During the SARS-CoV-2 pandemic, genomic epidemiological surveillance around the world is crucial to monitor the emergence of new variants of interest or concern. Emweb’s Genome Detective is contributing to SARS-CoV-2 genomic surveillance around the globe with its intuitive bioinformatics platform and genomic database. Genome Detective accurately and quickly assembles viruses to characterize the mutations of the SARS-CoV-2 virus. Professor Tulio de Oliveira, the director of the Centre for Epidemic Response & Innovation (CERI) (Stellenbosch, South Africa), started sampling SARS-CoV-2 genomes early in the pandemic for this purpose, and used Genome Detective to discover the Beta and Omicron variants.
Emweb is a Leuven (Belgium) based bioinformatics company offering Genome Detective, founded by two KULeuven alumni Koen Deforche and Wim Dumon. Emweb’s Genome Detective bioinformatics software can be used to analyze and identify viruses in sequenced samples. The utility of sequencing became even more evident in the SARS-CoV-2 pandemic, as sequencing enabled the unbiased discovery, identification and surveillance of the pathogen causing COVID-19, the creation of SARS-CoV-2 detection tools (PCR tests), and even the start for the development of vaccines.
During the SARS-CoV-2 pandemic, Professor Tulio de Oliveira analyzed tens of thousands of SARS-CoV-2 samples leading to the detection of the Beta variant of concern (December 2020), and more recently the discovery of the new Omicron variant in South Africa. Professor Tulio de Oliveira recognizes the quality of Genome Detective: “As one looks back on the last 20 months of genomics work on the COVID-19 pandemic, one realizes the crucial need for quick and accurate bioinformatics software. We could not really have done what we did without the support of Genome Detective.”. In addition to the groundbreaking work of professor Tulio de Oliveira in South Africa, many other laboratories throughout the world were enabled in this pandemic to analyze their genomic SARS-CoV-2 data using Genome Detective, by virtue of its ease of use.
Before the SARS-CoV-2 pandemic, the analysis of viral samples with Genome Detective was already regularly used in South Africa and South America, mainly in the context of HIV, Zika, and Dengue related epidemiological research. The experience in this field and collaborations with many universities over the world shaped Genome Detective into a reliable and well-known bioinformatics pipeline.
Genome Detective will continue to support the genomic surveillance of the SARS-CoV-2 pandemic and contribute to the creation of bioinformatics applications and databases for infectious diseases in research and diagnostic settings.
Safety and quality are non-negotiable in the health industry. The engineers and designers of Comate deliver high-quality products to our clients. The ISO 13485:2016 certification assures that Comate works according to the latest standards and regulations. Their quality management system meets or exceeds all requirements.
There are a few sectors where innovation can have such a profound impact on people’s lives as in the Healthcare sector. It is also one of the most regulated sectors where patients’ lives are literally at stake, and patient and caregiver safety are absolute priorities. Medical device companies need to ensure that their new products will be in full regulatory compliance prior to hitting the market.
Comate implemented a quality management system that is compliant with the ISO 13485:2016 standard. This means they have processes in place that indicate possible risks towards patient safety and that take the necessary measures to reduce these risks as low as possible. This quality accreditation ensures that the products they develop are designed and delivered to the highest standards as part of a fully controllable process.
The safety and effectiveness of a product is extremely important. Within the health sector, this is non-negotiable since it can be a matter of life and death. Quality and risk control throughout all stages of product development is therefore a must.
What is ISO 13485?
Within the medical device industry, standards are defined to ensure quality and reliability throughout the entire product life cycle, including product design. The ISO 13485 standard defines a broad range of requirements on quality management system (QMS) for medical devices and equipment.
When a company is ISO 13485-certified, it means that they implemented a quality management system and successfully met all of the requirements of ISO 13485. The company must comply with a list of documentation, design and development, traceability, testing and other production requirements. The certification shows that the processes used in the company are appropriate and effective while emphasizing the safety and efficacy of medical devices.
