Welcome to our new website for medical device human factors!
Human Ability Designs has been working on a project that we are proud to announce:
We have a new website and newsletter!
As we move closer towards 2021, it’s surprising how fast we reached the fourth quarter of 2020. But then again, as many have said throughout the year: the days navigating a pandemic, working from home, virtual schooling, etc. are long, but the weeks and months are speeding by!
Despite the challenges that the Covid-19 pandemic has introduced this year, we have seen most medical device and pharmaceutical companies continuing to work diligently to stay on target with product development timelines as much as possible. Thus, human factors planning, formative evaluations, summative validations and regulatory submissions have continued to be in high demand.
Even with the rather steady demand for human factors activities, our industry had to pivot into some non-conventional territory to keep projects moving forward. During the timely virtual HFES Healthcare Symposium (May, 2020), FDA and various industry thought leaders shared their perspectives related to one of the most frequently asked questions: Should we run simulated use studies remotely, including both formative and validation studies? Of note is that FDA continues to suggest a consult with them to determine on a case by case basis if your methodology and data from remote validation testing will be accepted for review.
We continue to see white papers, webinars, and other discussions related to creative adjustments we can make to our typical work practices to ensure we are doing our best to keep people safe, especially research participants and staff during human factors data collection activities. During the HFES Healthcare Symposium, FDA also shared data on first-time success of human factors submissions, which indicates our industry has room to improve.
Did you know that FDA reports less than 5% of 510(k) submissions in 2019 had no human factors deficiency identified during the first review cycle, which is down from only 11% in 2018?
We know that in one way or another, 2020 has been a challenging year for the industry. But, it’s also been amazing to see so many colleagues, even competitors, exploring and sharing ideas to keep our industry moving forward with conducting human factors studies to help ensure medical products that are safe and effective for end users are being developed and brought to the market. And Human Ability Designs has enjoyed working with our clients this year to come up with creative solutions to keep human factors strategies moving forward to yield successful regulatory submissions!
As we launch our new website and look ahead to 2021, we want to answer some questions we’ve been asked this year:
Did Human Ability Designs expand this year?
Yes! In April, Melissa transitioned back to working full-time with Human Ability Designs. In the past, the company was focused mostly on accessible design and disability research. We have now broadened the company’s focus to human factors and accessible design. So of course, we are excited that our new website now matches our expanded client services.
Pam Bayer also joined the company as our Client Support Specialist. We have been working with clients to address their regulatory human factors engineering, accessible design, and training needs. We also have volunteered with a few teams on human factors projects related to the pandemic, including a novel PPE. And we look forward to continuing to leverage our experience and expertise to help clients developing medical devices and combination products determine the best human factors strategies, processes, and methods to optimize their user interfaces and achieve regulatory human factors approvals.
What human factors services does Human Ability Designs offer?
As described on the new website, Human Ability Designs’ mission is to help individuals, teams, and organizations design and implement successful human factors engineering strategies, processes, methods and documentation to achieve regulatory approvals for safe, effective, usable, and accessible medical devices and combination products. Our services include protocol development and reviews, human factors trainings, HFE/UE submission reviews, heuristic and expert reviews of user interfaces, task and use-related risk analyses, etc. Explore the website to learn more!
Why should I subscribe to the mailing list?
Human Ability Design’s newsletter will allow us to share emerging topics, industry news, and insights related to human factors regulatory submissions for medical and combination products. Subscribe here!
The newsletter will focus on topics related to the key priorities that Human Ability Designs has experienced to have the greatest impact on successful programs and submissions, which are core to our services:
1. High quality science,
2. Submission and project strategies, and
3. Cross-functional stakeholder involvement.
High Quality Science
We know that good human factors engineering is foundational to meeting FDA and other international human factors regulatory requirements, and Human Ability Designs is focused on delivering high quality solutions. There are various regulatory standards and guidance documents (e.g., FDA guidance, IEC 62366-1) that contain guiding principles for implementing human factors methods that are acceptable to regulatory reviewers. Many may consider ‘following the guidance’ as a recipe for human factors regulatory success. However, there is a deep foundational science and expertise specific to human factors engineering that is required to successfully optimize a user interface during the medical device development process.
Similar to any scientific approach, human factors includes particular best practices, pitfalls, methods, etc. that must be considered in conjunction with the standards, guidance, and regulatory requirements. Human Ability Designs has the expertise, experience, and commitment to quality science to help our clients plan, implement and document sound human factors processes, to help produce safe and effective user interfaces that will be cleared by regulatory reviewers.
Submission and Project Strategies
Human factors projects and submissions need sound strategies to be successful, and Human Ability Designs is passionate about generating sound strategies with our clients. Unfortunately, all too often a lack of strategy leads to project, submission, and even market delays because a user interface may not be systematically optimized or documented to provide adequate human factors evidence for regulatory reviewers to approve. And there seems to be some confusion on strategy development altogether, which is one of the most important parts of the human factors process.
In general, strategy involves setting goals and priorities, determining the actions to achieve the goals, and then managing resources to execute the actions to achieve the goals. Strategy involves coordinated planning, implementation, and management efforts. So, a strategy describes how the goals will be achieved. And a sound strategy typically involves a set of choices for what a team is going to do (and what it is not going to do). So, instead of only stating the goal (e.g., clear ‘Product Y’ by December 2020), a strategy tells us what we are going to do, which will ultimately lead to the desired outcome of a cleared product.
Cross-functional Stakeholder Involvement
The regulatory human factors process requires a cross-functional approach, and Human Ability Designs has extensive experience working with diverse teams, organizations, and stakeholders to yield successful human factors regulatory submissions. We will share perspectives, challenges and best practices to help key stakeholders understand and implement human factors processes, such as task and use-related risk analyses, root cause analysis, residual risk analysis, etc. Human Ability Designs focuses on consulting throughout the product development process, including sharing expertise throughout the journey on how to assess and document the “Human Factors story” during development, updates, post-market audits, etc. We know that first time submission success is not easy to come by, but it’s more than possible and always the goal! We work with clients to conduct thorough planning, analysis, monitoring, and risk management activities for your human factors program, and our expertise helps your team generate more efficient and higher quality human factors regulatory clearance.
We invite you to subscribe to our mailing list, explore our website, and contact us to discuss how your organization will benefit from over 15 years of successful experience in regulatory Human Factors Engineering for medical and combination products.
Human Ability Designs continues to send positive thoughts, prayers, and sincere appreciation to frontline healthcare workers, first responders, and all people throughout the world who are fighting the heavy burdens of the Covid-19 pandemic.