Vienna, 07.05.2021
“I got questions!” is probably one of those statements that make the team realize: more work incoming! Paul Kressnik, Co-Founder of reha buddy, is responsible for quality management and known for his diligence. Lately, he has dedicated a significant amount of time to a training to become a medical device expert. With the certificate in hands he combines his passion for medtech and innovation with freshly gained insights into the regulatory framework. In this interview, he speaks about his experiences during the training to become a medical device expert, and shares why it pays off to go the rocky road of certifying reha buddy’s app.
- What are your responsibilities in the team of reha buddy?
I’m a co-founder, person responsible for regulatory compliance, authorized signatory and representative for our CEO Harald Jagoš. In the role of the head of quality and regulatory affairs I am dealing with anything related to compliance and quality assurance. In a nutshell: all contracts pass through my hands and I make sure that reha buddy acts inside the regulatory framework. My IT Background also allows me to support anyone with technical issues.
- The mentioned role as “head of quality and regulatory affairs” already points out that you are the one undergoing the training to become a medical device expert. Does that also fall into your personal strengths?
Early on we have decided to support patients in the clinic as well as at home. That left us with no other choice than filing for a medical device certification. We knew that would lead to higher requirements for our product development (documentation, testing, etc.). During my studies (Biomedical Engineering at TU Graz), I had touchpoints with regulatory topics as well as quality management. I always found that to be interesting and being able to make that part of my daily work seemed natural. I simply enjoy being a little detective and analysing contracts and grey areas within them. So yes, I would say this training definitely matched my personal strengths.
- Is this training also doable for someone without greater legal knowledge?
The insights I got during my studies was helpful, however, of course I was a complete beginner when it came to professional quality management for medical devices. All participants have read the medical device regulation, that was more or less the basis. The group was heterogeneous, different levels of experiences and various backgrounds. I learned quickly that I was in the lucky position to develop all quality management processes according to what the regulation requires.
- Was there something that really surprised you during the training, something you would consider a game changer?
A widespread opinion is that laws and regulations tell us what we are allowed to do and what we are not allowed to do. Actually, they don’t. They define a certain space in which you can move and act…and this space is quite large. I don’t think that the medical device regulation, for example, restricts us very much – I can’t understand this negative image. There is a lot of room to manoeuvre in the detail. That was definitely something that surprised me a lot. I am also of the opinion that this set of regulations helps us to bring good solutions to the market and demands a high quality standard. After all, we are talking about a very important, if not the most important asset: our health.
- What hurdles are there, especially for start-ups, when it comes to medical device approval? Do you have any specific tips?
I would say that such standards as ISO13485 force you to answer unpleasant questions very early on. Obviously, every company will have to do so at some point. The thing is: Do you want to ask these questions when you have a small, flexible, motivated team? Or later, when certain structures have become established, i.e. you have to fight against lived practice?
- reha buddy certifies an app as a medical device – can you please elaborate on that?
First of all: The term medical device is not primarily defined by whether it is something tangible or not, but the promise of benefit is actually more central. A large part revolves around the so-called intended purpose, which regulates what the solution can be used for. You basically just want to prove your value proposition in the certification, show that there is added medical value and that the general safety and performance requirements are met. The biggest challenge I see is the speed of development and iteration. An app has a very fast-moving development cycle compared to a physical product. Requirements such as patient safety must of course be met and thus extensively tested. But these checks take time, which is less conducive to agile software development. So the difficulty is to find the point where the app is very close to perfection when you release it – any changes (updates, upgrades, etc.) may in fact require re-approval in a regulatory sense. It is worth mentioning that this testing is carried out by external third parties – here, of course, a certain dependency arises again. This interplay between creating innovations and ensuring that these innovations are medically validated and safe must be mastered.
- Is this certification a one-time procedure?
No, it is checked at least annually. The period of validity is 3 years, and for each new upgrade (e.g. in our case a new assessment) it has to be checked again. So if you develop very closely to the customer’s wishes and want to create a wow effect with innovations on a regular basis, this means corresponding effort in the background – apart from the actual development. Ideally, the individual developments should be staggered so that new cycles can be started regularly and updates can be delivered continuously. The better quality management is established (e.g. technical documentation, operative processes), the more structured and fluid the cycle will be.
- What is the advantage of this certification? For clients and customers, but also for reha buddy?
We are creating clinical and medical added value. Accordingly, the highest good is the improvement of health. All the rules we follow on the way have a purpose: we guarantee safety for all patients. That has a strong value and creates trust.
- When does a company have to deal with medical device certification? There are many health apps available but are not certified…
The point is: how much can a user trust these apps? Can the user rely on them to deliver according to their value proposition? While most of these apps are used by end customers, reha buddy is used in clinics – being a medical product is a prerequisite for this. Thinking ahead: the clinic itself must also be responsible for the health and well-being of its patients and check on this regularly. For this purpose, there are functions in hospitals such as the technical safety officer, who checks all medical devices at certain maintenance intervals. In a way, the app is on a par with a classic ECG monitor: both need to function 24/7, undergo maintenance check-ups and so on. The user trusts us, and we owe it to him to prove that this trust is justified. The promise of safety is simply central when it comes to health.
- Now we would be interested in your opinion: How advanced do you think Austria is compared to Germany when it comes to the acceptance of apps as medical devices?
The Medical Device Regulation (EU) 2017/745 is dedicated to medical devices (note: this applies throughout the EU, individual member states can extend the regulation at their own discretion), which comes into force on 26.5.2021, explicitly regulates apps as medical devices for the first time ever. The national implementation is diverse. Germany has followed the regulation closely, Austria is a little more restrictive. While apps can be prescribed in Germany, this does not yet work in Austria. We do have electronic patient records (ELGA), but nothing that corresponds with the Digital Healthcare Act (which includes digital health apps (DiGAs)). To me it seems as in Germany, market approval is promoted and funded more strongly.
The WHO Constitution defines health as a state of complete physical, mental and social well-being, not merely freedom from disease or infirmity. In order to meet this definition, we cannot and must not compromise on the safety of patients and people in general. Developing a medical device means taking responsibility from an ethical, technical, scientific and medical point of view and helping people. We guarantee this through careful testing of all our development steps, ongoing verification of our safety and performance requirements and an active contribution to clinical and scientific research.
If you’re interested in testing reha buddy’s app, get in touch here!
