Into the Future: What's on the horizon in the human factors medical device product industry
Into the future
Enabling medical product development at the speed of life
If you have not already seen the news, we are excited to announce that Shannon Hoste has been named President of Agilis Consulting Group. Shannon brings over 20 years in the medical device, pharmaceutical and in vitro diagnostic industries. Together with her FDA regulatory experience in both CDRH and CDER, where she provided oversight to hundreds of human factors submissions, she is a recognized expert in risk management and product development.
"We are excited for this next stage of growth," said Pat Patterson, Founder & CEO of Agilis Consulting Group. "Agilis has played a key role in the growth of human factors in the life sciences industry over the last 20 years. Shannon’s vision will allow Agilis to continue that growth and leadership. We’re thrilled to have her accept the role of President, I know we will continue to lead and serve our clients with integrity.”
Beyond Shannon’s work as President of Agilis Consulting Group, she is also an assistant professor in the Quality Science Education program at Pathway for Patient Health and is active on several standards and conference committees for medical devices and combination products.
Shanonn's diverse experience brings expertise to help Agilis better support client needs in an ever-changing environment. Her vision allows Agilis to create a more robust offering for our clients through strategic partnerships, expanded services and product solutions.
Human Factors is entering a new space in digital health. Medical device functionality is exponentially increasing with telehealth, wearables, software as medical devices (SaMDs), and software in a medical device (SiMD). Artificial intelligence in the healthcare industry alone is projected to grow to approximately $120 billion in revenues by 2028. [1] To gain insights about the data gathered, artificial intelligence is advancing our ability to process and adapt from these advances. Cybersecurity is a growing topic of concern due to the evolution and increasing connectivity in the digital health space. The FDA’s plan to advance digital health, including the initiation of the Digital Health Center of Excellence and other strategic measures, encourages medical devices incorporate evaluations of cybersecurity in their human factors testing. These evaluations should include proper device use to ensure secure medical devices and security of patient health information (PHI), in addition to evaluations of whether users can detect and mitigate a situation where their device or data becomes compromised. Furthermore, the FDA has emphasized the importance of post-market surveillance of cybersecurity incidents and vulnerabilities to ensure users are aware of breaches to manufactured devices and/or PHI.
Considering an estimated 95% of cybersecurity breaches are due to human error [2], it is crucial to develop threat modeling and effective methods to evaluate your connected medical device.
The number of markets which identify combination products is gradually increasing, with each market having varying definitions of what falls into the scope of a combination product, along with the term used to identify a combined-use product. With these new definitions, the need to perform human factors work for each market is ever-evolving. A strong human factors program, initiated early in the development process, is advised for all markets where combination products are defined. Starting early and aligning with US FDA guidance (and any other market-specific guidance) and IEC 62366 is recommended to prevent gaps and be best prepared for marketing submissions globally.
A common theme across the global regulatory bodies is that risk management should focus on the end user, which highlights human factors as an integral component to the design and development of medical products. The application of human factors, including preliminary analyses and contextual information, coupled with the use-related risk assessment builds the evidence to support a regulatory decision. Since the available guidance and standards for human factors provide an overall process for considering use-related risks, rather than a prescriptive approach, manufacturers may be challenged with navigating the process for their product. Selecting a human factors firm that understands the guidance and standards of what regulatory bodies expect is crucial to a successful submission.
Commitment to our Core Values
The pandemic changed some things; but after 20 years our core values have remained the same.
Agilis specializes in understanding the guidance and standards as well as what regulatory bodies expect when it comes to human factors submissions. No matter the device or application, our team of skilled human factors consultants not only understand the process, but can identify appropriate strategies for successful submissions.
Look out for our November newsletter as we discuss Task Analysis.
References:
Reed, Z. (2021, August 12). The Regulatory Aspects of AI/ML-based SaMD. Retrieved from MedTech Intelligence: https://www.medtechintelligence.com/feature_article/the-regulatory-aspects-of-ai-ml-based-samd
IBM Cyber Security Intelligence Index Report.
About the Author:
Agilis Team
Agilis’ team are all seasoned human factors experts, many of whom are considered industry thought leaders. We strive to maintain consistency of your Agilis team throughout the project lifecycle. Our unabashed commitment to quality is evidenced by a rigorous internal quality control system including on-going professional development for all Agilis team members.