The University of Minnesota and their industry sponsors held the 16th Design of Medical Devices Conference, touted by the organizers as the world’s largest premiere medical devices conference. Hundreds of biomedical engineers, students, physicians, and industry representatives traveled from all over the world to gather in a truly unique atmosphere. The state of Minnesota has a rich history in medical innovation. Clinicians at the University of Minnesota performed the first successful open-heart operation and implanted the first small, portable, battery-powered pacemaker. In fact, a great deal of medical device technologies, particularly implantable devices, originated in this state. Today, Minnesota has around 1,000 health technology companies and is the home base for Mayo Clinic, the top-ranked hospital in the United States. It should come as no surprise that Minnesota has been dubbed the Medical Alley, with the Medical Alley Association promoting Minnesota as “the global epicenter of health innovation and care.”
The Design of Medical Devices Conference covered a vast array of topics related to medical innovation, such as the regulatory and financial aspects of medical innovation, entrepreneurship, and commercialization. The conference included numerous keynote speakers, scientific and technical presentations, and hundreds of scientific posters, all aiming to spark attendees’ imaginations on where the future of healthcare is heading.
An optional, all-day preconference workshop on “How to Become a Medical Innovator” was held on April 10th with the Conference officially beginning the following day. Here are some highlights from the Conference:
The first day of the Conference kicked off with a welcome address by Samuel Mukasa, Dean of the University of Minnesota College of Science and Engineering. Mukasa emphasized the importance of collaboration between the private sector and academic centers to support and propel medical innovation forward. Next, Angela Sykes from the US Patent & Trademark Office (USPTO) presented on intellectual property, a very critical subject for anyone working in the space of medical innovation. Sykes provided an overview of the USPTO and patenting prosecution. She highlighted the major change that occurred with the 2013 America Invents Act (AIA), where an intellectual property patent is now reserved to the first-to-file as opposed to the first-to-invent. This makes it extremely important for innovators to file a provisional application as soon as possible and before any public disclosure. To advance patent prosecution and bridge the gap between innovators and patent examiners, Sykes recommends sit-down meetings between both parties and for both parties to engage in multiple programs like the Patent Examiner Technical training Program (PETTP), PETTP Technology Fairs, and Site Experience Education Program.
Next on the Conference schedule was a keynote luncheon presentation by Dr. Michelle McMurry from Johnson & Johnson. Dr. McMurry tied the new global political climate and the rise of nationalism around the world to medical innovation. She explained how the world’s political climate might create obstacles for innovators and medical companies. Dr. McMurry discussed a new global trend in which many countries are installing their own approval bodies as well as demanding new devices be tested in their own countries and on their own population before entering the market. When appended to the increased demand for clinical evidence, it becomes clear that the medical device industry cannot meet these demands by using traditional clinical study methods. Rather, Dr. McMurry believes, patients, innovators and medical companies should collaborate with regulatory bodies and computer engineers to utilize computer modeling and simulations to bring innovative medical solutions to patients in a faster, safer, and more cost effective manner.
That afternoon six innovators participated in the Emerging Medical Innovation Valuation Competition. The innovators presented their new medical devices to a panel of judges and received immediate feedback. Summaries of the top three devices are included below:
1st Place : RAS-Q is a portable heart-lung support device that utilizes an oxygenator, with elasticity similar to a normal lung and with relatively low resistance, which could serve as a passive lung substitute without the need for an active blood pump.
2nd Place: Traceless Biopsy is a low-cost device that minimizes complications, such as bleeding and tumor seeding, that occur with percutaneous biopsies.
3rd Place: Eucontra is a resorbable contraceptive arm implant made from a biodegradable material that differs from current contraceptive implants in that it does not need to be removed when the implant’s effective period is over.
The first day closed with the Student Design Showcase, during which young innovators shared their innovative projects and ideas.
