Danish med-tech start-up Hedia has designed a digital assistant for people with insulin-dependent diabetes. A tool that can be of particular importance during the current pandemic where many countries are in complete lockdown and online solutions are keeping the world going.
Having type 1 diabetes himself, co-founder Peter Lucas has an intimate understanding of the challenges diabetics experience. Which includes calculating your insulin dosages and the amount of carbs in your food as well as tracking your blood glucose levels. He believes that a digital solution like this diabetes assistant is not a luxury. It’s a necessity.
Recently, Hedia’s software has been CE marked as class IIb and gained an ISO certification. The former indicates compliance with the European Economic Area (EEA) health and environmental safety standards. The latter guarantees that the company operates in line with the energy management systems of the globally recognized International Organization for Standardization (ISO).
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Innovation Origins spoke with Lucas about the certifications and the start-up, here’s what he had to say:
How was the idea for Hedia born?
I got diagnosed with type 1 diabetes and in the beginning I didn’t cope with it very well. I was in shock and really didn’t know how to deal with the news. After a while though, I started looking at solutions. I tried several tools and apps the market had on offer. But no tool seemed to work for me. As you might know, having diabetes is not just about remembering to take your insulin. It actually takes a lot of energy and time to self-manage. For example: understanding carb counting, calculating your insulin dosage, understanding how your body reacts to insulin, and knowing when you have low or high blood sugar levels.
I wanted to create a solution that could help people like me. As in, the approximately 191 million others with insulin-dependent diabetes. Life with diabetes should be easier. And that’s what our diabetes assistant is trying to achieve.
What makes Hedia stand out?
It’s no secret that Hedia is not the only diabetes software solution out there. And that’s OK too – it is not a one-player market. But Hedia does stand out in several ways. The most important way, I would say, is having a CE-certified insulin calculator (known as Class IIb Medical Device).
You really cannot overstate the importance of the insulin calculator or the certification of it. It is what differentiates us, so that we are not just a health app – we are a medical app. Because we are giving medical advice that aims to make your everyday life as a diabetic easier. So you can gain control of your diabetes management – and enable you to loosen up a bit. The certification of our insulin calculator is there to give our users a sense of security and the assurance they can rely on our app. Our most important job is to make sure that we live up to the strictest standards.
Do you think the future of medicine lies in apps like this one?
I believe that online solutions are helping to make the world go round during the current pandemic situation. Internet and digital solutions such as a diabetes assistant are not luxuries. They are absolute necessities. So many people all over the world are quarantined right now and some people might need med tech solutions to help them.
That’s why it is of the utmost importance that users of digital healthcare solutions can quickly check out a product like an app to see if it’s trustworthy. And most importantly – if it’s meeting the legal requirements for medical software. The coronavirus right now is really underscoring how crucial the security and safety of med tech is. There will probably be more situations like this in the future. So yes, I do believe that a part of the future in medicine lies in apps like ours.
What has been the biggest challenge that you’ve faced during the Hedia journey?
It was definitely when we found out out after 6 months that we were no longer “just” a tech start-up. When we ran our pilot, it occurred to us that our insulin calculator made us go from being “regular” tech to medical tech. Now, this might just sound like semantics, but it actually changes quite a bit! It changed the way we had to raise capital, our sales forecasts, the timeline of the development of our product, and, of course, the validation of it. At first, it seemed overwhelming, but now we are extremely glad that we went this way.
And the most gratifying moment?
At the risk of sounding a bit cheesy, there have been plenty of gratifying moments, and they all are pretty similar. It’s when people who have diabetes tell us that we have made a difference in their lives. This journey is a personal one for me. I know that other people with diabetes probably feel the same way as I did when I was diagnosed. So, it makes me very grateful each and every time Hedia helps someone out.
Because – and this is actually really important to emphasize – diabetes is not just a physical challenge. It is an emotional challenge as well. Ninety percent of your time, you are alone when it comes to managing your disease. You tend to have very few doctor consultations per year. It’s also a full-time job trying to balance your blood sugar levels while also living your life.
What does it mean to have your product CE and ISO certification?
It means the world to me. The CE marking is an extra layer of assurance to our users that Hedia’s Personal Diabetes Assistant conforms to the strictest safety and performance requirements. The ISO 13485:2016 certification is the assurance that we need in order to work according to the latest standards and regulations. This demonstrates our commitment to providing high-quality and consistent products and services to our users.
What is the next step for Hedia?
We’re always looking for new, useful ways to develop our assistant further. Besides that, we’re also working on getting FDA approval so we can get onto the market in the US. Plus, our data science team is working on clinical trials to validate our machine learning.
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