eNews April 19, 2022

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

Cybersecurity guidance for device makers

The FDA cited rapidly evolving cybersecurity threats and hacker attacks as the basis for its newly released draft document on cybersecurity guidance, reports MedTech Dive. The document lays out a total product lifecycle approach to cybersecurity with recommendations for how medical device manufacturers should address security in premarket submissions and in order to maintain their software-based products postmarket. Also included are mitigations for older legacy devices that were not built with security in mind.


‘Back to basics’ on severe acute respiratory infections

A free downloadable toolkit to guide providers in the care of patients with severe acute respiratory infection has been developed by the World Health Organization, according to the American Association for Respiratory Care. Spurred by SARS CoV-2, the toolkit is a “return to basics” targeting providers who need a refresher on physiology and technology. During the pandemic, it became clear that oxygen delivery systems were incompletely understood, hospital-based oxygen systems (e.g., liquid, concentrators, and cylinders) were under strain, and only a few hospital systems understood the design and demand of their oxygen supply, said Rich Branson, MSc, RRT, FAARC, FCCM, who contributed to the toolkit. “Although this is a particularly useful book for providers in the setting of limited healthcare resources, I would highly recommend that every respiratory therapist as well as students take full advantage [it],” said Richard Kallet, MS, RRT, FAARC, another member of the task force.


If it’s truly a breakthrough device …

Are you working with a startup company that believes it is developing a breakthrough device? If so, it may be eligible for the FDA’s “Breakthrough Devices Program,” designed to expedite the regulatory process so these devices can enter the market quickly. The program offers manufacturers an opportunity to interact with FDA experts to address topics as they arise during the premarket review phase. Click here for FAQs about the program.


The latest healthcare system to nurture startups

Northwell Health, a New York-based health system, has joined with Aegis Ventures to form a startup venture (called Ascertain) to launch multiple companies in 2022 focusing on maternal health, chronic disease detection and management, and artificial intelligence (AI). For example, the team hopes to develop an AI solution that helps clinicians predict the risk of developing preeclampsia, enabling obstetricians to intervene earlier than previously possible.


See and be seen at the IMDA/HIRA Annual Conference

We look forward to welcoming you to the IMDA/HIRA Annual Conference, July 25-27, in suburban Chicago. Sponsoring a session or event will heighten your profile and enhance your networking opportunities among the professionals of IMDA and HIRA – the people who can help you build your market. Unable to attend in person? Don’t be forgotten! Display your support of IMDA and HIRA by becoming a sponsor. We’ll make sure your name is in front of all attendees. Click here to learn more about sponsorship opportunities.