A variety of trends will present opportunities and challenges for the medical device industry in 2015. The role of medical devices in our lives is growing by the day in a variety of settings, including at the point-of-care, in the home, in hospitals and commercial labs. With exploding growth in identification of biomarkers, the need for new assays has probably never been greater. However, a difficult reimbursement environment is giving venture capitalists second thoughts about investing in new device development projects early, when funds are needed most. It would be a great shame if reimbursement challenges slow development of diagnostics that are essential for advances in patient care. We hope to see the flow of capital to early device development projects freed up soon.
The technology of 3D printing will play a growing role in the medical-device industry in 2015 and beyond, enabling new competitors to enter some markets while presenting an alternative manufacturing approach for new and established companies alike. New implants, many with wireless communications, will proliferate to meet the needs of an aging population, in many cases involving not only an implant but also an instrument for insertion and an external monitoring device.
Despite venture-capital issues, progress in diagnostics will be swift and varied in 2015. Discrete and multiplexed assays and Next Generation Sequencing will test for an ever-expanding universe of biomarkers. We will see the emergence of diagnostics based on miRNAs, in part to enable targeting of miRNA-based therapeutics. The boom in biologics will drive development of many immunoassays. Companion diagnostics will become even more central in oncology while making inroads in infectious disease, cardiovascular, CNS and other therapeutic areas.
Like everybody else, regulatory agencies will have their own challenges keeping pace with evolving technology. A recent FDA workshop reflects the agency’s recognition that evaluation of 3D-printed medical devices will require fresh thinking. IVD developers will welcome the FDA’s flexible approach to Next Generation Sequencing products and validation of tests for rare variants. Some IVD companies will welcome the FDA’s emerging role in regulation of Laboratory Developed Tests because the historically lesser regulatory burden for LDTs puts diagnostics companies at a competitive disadvantage. Anticipation of the new European Medical Device Regulations will roil the environment for device development in the EU until the extent of increased regulation by Notified Bodies becomes clear. Developers will watch anxiously as the EU decides the extent of post-Notified-Body review of high-risk devices.
The new white paper Top 10 Medical Device Development Trends for 2015 highlights trends that medical-device developers should follow closely in the New Year.