Safeguarding stand-alone medical devices while navigating FDA’s evolving security standards

Will your stand-alone medical device stand up to scrutiny from the FDA’s cybersecurity reviewers? [Photo by Friends Stock via]

By Normand Martel, MedAcuity

In the highly competitive medical device industry, scientists and engineers are continually pushing boundaries to create innovative medical devices, including stand-alone devices.

The medtech security landscape is rapidly evolving as the FDA introduces changes in regulations that fundamentally redefine the perception and management of security for these devices.

This article aims to demystify the changes to the guidance and security standards. It seeks to empower professionals by providing invaluable insights, enabling you to successfully navigate the complex landscape of regulatory compliance, and fortify security measures when developing stand-alone medical devices.

The premise: Your FDA submission

Let’s say you’r…

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MedAcuity hires VP of people operations and director of quality assurance

Left, Jeanne Raney, VP of people operations. Right, Andy Sageman, director of quality assurance. [Images from MedAcuity]

MedAcuity announced that it appointed Jeanne Raney as VP of people operations and Andy Sageman as director of quality assurance.

Westford, Massachusetts-based MedAcuity partners with leading medtech companies on software development. The company said yesterday that it prioritizes team development and a “quality-first” mindset as it adds two new members to its leadership team.

Raney’s role includes prioritizing humanizing business processes and continuously improving employee training, development, engagement and retention, the company said. She holds more than 25 years of human resource management and people operations experience. Her roles range across multiple industries, including professional and managed services/consulting, clinical research, and managed IT servi…

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MedAcuity hires SVP of business development

Medtech software development firm MedAcuity today said it has hired Simon Johnson as SVP of business development.

Westford, Massachusetts-based MedAcuity said Johnson previously built the client partner team and managed strategic clients at digital consultancy Mobiquity. He also served as SVP of client services at GreenPages Technologies, responsible for driving services revenue growth leading to the company’s acquisition by Abry Partners in December 2020.

Simon Johnson is SVP of business development at MedAcuity [Photo courtesy of MedAcuity]

“Simon has a proven record of success in sales leadership, combined with consulting services expertise with an emphasis on client-focused practices,” MedAcuity said in a news release. “Simon has extensive experience working directly with client organizations in biotech, healthcare technology, financial services, retail and manufacturing. He h…
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MedAcuity appoints new COO, VP of engineering

MedAcuity announced today that it appointed Karl Pessinis as its COO and promoted Tony Carter to VP of engineering.

Pessinis joins Westford, Massachusetts-based MedAcuity having most recently served as managing director at All Covered (Konica Minolta Technology Services), responsible for New England.

His experience ranges across other technology services leadership roles as he has also provided management consulting to companies similar to MedAcuity, according to a news release.

Carter joined MedAcuity in 2017 as a program manager and eventually moved up to director of engineering, MedAcuity said. His new role as VP of engineering hands him the responsibility of overseeing the company’s software and quality engineering teams.

MedAcuity said Carter has prioritized establishing a comprehensive learning and development culture to support the education of the company’s technical staff.

“After 14 successful years of business, we are …

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Creating Safe Usable Medical Device Solutions: Free webinar from MedAcuity and Fathom Consulting

Panelist Mary Donnelly from Fathom Consulting [Photo via Fathom Consulting]

MedAcuity — a Boston-based software development partner for medical device makers — and Minneapolis-based Fathom Consulting are offering a free webinar exploring “the importance of design and development collaboration to keep projects on time and on budget.”

The four panelists — Mary Donnelly and Elizabeth Sipple from Fathom and Bruce Johnston and Mike Kropp from MedAcuity — will discuss why and how collaboration is essential for innovation, usability and safety in medical device interfaces.

Registration for the Sept. 15 webinar is free of charge.

Topics addressed will include: breaking down communication barriers; putting users first coupled with safety and reliability; why to prototype; when to user test; avoiding FDA pushback due to poor UI/UX design; meeting business objectives; and ensuring reasonable development effo…

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