Interview with innovator Egbert Smit (MLA Diagnostics)

What progress have you made with your innovation since you completed your HI-NL Round table trajectory? 

Our HI-NL Round Table took place in 2019 and at that time our innovation was still mainly thoughts and a lot of assumptions. The technology was patented, licensed to us and it was tested to be working. But it was only verified by research carried out in an academic setting. Back then, it was essential to start improving our innovation through many technical enhancements to make it a marketable technology.  

Currently, we have completed most of the enhancements and our product is now a robust test that is vitro diagnostics (IVD) industry-grade and therefore is very implementable in a routine lab. I think we are in a very good position in terms of technology. Clinical validation studies  are ongoing and will yield their first results next year. 

At the time of the Round Table it was not yet entirely clear that the IVD Regulatory landscape in Europe would change considerably. With the new regulations, not only for IVD but also for medical devices in general, this is now the case. For Europe this has an unfavourable effect on innovators as it delays innovation processes. The regulations are similarly strict in the US, but it is a larger market and there is more value in the market. 

"At some point we realized that getting CE marking under the IVDR would take twice as long as we originally thought. So, the logical step for us was to look at the US."
 

We are now focusing the majority of our efforts on the US, which is a logical choice for us and many other innovators are doing the same. Of course, CE marking is still an aim, but we now know that it will us take longer than we had originally anticipated. 

What is your innovation’s current estimated time to market? 

The time to market for innovations varies depending on type of innovative technology. Technology development can take quite some time especially what you are a first-time developer of a molecular test for the market. Finding the right clinical research partnerships that you need for setting up validation studies can also take significant time. This means connecting with hospitals and clinical researchers in your relevant domain, and getting their cooperation to test the innovative solution. Further steps before validation studies can actually happen include contracting, protocol design, ethical approvals and so on, which are very time-consuming as well. 

As things stand today, marketing a solution like ours in the US will likely go faster than in Europe. Currently, once you have your technical documentation ready for submission to an EU Notified Body (NB) it still may take up to two years or so to finally get CE certification. Unlike the NBs in Europe, the US FDA can be engaged in the process and can be asked question to confirm that you are creating the correct documentation. What is also easier in the US is setting up a so-called testing service that has a somewhat lower regulatory entry barrier.  

In the end it may realistically take as much as 6 years or more from the start to getting to the EU/US market. This timeframe is something people are unaware of. Of course, persistence pays off, but market introduction for our type of innovation (diagnostics, prognostics, molecular tools, etc.) can take more time than an average medical device. 

How did you first come into contact with HI-NL? 

When we started in 2019, I already wanted to know more about what kind of impact we could achieve numerically with our innovation and was looking into ways to get a clear picture of that. 

"Realising that there is much that you may not know about your technology, current standard technologies, the users or the actual use environment, is a great start. Next you go and find those with the right expertise an experience that can help you figure out those unknowns."
 

From my past as an entrepreneur and involvement in various other startups, I already knew that doing health economic analyses were a good way to do that. So, with MLA Diagnostics I started a project with Professor Manuela Joore and her team in Maastricht to perform such an analysis for our innovation and she introduced me to HI-NL, which was starting up at that time. 

What can you tell us about your experience with the HI-NL Round Table service? 

What I remember very well from the Round Table preparation is the structured approach to clinical evaluation, the study designs, and how to perform them. What also really stuck with me is that the Innovation Guide we received at the end of the process included comprehensive advice in key areas such as product & intended use, stakeholders to involve or to be aware of, available evidence and recommended studies, CE-certification and implementation.  

Based on solid preparation and the pitch to the Round Table group, our innovation was assessed positively by all experts present, which was special. The experts at our Round Table were methodologists, pathologists, dermatologists, a health insurer, a patient representative, a regulatory expert, and representatives from NZA and ZIN. Getting such a positive response from all these stakeholders was quite unique and has strengthened our resolve to bring our innovation to the market. 

The innovation guide we received from HI-NL has since also convinced investors of the value of our innovation. For investors, it is always important to see that an innovation is assessed by an independent party and compares positively to current clinical standard methods. In addition, in our case having a solid, science-based, health-economic model prepared for Round Table assessment and for parties like investors later, makes all the difference. Such a model allows for more accurate business financial modelling as well, which investors also highly appreciate. 

"The relevant, high-ranking, and independent experts at the table unanimously said: this is a very good idea with high potential. That helped us a lot."
 

Has the HI-NL Round Table service been valuable for your innovation and does it still add value? 

Yes, the confirmation we received as a result of the Round Table was that we are taking the right approach with our innovation, and that it has quantifiable impact. This recognition has been time-saving and has resulted in successful fundraising for us and our academic partners. 

For example, with our last investment round we got a number of new investors on board. They were also very happy with the fact that we had done such in-depth preliminary work and that it was independently assessed (and positively so) was very important to them. 

Finally, together with Maastricht University we also successfully obtained subsidy for a (KWF) cancer research project for validation and implementation of our innovative technology. An HTA analysis was considered very important in this call, and having such an analysis available made our proposal stand out. 

What would you be your advice to other innovators who might consider the HI-NL Round Table service for their innovation? 

We were one of the first round tables for HI-NL, and I can definitely recommend it to other innovators. In addition, my advice to get most out of the Round Table service is to come well-prepared. If you want, you can present a rough sketch of an idea to the Round Table. You will then probably get a lot of feedback. But in my opinion that is not nearly as valuable as when you have really done a serious piece of preliminary work and already know a lot about, for example, the clinical pathways in which you operate, and what the current standards look like. 

For entrepreneurs and innovators, this preparation should actually be standard work that you do before you even start developing an innovation for the market. I am surprised sometimes how often this is not done, or only to a very limited extent. 

Finally, do you have any suggestions for improvement of HI-NL’s Round Table service? 

I think HI-NL should offer a follow-up Round Table service to innovators who have made use of the service at an early stage of development. Questions that could be in scope for such a Round Table are: did everything go as you anticipated, or did things go differently? What is the best way to get reimbursement? What are the steps to achieve that?  Also, legislation and regulations change and in addition (specifically for our case) how people view molecular diagnostics. This has impact on your innovation path. 

What we know now, for example, is that in many countries, the standard that we compared ourselves to, which is a surgical method, is actually not at all popular anymore. So, a follow up HI-NL Round Table might be a good idea to address new questions and changed circumstances during the innovation development after a couple of years. 

Finally, I would advise all funders and subsidy providers -governmental or otherwise- to offer financial support to innovators for the HI-NL Round Table service as well as for solid preliminary work. This is being discussed I believe, and in my view should become a prerequisite to get further funding. This could also be part of a staged funding approach (example: NWO Take-off 1 and then Take-off 2 funding).