On September 6th, the FDA issued the guidance document Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices.
According to the document:
“This guidance is intended to highlight the following items that medical device manufacturers should consider to provide a reasonable assurance of safety and effectiveness of their interoperable medical devices: 1) designing systems with interoperability as an objective; 2) conducting appropriate verification, validation and risk management activities; and 3) specifying the relevant functional, performance, and interface characteristics in a user-available manner such as labeling.” (p. 3)
For those new to the topic, they define interoperability “…as the ability of two or more products, technologies or systems to exchange information and to use the information that has been exchanged.” (p. 2)
With respect to human factors, it highlights a couple areas of importance for our discipline, including:
- “Validate the user(s) interface. Determine that the user(s) are capable of correctly using the interface(s)” (p. 11)
- “Validation of labeling regarding the use of the electronic interface should consider human factors as appropriate.” (p. 17)
It’s good to see that the FDA understands the challenges associated with interoperability and that human factors is an important part of designing, developing, and deploying interoperable technology that allows users to safely and effectively perform their duties.
“Numerous other problems help account for why there has been so little positive change in workplaces or careers. Here’s one of the more important: There are no “barriers to entry” into the leadership industry; no credentials, rigorous research, knowledge of the relevant scientific evidence, or anything else required to pass oneself off as a leadership expert. Anyone and everyone can write a book, be a leadership speaker or a blogger, offer consulting and advice, or start a leadership-development or consulting firm.” (p. 24)
Pfeffer, J. (2015). Leadership BS: Fixing Workplaces and Careers One Truth at a Time. New York: Harper Business.
For readers in the United States, I hope that you’ve had a great Labor Day weekend! We’ve just returned from a nice getaway to one of my favorite places – Ketchum, Idaho. I had the opportunity to hike to Pioneer Cabin (photo above), mountain bike Bald Mountain (photo below), and spend quality time with family.
I also spent time contemplating the future of healthcare – something I’ll be writing about more over the coming months.
Until then, let me stress the importance of taking time off from work to recharge your batteries and stay in touch with what’s most important with each of your lives. Work is great – especially if you love what you do – but it shouldn’t be your only reason for rising each morning.
When most people think of Idaho, it typically conjures images of rugged mountains, fast running rivers, or maybe even potatoes. But what about medical innovation? Probably not.
While historically not a hotbed for medical innovation, Idaho has been making strides over the last several years. Below are some of the medical innovation companies that are making a difference around the world.
NOTE: This post will be updated as more medical innovation companies are identified. If you know of Idaho-based medical innovation companies that should be added to this list, please contact me.
I have started a series for the Human Factors MD blog on the design, presentation, and evaluation of safety information (warnings, precautions, and contraindications) in medical device labeling.
Last week I posted the first in the series that provided an overview of the challenges medical device companies face when developing safety information for their products. Yesterday, I posted the second in the series that discussed the four components (signal word, identification of the hazard, information on how to avoid the hazard, and consequences for failing to avoid the hazard) typically included when developing safety information.
Some of the additional topics that will be covered in the series include:
- Purpose of safety information
- When safety information is required
- Challenges developing safety information
- Why safety information isn’t always effective
- Questions to ask when developing safety information
- Design considerations when developing safety information
- Issues seen in device labeling safety information