TECHNICAL NEWS AND TRENDS FROM PREVAS
LIFE SCIENCE Editorial Taking advantage of technology in modern healthcare PAGE 2
Prevas
Case
Prevas introduces Medico Template packages for medical devices. PAGE 3
Revolutionary implant and surgical tool for treatment of acid reflux. PAGE 12
LIFE SCIENCE SPECIAL! HOME FERTILITY TREATMENT EXSEED HEALTH HAS developed a digital platform that can help couples to fulfill their dreams of becoming parents. Page 8
THE MEASURING TOILET
WINNING MULTIPLE PRIZES FOR HER IDEA, Nurse Marie Lommer Bagger is developing a med-tech device to separate and measure patient output. Page 10
PORTABLE COOLING SYSTEM FOR SAVING LIVES THE MEDTECH COMPANY QUICKCOOL is developing a portable system for cooling patients with cardiac arrest and other severe states. Page 4
PREVAS / TECH TRENDS
TAKING ADVANTAGE OF ELECTRONICS IN MODERN HEALTHCARE INTEREST IS INCREASING in electro-
nic and communicative healthcare solutions, both among professional EDITORIAL healthcare providers and consumers who wish to live a long and healthy life. Prevas’ specialists are fortunate to meet people and companies looking for development support in order to realize their innovative ideas for medical devices, eHealth and mHealth or healthcare solutions, often for the benefit of both individuals and society. We seek to assist our customers in making healthcare more efficient, reliable and at the same time make it more personal and comfortable. You will be able to learn more about some of these companies in this issue of Tech Trends. eHealth and mHealth are some of the largest trends we see amongst our customers. eHealth and mHealth enable an entirely new level of accessibility, compared to what we are accustomed to with traditional healthcare. It is now possible to have a data collector with us in the form of a smartphone, in combination with various types of sensors - maybe within a wearable. We can get an overview of our current health status and even send the related data via cloud services to medical personnel for evaluation. eHealth and mHealth solutions contribute to the comfort of patients, the extensiveness of data collection, and thus the thoroughness of patient care. In the case of ExSeed Health, we see an exceptional product that can change the lives of couples struggling with fertility issues – now from the comfort of their own home. Sometimes the requirements for medical equipment, along with
the safety and security factors that relate to them, can be a challenge to overcome. Many good ideas are realised by people with knowledge and drive, but the tough regulations that apply to medical and invitro diagnostic products field require attention from professionals with expertise in these areas. Whether it is a quality system that needs implementation, a directive that needs to be complied with or a certification that a product needs, Prevas’ solid experience in this area often makes a real difference for our customers. In the case of Quickcool, we were proud to be able to assist them in the external audit by the notified body, for approval of the quality system to ISO 13485. The stories of our customers Quickcool, Measurelet and ExSeed Health are examples of how electronics in healthcare can provide the missing piece of the puzzle in the lives of both patients and consumers. Besides exciting technical solutions, flexible platforms and how each company takes advantage of new technology and digitalization, these companies share an inspiring, strong approach to improve the comfort and well-being of the user. × For more information contact:
Robert Tönhardt
robert.tonhardt@ prevas.se +46 8 799 6428
BUSINESS REGION MANAGER, SUNDBYBERG, SWEDEN
For more information contact:
Henrik Møller
henrik.moller@ prevas.dk +45 29 49 92 02
PRESIDENT PREVAS DENMARK
Innovation for Growth Prevas has approximately 600 employees and is the primary supplier and development partner for many leading companies in the energy, automotive, defense, life science, telecom and manufacturing industries.If you do not want to receive Tech Trends from us, you can decline at any time by sending an email to info@prevas.com.
www.prevas.com
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PREVAS Prevas has made it easier and faster to get medical devices approved.
PREVAS INTRODUCES MEDICO TEMPLATES The market for medical devices is growing rapidly. Innovations in the technical world is constantly providing new opportunities for faster diagnosis, as well as better treatment options, more precise examinations, and more precise studies. It is obvious that the requirements placed on medical devices need to be high—after all, it is a matter of people’s lives, and sometimes a little bug in the software or a battery failure can be fatal and cost human lives. Ideas for life-saving technologies are often devised by enthusiasts with drive and vision. However, they often face significant challenges when they start to realize how much it actually requires to meet the regulatory requirements for medical technology. Prevas’ Life Science specialists have many years of experience in developing and approving medical devices, so they know all about the challenges involved. To make the approval process easier for customers in both financial and planning terms, Prevas is now introducing a series of Medico Template packages to help ensure that preparing and approving medical equipment for launch goes smoothly.
