Earlier this week, I posted Limitations of Stand-Alone in Labeling, on the Human Factors MD website. It summarizes a recently published article about healthcare providers comprehension of 38 medical device symbols that are routinely included in labeling. Check it out to learn about the results, along with my suggestions for medical device companies.
Anyone that has been involved with designing, developing, and deploying medical devices knows there are lots of questions the product development team – and the larger organization – need to address in order to achieve success. Unfortunately, the magnitude of daily “small” questions can crowd out the fewer “big” questions, thus leading to drift, frustration, and failure.
Over the years, I’ve found there are ten questions that are vital to successful medical device development. They include:
- Is there a market for the medical device?
- Who will purchase the medical device?
- What should we charge for the medical device?
- Who are the users of the medical device?
- Where will the medical device be used?
- What is necessary to successfully use the medical device?
- Can we build the medical device?
- Should we build the medical device?
- Did we build the medical device right?
- Did we build the right medical device?
While this list of questions is by no means exhaustive, they are key high-level questions that, if answered correctly, can contribute to appropriately focusing scarce resources and achieving product realization. Moreover, without concrete answers to these questions, the product development team may be setting themselves up for failure, or at the very least, a very rocky development lifecycle.
Earlier this week, I posted Dear FDA, which summarizes a panel discussion from the 2016 International Symposium on Human Factors and Ergonomics in Health Care: Shaping the Future, on the Human Factors MD website.
The panel was chaired by Tim Reeves, PhD CHFP, Managing Director of Human Factors MD, and included the following panelists:
Earlier this month, the Human Factors and Ergonomics Society (@HFES) held the 2016 International Symposium on Human Factors and Ergonomics in Health Care: Shaping the Future at the Hilton San Diego Bayfront Hotel.
It was attended by nearly 400 human factors practitioners, industry representatives, researchers, and students. One of the many reasons it’s a worthwhile experience is the opportunity to meet and hear from the human factors staff at the FDA. Plus, it’s always nice to see old friends, along with meeting new people that are passionate about positively impacting the health care community.
The event started on Wednesday afternoon with the pre-symposium workshop Improving the Safety and Effectiveness of Medical Devices Through Human Factors Considerations: An Interactive Workshop with the FDA’s CDRH Human Factors Premarket Evaluation Team. The workshop was chaired by Anthony D. Andre, with insightful commentary provided by the three panelists: Shannon Hoste, Hanniebey Wiyor, and Xin Feng.
The symposium kicked off Wednesday evening with the opening network reception, followed by talks, panels, and poster sessions on Thursday through Saturday. A few of the more interesting panels and talks I attended included:
Tim Reeves, Human Factors MD, Inc. (Chair); Anthony D. Andre, Interface Analysis Associates/San Jose State U.; Eric Bergman, Fresenius; Adam Shames, Core HF; Shannon Clark, UserWise, Inc.
Meet the New CDRH Human Factors Premarket Evaluation Team
Michael Wiklund, UL-Wiklund (Chair); Shannon Hoste, Hanniebey Wiyor, and Xin Feng, FDA CDRH Human Factors Team
CDER Perspective on the Role of Human Factors in Combination Product Design and Development
Anthony D. Andre, Interface Analysis Associates/San Jose State U. (Chair); Irene Chan and Kellie Taylor, Division of Medication Error Prevention and Analysis at FDA/CDER/OSE/OMEPRM/DMEPA
How Many Lives Could We Save by Spending $1 Billion More on HFE?
Michael Wiklund, UL-Wiklund; Sean Hägen, BlackHägen Design; Shannon Hoste, FDA/CDRH; Stephen Wilcox, Design Science; Lawrence Wolpert, MedStar Health − National Center for Human Factors in Healthcare
From Devices to Platforms: Implications of the Internet of Things for Health Care
Hugh Dubberly, Dubberly Design Office; Stephen Wilcox, Design Science
Overall, it was an informative and worthwhile event. I look forward to attending – and potentially presenting at – the 2017 International Symposium, which will be held in New Orleans on March 5–8.
On April 13th-16th, the Human Factors and Ergonomics Society (@HFES) will hold the 2016 International Symposium on Human Factors and Ergonomics in Health Care: Shaping the Future (#2016HCS) at the Hilton San Diego Bayfront Hotel.
The symposium will include lectures, panels, and posters in four program tracks:
- Clinical and Consumer Health Care IT
- Health Care Environments
- Medical and Drug-Delivery Devices
- Patient Safety Research and Initiatives
On February 3rd, the Food and Drug Administration (FDA) published the Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development draft guidance.
As noted in the Introduction and Scope:
This guidance describes Agency recommendations regarding HF information in a combination product investigational or marketing application and clarifies the different types of HF studies; the recommended timing and sequencing of HF studies; and how HF studies are part of the process to maximize the likelihood that the combination product user interface is safe and effective for use by the intended users, uses, and environments. In addition, the guidance describes how HF studies relate to other clinical studies. The guidance also provides process considerations for HF information in investigational or marketing applications to promote development and timely review of safe and effective combination products. (p. 2)
The comment period for the draft guidance is open until May 3rd. For those interested in submitting electronic or written comments, visit this link for details.