At DSP Valley, we love to see our member organizations succeed. We’re happy for them, of course! We’re also thrilled to see our digitization ecosystem thriving and rewarding innovation. That’s why we’re delighted to share exciting news about one of our startup members, Helpilepsy.
Managing Epilepsy with Digital Technology and Personalized Medicine
Launched in 2017, Helpilepsy is a platform for both patients and their care team to monitor epileptic seizures, side effects, medication and other parameters. Billed as “a complete digital solution for people with epilepsy and neurologists,” the software allows for more personalized approaches to Epilepsy in patients. Currently, patients and doctors in 5 countries (Belgium, Luxembourg, France, Germany, and Hungary) use Helpilepsy, with more expansion on the horizon.
It works like any app: a patient can download it on their app platform of choice (the Apple store, Google Play, etc) and begin using it. Physicians and healthcare workers can track and monitor patient inputs through beautifully visualized web dashboards.
This summer, the team announced an exciting development: official ISO13485:2016 certification, with many thanks to their Quality and Regulatory Lead Amandine Berton. This may not sound like a huge deal, but it’s a big achievement, especially for a small startup team.
ISO certification pertains to a manufacturer’s quality management system, which in turn involves their documentation and processes. All new releases need to be fully documented, the team must be able to show clinical proof of their software’s effectiveness, new employees must go through a welcome checklist, and more. These must comply with ISO13485 in order to meet European regulations. EU regulations govern myriad elements, including customer feedback, logistics, development and more — all before a product can be sold with the CE mark within the EU single market.
The CE symbol, which we probably all recognize but never really think about, indicates “that products sold in the EEA have been assessed to meet high safety, health, and environmental protection requirements. When you buy a new phone, a teddy bear, or a TV within the EEA, you can find the CE mark on them. CE marking also supports fair competition by holding all companies accountable to the same rules.”1 Crucially, it is up to manufacturers to make sure their products adhere to CE standards and EU regulations.
Recently, the rules regarding medical devices and medical technology changed. From now on, medical software including apps like Helpilepsy and the team’s newest product, Migraine Manager, fall into a higher classification. This means that they are subject to much stricter oversight. Affected class I medical software companies have been given until 2024 to fully conform to the new regulations.
The fact that the Helpilepsy team has been able to secure ISO certification ahead of the deadline is a testament to their talent and dedication.
While ISO certification, and subsequent CE marking, is administratively necessary, it brings with it tangible benefits. For one thing, the team is ahead of the game. The biggest part of their work to fully comply with new regulations is complete. They can once again focus on their core business!
Moreover, the processes necessary for the certification lend further credibility to Helpilepsy’s technology. It’s a strong selling point that they can offer to potential patients, doctors, and business partners.
What’s more, as co-founder Ludovic Ampe explains, ISO certification will hopefully be a catalyst for further expansion. Since the CE mark is a European-widely recognized standard, achieving it should open up more international markets.
Last but not least, at the end of August, Helpilepsy was named one of the top 10 health tech startups in the Benelux region. A great achievement — Congratulations!
Be sure to keep your eye on this up-and-coming organization! We’re willing to bet they have even more exciting developments in store 😊