As cost constraints continue for medical device manufacturers, they are seeking relief by any means available. One opportunity is to partner with research and development experts to help with the idea generation portion of a project. Since R&D expenditures can become burdensome for a single company to handle (especially those at the start-up level), employing an organization that specializes in this early stage aspect of product development could be a more affordable option.
 
With this in mind, MPO spoke with the program director of wearables at imec, Ruben De Francisco, to learn more about what the organization does with regard to medical device R&D. He also provided insight on a recent project he worked on for the ER and ICU environment. Also, Dr. Hilja Ibert, the CEO of miDIAGNOSTICS—a company developing an innovative diagnostic test solution—joined the discussion to share her experience with imec and give a bit of insight into her company’s development project.
 
Sean Fenske: I’m going to start with Ruben De Francisco. Can you please tell me what imec is?
Ruben De Francisco: imec performs world-leading research in nanoelectronics and digital technology, leveraging its scientific knowledge with the innovative power of its global partnerships in ICT, healthcare, and energy to deliver industry-relevant technology solutions. In a unique, high-tech environment, imec’s international top talent is committed to providing the building blocks for a better life in a sustainable society. imec is headquartered in Leuven, Belgium, and has offices in Belgium, the Netherlands, Taiwan, USA, China, India, and Japan.
 
Fenske: Can you expand on what the organization does in the medtech space specifically?
De Francisco: In the medical technology field, imec is focused on researching nanoelectronics for wearable health applications, including items such as patch monitors, chest band heart rate monitors, respiration or hydration monitors, and devices for blood-pressure calculation. imec and its Dutch affiliate, Holst Centre, develop Body Area Networks (BANs) that are highly sensitive, intelligent, small, ultra-low power, wearable sensor networks comfortable enough for continuous, reliable, and long-term monitoring of health parameters during daily-life activities. imec develops functional prototypes of their body area networks, meant as platforms for collaboration and further research and development. Moreover, imec leverages its nanoelectronics expertise, chip integration capabilities, and bio-lab infrastructure to develop innovative solutions for the life sciences, pharma R&D, clinical diagnostics, therapy and surgery, biopharma production, and analytical biochemistry industries.
 
Fenske: I understand imec is behind an event that promotes medical electronics specifically. Can you share some information about that?
De Francisco: imec (together with Johns Hopkins Medical) hosted ITF Healthcare most recently in October 2016. ITF Healthcare is a summit focused on advancing nanoelectronics research in regard to healthcare specifically. The event featured thought leaders from imec and other organizations, such as GSK, Intel, Johns Hopkins University, Johnson & Johnson Innovation Center, miDIAGNOSTICS, Philips, and Under Armour. Topics discussed included transforming precision medicine, developments in nanotechnology and their effect on healthcare, the proliferation of the internet of healthy things, and bioelectronics medicines.
 
Fenske: What about the Holst Centre? What is its role and focus and how is it impacting medtech?
De Francisco: Holst Centre is an R&D center set up by imec and the Dutch research organization TNO. It develops technologies for wireless, autonomous, sensor technologies and for flexible electronics in an open innovation setting and in dedicated research trajectories.
 
The Holst Centre was set up in 2005. It is supported by local, regional, and national governments. It has more than 200 employees from some 28 nations and a commitment from over 40 industrial partners.
 
imec’s research on wearable health solutions is performed in collaboration with Holst Centre. Combining imec’s wireless sensor technology expertise with TNO’s expertise in flexible electronics enables the realization of wearable health solutions that are small, more flexible, and stretchable so they are comfortable to wear.
 
Fenske: You seem to work with an array of different partners from manufacturers to universities. How do you attract such a diverse group of organizations?
De Francisco: The risk and cost of advanced research is extremely high and some research challenges are so large that companies cannot afford to tackle them alone. imec collaborates with the industry bilaterally, or in the framework of joint research programs. Such programs gather technology leaders across the value chain to jointly perform precompetitive research. Partners share expertise and lower risk and cost of advanced research to accelerate innovation on a generic level.
 
Additionally, imec offers state of the art facilities, giving researchers all the tools they need to explore future technologies with the greatest success. Currently, imec has about 3,500 researchers representing over 70 countries.
 
Fenske: Recently, you worked on a project to develop an EEG headset for the ER and ICU. Why was this important technology to be made available?
De Francisco: For the development of the wireless electroencephalogram (EEG) monitoring device for clinical applications, the Japanese manufacturer, developer, and distributor of medical electronic equipment worked with imec and Holst Centre. Their customized wireless EEG headset monitors emergency room (ER) and intensive care unit (ICU) patients. Current solutions to measure electrical activity in the brain are cumbersome, uncomfortable, and ultimately, a burdensome experience for patients. With these pain points in mind, imec supported Nihon Kohden to develop a wireless EEG monitoring device that provides a lightweight, comfortable, sustainable, and patient-centric EEG monitoring solution.
 
