Medical devices have the potential to revolutionize healthcare, but this potential is not just in technical prowess but also in intuitive user interaction. The Food and Drug Administration (FDA) in the United States oversees a meticulous regulatory process for usability engineering, fostering the design of medical devices for safe and effective use in real-world environments.
Key Steps in the Regulatory Framework:
User Research and Task Analysis: This foundational stage involves understanding the device’s intended users, their expertise levels, and specific usage environments. Tasks users will perform are meticulously identified to pinpoint potential challenges and use errors.
Use-Related Risk Analysis (URRA): Potential use errors are evaluated to assess associated risks and hazardous situations that affect all potential end users. This stage helps prioritize areas for design improvements.
Deriving Use-Related Design Requirements: The usability engineer identifies user interface elements critical to caregiver and patient safety, deriving design requirements for the development team.
Formative Evaluations: Throughout development, iterative testing with representative users provides real-time feedback for continuous design refinement. The goal is to mitigate use-related risks to acceptable levels before finalizing the device.
Summative Testing: Once the design is finalized, summative testing formally validates its safety and effectiveness, serving as the final checkpoint before regulatory submission.
Benefits of a Robust Usability Engineering Process:
Enhanced Patient Safety: By minimizing use errors, the risk of patient harm is significantly reduced.
Reduced Training and Support Needs: Intuitive devices require less post-market effort in training and technical support.
Elevated User Satisfaction: Well-designed devices foster a more positive user experience for healthcare professionals and patients.
Streamlined Regulatory Approval: A comprehensive usability engineering program can expedite the regulatory approval process.
Conclusion: The regulatory process for usability engineering plays a pivotal role in ensuring the safety and effectiveness of medical devices. By integrating usability considerations from the outset, manufacturers can create devices that are both technologically advanced and user-friendly, ultimately paving the way for improved healthcare outcomes.
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Incorporating usability in medical device development is a comprehensive, multifaceted process that spans the entire product lifecycle. At its core, it involves three key phases:
Early-stage user research and requirements gathering, where the needs and capabilities of end-users are thoroughly analyzed;
Iterative design and testing, where prototypes are developed and refined based on user feedback and usability evaluations;
Validation and post-market surveillance, ensuring the final product meets usability standards and continues to perform effectively in real-world settings. This holistic approach not only satisfies regulatory requirements but also significantly enhances the safety, efficacy, and user satisfaction of medical devices.
Medical devices are integral to modern healthcare, facilitating diagnosis, treatment, and patient monitoring. However, their effectiveness extends beyond technical capabilities. A critical, often underestimated factor is usability: the ease with which healthcare professionals and patients can interact with these devices.
Impact on Patient Outcomes:
Usability directly influences patient safety and treatment efficacy. Poor usability can lead to:
Increased Error Rates: Complex interfaces may contribute to misdiagnosis or incorrect treatment administration.
Suboptimal Treatment Delivery: Cumbersome devices may not be used to their full potential, hindering treatment effectiveness.
Elevated Costs: Unintuitive devices require more extensive training for healthcare professionals and at times extensive technical support.
Device Rejection: Both caregivers and patients may abandon difficult-to-use devices, leading to poorer health outcomes.
Regulatory Landscape:
Regulatory requirements worldwide mandate that medical devices undergo rigorous design, testing, and monitoring to ensure they are safe, effective, and user-friendly. Integrating human factors throughout the development process, conducting thorough usability testing, and documenting these activities are essential components. Post-market surveillance further monitors device usability in real-world settings to continually improve patient safety and device effectiveness.
The FDA’s Human Factors and Usability Engineering Guidance outlines expectations for incorporating human factors into device design and development. While not legally binding, this guidance reflects the FDA’s current perspective and serves as a valuable resource for manufacturers aiming for regulatory approval. Compliance with FDA recommendations is crucial as industry standards evolve, ensuring devices meet usability expectations and enhance patient care.
Under the EU MDR, similar stringent requirements are binding in Europe. Manufacturers must integrate usability engineering into the entire device lifecycle, perform systematic usability evaluations, and manage usability-related risks effectively.
ISO 62366 helps put these requirements into practice by providing a structured approach to Usability Engineering. The standard guides manufacturers in integrating usability considerations across the device lifecycle, including defining and evaluating user needs and risks.
Adhering to FDA guidance, MDR requirements, and ISO standards not only facilitates regulatory compliance but also demonstrates a commitment to producing safe, effective, and user-friendly medical devices that improve healthcare outcomes globally.
Conclusion:
Usability in medical devices is no longer peripheral; it’s a scientific imperative for ensuring patient safety, treatment efficacy, and regulatory compliance. Prioritizing user-centered design principles can foster improved patient outcomes and streamline regulatory approval processes.
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We are pleased to attend together with SE Pharma for the upcoming IPL Forum 2021- supply chain management conferences for the healthcare and food-tech industries!
The conference was held on 20.10.2021 at the Avenue Congress Center.
Gsap experts provide professional lectures:
The Annual Healthcare Industry Supply Chain Management Conference-IPL Forum 2021
Opening seat
9:20 – Implementing GDP in Israel – Regulatory Challenges and Key Insights from Audits:
We are happy to share our range of services that we are providing to the digital health community to accelerate and promote startups- from concept stage to product approval.