The leading micro-electronics research center imec and the pioneering product development group Verhaert Masters in Innovation entered a strong partnership to ultrafast develop a ground-breaking rapid Covid test based on breath sampling and accelerated PCR technology. A functional prototype will now be commercialized by MiDiagnostics.
Imec announces collaboration with MiDiagnostics for commercialization
Imec and the Flemish government have announced the collaboration between imec and its spinoff MiDiagnostics to further commercialize imec’s breath sampling and ultrafast PCR technology. Together with the Verhaert group they realized a functional prototype through an intense high-risk/high-gain process.
This ground-breaking innovation creates an almost holy grail of testing for the Covid-19 pandemic. The device is able to collect sample material from people through breathing rather than the widely-used nasal pharyngal sampling. On top of that, ultrafast PCR can be performed directly, allowing for extremely fast time-to-results. This provides a far more comfortable sample collection, as well as more efficient processing.
Collaboration imec & Verhaert
At the end of 2019, Verhaert and imec entered a strategic collaboration to co-develop a breakthrough solution based on imec technology platforms. In this context Verhaert also invested in the imec.istart fund to provide seed capital to new technology start-ups.
In January 2020, Verhaert and imec partnered up for this breakthrough rapid Covid PCR test development. In no time, they built a breath sampling consumable containing imec’s innovative chip solution and a high-end PCR processing instrument. These developments will be used as an assay and technology development platform to assess aspects beyond clinical performance. This is a significant step towards a real-life solution and allowing for future expansion into domains other than Sars-Cov-like cancers.
This collaboration required constant interaction between very different disciplines, for example biochemistry and chip development on imec’s part, and product development skills such as optical & thermal design, software development, mechatronics, electronics and mechanics from Verhaert.
To accomplish this strict timeframe, a distinctive and agile project management approach was needed for fast decision-making and pursuing a parallel-path approach.
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About Verhaert Masters in Innovation Since 1969, Verhaert Masters in Innovation has been a pioneer in the field of product innovation. As a leading innovation group in integrated product development, Verhaert helps companies and entrepreneurs to develop and implement successful innovation projects. Today, the group has more than 200 employees with offices in Kruibeke, Gentbrugge, Kortrijk, Nivelles, Utrecht and Aveiro.
Sapiens Steering Brain Stimulation (Eindhoven, NL) is founded in 2011 as a spin-out of Philips Research and got integrated into Medtronic in 2014. Their mission: to revolutionize personalized brain stimulation and treat neurological disorders such as Parkinson’s disease. Sapiens selected ICsense (www.icsense.com) for the development of the core component in its product, the stimulation ASIC (Application Specific IC).
DBS (Deep Brain Stimulation) is an effective and well-established treatment; an implanted device sends electrical impulses to carefully selected parts of the brain to treat neurological diseases. By personalizing these impulses using advanced implanted leads with 40 individual stimulation points, Sapiens aims to improve the therapeutic effect of deep brain stimulation, shorten the clinical procedure, and improve patient comfort by reducing stimulation-induced side effects as shown in the picture below.
FIRST OF A KIND
From day one, it was clear that a custom neuromodulation chip (or ASIC) was essential since a DBS device with 40 stimulation points was never done before. Standard deep brain implants have 3-5 electrodes and are driven by an IPG (Implanted Pulse generator) in the chest. Sapiens’ solution used an adapted chest based IPG design that supplies the stimulation pulses through the lead to the ASIC which is on the patient’s skull. The ASIC distributes the pulses through a high-voltage matrix and is able to sense all electrodes with artefact reduction and to measure impedances. Powering of the ASIC is done over the lead through DC-AC-DC conversion.
THE PATH TO THE BEST ASIC FOR SAPIENS
Sapiens selected ICsense based on its impressive track record in medical implantable ASICs. The team at Sapiens appreciated the transparent and honest communication of ICsense and chose the Leuven company to be their preferred custom ASIC design partner. ICsense’s ASIC expertise but also its system level thinking was an added value for Sapiens in order to take this next step.