Fenske: Can you share a bit of insight into the design process of this technology?
De Francisco: To design the headset, a systematic approach was used to tailor electronics design, circuit design, and mechanical design to the needs of the ER and ICU environments. The resulting prototype was then used by Nihon Kohden to further develop a wireless EEG monitoring solution for ER and ICU patients, which was launched last year in Japan. The prototype was based on imec’s proprietary EEG solution and featured eight channels of EEG with disposable electrodes that optimize speed and ease of setup. Additionally, the prototype headset had to meet the performance requirements of the Japanese standard for clinical EEG monitoring.
 
Fenske: Now I turn to you, Dr. Ibert, regarding one of imec’s other projects. This one involved your company, miDIAGNOSTICS, and the development of small diagnostic chips that better facilitate point-of-care testing. Can you please provide some insights into your company and the project with imec?
Dr. Hilja Ibert: Founded in October 2015, miDIAGNOSTICS aims to globally shift the way in which individuals and communities manage their healthcare by combining the knowledge and technical expertise of researchers at imec and Johns Hopkins University. This unique, collaborative life science venture is developing highly accurate, single-use, diagnostic devices to enable faster, more efficient healthcare at any point of need. Further, they need to be available anywhere and anytime via a fully integrated format, which minimizes and eventually eliminates the need for any kind of instrumentation. The primary goal of miDIAGNOSTICS is to empower healthcare professionals, patients, and consumers to test and act immediately, and to enable informed health decisions, which will result in more efficient healthcare.
 
Fenske: Can you expand a bit more on the device technology and the benefits it will offer?
Dr. Ibert: Our devices are addressing three major market needs. First, they will allow for the avoidance of context disruptions for healthcare professionals. With our devices, the diagnostic test can be performed directly at the point of care (POC) or point of need (PON). The sample transport and process time at the central laboratory, which takes hours or often days, can be avoided. The patient doesn’t need to come back or be called back.
 
Second, these devices will allow for the immediate availability of diagnostic results and enable caregivers to avoid delayed or false treatment.
 
Third, a POC/PON test will enable diagnostic testing in areas where there are infrastructure gaps, such as in frontier markets and developing countries.
 
Fenske: What are the diagnostic application areas for which this device would be utilized?
Dr. Ibert: To prove our concept, we have identified four applications, which will provide significant benefits to healthcare providers and patients worldwide. First, we are developing a complete blood test with a three-part differential. In terms of volume, this is the leading diagnostic test in the world. In situations such as fever or anemia that are unclear in the patient, a POC/PON application will allow for all of the aforementioned benefits. Another example of an application that we foresee in the future is for chemotherapy patients. These individuals will be able to perform a white blood cell test at PON with our devices to ensure their numbers are high enough for their next treatment.
 
The second application will be to test for metabolites such as alanine transaminase (ALT) or creatinine, which are indicators for stressed liver and kidneys, respectively. miDIAGNOSTICS’ technology will be extremely valuable for patients who are required to take a wide variety of medicines that are potentially toxic for the liver and kidneys. With regular testing, patients will be able to determine whether they will be able to continue treatment without damage to their organs.
 
The third application will be to detect RNA and DNA quickly and easily. Hepatitis C virus (HCV) RNA quant (commonly called “viral load”) will be our first test, addressing a leading cause of liver failure and liver cancer that kills more Americans than any other infectious disease. Even though revolutionary cures for hepatitis C virus (HCV) infection are now available and well-tolerated, most HCV-infected people are unaware of their infection. Nucleic acid (NA) testing is needed to confirm HCV infection, because antibody-based tests cannot distinguish past from current infection. Current NA tests are inconvenient and expensive. Our test will make screening fast and convenient, facilitate earlier linkage to treatment, and enable monitoring during therapy that could enhance monitoring for treatment adherence, increasing the uptake and success of curative treatments for a lethal disease.
 
And finally, our chip will be able to detect binding of large molecules like proteins, including antibodies and hormones. This will allow us to measure the concentration of indicators like C reactive protein (CRP), an indicator of inflammation that is an important indicator of risk for cardiovascular disease and of the presence of serious infectious diseases. CRP is widely used to target heart disease interventions, and to guide judicious use of antimicrobial drugs.