The healthcare industry is constantly adapting to the introduction of the newest technologies and innovations that will determine the medical care available to both healthcare providers and, most importantly, patients.
It is a challenging landscape, especially for those engaged in developing and delivering cost-effective, quality medical products, but MedSource Labs is up to the challenge and proving its capabilities as an end-to-end solution provider with both integrity and a commitment to social and environmental consciousness. The company of approximately fifty people provides products to healthcare providers such as hospitals and surgical centers, dental offices, emergency medical services (EMS) teams, and government agencies.
Founded by CEO Todd Fagley in 2002 and headquartered in Chaska, Minnesota, MedSource Labs was known as MedSource International prior to 2018. Since its inception, the company has secured and maintained numerous carefully selected partnerships both at home and overseas in Asia, Pakistan, and Europe. “I think a partnership for us is really personal. It starts with us people,” Fagley says.
When the company was established, overseas contacts were made to engage people and develop an understanding of how to conduct business with them. That knowledge was brought back to the United States and incorporated “into our manufacturing and development here.”
Before committing to a partnership, certifications, capabilities to scale the business, and the use of various medical device technologies will be assessed to ensure potential partners are a good fit. “We really want to meet the people. Our connectivity over the years as people has really helped us in tough times as in the current situation,” he says, referring to the COVID-19 pandemic crisis.
“That rapport that you build between businesses and, more importantly, individuals is really what we look for first. It’s about having that interpersonal connectivity that really set us apart, that drives through our entire organization.” This approach is based on “really caring about people, especially the end-user – the patient.”
Dave Kunelius, MedSource Labs’ president, agrees. “We have a pretty robust process that we have to go through to make sure that the factories have the proper certifications.” The process ensures that the company is viewed favorably by those interested in what MedSource Labs has to offer.
MedSource Labs initially focused on Class I medical products which carry low to moderate risk to both user and patient and include such products as bandages, enemas, and manual stethoscopes, for example. The company then moved into Class II products, which carry moderate to high risk. Most medical devices will fall under this class. Examples of such products include catheters, pulse oximeters, and non-contact infrared thermometers.
“I wouldn’t rule anything out of going to a Class III realm. But really what we’ve found is our sweet spot is in the Class II area,” Fagley says. Class III medical products carry high risk and are considered life-supporting. These represent about ten percent of devices regulated by the Food and Drug Administration (FDA).
Many large distributors in the United States manufacture their own Class I products. What MedSource Labs has discerned is that most of these companies do not have what is needed “to get to the Class II space,” notes Fagley, adding that there are many products within this category that require smarter technologies. “This Class II space needs to get smarter products that give better outcomes to the patient.”
“We just see a lot of need for innovation in that space. As technology keeps advancing all over the world, this is allowing for more innovation. There’s always a constant need to keep improving,” Kunelius adds.
In Class II products, MedSource Labs’ EMERGE design and development process acts as a catalyst for product innovation. “The EMERGE process started informally over a decade ago,” continues Fagley. Rather than simply showing customers the company’s product line, customers were approached and asked what they needed or thought the end-user needed.
Then the company will go with its customers to the end-users and observe how people and devices interact to assess a device’s effectiveness or determine where a design might require some improvements. “It’s a feedback loop that has made EMERGE very powerful,” continues Fagley, adding that EMERGE is “a unique way of approaching design and development that we’ve found is super effective to get the right device in the right market for the people needing the device.”
MedSource Labs is ISO 13485 certified, an internationally recognized standard for those companies in medical device manufacturing and abides by all regulatory requirements for quality management systems.
The company continues to diversify beyond the EMS space with EMERGE used as a tool to increase products in its portfolio. “We’re finding a need to maybe invest and merge into more manufacturing,” says Fagley.
Biomedix-WAI in Bloomington, Indiana, is a standalone manufacturing facility of MedSource Labs, and this is where Fagley would like to see more technology employed and possible expansion. “We’ve positioned it separately to help leverage its manufacturing capability into MedSource. It serves almost as a customer to the MedSource Labs family.”
Acquisition is another option for MedSource Labs, particularly if a company “has some of those technologies on board. We’ve found the EMERGE tool drives us into these opportunities, which actually drives us into a need for some of these different developments or manufacturing technologies. So we see expansion happening in a lot of areas for ourselves. We’re in a lot of markets right now.”
MedSource Labs donates and exports its products to countries that are in need. “We donate where the need is most acute,” says Fagley, noting that one of the company’s donations of medical products went to Ethiopia to assist in that country’s battle against the COVID-19 virus. “We thought that’s probably where the most need is for our products – that we can do the most good.”
But the company is now actively engaged in providing support and products within the United States as it too confronts the COVID-19 crisis. MedSource Labs has a line of personal protection equipment (PPE) and kits for distribution to EMS providers. “We’re on the front line with this,” says Fagley. “We’re trying to scale up as much as possible to do our part in the fight right now. We see a lot of PPE in our current future, for the next quarter or so. It’s a calling that no one has ever imagined on a scale like this.” More recently, the company has also been donating needed medical supplies to local non-profit entities to help combat the pandemic crisis.
There are also tens of thousands of non-contact, infrared thermometers that are greatly needed and are in the manufacturing line-up. “All of our focus is where the need is, and, right now, it is here in our national, local, and state communities,” he adds.
“Our mission at MedSource Labs is to improve patient outcomes,” Kunelius states, acknowledging that it is also vitally important to protect healthcare providers at this time, so PPE is “very key for what’s going on today.”
Innovation, the growth of emerging markets, constantly shifting healthcare delivery models, and regulations and compliance standards are several factors that are influencing the dynamics of the medical products industry, but Fagley says that COVID-19 “has changed everything.” The acute medical care need resulting from this virus “is really driving the market. But behind the scenes, we’re still working on that technology advancement. That’s ongoing continuously to fill that need,” he explains.
“We have to build a platform through our quality management system that adheres to and understand regulations. So it’s a challenge always to make sure that you’re always on the cutting edge of that,” Fagley says of the ever-changing standards.
“That’s really the value to our customers that don’t have that system onboard. We can be that system for them and help them realize their product development potential if they have a dream or an idea of how they can make a better product for the world. We can help fulfill that.”
Kunelius shares his vision for MedSource Labs moving forward. He would like to “continue to capture those technologies so that we can continue to innovate in the medical space. The more that we can do that [and] the smarter products that we can make, the more we can help do our part in advancing healthcare.”