At the start of the cooperation, both teams from Sapiens and ICsense worked very close together on the feasibility of the target architecture and balancing the trade-offs of the full system. Given the leapfrog in the state-of-the-art and many challenges, ICsense’s flexibility and open way of working, proved to be key to the success. By advancing at the pace of the customer and taking the time to explore, the best solution for Sapiens’ system was found.
Hubert Martens, Vice President of Product Development and co-Founder at Sapiens, confirms: “ICsense developed this first-of-a-kind and innovative ASIC for stimulation and measurement in our 40-electrode deep brain implant. Next to the high technical and quality standards that ICsense employs, we strongly appreciate their open, honest and flexible way of working, which was key to the success of this development.”
By combining ICsense’s ASIC design expertise with Sapiens in-depth system know-how, both companies managed together to define the right set of ASIC specifications and system requirements (lead integration, packaging, …). An important factor for this cooperation was having a person at Sapiens who has in-depth knowledge of electronics and the system.
“We selected ICsense, because they have all the right profiles in-house, unlike aggregation partners that just bring together different companies to do the work without creating additional value. In every step of the development, we could rely on ICsense’s support and have in-depth and open discussions without any unpleasant surprises. ICsense does not work as a consultant but as a true partner we can trust,“ concludes Martens.
BEYOND THE DESIGN
Based on the specifications, ICsense designed, manufactured and tested this IC for full functionality in its lab facilities in Leuven, Belgium. In parallel, ICsense coordinated the test development with the selected OSAT (Outsourced Semiconductor and Test) partner, to test the custom chip in production with high test coverage (medical grade) and at the agreed price.
Also, in this last phase of the project, a close and open cooperation was key, with regular status meetings, in-depth reviews and even changes in specifications along the way to further optimize the system. ICsense proved to be flexible throughout the whole development process, which led to a successful ASIC that could steer the 40 electrodes from a conventional IPG, measure the brain signals and brain impedance with high-accuracy and low power and fit into a small cannister for implantation.
NOT A ONE-SHOT COOPERATION
As a follow-up of this fruitful cooperation, ICsense designed two more ICs targeting Sapiens’ next-generation product requirements. Part of this work was financed via public funding (ECSEL InForMED, BRAINS Eurostars).
Bram De Muer, CEO of ICsense, comments: “ICsense also loves working with startup companies. They bring projects that go beyond the state-of-the-art and require an ASIC partner that can adapt to their changing ideas, is flexible and open and works closely with them to co-optimize the entire system. That’s a perfect fit with the ICsense way of working and culture: open, honest and a strong partner for its customers.”
“Thanks to our company culture”, continues De Muer, “we have a strong and stable growing turnover and one of the highest employee retention figures in industry. This is important, also for startups. It proves the successful execution of projects, and all know-how stays in the company. When customers return years later, they will see the same people who build their first ASIC. And happy customers always come back….”
In 2014, Medtronic (NASDAQ: MDT) acquired Sapiens for an all-cash upfront consideration of approximately $200M. Medtronic established a global research and development center for its Neuromodulation business at Sapiens’ facility based in Eindhoven (The Netherlands).
ICsense -an independent subsidiary of the TDK group- is Europe’s premier IC design company. ICsense’s core business is ASIC development and supply and custom IC designservices. ICsense has the largest fab-independent European design group with world-class expertise in analog, digital, mixed-signal and high-voltage IC design. The company develops and supplies customer exclusive ASIC solutions for the automotive, medical, industrial and consumer market compliant with ISO9001, ISO13485, IEC61508-ISO26262.
The University of Antwerp, the University Hospital of Antwerp and Verhaert Masters in Innovation team up once again in 2021 to boost medical innovation in Flanders. This year the City of Antwerp is joining the Medical Solutions Accelerator. Together they will help start-ups develop successful medical products and services in an inspiring coaching programme.
Why this programme The Medical Solutions Accelerator gives medical start-ups access to a unique mix of state-of-the-art technology with breakthrough product innovation services. In addition, they’ll get input from end-users and medical experts in a clinical setting, and access funding and investment opportunities. Thanks to this program start-ups will launch a valuable and successful medical solution, validated by user and patient experience in clinical testing.
