Yesterday, Consumers Union published quality rankings of 221 of 1,100 cardiac surgery programs in the US. If you haven’t already, I encourage you to read the New England Journal of Medicine and New York Times coverage. The underlying data come from a clinical registry developed by the Society of Thoracic Surgeons, and managed by Duke Clinical Research Institute. I expect to see registries used more commonly for the clinical, regulatory and market development of new medical devices.
Historically, medical device companies performed case reports, pilot studies, and pivotal trials as part of new product development and market expansion. However, my former company, InfraReDx is one of several medical device companies using registries as a key part of its clinical program.
What’s driving the growth of registries in the medical device industry?
- Increased use of registries and acceptance of registry data by medical societies (like the Society of Thoracic Surgery) and the FDA.
- Ability to collect high quality data from general use of devices, eliminating the costs of study devices and payments for experimental treatments.
- Ability to gather data on real-world patients, not just a subset who happen to meet a narrow set of inclusion criteria.
- Ubiquitous high-speed networks, powerful computers, and large databases enabling easy and inexpensive collection and analysis of registry data.
What can a medical device company achieve by using registries?
- Companies that launch a product in Europe first can collect European registry data to support US regulatory submissions.
- Companies can mine off-label device usage from registry data to apply for label expansions.
- After regulatory clearance, registries can support efforts to obtain coverage, coding and appropriate reimbursement levels.
- Registries can be useful for post-market surveillance and for generating market-expanding clinical papers.
Registries are an emerging option for the clinical, regulatory and market development of new medical devices. As costs of running registries continue to come down, and awareness and acceptance continue to increase, we can expect to see registries used more often. In fact, in the not-too-distant future, it may be possible to create a registry by mining patients’ electronic health records. Then again, the horizon is often further than it appears…
Update 14 September 2010: As if to prove my point, medical device company SpineAlign Medical today announced their VerteLift European registry initiation. See press release here.
- Consumer Reports Is Rating Surgical Groups (nytimes.com)