The Medico Template packages support the requirements set out in the: ISO 13485 ISO 14971 IEC 62304 IEC 62366-1 IEC 60601-1 IEC 61010-1 standards And the documentation requirements described IVDD/IVDR och MDD/MDR.
“These templates provide the customer with a thoroughly tried-and-tested starting point,” says Robert Tönhardt, Business Region Manager at Prevas, Sundbyberg, Sweden. “They are designed to be adapted to the customer’s chosen quality system and to cover, for example, the documentation of medical software in accordance with the IEC 62304 standard. Another template package supports the start-up and initialization of a Medico project, covering software, electronic, and mechanical design—the starting point for the development and approval of medical technology.” Prevas already has a number of customers who have benefited from these templates. We strive to play our part in promoting the development of lifesaving technology and we hope that this action will make a difference for innovative startups and other businesses with ideas. × www.prevas.com/lifescience
”WE STRIVE TO PLAY OUR PART IN PROMOTING THE DEVELOPMENT OF LIFE-SAVING TECHNOLOGY AND WE HOPE THAT THIS ACTION WILL MAKE A DIFFERENCE FOR INNOVATIVE STARTUPS AND OTHER BUSINESSES WITH IDEAS.”
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CASE
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PREVAS / TECH TRENDS
PORTABLE COOLING SYSTEM FOR SAVING LIVES THE MEDICAL TECHNOLOGY COMPANY QUICKCOOL IS DEVELOPING A PORTABLE SYSTEM FOR COOLING PATIENTS WITH CARDIAC ARREST AND OTHER SERIOUS MEDICAL CONDITIONS. AS A PROJECT PARTNER, PREVAS HAS TAKEN CARE OF THE SOFTWARE, DOCUMENTATION AND QUALITY ASSURANCE SYSTEM. THE PRODUCT LAUNCH IS PLANNED DURING THE YEAR. With offices and lab facilities at the Ideon Science Park in Lund, QuickCool is a cooling system in which a salt solution circulates in a closed system in the patients nostrils. Measurement points on the incoming and outgoing liquid are continuously monitored, and cooling is regulated to keep the temperature at 36 degrees Celsius. The system is portable and the treatment can be provided by nurses without special training. “Our product is so small that it can be suspended from a stretcher or bed,” says Fredrik Radencrantz, CEO for QuickCool. “In combination with a simple user interface, cooling can be immediately initiated directly upon arrival at the hospital.” INCREASED SURVIVAL RATES AND FEWER COMPLICATIONS Throughout history there have been documented cases indicating that cooling increases survival rates in the event of serious injuries. “A doctor who served at the Battle of Lund in 1676 observed that wounded officers carried into warm tents did not do as well as wounded soldiers left out in the cold,” says Fredrik Radencrantz. The positive effects of cooling could be scientifically confirmed after the Second World War. During the 1980s, an extensive research project was conducted under the leadership of Tadeusz Wieloch, professor of neuroscience at Lund University and presently a QuickCool board member. He was able to prove that cooling increases cardiac arrest survival rates – and also reduces complications for survivors. During the 1990s, research was taken further and a conflict arose between those who advised cooling to 33 degrees and those who preferred 36 degrees. In 2013, results of a major European study on cardiac arrest patients were released that showed that there were no differences in clinical effect for cooling to 33 degrees versus 36 degrees. However, the study indicated the importance of maintaining a constant temperature. “Although our technical solution is not appropriate for high effect, extremely rapid cooling, it is excellent for maintaining a constant temperature,” says Fredrik Radencrantz. “For QuickCool, this was very positive and entails that there is nothing to hold back product development.” Innovation for Growth /
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”I REALIZED THAT THE DEVELOPMENT PROJECT NEEDED TO BE PROPERLY MANAGED” Fredrik Radencrantz became the CEO for QuickCool in April of 2017 and was charged with launching the company’s product. As it turned out, the system at that stage was not even close to being ready for the market. “There were no functioning devices and documentation was lacking for software development. I initially thought that it was a matter of a few minor additions, but I soon saw that the development project needed to be revised and structured in an entirely new way.” At this point, Fredrik Radencrantz decided to meet with Prevas for a second opinion on the situation. After a preliminary study that encompassed among other things, an evaluation of the existing code, QuickCool decided to redo the software. They also broke off collaboration with their previous development partner. “I had a gut feeling that it wasn’t working, that we had put major resources into a supplier that couldn’t handle the job,” says Fredrik Radencrantz. “Prevas produced solid decision-making data that enabled us to take a new approach to development.” A SKILLED DEVELOPMENT PARTNER As development continued of QuickCool’s system, Prevas could contribute with skills in among other things, project development and software development, as well as testing and validation. Prevas has also helped with updating and maintaining their