From Medical Devices to Software As a Medical Device (SaMD) – My Journey to Hedia

Hedia, blog post

Hello. My name is Ninette N Florboe. I joined Hedia together with four other talented people a bit over two months ago as Regulatory Affairs Officer. The past 18 years of my professional life I have worked in the medical industry – both as an entrepreneur and for large international medical corporations. Both in Europe and abroad.

Hedia – Diabetes Assistant is a mobile application classified as a medical device. Like other medical devices, Hedia cannot place its application on the market without conforming to strict safety requirements. My role is to ensure that Hedia follows those requirements.

What Attracted Me to Hedia

I was immediately intrigued by Hedia’s mantra to “Always seek to understand the end-user and implement that knowledge to assure excellent user friendliness”. With a Masters in Anthropology of Health, I was compelled to apply when I came across their job posting looking for a Regulatory Affairs Officer.

Later I learned that Hedia was awarded the 2017 Startupbootcamp Digital Health Berlin – the leading programme that supports companies by combining medical knowledge with smart technologies. Hedia was picked out of more than 3,000 companies scouted from all around the world. That told me that there was a belief in the company beyond the founders themselves.

This year Hedia is nominated in the Health Tech category in Nordic Startup Awards.

Why I Was Right for Hedia

I offer Hedia 18 years of international work experience in a health regulated environment. After working years in Clinical R&D for Coloplast, my entrepreneurial self took me down the road of founding a wound care device distributor in Canada and later a Danish-based consulting firm specializing in regulatory writing and patient engagement in R&D. That, combined with international business development know-how, aligns well with my duties of developing Hedia’s regulatory and clinical strategy.

The Benefits of Working in a Startup

Being part of a startup gives you the opportunity to be part of something from the beginning. You help build something from the bottom up on all levels. This also means having to have a diverse skill set and the willingness to take on a lot of responsibility.  

Every day brings new challenges that we must overcome as a team at Hedia. While the team consists of individual experts in a range of disciplines, we subscribe to collective problem-solving at our core. Something that is necessary for a startup.

If you find inspiration in business modelling and varied tasks, then being involved in a startup can be exciting and rewarding. In contrast, if you are inclined to succumb to stress from the unknown and prefer motionless structure in your day-to-day life, then perhaps a startup is not for you.

The Startup Challenges

Hedia’s new team is purposefully transitioning from a Software company to a more complicated “Software as a Medical Device” (SaMD) company. As a result, strong representation in software development is required in combination with medical device expertise.

At times this “clash” of two worlds can result in failed communication efforts and, to an extent, frustrations. Therefore I aim to understand the points of views of the whole team to ensure a clear alignment can be set as I see it as pivotal for the success of the company.

It’s a steep learning curve for all of us, but that is also where I feel like I grow – in the unfamiliar and unknown. It’s a place to grow since not everyone has a background in MedTech.

We’re Still Growing

In summary, I find it gratifying to put forward ideas to the team and contributing to the debates that unfold. At the end of the day, what started as a rough thought over time churns itself into a refined concept that may likely find its way into the company’s business strategy.

Now that is rewarding to me!

If you’d like to join me and the rest of Hedia and potentially be part of celebrating the win of Best HealthTech Startup Nordic this year (vote for us here please!), check out Hedia’s job postings. We’re still looking for talented people to be part of the team. You can also sign up for our newsletter below to follow our journey.

What inspired you to get into your industry? Leave me a comment below!

Related post: How to get the most out of Hedia

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