Technology Allows Clinical Trial Participants to “Phone In” Data
In March of 2015, Apple introduced another form of mobile technology that promises to increase and diversify participation in clinical trials. Its new HealthKit app turns the iPhone into a medical diagnostic tool for clinical trials and studies. The app essentially allows anyone with an iPhone to contribute to research on maladies, such as Parkinson’s disease. It also makes it easier to collect data on blood pressure, weight, blood glucose levels, and exercise habits.
Apple recently forged its first ever partnership in the healthcare sector with pharmaceutical giant GlaxoSmithKline (GSK), who plans to use the app for a study on rheumatoid arthritis. The GSK partnership was Apple’s inaugural effort to establish itself as a legitimate player in the healthcare industry.
Apple is just one example of the variety of technology companies carving out a niche in healthcare. Verily Life Sciences, a company that specializes in low-power electronics and software development, has teamed up with GlaxoSmithKline to form Galvani Bioelectronics. Bioelectronics is a new class of medicines consisting of miniaturized, implantable devices. These devices are roughly the size of a grain of rice and are designed to change precise electrical signals in the body’s nervous system to treat a range of chronic diseases.
Pre-Certification Program Expedites Regulatory Approval
Digital technology continues to drive a revolution in healthcare, which continues to bring more non-traditional medical device manufacturers into the medical devices space. The FDA recently announced a pilot pre-certification program that will reduce the time and cost of market entry for digital health devices. The program defines a more tailored approach to technology development where the FDA looks at technology developers instead of at a product. If the FDA is satisfied that the company builds reliable, safe, and high quality products, it won’t need to regulate every product the company develops.
Logistics Experts Fulfill Inventory Management Need
Even companies that don’t specialize in technology are finding ways to lend their expertise to the healthcare sector. For example, supply kits used for surgical procedures must be complete, accurate, and available in time for surgery. This requires precision inventory management and fulfillment, which can be challenging and time consuming for medical device manufacturers. However, major couriers such as FedEx, DHL, and UPS have long proven their ability to manage extensive inventory and deliver items anywhere in the world in a short amount of time. Each of these organizations have made significant investments in healthcare supply chains.
UPS has a warehousing and distribution facility dedicated to high-end medical devices. A central component of its healthcare strategy is a 300-piece spine surgery kit that it ships to hospitals on a loaner basis. Kits with parts remaining after surgery are returned to UPS to be replenished and shipped to other hospitals. This reduces the amount of inventory the parts manufacturers need to produce.
Advancing technology continues to present more opportunities for non-traditional companies to contribute to the healthcare industry. This trend is fostering more innovation and helping reduce the overall costs of healthcare. As a result, new areas of research and development are leading to the evolution of medical devices that are used as the first line of treatment, instead of as a last resort. I expect to see this trend continue in 2018.
Other parts of this series:
5 Medtech Trends Shaping 2017: Connected Health and Seniors
5 Medtech Trends Shaping 2017: Cybersecurity
5 Medtech Trends Shaping 2017: The Pharma/Medtech Convergence
5 Medtech Trends Shaping 2017: Trump’s Impact
As the medical device product manager, Alex Butler is focused on developing solutions that help medical device companies increase efficiencies, ensure compliance and speed time to market. Before joining MasterControl in 2014, Butler worked as a product development manager for Opal Orthodontics, a division of Ultradent Products Inc., where he helped launch several Class II medical devices, including the Opal Espirit™ Class II Corrector. With more than five years of direct medical device experience, as well as a deep understanding of the FDA’s submission process and audit procedures, Butler is a vital part of the MasterControl product management team.