What to expect This year 8 ambitious start-ups will be selected to refine their innovative idea with coaches from UAntwerpen, UZA and Verhaert. The 3-month programme consists of:
5 inspiring workshops to guide the medical solutions towards market success
One-on-one coaching from industry experts & access to specialist equipment
A pitch event in which a jury of innovation experts, entrepreneurs and investors will select the most promising medical business and product concept.
Join the Medical Solutions Accelerator Are you the ambitious start-up we are looking for? Don’t miss out on this exciting opportunity to boost your innovative idea. Submit your idea before 2 July 2021. Visit the Medical Solutions Accelerator website for more information and application.
DSP member Verhaert Masters in Innovation has received a research grant from VLAIO to develop state-of-the-art artificial intelligence (AI-)driven robot technology.
In the research project, Verhaert will develop a robotic platform for spinal surgery which uses algorithms developed by Deep Learning (AI). The developed algorithms will transform high resolution preoperative 3D images, like CT scans and MRIs, to high resolution images of the patient in his or her new physical laying position during surgery. The novel part of the proposed procedure is the significant reduction of the use of cancerogenous ionizing x-ray beams during surgery, like CT-scans, while still being able to perform sub-millimeter surgery and catheter tracking.
3-step surgical procedure Defining the concept The physical laying position of the patient changes before, at the start and during surgery, which has an impact on the physical position and form of the spinal cord. All these changes in position need to be taken into account in order to perform sub-mm surgery.
Before: the patient is laying on her back for high resolution CT/MRI scans.
At the start: the patient is laying on her stomach.
During: the patient is laying on her stomach and slightly moves because of breathing, heartbeat and the impact of the surgery itself.
A high resolution sub millimeter 3D image is taken from the patient several days before surgery. This is done either by a CT-scan or MRI. Typically, the scan is taken while the patient is laying on his/her back. Based on the image the surgery is planned and a trajectory is calculated in order to reach the desired location in the spinal cord.
At the start of surgery At this stage the patient will be laying on his/her stomach. Markers are placed on the patient which are detected by a set of Infra-Red cameras in order to create a 3D model of the patients’ physical position on the operating table. In this new position, a low dose low resolution (supra-millimeter) 2D image is take of the patients’ spine. The 2D image is taken with a C-arm 2D fluoroscopic scanner.
The 2D image and the external marker localizations are used to transform the high resolution pre-surgery 3D image into a newly reconstructed high resolution 3D image of the spine in its new position and form. At this point, the surgeon and its team has a 3D image of the patients’ anatomy in combination with an external reference frame.
CellSine is a revolutionary new technology for early stage drug testing. It could easily mean medications brought to patients faster and with less testing on animals. A win-win!
The technology behind CellSine, based on electrochemical impedance spectroscopy (EIS), was developed as part of a doctoral research project at the University of Leuven (KU Leuven) and the University of Brussels (VUB), resulting in a proof of concept. As anyone who’s brought a concept to market knows, though, this is but a step in a much longer process.
That’s where Comate came in. As they put it themselves, “CellSine relied on the expertise of Comate’s engineers and designers for the technical development, to translate the PoC into a market-ready product.”
Thanks to Comate’s expertise in taking a proof of concept to market, CellSine has launched a truly innovative device. Their ambitions run high, including integrating AI to their data analysis and boosting personalized medicine.
DSP Valley active in Flexible Electronics and Healthcare
Healthcare is a major market for both established and emerging technologies. Flexible Electronics is a growing field gaining more and more momentum. Flexible electronics in healthcare is a combination with a bright future.
As our Newsletter readers and members will know, DSP Valley is currently active in three Flexible (and Wearable) Electronics projects: Flexlines (focused on creating a one-stop-shop for flexible electronics), SmartX (specifically geared towards flexible electronics in textiles), and SmartEEs (aimed at helping innovative companies digitize). This is by design: flexible (and wearable) electronics have high potential. This is in part because of their many possible applications.
