Ground-breaking rapid Covid test as a result of strong partnership between imec & Verhaert

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.

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Contact
Nicky Sterck
Communications, Verhaert Masters in Innovation
+32 491 249 864

Visit Verhaert at their website and follow their social media channels:

ICsense and Sapiens Join Forces Around Deep Brain Stimulation

THE STORY OF SAPIENS AND DEEP BRAIN STIMULATION

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 is used to treat neurological disorders such as Parkinson’s disease, the right picture shows the custom 40-channel ASIC developed for Sapiens

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. 

The left picture shows a conventional DBS, while the right picture shows Sapiens steering brain stimulation with 40 configurable electrodes leading to improved directional stimulation

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, VP Product Development and co-founder of Sapiens

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

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).

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About ICsense

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.

Website: www.icsense.com
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Contact
Press contact
Jeroen Van Ham
vanham@icsense.com
+32(0)589721

Visit ICsense at their website and follow their social media channels:

Verhaert’s Medical Solutions Accelerator is back to boost medical innovation

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. 

Verhaert : AI assisted robotic spinal surgery

digital rendering of a robotic arm scanning a patient lying on a surgical table

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.
Overview of the patient’s physical position before, at the start, and during surgery © VERHAERT

 Before surgery

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.

Before surgery the patient is lying on her back for high resolution CT/MRI scans © VERHAERT

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.

At the start of the surgery the patient is laying on her stomach © VERHAERT

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.

This article was written by the Verheart Team

You can visit Verhaert at their website and follow them at their social media accounts:

World Class Research Meets the Market, Thanks to Comate

In July 2020, we published an article written by the team at Comate Engineering and Design explaining how they help ideas go “from core technology to marketable products.” We’re happy to bring you a new piece of their success story: CellSine.

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.”

A visual representations of the process Comate uses to take a proof of concept to a marketable 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.

Read the whole story at Comate’s website.

IDTechEx Predicts Flexible Electronics will own a Major Slice of the Healthcare Market by 2030

smart Health Patches 2
Athlete wearing the smart Health Patch.

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:

22
October2020
Flexible Electronics Webinar Flexlines 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. 
14:00 CETOnline
12
November2020
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.
14:00 CETOnline
17
November2020
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.
11:00 CETOnline

IDTechEx Report Summary of “Flexible Electronics in Healthcare 2020-2030”

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.

Pitctures of various types of flexible electronics in healthcare: skin patches
Cardiac monitoring devices range from (left to right) the 12-lead ECG, Holter monitor, patch with snap fasteners, and patch with integrated electronics. // Source: IDTechEx research report, “Flexible Electronics in Healthcare 2020-2030

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.

To find out more about electronic skin patches, please refer to IDTechEx’s report, “Electronic Skin Patches 2020-2030“.

E-Textiles

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.

To find out more about electronic textiles, please refer to IDTechEx’s report, “E-textiles and Smart Clothing 2020-2030: Technologies, Markets and Players“.

What’s Next?

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.

You can read the full report here: Flexible Electronics in Healthcare 2020-2030, IDTechEx

Dr. Nadia Tsao
Dr. Nadia Tsao

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.

Sky’s the Limit for Flemish Startup Helpilepsy

Helpilepsy app visualization for patient care

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.

Moving Forward

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.

Top Tier

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 😊

You can visit Helpilepsy at their website and follow them via their social media channels:

What You Need To Bring an Innovative Healthcare Product To Market

Innovating in the field of medical devices can get extremely complicated and overwhelm even the most experienced engineers.

For startups all the necessary areas of expertise can prove be too much, but even for well-established medical companies it is not an easy task to keep up with the ever-changing field, increased complexity and regulations of medical devices.

Nyxoah – Surgical implant tool
Nyxoah – Surgical implant tool
Areas of expertise

The first thing you need is a multidisciplinary team that covers all the different areas of expertise. For startups, this is often impossible, and they need to look for external services to complement their skills. If you take this external route, look for teams that are flexible and can work well together with your team. Look for a team that has an extensive history in medical products and other fields. They can provide a wealth of expertise and experience in various areas that even some medical device manufacturers may lack internally. This will ensure you look at your project from different angles and transfer solutions from other fields.

Experienced design firms have tried and tested development methodologies that will guide you through the whole process. They know where the pitfalls are, and can work according to the required ISO standards.

MEDEC - Anaesthesia device
MEDEC – Anaesthesia device
Start from the user

Human factors, user-centric design, and usability engineering play an increasingly important role in the medical device industry.

Designing for healthcare must start from the user (patient, doctor, caregiver), not the technology. Particularly crucial is designing for human factors from patient acceptance, to increasing patient and user safety, to minimizing the risks of potential human errors.

Acquiring insights into user needs, fears, and use from patients and workers is essential for designing a successful medical device. Therefore, extensive user research and testing are an absolute must in the development process.

A couple sleeps peacefully. The man is wearing a medical patch device on his throat
Nyxoah – Obstructive Sleep Apnoea implant
Connected

Medical devices are not stand alone anymore. Many products are connected to platforms and exchange data with patients, doctors, and caregivers. This requires new insights and disciplines to design frustration-free user interfaces, secure data protection, and interconnected products.

