from the wholesaler. If you need a drug, you can see where this particular dose is located at your 10 hospitals or 300 clinics.

“I think what makes ARxIUM special is our single technology platform, and all hardware products, even competing solutions, can connect to this platform,” Ngo explains. “Having a connected system work that works well together is a beautiful thing, and RxWorks is the brain and backbone to make that happen.”

Along with the best-in-class RIVA, ARxIUM believes its combination of RxWorks and the smart conveyance system uniquely positions the company to partner with health systems as they implement consolidated service centers in the coming years. “We believe we have a game changer,” Ngo says. “Given the financial pressures facing health systems, pharmacies can utilize ARxIUM solutions to reduce cost while repositioning strategically as a revenue and profit center.”

Eight to 10 percent of a hospital’s annual drug budget is being wasted due to drug expiration or diverted. For a $100 million annual drug spend, for example, the cost of waste is substantial. With the ARxIUM systems, “you can ensure that significantly more of the drug budget is actually used for patient care. When I visit hospital pharmacies, they have waste bins for expired medications,” Ngo says. “There has to be a better way. It’s a huge opportunity to automate and optimize manual workflows, eliminate operational headaches, and make sure medications are available when patients need them.”

Ngo says he’s particularly proud not only of having the solution and technology, but the ARxIUM ability to support clinicians to provide quality patient care, while doing so at a reduced cost.

“We do that through our people, and our people have very deep knowledge and expertise and understanding of pharmacy workflows,” he says. “I’m super excited about the positive impact we’re making in healthcare. ARxIUM is delivering compelling next-generation solutions that are taking pharmacy operations to the next level.”

The post Game Changer: Making Medication Dispensing Easier, Faster, Safer<p class="company">ARxIUM</p> appeared first on Manufacturing In Focus.