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Newsletter V. 2022 Issue 2

September 2022 Newsletter – Integrating Two Worlds of Product Development & Design Controls Gone Bad

Design Controls Ice Sculpting
Image source: Sunstone Pilot

Software is key to many innovative new solutions in healthcare but medical device companies are faced with the challenge of integrating the world of traditional medical device development with the world of modern (unregulated) software development. People from these two worlds have very different approaches, like these images of sculptors, where both artists are using techniques and tools that are optimized for their work. The stone sculptor is slowly chipping away at the stone to create a sculpture that will last for a long time but the ice sculptor needs to work very quickly with power tools to create an artwork that may only last a few hours.

Just as the ice sculptor shouldn’t be expected to use a hammer and chisel, we shouldn’t expect that quality system procedures intended for hardware will properly support software development. Medical device companies need to find ways to integrate these two worlds to effectively tackle the challenges of developing software-intensive medical devices (and engineers who want to use a “chainsaw” for their work aren’t necessarily reckless–they may just have very different experiences).

Fluid and Scalable Medical Software Development

Join us for my upcoming presentation, “How to Teach an Old Industry New Tricks: Utilizing Agile Methods for Medical Devices” to SVELC on OCT 20. I will explore the challenges of integrating people from very different backgrounds into a single, coherent product development organization.

Additionally, Orthogonal is offering a series of free webinars on agile and medical software – Move Fast and Break Nothing (next one is scheduled for SEP 29)

Design Controls Gone Bad

Nobody sets out to write design control procedures that undermine product development but unfortunately that’s the situation I’ve observed at many medical device companies. In this blog post I describe some common ways that your quality system can undermine your product teams (part 1 of 2).

Raising Expectations for Cybersecurity

In the face of growing threats to the healthcare industry, FDA has issued a new cybersecurity guidance which is a significant change from previous guidances and raises the bar for medical device companies. This is still a draft guidance but is likely to be released early next year so companies need to be aware of FDA expectations and prepare now.

The new guidance introduces the concept of a “Secure Product Development Framework” (SPDF) which is complementary to the requirements of the QSR (to produce medical devices that are both safe and secure). It also describes in detail many types of security controls to consider.

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