The Digital Health Revolution is happening all around us and it is both exciting and terrifying. As a member of the Medical Device community, we have a responsibility to our patients, our families, and our shareholders to follow the current best practices. To date, the standards and regulations have not been able to keep pace with the needs of the patients and the industry that satisfies these patient and user needs.
Many regulatory agencies including the FDA are talking about forming committees that will codify the “current best practice”, often referred to as GxP or “Good [insert name] Practice”. In January 2020, the FDA released a discussion paper titled US FDA Artificial Intelligence and Machine Learning Discussion Paper,in this paper, the agency proposes a framework for Good Machine Learning Practices, and below is a visual representation of the GMLP workflow.
In addition, to address the critical question of when a continuously learning AI/ML SaMD may require a premarket submission for an algorithm change, this discussion paper proposes a framework for modifications to AI/ML-based SaMD.
To date, the FDA has cleared or approved several AI/ML-based SaMD however these have only included algorithms that are “locked”. The power of many of these AI/ML-based SaMD lies within the ability to continuously learn, where the adaptation or change to the algorithm is realized after the SaMD is distributed for use and has “learned” from real-world experience. Following the distribution, these types of continuously learning and adaptive AI/ML algorithms may provide a different output in comparison to the output initially cleared for a given set of inputs.
To adapt to this, the FDA is proposing a principle of a “predetermined change control plan.” The predetermined change control plan would include the types of anticipated modifications based on the retraining and model updating strategy, and the associated methodology – referred to as the Algorithm Change Protocol (ACP) – to be used to implement those changes in a controlled manner that manages risks to patients, see below for an outline of the main components of an ACP:
Back in July 2020, the FDA released a Final Guidance Document looking at what happens when the same medical product has both functions covered by the FDA and functions not covered by the FDA. The uniquely unclear guidance titled Multiple Function Device Products: Policy and Considerations look at what happens when a single product with multiple functions have some that are “regulated” and require FDA review, clearance, or approval other functions that do not require FDA involvement (other regulations like FCC or CE standards for electronics, RoHS, WEEE, UL and other TLA’s may be required).
A “function” is a distinct purpose of the product, which could be the intended use or a subset of the intended use of the product. A product with an intended use is to store, transfer, and analyze data has three functions: (1) storage, (2) transfer, and (3) analysis.
While storage & transfer may not be considered requiring regulatory oversight, the addition of analysis and the type of analysis may require FDA involvement. To make things even more complicated, the FDA has issued guidance that indicates while not “fully ok” the FDA does not intend to focus its regulatory oversight on some devices that pose a low risk to patients for more on this ever-growing category see the FDA’s guidance “Policy for Device Software Functions and Mobile Medical Applications” and “General Wellness: Policy for Low-Risk Devices.”
Many CEO’s will attempt to push themselves into this “low-risk category”, as with most things, the agency has discretion, but with software being the leading cause of recalls in the US, the FDA will be waiting to investigate any complaints and will be looking to punish those that have not followed the guidelines to the agencies liking.
So how do we determine if the “non-FDA-regulated” or as the FDA likes to call it the “other function” impacts on the “regulated” feature? Start with 2 questions, and answer them as if you were working for the FDA:
1) Is there an impact on the safety or effectiveness of the “regulated” feature as a result of the “other function?”
if yes,
2) Could the impact result in increased risk or have an adverse effect on the performance of the device function-under-review.
I would very much like to say that from the FDA’s perspective the following is true:
if the “other function” shares code then the answer to both is yes.
if the “other function” shares the same output screen or graphical user interface, the answer to both is yes.
However, there are always exceptions and those edge cases are why we sometimes need to speak with a member of the Gsap digital health team Regulatory Review Team to confirm.
Below are a number of relevant examples from the guidance for your consideration, while some may enlighten, others may confuse, but that is the art of regulatory science.
This Newsletter Prepared by:
Yaron Eshel,Q&R project manager
Medical device, Digital Health Discussion Team
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The Nobel Prize for Chemistry was awarded this year for the invention of Genetic Scissors: a tool for rewriting the code of life.
Emmanuelle Charpentier and Jennifer A. Doudna have discovered one of gene technology’s sharpest tools: the CRISPR/Cas9 genetic scissors. Using these, the DNA of animals, plants and microorganisms can be changed/edited with extremely high precision.
This technology has had a revolutionary impact on the life sciences, is contributing to new cancer therapies and may make the dream of curing inherited diseases come true.
Since the discovery of CRISPR/Cas9, the research of this tool has led to a blooming landscape of pre-clinical and clinical studies in humans. FDA considers any use of CRISPR/Cas9 gene editing in humans to be gene therapy, thus requiring extensive regulatory efforts in order to bring such products from early concept to clinical application.
Gene therapy products are regulated by the FDA’s Center for Biologics Evaluation and Research (CBER). Clinical studies of gene therapy in humans require the submission of an investigational new drug application (IND) prior to their initiation in the United States, and marketing of a gene therapy product requires submission and approval of a biologics license application (BLA).
At Gsap, our team of Advanced Therapies experts is excited to be at the frontier of this field, with a unique portfolio of process development, preclinical, clinical and regulatory services, assisting our clients to bring gene-therapy products from early POC to realization into clinical use.
If you develop a gene-editing product, do not hesitate to contact us!
Dr. Sigalit Arieli Portnoy, CEO and Founder of Gsap, talks in an exclusive interview about accelerating the development and approval processes of drugs and medical equipment for COVID, including from foreign companies, and reports On the enormous scope of action that accompanies a sense of mission.
