A Guide to Widespread Adoption in Medtech

Greg Bullington, co-founder and CEO of Magnolia Medical, has overseen everything from clinical trials and product development to setting up exceptional partnerships with industry giants.

Magnolia Medical is the company behind Steripath, a device platform that significantly reduces contamination in blood cultures – a critical step in diagnosing sepsis.

While sepsis ranks as the primary cause of death in US hospitals and the fifth leading cause of death worldwide, the standard tests used to diagnose it are inaccurate – approximately 40% of the time in hospitals nationwide. However, Steripath has shown a 90%+ reduction in false-positive sepsis tests in large-scale clinical studies at leading institutions.

When viewed in this light, the critical situation of sepsis and the significance of Steripath become evident. This is why Greg prioritizes data collection above most other aspects.

Magnolia’s success is built on rigorous scientific evidence. The robust data foundation has been instrumental in gaining support from key opinion leaders, influential societies, and standard-setting bodies.

Greg shares, “I think that really focusing on the data, focusing on the repeatability, focusing on the sustainability early on, gives you the calling card that you need to be able to really garner support and begin building traction.” The traction he’s talking about isn’t just commercial. Magnolia has successfully gained governmental support for Steripath from both the Senate and the House, as well as various federal agencies.

In short, as Greg puts it, “The combination of the data, the magnitude of the solution, and understanding that this is something that preventably harms folks within every district within the United States, has been a compelling narrative and opportunity for driving support from all stakeholders, including governing bodies and end users.”

L.R. Fox, founder of NEXT Life Sciences, is a young and ambitious innovator with a background in engineering and a track record of successful ventures in highly-regulated industries like cybersecurity, defense, and aerospace. At NEXT, his team is developing Plan A, a non-hormonal, long-lasting, reversible male contraceptive.

Fox’s algorithm for medtech starts by dismantling the stakeholders and understanding each of their needs. Potential users, healthcare providers, payers, and regulatory bodies will have different concerns. Once you identify your key stakeholders, you can start a meaningful dialogue. Think carefully whom your product or service concerns. For example, addressing the spouses or partners of their end users was an unexpected, but good step in NEXT’s case.

By actively engaging in conversations with these various audiences, Fox and his team gained valuable insights that enabled them to tailor Plan A itself as well as its messaging.

Secondly, as an entrepreneur who likes to try his hand at different industries, Fox understands the value of experience and actively seeks out domain experts and leaders in the pertinent field. He asks himself, “If there's one person that I need to talk to to really understand this, who is that person?” This attitude opens doors to valuable partnerships, collaborations, and opportunities for further innovation. Thanks to the network he built in this fashion, Fox positioned Plan A not only as a contraceptive but as an impetus for addressing structural problems in society.

To take a leaf from Fox’s book, take some time to identify the different groups who have a stake in your product or service. Remember, skepticism is healthy and deserves engagement. That’s the only way to tailor your solution or message to their respective needs. While doing that, actively seek out subject matter experts in your field, offer support, and foster collaborations. Connect with others who share your goals and stand together in the niche you’re seeking to reshape.

John Bertrand is the CEO of Digital Diagnostics, whose flagship product, LumineticsCore, is an algorithm that conducts diabetic retinopathy exams for people living with diabetes. It’s the first – and so far, only – algorithm that diagnoses a patient without the need for hands-on physician involvement. Developing, obtaining regulatory clearance, pursuing reimbursement, and achieving healthcare integration for such a radically innovative device is no small feat.

To get there, John champions close collaboration with customers and end-users throughout the development process. At Digital Diagnostics, for example, engineers regularly immerse themselves in real-world clinical settings to observe how LumineticsCore is used and to gather feedback directly from users. “You'll be shocked at the aha moments that you get out of folks,” John remarks. These insights help identify even minor issues or inefficiencies that, when addressed, can significantly improve the product and its workflow. This hands-on approach ensures that LumineticsCore remains not only cutting-edge but also user-friendly and highly effective for its intended users.

Next, “You need the reimbursement to justify making the investment,” John says. That was the first issue he addressed – positioning the product as a value-based care tool. However, the fact that it doesn’t directly rely on a provider conflicted with existing reimbursement models and required more in-depth conversations with different bodies.

Digital Diagnostics' success stems from John's strategy of actively engaging with stakeholders, building trust, and addressing their needs through genuine collaboration. He explains, “Creating that buy-in, that understanding made it easier to bring new products to the market. It's much easier because we have the reputation of working with folks rather than around them.”

By prioritizing end-user feedback and engaging with regulatory bodies, John’s strategy highlights the essential elements required to bring a new solution to market – especially disruptive ones. To follow in his footsteps, never try to force your offering. Instead, be a collaborator and make a concerted effort to build relationships with your key audiences and stakeholders.

Patrick Anquetil and his team at Portal Instruments are working to alleviate the painful daily ritual of needles for those who are suffering from chronic diseases. Their needle-free drug delivery system is considerably less invasive, more precise, and much more comfortable for patients.

Portal’s mission is noble, but it takes a lot of convincing and resources to change the workflow of healthcare providers. For this, Patrick’s first advice is “follow the money”. In his case, for example, it wasn’t the patients, not even the insurance providers – it was the pharma companies that not only had money, but also injectable drugs that could be enhanced by Portal’s platform.

Patrick recognized this opportunity and structured deals with pharma companies that included royalties, upfront capital, and milestone payments. Aligning their interests with the financial incentives of pharmaceutical companies, Portal was able to secure the necessary resources to drive adoption and scale up their R&D efforts. And it wasn’t for only Portal’s benefit, it was a win-win for both parties involved.

When you have a platform technology that you can apply to many areas, it’s important to think about the value of the entire ecosystem and what part your solution plays within it. “If what we inject is of high value, then there's an opportunity for us to actually capture some of that value back,” simplifies Patrick.

Following Patrick’s example, it’s crucial to recognize the value generated by larger ecosystems. When deciding on an area of focus, don’t follow commoditized or low-value solutions where margins are thin. Identify whether you can contribute to a greater network by addressing a specific pain point that allows you to increase your venture’s worth.

Before launching Proprio in 2016, Gabriel Jones’ career spanned engineering, law, finance, and philanthropy across the globe.

Proprio’s name comes from ‘proprioception,’ also known as kinesthesia, our body's ability to sense movement. His team is working on improving surgical precision with AI-powered technology that immerses surgeons in a real-time 3D environment, providing immediate feedback during operations. Almost like using a real-time GPS.

Propio is based in Seattle for a reason. It’s the cloud capital of the world that hosts major strategics including Microsoft and Amazon as well as world-class healthcare institutions like the University of Washington which receives significant grants from NIH. “It’s the perfect place to build something like Propio, and to try to seed an ecosystem where technology and medicine can intersect and amplify each other,” shares Gabriel.

To build an ecosystem where you don’t play a zero sum game but work together, Gabriel emphasizes the importance of building platform technologies that integrate well with other products and services. "Your products must make other products sing," he advises. “For example, you should be able to plug the app into the App Store and make money for that partner of yours.”

Ideally, you should try to leverage local resources and established institutions, particularly those rich in technology and healthcare innovation. However, if you don't have access to such institutions in your area, remember the saying: if the mountain won't come to you, then you must go to the mountain. Additionally, think about the ways you can create a platform where members can integrate their offerings and generate mutual benefits. By doing so, you can build a thriving, interconnected ecosystem that drives innovation and growth.