Additionally, some healthcare is shifting away from hospitals and other medical environments to patients’ homes. Connected smart products collect medical data and make it available for patients, and doctors, in real time, to make the right decisions. This not only makes the development of products more complex, with smart censors and high connectivity, but also demands a complete rethinking of how healthcare services are delivered. These products become product-service systems that require a service design expertise to make them successful on the market.

TERUMO BCT – Laboratory tube sealing
TERUMO BCT – Laboratory tube sealing
Production

Finally, when you have your minimal viable product, proof of concept, and final prototype, you must be able to produce it in a consistent error-free way.

Thinking about this is not something you start with after the design is finished. Design for manufacturing should already be part of the design process from the very beginning. Production and product cost need to be taken into account at the very start of development.

Finding the right partner to produce your product is also essential, and if you start early enough, a good partner will help you in the last stage to go to production.

UNEEG Medical– For long-term monitoring EEG
UNEEG Medical– For long-term monitoring EEG
Go to market

Established healthcare companies have the necessary expertise to market their products in-house. For startups this can be a challenge. Even the best designed product can fail if it is not brought to market the right way. At the start of the development, product marketing and branding must already be part of the thinking process. This is the only way to make sure they will reinforce each other and avoid unpleasant surprises at launch.

How does Achilles face medical design?

At Achilles, we advance healthcare through people-centered design. We prototype early and often, to ensure we keep the people we design for at the heart of the process. By putting ideas in the hands of users from low-fidelity paper interfaces to 3D-printed prototypes and high-level immersion VR, we systematically identify improvements and preventively exclude risks without compromising our intuition.

We believe better health is achieved by engaging people at every stage of their health journey. Our cross functional team — consisting of biomedical engineers, designers, usability experts, and a doctor — work across disciplines to integrate people’s needs with responsible technology and sustainable business models. We strive to establish innovative healthcare service solutions that drive business value by advancing the standard of healthcare.


Visit Achilles Design at MEDICA Düsseldorf from 16-19/11/2020.

Written by

Jurgen Oskamp
Jurgen Oskamp

Founding partner at Achilles Design

AI-based platform Hai brings COVID-related safety awareness to the public

To help face COVID-19 and ensure both health and well-being, the European service provider in product innovation Verhaert Masters in Innovation developed ‘Hai’: a digital demonstrator platform, based on user-centered Artificial Intelligence.

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New platform Hai for safer behavior

After 3 months of lockdown, strong regulations, and economic struggle, we’re carefully going back to our “normal” life. It’s a challenge to find the right balance between the well-being and health of the population, and a steady recovery after this critical period. 

To provide an answer to this challenging situation, Verhaert developed a demonstrator of a digital platform that uses AI-based Computer Vision to extract essential metrics from any room or area. The ‘Hai’ platform can bring COVID-related safety awareness to the public, allowing them to make informed decisions. It’s not a surveillance system, but a tool to empower people with relevant data about a specific space and to nudge them in a positive way towards a safer behavior. 

Components of the AI system

The digital platform consists of 3 components:

  1. Cameras to record a live feed of the people present in a particular area, the people entering and leaving the place.
  2. An edge AI system to process the footage on-the-fly. The system extracts the number of people, how many of them wear face masks, and measures the physical distance between individuals.
  3. Online dashboard to display this information in a friendly and educational way. 

Let’s say you work at your desk and you want to get something from the cafeteria. On the dashboard, you can see whether or not you should wait a while until fewer people are present at that place.

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Artificial Intelligence algorithms

Verhaert’s AILab trained the AI algorithms to calculate the number of people present in any space and detect how many of them are wearing face masks. What about the security and protection of private data? The cameras’ live feed never leaves the AI system. The edge AI device treats the information locally and only transfers processed and anonymous data to the dashboard. No human being sees, stores or transfers any images, safeguarding everyone’s identity and privacy.

Hai is about our health

The online platform is a tool to organize ourselves and our spaces, it doesn’t judge individuals. It allows us to access real-time information from anywhere to make informed consent whether or not to enter a room. Hai will display the total number of people in an area versus the maximum quantity allowed. Additionally, it creates a heat map of “close-encounters” (distance less than 1.5 meters) giving valuable information for cleaning, disinfecting, optimizing walking flows, and detecting bottlenecks.

Hai is about you

Hai will recognize in the near future  your gestures, so if you wave hello to the camera or raise a thumb, Hai will respond interactively. The digital platform has been created to demonstrate how AI technology can help us in managing our presence and common spaces better during COVID. Ensuring we all stay safe, not only at home.

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About VERHAERT

Since 1969, Verhaert Masters in Innovation has pioneered the field of product innovation. As a leading innovation group in integrated product development, Verhaert assists companies and entrepreneurs in the development and implementation of successful innovation processes. The group now has more than 200 employees with offices in Kruibeke, Gentbrugge, Kortrijk, Nivelles, Noordwijk, Utrecht and Aveiro.

For more information, please visit our website.

Contact
Nicky Sterck, Communicatie Verhaert Masters in Innovation
T +32 3 250 19 00 – M +32 491 24 98 64 – nicky.sterck@verhaert.com Jochem Grietens, Coordinator AILab at Verhaert Masters in Innovation
T +32 3 250 19 00 – jochem.grietens@verhaert.com

You can visit Verhaert at their website and follow them via their social media channels

This is a press release from the Verhaert Team