The first session was a crowd favorite that involved an interesting, fast-paced competition called “Three-in-Five”. Each of the ten competitors was given five minutes to pitch his/her new medical device idea in three slides. All 10 competitors demonstrated high-energy and passion for their devices, but unfortunately, not everyone could be a winner. Here are the top three devices:
1st Place: An Active Limb Warming Device to Treat Insomnia:
The idea for this device is based on research that links distal vasodilation to sleep induction. When a person goes to sleep, his/her core body temperature drops while the distal skin temperature increases. By using an active warming device to heat the distal limbs and promote vasodilation, the device creates enough of a heat gradient between the distal limbs and core body temperature to help the user fall asleep more quickly.
2nd Place: Pop-Up-Inspired Design of a Septal Anchor for Ventricular Assist Device: This is the first proposed medical device implant application using pop-up fabrication methods. The device opens automatically once it is out of the delivery sheet and is the first of its kind for ventricular assist devices.
3rd Place (Tie): Active Compression Garments for Orthostatic Intolerance:
This new device uses shape memory alloy (SMA) wire formed into springs that are engineered to contract when heated. The SMAs are embedded in the garment, allowing for dynamic control over compression in a low profile and mobile form factor for people with venous insufficiency.
3rd Place (Tie): MRI- Compatible Robot for Intracerebral Hemorrhage Removal:
A robot arm uses a small entry port in the cranium and is controlled by a physician to evacuate intracerebaral hematoma while the patient is inside an MRI machine.
3D printing has gained a lot of attention in the medical field over the last few years and its growing popularity was apparent at the Design of Medical Devices Conference. Walking past the different booths in the Sponsor Exhibit Showcase, it was hard to miss the diverse shapes and sizes of the many 3D printers. Several presenters see a big future for 3D printers in the medical field, suggesting many hospitals will likely begin installing these tools in-house to supply personalized, on-demand medical devices.
Several companies have already managed to transition the role of 3D printing in medicine from theory to practice. OsteoFab a Connecticut-based company uses 3D printing and a material called PEKK (polyetherketoneketone) to build cranial, facial, and vertebral body replacement implants. Metamason, a California-based company, utilizes 3D printing to customize CPAP masks, which are used to treat obstructive sleep apnea. This field seems to be set to expand exponentially over the next few years.
Over lunch attendees enjoyed a long-awaited presentation by Dr. Stephen Oesterle. Dr. Oesterle is a renowned leader in the medical device industry, who represented Medtronic for over 14 years. Dr. Oesterle provided great insight into the field of medical innovation and what specific areas he predicts will be at the forefront of innovation and investment opportunities in the future. His list included sectors like artificial intelligence, communication technology, gene sequencing, 3D printing, and robotics. Dr. Oesterle also discussed how the rise in personal sensors would generate an enormous amount of data. He states that “data wins,” and companies capable of aggregating and putting this data to good use will likely lead medical innovation in the years to come.
The theme of the conference’s final day was “Personalized Medical Devices and Care”. We listened to a number of respectable speakers, including Josiah Allen from OneOme. Josiah discussed how his company utilizes personal genomics testing to help providers identify optimal drug therapy for each patient. Personalizing medication could maximize drug effectiveness and avoid potentially lethal drug allergies and adverse interactions.
John Daley from IBM Watson Health brought cognitive computing to the stage. “The world publishes about 700,000 articles a year. No matter how smart you are, no human can keep up with this explosion of knowledge,” he noted. Watson Health utilizes cognitive computing to weed through new material and data, making new information more intelligible and accessible to physicians to aid them in their day-to-day practice.
The final presentation was by Dr. Jeffrey Shuren from the U.S. Food and Drug Administration. Dr. Shuren gave voice to the National Evaluation System for health Technology (NEST). NEST is a new system that the FDA is working on to establish new data sources to better evaluate and regulate medical devices. The program will consolidate and interpret data from different sources like electronic health records, clinical registries, and mobile devices. The goal of NEST is to sufficiently reduce the time and cost of the total product life cycle without sacrificing the standard of assurance safety and effectiveness of new medical products.
The conference concluded with guided tours to multiple labs and centers at the University of Minnesota, such as the Visible Heart Lab, Medical Device Center, and Minnesota Nano Center. Overall, the Design of Medical Devices Conference was a huge success, delivering up-to-date information on recent medical technologies and offering insights into what the future holds for this exciting field.
Next year’s event: 2018 Design of Medical Devices Conference…