One of DSP Valley’s core programs in Smart Health. We’re co-founders of the IBN flanders.health. This year, we’ve worked hard alongside our partners Flanders.bio and MedTech Flanders in getting a Spearhead Cluster for Health Tech off the ground in Flanders.
Collaborative Digital Business Breeding
Our work in the health technology and flexible electronics sectors is essential to our central mission: breeding digital business through collaborative business development. The European Flexible and Wearable Electronics projects and the flanders.health IBN and coming Spearhead Cluster are concrete examples of creating collaborative business opportunities. These go beyond single company, or even single application, vision and seek to build and support strong ecosystems that will be economically sustainable.
This is why we were delighted to read IDTechEx’s analysis. The abstract of their report “Flexible Electronics in Healthcare 2020-2030” confirms DSP Valley’s perceptions. It reinforces our resolve to continue to work hard to bring Flexible Electronics and Health Tech together, in our region and beyond.
Click here to read the summary sent to us by IDTechEx. Please note that we have nothing to do with their research. This is neither an endorsement nor a promotion.
Join us to find out more
Want to find out more about our Flexible (and Wearable) Electronics projects? Check out the upcoming FREE events – click the titles for more information and to register:
Flexible Electronics WebinarFlexlines unites different players providing access to new Flexible Electronics technologies through one-stop-shop concepts in order to accelerate the design, development, and uptake of advanced applications in Flexible & Wearable Electronics.
SmartEEs information Session with TNOThe SmartEEs Project is funded by Horizon 2020 and is aimed at supporting SMEs and Mid-caps in integrating flexible and wearable electronics into novel (series of) products.
In this webinar, Corne Rentrop (TNO) and Dieter Therssen (DSP Valley) will explain all about the project and what the benefits are for companies and service providers thinking about applying.
SmartEEs Information Session with imecThe SmartEEs Project is funded by Horizon 2020 and is aimed at supporting SMEs and Mid-caps in integrating flexible and wearable electronics into novel (series of) products.
In this webinar, Dieter Therssen (DSP Valley), Maarten Cauwe (imec), and Frederick Bossuyt (imec) will explain all about the project and what the benefits are for companies and service providers thinking about applying.
IDTechEx sent this report summary to DSP Valley. You can read more about DSP Valley’s activities regarding Flexible Electronics and Smart Healthcare here.
NB: We are sharing this summary as a service to our readers and members. We are in no way affiliated with IDTechEx.
IDTechEx Report Summary
“The market size for flexible electronics in healthcare will exceed $8.3 billion by 2030”
Dr Nadia Tsao, Principal Analyst at IDTechEx, recently published the below article on the topic of flexible electronics within the healthcare industry.
Flexible Electronics in Wearable Cardiac Monitoring Technologies
In today’s digital age, focus on digital health and the quantified self have led to the rapid rise of heart rate monitoring technologies through wearables such as fitness trackers and smartwatches. Such devices have already proven their ability in detecting hidden heart conditions such as tachycardia and atrial fibrillation in seemingly healthy people. However, the majority of wrist-based devices currently serve only as an advance warning, they are not approved by the FDA for use as medical devices. Thus, cardiologists still need to use alternative technologies for their diagnostic and monitoring needs.
This is where flexible electronics comes in. Cardiac monitoring requires devices to make close contact with the skin, making devices that integrate flexible and even stretchable electronics ideal due to their ability to conform to the skin, the potential for a low profile, and overall patient comfort. IDTechEx forecasts that flexible electronics in cardiac monitoring, deployed in electronic skin patches and electronic textiles, will be a $2 billion market in the year 2030.
IDTechEx have been reporting on flexible electronics for the past decade and have recently published “Flexible Electronics in Healthcare 2020-2030”. In this article, IDTechEx describe how electronic skin patches and electronic textiles are used in cardiac monitoring. To find out more about other technologies for monitoring cardiovascular health, please refer to the IDTechEx report, “Cardiovascular Disease 2020-2030: Trends, Technologies & Outlook“.
Electronic Skin Patches
Electronic skin patches are wearable devices that contain electrical components which are attached to the skin, typically using an adhesive.
