Shifting the Paradigm: Four Key Principles for Successful Human Factors Validation for Combination Drug and Medical Devices
By Anthony Andre, PhD, CPE, Director, Interface Analysis Associates LLC
What is involved in successful human factors (HF) validation of combination product and medical devices? Whether fair or not, the FDA requires HF studies to demonstrate that regulated products can be used safely and effectively by intended users upon first-time use. Sponsors must understand the users, the step-by-step tasks involved, and the settings for use. Analysis also includes identifying and mitigating all possible risks throughout the process, including those related to instructions, labeling, use, and storage.
This process must be iterative, so human factors should be applied throughout the development process, with problems, resolutions, and results documented. The FDA then requires a first-time, simulated-use study report that confirms safety and effectiveness for HF validation.
Failure to achieve validation can mean “starting over” to address FDA questions, missed steps, or even device selection. Rejection has significant impacts on timelines, budgets, and missed opportunities in a highly competitive marketplace. With so much at stake, you want to ensure success.
Savvy sponsors are shifting the paradigm for HF validation success by applying behavioral insights up front and throughout the development process.
Let’s explore four keys to successful validation of combination drug and medical devices, using modern human factors approaches:
- Shift the Starting Line
Success-driven sponsors are engaging HF experts from the outset of product development or selection—not after a device has been chosen. We see that 90% of a sponsor’s destiny is determined by the product they select, including its inherent attributes and the flexibility (or lack thereof) to modify it for the best fit.
Including human factors in the concept phase will streamline the process, saving time and money while ensuring the best fit for your population and product.
HF experts study hundreds of drug delivery devices and know their suitability for your needs. Example: For a biologic treating rheumatoid arthritis and related indications, which autoinjector can patients best use with their stiff or swollen fingers? Considerations will include the product’s shape, grip, and handling abilities. Selecting the wrong device may mean dealing with mitigations, customized instructions, and special labeling throughout the process, so start out right.
2. Redefine the Journey
There is a human component to using your product. HF is a complex specialty that involves ergonomics, human behavior, and cognitive science to evaluate patient use in terms of safety and effectiveness. Smart sponsors are involving HF professionals throughout the process, not just at the final stage of the study. This move helps avoid regulatory concerns regarding gaps and a lack of proper consideration for human factors.
The FDA guidance does not intend for a one-time HF review, but rather ongoing, iterative involvement to ensure safety and effectiveness.
Allow your HF team to guide you on an impactful journey as part of the development process. This ongoing involvement will ensure that you have a robust human factors story to tell when you submit your validation study report. Your story will have a happy ending, with a successful FDA review.
Further, you will establish a reputation with the FDA for incorporating HF into your product design process, leading to more favorable reviews. Another benefit is fewer recalls or adverse events, because you are marketing a better, safer product that patients actually like using.
3. Leverage Expertise
Respect the uniqueness of the human engineering discipline. HF experts have spent years studying human behavior and developing compliant, user-friendly products. They have submitted hundreds of successful HF validation studies and can readily anticipate FDA questions.
Remember how challenging HF analysis can be, as it involves a subject’s first use of a product, with no training.
HF experts identify every possible step in first product use, from opening the package to using the device to storing the product correctly. The device must be better than just usable; it needs to be virtually foolproof. The HF team identifies all possible points of failure and addresses each one to support successful use.
Next comes the HF validation report, which has three main parts:
- Description of the human factors journey – including research on chosen devices, formative studies, plus any user issues and resolutions.
- Summary of the HF protocol – including the methodology used for validation of the device.
- Outcome of the summative study based on behavioral data – demonstrating safety and effectiveness, with benefits outweighing risks of use.
4. Avoid Surprises
Your mantra for the HF process should be “no surprises.” Build in HF from the beginning, document the journey, and tell a complete story in the validation report. That way, at the end of your journey, there will be no surprises—no revisions to timelines, budgets changes, or worse, failure to achieve validation.
HF analysis can anticipate potential issues and proactively resolve them, ensuring successful validation plus safe and effective consumer use.
Applying human factors throughout the product journey will result in improved clinical outcomes with a reduced risk of dosing errors or device misuse.
Conclusion
Adopting these four principles should make your HF validation journey easier and your outcome more assured. Our team’s experience with dozens of FDA responses per year, for over 30 years running, has shown the difference between putting HF last on the timeline versus incorporating behavioral science into a structured, outcome-driven journey. Become one of today’s savvy sponsors as you shift the paradigm for human factors success.
To learn more about how Interface Analysis Associates’ human factors services can help gain FDA approval or clearance for your combination drug product or medical device, please contact us.
Anthony Andre, PhD, CPE, is a world-recognized thought leader in healthcare human factors. He is Director of Interface Analysis Associates LLC, a leading healthcare human factors consultancy in business since 1993. He is a Professor of Human Factors/Ergonomics at San Jose State University, the Founding Chair of the International Symposium on Human Factors and Ergonomics in Healthcare and the Founding Editor-in-Chief of the journal “Human Factors in Healthcare.”
Dr. Andre and his staff have been at the forefront of the combination drug product and medical device Human Factors movement, having managed and executed hundreds of HF programs for pharma, biotech, and medical device sponsors all over the world. IAA’s 32 years of healthcare human factors experience is incomparable. Dr. Andre has provided human factors training to the FDA reviewers, and for 10 years moderated an annual FDA-Industry human factors workshop.