quality assurance system, and has been involved in the external audit in accordance with ISO 13485:2016. “When we entered the project, sales should have already begun,” says Håkan Erlandsson. “The first thing we had to do was explain that there would be delay, which was not especially nice for the customer to hear. Although there are still a few minor development steps remaining, we now have full control of the situation and we foresee no uncertainties or risks of any significance.” There are many suppliers that develop software, but to work in the development of life science products and solutions, there are stringent regulatory requirements. With many years of experience in life science, Prevas has branded itself as a skilled development partner that can handle these requirements. “It feels great that we’ve been able to help with product development for an exciting company like QuickCool,” says Håkan Erlandsson. “We’ve contributed with the engineering, but perhaps above all, with knowledge of the industry and experience in the development of life science products.” QuickCool is now leaving the development phase and moving towards approval and then on to production. As soon as CElabeling is finished, the product will be initially launched on the European market. Work is also underway with complying with the more complex regulations that apply in the US, China, India and Brazil, for example. “We still have several people from Prevas with us and we’re extremely satisfied with them all,” Fredrik Radencrantz. “Prevas is a natural partner in our work. Things are going amazingly well and we should have had them along from the start.” ×
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For more information contact:
Patrick Buschow
patrick.buschow@ prevas.se +46 40 691 95 50
BUSINESS REGION MANAGER, MALMÖ, SWEDEN
METHODS FOR MEDICAL COOLING Cooling has positive effects for patients suffering from cardiac arrest, chemical stroke, traumatic brain damage, fever illnesses and liver damage. In TTM (Targeted Temperature Management) there are several proven methods for patient cooling: • The most common involves placing plates along the chest, back and thighs, and then connecting a cooling system. Cooling goes quickly but the problem is in the difficulty of maintaining an even body temperature. Moreover, the patient begins shivering at about 35.5 degrees. The body shivers to generate heat, which counteracts the cooling effect. • An alternative solution is to insert a catheter into the femoral vein in the thigh. A small balloon is used to cool the blood that passes on the way to the brain. Cooling goes quickly but a doctor is needed to make the incision for the catheter. It is also timeconsuming and entails a risk of infection. • QuickCool cools with a third method in which a salt solution circulates in two balloon catheters that are inserted into the patient’s nostrils. The body temperature is monitored with measurement points on the incoming and outgoing fluid, which enables a stable temperature to be maintained. QuickCool’s system is portable and easy to use.
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CASE CASE
TEST SPERM QUALITY WITH YOUR CELL PHONE The Danish company, ExSeed Health has developed a platform that allows couples who are trying to get pregnant to be able test the man’s sperm quality quickly and easily. Usually, an expert using a microscope to be able to count how many viable sperm cells are found in a sample is required to evaluate sperm quality. But can this be automated? Is it possible to find software that can do the hard work? This was the idea that biologist and PhD student Emil Andersen came up with three years ago. He works at the Center for Basic Metabolic Research at the University of Copenhagen. He began experimenting with different lenses that could make it possible to see the microscopic sperm cells, combined with software to count the number of healthy cells. Andersen formed ExSeed Health along with partners Morten G. Ulsted and Daniel Daugaard and they found that the principle worked. The system detects 99% of viable sperm cells. That’s a high degree of reliability. The process of making it an efficient device then began. The result was a device within which a sperm sample can be placed. A lens acts as a microscope, magnifying the cells. The
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user’s smartphone takes a video sequence, which is then examined in the cloud to produce a sperm analysis that, until now, required expensive microscopes available only in hospitals and clinics. The product has just been launched.. Roughly 20% of couples experience infertility. Studies show that 40% of infertility is actually due to the male partner, but historically, the focus has been on female fertility problems. APP GIVES RECOMMENDATIONS The device measures the number of healthy sperm cells. The number is converted to categorize whether the man is infertile, sub-fertile, or normally fertile. If the sperm sample is in the infertile or sub-fertile range, the cell phone app can provide recommendations for a change of lifestyle that may result in higher fertility or advise the man to consult a doctor. “We’re targeting the device at a large group of men who would not normally have their sperm analyzed at a clinic,” says Morten G. Ulsted, CEO of ExSeed Health.
