Navigating Innovation and Challenges in Medical Device Development for SMEs with Miłosz Jamroży, CEO at EFM S.A. [Speaker Spotlight]

Please introduce yourself and describe your role/responsibilities as the CEO at EFM and your journey into the medical device world.

My name is Miłosz Jamroży, and I am one of the Founders and CEO of EFM, a company that helps insurers save billions of euros by keeping heart failure and COPD patients out of hospital with our patented telemedicine device. The global market for chronic heart failure diagnosis and treatment exceeds $45B, with 80% of costs tied to hospitalizations due to inadequate diagnostic tools. Our patented system enables rapid heart failure assessment, reducing diagnosis time from weeks to minutes. This allows for earlier treatment, fewer hospitalizations, and significant savings for insurers. 

I have a Ph.D. in biomedical engineering and a medical degree. I have over 10 years of experience in the management, development, and certification of telemedicine products. I have also held management and board positions in companies listed on the Warsaw Stock Exchange and NewConnect.

EFM is the most important project of my life; it is a spin-off of my doctoral thesis, and I have already devoted more than 10 years to it. My role in the project is typical for a CEO - to build a global company and enable investors to get high returns on their investments. I have managed to assemble a fantastic team around the project, and thanks to them, we are achieving all our goals.

What are some of the biggest hurdles small- to mid-sized medical device companies face in bringing a product from concept to market, and how can they overcome them?

Startups working on new medical technologies currently have a huge problem accessing funding at the Seed stage - funds for preparing a product for market launch. This is due to several phenomena - the introduction of the MDR regulation, the unstable economic situation caused by the geopolitical situation, and problems that medium-sized companies encounter when launching products on the market. Investors are saying, “de-risk my investment” - there is only one way to do this: by proving demand, by documenting traction. The medical industry cannot easily do this due to the restrictions of the MDR. 

At the moment, it is difficult to see how this difficulty can be overcome other than by “getting good and competitive”. Local programs are being organized in various countries to support this stage. It is necessary to talk to many potential investors about co-investment and risk sharing. 

It would be very helpful if industry CVCs considered looking favorably on startups from outside their usual regions where they source projects. Many startups are willing to relocate to areas with greater availability of investment capital.

Mid-sized medical device companies have problems bringing new solutions to market. Despite organizing pilot programs and declarations of interest, the medical sector avoids solutions that improve processes. Improvement today is not enough - the cost of giving up something that works, that everyone is used to, something that fits into the revenue equations of medical entities and insurers, is too high with the promise of improving one parameter of therapy. 

To overcome this problem, it is necessary to find a product with significant pulling power for a small and specific market segment. A product for which the target group cannot imagine life without it. This is the right mindset for the search for a killer application that will change modern medicine.

"To overcome this problem, it is necessary to find a product with significant pulling power for a small and specific market segment. A product for which the target group cannot imagine life without it. This is the right mindset for the search for a killer application that will change modern medicine."

In your experience, how can SMEs use innovation as a differentiator in a crowded and highly regulated market?

In my opinion, there are many ways. In sales dominated by tenders, one useful innovation that the competition does not have is often enough. It doesn't have to be patented; I've seen proprietary technologies protected only by a trademark, and that was enough to prevent competitors from selling their solutions. 

Innovation has two roles. The first is to be able to secure investment in a new product with a patent or other form of intellectual property protection. The second role is to use innovative technology to solve an important, pressing problem. Investment in innovation most often pays off when you can quickly and globally capture a large share of the market with a new solution.

In the medical industry, fast means something different than in the consumer industry; nonetheless, the rule is the same - without the promise of large sales in the near future, it is hard to justify investment in innovation.

What are some of the most effective ways for SMEs to establish strategic partnerships or collaborations to accelerate innovation and commercialization?

I think the most important things are to understand how your partner works and not waste their time.

Time is the most valuable resource, and it doesn't matter how big the organization is. Every time an SME decides to interact with a potential partner, whether it is a key opinion leader or a corporation, it must know what it has to offer and what it expects from this interaction, as well as who in the organization should be contacted. If the partner is correctly informed about the SME's interest in meeting and is the right one, a meeting can be arranged. If the SME is ready to take the next steps, such a meeting makes sense for both parties. However, if the meeting is only intended to try to identify potential areas of cooperation, it is often difficult to arrange a follow-up meeting.

The decision-making structure of the organization with which the SME is trying to enter into cooperation also plays a key role. The activities must be designed for a sequence of meetings with individual people so that, in the end, the decision-maker receives the right set of information needed to make a decision.

The statement would be incomplete if I did not mention the role of trust in the whole process. It is difficult to start the process without recommendations, a warm introduction, and the use of people who already have the organization's trust. This is very consistent with the fact that an SME must have knowledge about its partner - not only to be able to effectively pursue its interests but also to ensure that its actions do not harm the partner.

With the evolving European regulatory landscape, including MDR and IVDR, what are the biggest compliance challenges for SMEs, and how can they proactively address them?

I think it is important to mention two major challenges. The first one is the tightening of auditing processes by notified bodies, which means that in every area, auditors' expectations are increasing, and methods of meeting requirements are no longer effective. This is because the notified bodies themselves are subject to audits by accreditation bodies. Many organizations have fought for the right to MDR certification for several years and are now doing everything they can to retain this opportunity. This is at the expense of SMEs, which are now required to conduct clinical trials for products that have been on the European market for 30 years, for example. 

The second problem is that in some technological areas, new regulations are being introduced at a pace several times faster than the certification cycle for medical devices. This means that a product that has been designed and manufactured and is in the process of being certified may be found to be non-compliant one month after the start of the audit. 

It should be remembered that new medical devices, especially innovative ones, are created as an investment. This situation is radically discouraging for investors.

What has been a favorite memory from the 2024 European Medical Device Summit, and what are you most excited about this year?

There was a moment when I realized that we are a community that has common problems and is open to sharing solutions.

Regardless of whether you are in a corporation or an SME, regulations, clinical trials, customer interactions, and technological challenges are the same for everyone. In addition, the ecosystem of the industry is a very beautiful aspect - there are key corporations and service providers, and there is room for startups that stimulate product development. The opportunity to talk, exchange experiences, and connect with people so they can realize their plans. Time is spent very effectively and positively.