eNews Dec 14, 2021

The latest news affecting you and your customers… from the Independent Medical Specialty Dealers Association

Monitoring patient breathing via smartphone

Seattle, Washington-based Sound Life Sciences received FDA 510(k) clearance for its prescription app that uses a smartphone or smartspeaker to monitor patients’ breathing at home or in the clinical setting. The app produces ultrasonic sonar pulses to detect reflections caused by nearby patient respiration. Testing as part of the FDA submission involved patients with conditions such as chronic respiratory pulmonary disease (COPD), asthma, congestive heart failure and anxiety. Jacob Sunshine, M.D., chief medical officer and co-founder, said the company is intent on exploring additional use cases including opioid safety monitoring, infant monitoring, incipient respiratory infection detection and identifying when an unwitnessed cardiac arrest occurs.

What can go wrong?

If the devices you sell are subject to cyberhacking or ransomware attacks, direct your manufacturer partners to “The Playbook for Threat Modeling Medical Devices,” an FDA-backed document published by MITRE and the Medical Device Innovation Consortium. Threat modeling is analyzing a system to highlight concerns about security and privacy characteristics, and it demands the manufacturer answer four key questions: 1) What are we working on? 2) What can go wrong? 3) What are we going to do about it? 4) Did we do a good enough job?

Where the innovators are

This summer, Medical Device and Diagnostic Industry published a listing of more than 50 medical device accelerators and incubators around the country. The organizations support young medical device, diagnostics and digital health companies through education, mentoring and guidance, innovation challenges, lab and technical space, and more. Check it out. 

The big squeeze on computer chips

Computer chips remain in short supply, and the medical device industry may find itself at the short end of the stick, reports the New York Times. Here’s why: Medical device manufacturers have spent an estimated $6.4 billion on computer chips in 2021. Sounds like a lot, until you stack that up against what the automotive industry has spent ($49 billion) and makers of wireless communications gadgets like cellphones and tablets ($170 billion). Medical device maker ResMed says that because of the shortage, it is producing less than 75 percent of what its customers need.

FDA keeps its eye on 3D printing

One of these days, your customers may be 3D printing their own cranioplasty plates. In anticipation of more “point-of-care” 3D printing of medical devices, the FDA issued a Discussion Paper on the topic. The big questions are: What do healthcare facilities know about manufacturing, and what regulatory oversight must the FDA provide? The agency is considering whether and how it might be appropriate to provide a level of regulatory flexibility when very low risk devices are 3D printed at a healthcare facility.

Necessity: The mother of invention

Check out pages 54-56 of the December issue of Repertoire magazine for a recap of this fall’s IMDA/HIRA Annual Conference.