DESIGN ExSeed has chosen to focus on attractive designs with a certain “Apple appeal.” “We wanted to pack the mechanics into a high-quality design. There’s a lot of denial concerning poor sperm quality. We believe that a cool design can contribute to breaking down that taboo,” says Morten Ulsted. “We chose Prevas to develop the product prototype because they have a lot of inhouse expertise. This applies to product development, dealing with suppliers, and CE marking. They also have an agile mindset. They helped us from prototype to a full consumer device that was ready to sell,” says Morten Ulsted. Prevas have dealt with a range of clients in the field of medical products over the years. Prevas was asked to take on the mechanical and electronic aspects of the ExSeed project, as well as dealing with suppliers. “We were also deeply involved in validating and choosing suppliers,” explains Henrik Møller, President of Prevas Denmark. “ExSeed were able concentrate on the function of their device and marketing, while we arranged the logistics for production and packing.”
STEERING GROUP Henrik Møller strongly believes in structured collaboration. One of the means of doing so is a steering group, set up to follow the product through its various phases. “The steering group meets at least once a month. We discuss what works and what doesn’t, bringing problems out into the open. Our way of working is to focus on identifying what’s good and what’s not so good so we can come up with a solution. We reached a point in this project when we realized that we were heading in the wrong direction with the lens. So, we backtracked and found a different approach,” says Henrik Møller.
The software for the system was developed by ExSeed in consultation with Trifork. ON THE MARKET ExSeed launched was ready for the Danish market in January 2019. “We wanted to start in our home market as it is a Danish product. We can also test the concept here. We expect to be able to proceed into the British market within a couple of months,” says Morten Ulsted. ×
“We have lots of clients who are developing medical devices. They usually come up with a new method for measurement or a new principle. We handle the development process through to the final product,” explains Henrik Møller. LINSER One of the technical challenges with the ExSeed Health project was finding the right lens for the device. “The better the lens, the better the analysis. We invested a lot of time in finding the right lens able to fit in the small device. We had to consult a number of experts and ran several trials,” says Henrik Møller.
For more information contact:
Henrik Møller
henrik.moller@ prevas.dk +45 29 49 92 02
PRESIDENT PREVAS DENMARK
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CASE
THE MEASURING TOILET Measurelet has invented a technological toilet, which can measure the amount of urine and faeces excreted, directly updating a patient’s medical records. The solution will optimize an otherwise very time-consuming process continually performed in hospitals. Fifteen percent of hospitalized patients are monitored for fluid balance, where the amount of ingested fluid and excreted urine and faeces are measured over several days. This is a manual and time-consuming procedure of 16 steps, which can take a nurse over 9 minutes for each toilet visit. The measurement is subject to significant human errors and associated with great discomfort for both patients and nurses. THE IDEA The new concept developed by Measurelet will be able to take measurements of excreted material in a hygienic and cost-effective manner, without the use of traditional bed pans and scales. The two nurses behind Measurelet, Marie L. Bagger and Louise Bangsgaard, have invented a technological toilet specifically for the healthcare sector. It can automatically measure the amount of urine and faeces and insert the data directly into a patient’s electronic medical records. “Our aim is not just to improve and automate the procedure for nurses and reduce the costs for hospital administrations, but also make the whole process more comfortable for patients” explains Bagger. “As nurses we see on a daily basis how embarrassing the current method is”. It is projected that in the future there will be a lack of healthcare professionals in Den - mark and other countries, which together with an aging population requiring more care, will necessitate
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increasing levels of automation in the nursing profession. The Measurelet toilet is a product that can release many nursing hours and it will therefore be interesting not just in hospitals, but also in nursing homes, etc. COMMERCIALISATION Prevas have been selected by Measurelet as their technology partner, bringing many years of automation and sensor experience to the project. To date this work has concentrated on the R&D required to accurately differentiate and measure the excreted products. A first technology demonstrator has already been constructed in record time, with plans are now underway to rapidly commercialise this research into a fully functioning product that can go to field trial. ×
For more information contact:
Henrik Møller
henrik.moller@ prevas.dk +45 29 49 92 02
PRESIDENT PREVAS DENMARK
PREVAS / TECH TRENDS
�Our aim is not just to improve and automate the procedure for nurses and reduce the costs for hospital administrations, but also make the whole process more comfortable for patients�
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Implantica launching new standard of care Heartburn is a global public health problem that causes considerable suffering. The company Implantica is developing an implant and a surgical tool that provides revolutionary treatment. problem. “We want to provide a simple and standardized surgical method that facilitates the work of the surgeon.”