In cardiac monitoring, electronic skin patches present an interesting balance between the medical standard, which is a 12-lead ECG test, and consumer electronics such as smartwatches and fitness trackers. While electronic skin patches offer less data than can be obtained through a 12-lead ECG, they present more useful and accurate information than the optical technology used in smartwatches and fitness trackers, and offer continuous monitoring, unlike the 1-lead ECG in the newer smartwatch models.
Within medical applications, electronic skin patches bring increased mobility to the patient over the 12-lead test. The first step from the 12-lead ECG is the Holter monitor, a portable, wired, device designed to be used over 24 – 48 hours. However, this device remains unwieldy and intrusive.
To increase patient comfort, companies have developed cardiac monitoring patches in the form of 1 integrated device over a flexible substrate. By removing the wires and decreasing device footprint and weight, electronic skin patches are more comfortable to wear, and can be used for longer monitoring periods, up to 30 days. This longevity is critical in detecting events for patients who do not experience them daily. The next step for devices will be to incorporate printed electronics to manufacture integrated electrodes and devices with even close-fitting designs for greater patient comfort.
Overall, electronic skin patches for cardiac monitoring fill the gap between in-patient cardiac monitoring (accurate, safe, non-ambulatory, expensive), implantable cardiac monitors (accurate, less safe, ambulatory, expensive) and other wearable fitness devices (poor accuracy/no medical approval, safe, ambulatory, cheap). But the deployment of cardiac monitoring skin patches is not just limited to event monitoring or mobile cardiac telemetry. Outside of cardiac monitoring, electronic skin patches for monitoring of other diseases (e.g. respiratory), or general patient monitoring (in-patient, post-discharge, etc.) also contain cardiac monitoring capabilities.
Electronic textiles, or e-textiles for short, are products that involve both electronic and textile components in a single device. The idea is to combine the functionality from electronic components with the comfort, esthetics and ubiquity of textile products.
Smart clothing for sports used to be the major focus in the e-textiles industry – companies have made many attempts to develop mass-market products. Though e-textile companies may choose different strategies and technologies, the end products all have very similar functionalities such as tracking of activity, heart rate, respiratory rate, etc. There remains sporadic interest from apparel giants for sports applications, but many of the e-textile players have now shifted towards healthcare applications.
There is a close match between sports and medicine as the same vital signs are being detected and the same form factor (clothing) can be used. Within smart clothing, companies can design in 12- or even 15 leads for ECG readings, much more than the 2 – 3 offered by electronic skin patches. Moreover, smart clothing can be much more comfortable than electronic skin patches. The latter often causes discomfort through issues such as skin irritation. Despite the higher regulatory hurdle in healthcare vs sports, companies see the long-term benefit of e-textiles in healthcare. Smart clothing that is as comfortable as everyday clothing while still delivering medical-grade data will be key to automatic and continuous monitoring of patients going about their daily lives.
E-textiles are not just limited to clothing as a form factor, they may be incorporated into non-apparel textiles such as bed sheets, blankets, and even furniture. Regardless, the key for e-textile players today is validate their product through regulatory bodies such as the FDA, and to look into reimbursement for their products.
The COVID-19 pandemic has forced clinicians around the world to test out medical technologies to continue treating and monitoring their patients remotely. Though many physicians will eventually return to in-person practice, a fraction will continue utilizing telemedicine and remote patient monitoring technologies. Technologies such as electronic skin patches and e-textiles have much to offer to the healthcare system – remote patient monitoring has been shown to result in better outcomes, higher quality of care, and increased patient satisfaction. Healthcare systems will achieve cost savings through better management of patients and thus avoiding costly hospitalization and emergency room visits. While reimbursement of remote patient monitoring technologies is moving in the right direction, it will remain a major hurdle for companies entering this space.
Dr Nadia Tsao is a Principal Analyst at IDTechEx where she has been driving the company’s research in the life sciences. Her research spans a range of topics within healthcare, including digital health, bioelectronic medicine, and tissue engineering.
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.