The problems we face in healthcare today cannot be changed with technology alone. It is the people behind the scenes, who are dedicated to advancing and pushing for change, that will make a real positive impact. We are excited to introduce you to a key member of the Orbit family, Mathias Sander.
Q: Why did you decide to work with Orbit?
I think there are two main reasons. One, I’ve seen firsthand how inefficient and impersonalized our healthcare treatments can be and how this can drastically affect a person’s quality of life. So the idea of being part of a team, building digital solutions to improve our current system, really resonated with me. The mission here at Orbit, to create better outcomes for patients through personalized treatment which I find very purposeful.
And secondly, I would say it was the team. After speaking with our co-founders Patty and Franz and learning more about Orbit Health — its mission, its values, and its vision, I knew there was just no way I could say no.
Q: Since joining Orbit, what is something that has surprised you about Parkinson’s or chronic diseases in general?
What surprised me the most is that there are so many great ideaspublished on how we can leverage state-of-the-art technology, such as innovative data science methodologies, to drive innovation in treating chronic diseases.
With that said, there are very few actual products on the market which clinicians can use. I feel that there is a large gap between research and market access that needs to be addressed. This is especially true as we continue to see a rising number of patients suffering from chronic diseases.
Q: What do you think is the biggest regulatory challenge for startups operating in digital health?
I think the biggest hurdle is that startups must comply with the same regulations as corporations but without having a large regulatory affairs department with dozens of experts on hand. With the transition to medical device regulation (MDR), there is an increased amount of requirements and a lot of uncertainty in the entire Medtech space.
It’s not only MDR that startups need to be aware of. In order to show compliance, organizations must gather applicable standards for their products and processes. For digital products, you also need to comply with data privacy and information security regulations as soon as sensitive patient data is involved. Additionally, cybersecurity is increasingly recognized as an integral requirement for digital health applications.
Large corporations even struggle with the shifting and growing regulatory landscape despite their resources. All in all, compliance with these regulations is one of the key challenges startups face.
This is a very interesting question. From a regulatory standpoint, you have a different set of requirements that apply to your products. In the traditional (hardware) medical device sector, you have to think about things like biocompatibility, electrical, mechanical safety, etc which are completely irrelevant for digital health applications. For digital devices, you must deal with agile processes, cybersecurity, data privacy, and more.
But there are more differences besides regulatory. Digital health is still in its infancy compared to the traditional medical device sector. As such, there is a lot of skepticism from patients, healthcare providers, and regulators that they must overcome. The way of thinking about device risks and benefits can also be quite different. Digital devices often have a more indirect effect than hardware devices. The software might only provide information that is used by the physician to improve diagnosis or treatment. Here, the clinical benefit might be more difficult to define than it is the case for a traditional hardware device like a defibrillator.
Now for the really difficult questions