Globally, an estimated 400 million people suffer from gastroesophageal reflux disease (GERD). This chronic disease entails the leakage of stomach contents up to the esophagus due to insufficient closure of the upper orifice of the stomach. The symptoms are heartburn and chest pain, but about 15 percent of those inflicted also develop precancerous changes to the esophagus. The most common GERD treatment is with acid inhibiting pharmaceuticals, know as PPI (Proton Pump Inhibitors). “The medicines treat the symptoms but not the cause of the problems,” explains Leif Granat, head of R&D at Implantica. “Patients that take PPI seldom become entirely free of discomfort and still have overly high contents of gastric juice in the esophagus. The risk of cancer remains as well due to the damage to the tissue of the esophagus.” THE ALTERNATIVE – LASTING TREATMENT To provide lasting treatment that eliminates the need for medication, Implantica has developed the passive implant RefluxStop. The implant consists of a small silicon ball that is divided into five parts. With the help of the specially developed Reflux Deployment Tool, the implant is compressed before insertion via a keyhole operation. It is subsequently expanded again, once it is in place. “The implant creates a mechanical space between the diaphragm and the stomach,” says Leif Granat. “This restores the natural barrier between the stomach and esophagus.” The goal of RefluxStop is to replace the current, relatively complicated surgical method in which tissue from the stomach is wrapped around the lower part of the esophagus to compress the passage. This operation can help patients but the results vary. The risk for complications is also considerable. As an example, those who undergo the operation can have problems with swallowing, burping or vomiting. ”Surgery is an art. It’s the surgeon’s skill that determines the quality of the results,” says Leif Granat. “We hope that our method will become the standard of care for this type of
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CLOSE COLLABORATION WITH PREVAS Even in earlier development projects, Implantica has engaged consultants from Prevas and its network. On two current projects – development of the RefluxStop implant and the surgical instrument Reflux Deployment Tool – more than 50 consultants have been involved. They have contributed with expertise in among other things, project management, mechanical design, quality assurance and regulatory documentation. Moreover, a larger number of subcontractors and test labs in Sweden, Europe and the US have contributed with their services. “Implantica is a small and lithe company with an incredible scope to its products and ideas,” says Jonas Liedberg, lead consultant at Prevas. “It’s very exciting for us to be able to participate and develop technology that so clearly improves human health and well-being.” Several professions have been involved in both projects. It has therefore been important to create a common understanding of the regulations and demands that apply to development of life science equipment. Prevas has many years of experience in life science and is also certified in accordance with ISO 13485 – quality management for development of medico-classified products. For the engineers, it is also a matter of compliance with the conditions for surgical devices. That the implant must be possible to insert in a way that works both for patients and surgeons. All in all, a complexity that entails that the conditions can rapidly change while an operation is underway. “In this type of development project, we must constantly be open to new methods and solutions,” says Leif Granat. “It doesn’t work to lock in all the parameters from the start. “It’s obvious that Prevas has a genuine interest in our product and that they also have the capability to support all phases of development.” GOOD RESULTS AND MAJOR POTENTIAL The implant and the surgical instrument is now CE-labelled. Production is also being adapted for scaling up, subsequently requiring new, supplemental validations and tests, such as with regard to bio-combability and sterility. “We’ve worked hard with this and our clinical test have produced very encouraging results,” says Leif Granat. “We have performed the procedure on 50 patients with our new method, and now, 14–24 months later, all are largely free of symptoms.” The goal is for the implant and surgical instrument to reach the market during 2019. The global For more information need is estimated at contact: 2.2. million proceJonas dures each year. × Liedberg jonas.liedberg@prevas. se +46 70-578 1352
CONSULTANT MANAGER, SUNDBYBERG, SWEDEN
www.prevas.com