eNews February 5, 2020
The latest news affecting you and your customers…
from the Independent Medical Specialty Dealers Association
A brighter day for the sleep market
Growth in the sleep market is on the rise. Research from Needham and HME News reports a 15% rise in patient volumes over the past year and predicted comparable performance for the next 12 months, according to MedTech Dive. The figures are up from the 10% and 11% growth, respectively, experienced and forecast when Needham last ran the survey six months ago. The findings suggest demand for flow generators, masks and other medical devices used in the care of patients with sleep disorders will rise over the coming year. Needham found encouragement on the pricing front, too. Survey respondents said flow generator prices fell 1% over the past 12 months — an improvement over the 2% decline tracked in the previous survey. The rise is part of a multi-year trend that has seen pricing recover from the minus 6% slump that hit the industry in 2014. The positive trend was offset by a fall in the price of sleep masks.
Patient-specific airway stents
The U.S. Food and Drug Administration cleared patient-specific airway stents developed by Cleveland Clinic physician Tom Gildea, M.D. The stents are used to keep open the airways of patients with serious breathing disorders, such as those caused by tumors, inflammation, trauma or other masses. Until now, the patient-specific devices were being implanted under FDA’s compassionate use program, which allows patients who have failed all available forms of treatment to receive investigational ones not yet available to the public. The patient-specific stents developed by Gildea and his engineering team are designed using CT scans and proprietary 3D visualization software. The molds for the stents are then printed using a 3D printer and injected with medical-grade silicone.
‘Real-world evidence’ to play bigger role
The FDA will use more real-world evidence – such as electronic health records, clinical trials, medical studies and patient registries – in the year ahead, new FDA Commission Stephen Hahn outlined in a Jan 30 email. “My hope is that consumers may be even more informed and aware about the entire lifecycle of products we regulate in order to live more healthy and productive lives,” Hahn was quoted as writing by Medical Design & Outsourcing. Hahn also stressed balancing speedy approval of new products with the integrity of sponsor data and the approval process. “This will allow us to support innovation and the development of newer, more effective products while maintaining the FDA’s gold standard for safety and effectiveness,” Hahn said.
Medovate to launch at ASRA in April
Medovate will launch its SAFIRA regional anesthesia innovation at the 45th Annual Regional Anesthesiology and Acute Pain Medicine Meeting of the American Society of Regional Anesthesia and Pain Medicine (ASRA), which will take place in San Francisco on April 23-25. The device was the subject of an IMDA “Request for Representation” last fall. SAFIRA (SAFer Injection for Regional Anaesthesia) is set to advance standard clinical practice with regards to regional blocks in a number of ways. First, a safety feature helps prevent anaesthetic being injected at unsafe pressures, reducing the risk of significant or peripheral nerve damage. In addition, because SAFIRA makes the regional anaesthesia process a one-person procedure by a single anaesthetist (current processes require two operators, an anaesthetist and a technician), he or she has full control throughout. This has the effect of reducing theatre time, and is expected to deliver savings of up to $102 per regional block. An estimated 10 million regional blocks are carried out each year in the US.
The FDA would have the authority to destroy counterfeit or fake medical devices at the U.S. border, rather than sending them back to their point of origin, per a new bill – H.R. 5663 – being considered by the House Energy & Commerce Committee, reports the Regulatory Affairs Professionals Society. FDA already has such destruction authority on the pharmaceutical side.
Don’t forget the patient
If you or your manufacturer partners are going to be in Washington, D.C., next month, consider attending the Patient Engagement Forum, sponsored by the Medical Device Innovation Consortium, or MDIC. The forum is both a learning opportunity and educational workshop on best practices for communicating benefit, risk, and uncertainty to patients, says MDIC. Topics to be discussed include communication gaps and challenges in healthcare related communication with patients, as well as techniques for engaging patients and communicating benefit, risk and uncertainty of treatment options.