Think Agile, Think Safe

5 Considerations for Developing Medical Products in our Changing Regulatory Landscape

Gregor Mittersinker

Taking a medical device from concept to completion can be a long process (not to mention expensive). Here we share 5 considerations for navigating the changing regulatory landscape.

In the race to address COVID-19, these considerations are more relevant than ever. Some of the regulatory hurdles that used to anchor the medical development process have been relaxed by the FDA. Collectively we are now balancing two pressures: the accelerated speed of innovation as the industry rushes to take advantage of this relaxation, and adhering and adapting to constantly changing regulatory guidelines. As researchers, designers, and developers, our challenge—no, our responsibility—is to respond quickly, and with safe and error-free development processes.

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1. The Sandbox Just Got Bigger… So Use the Right Tools to Build a Better Sandcastle

V&V, HFE, FMEA, HIPAA, MDR, Device Classification… There’s no shortage of jargon scattered throughout the medical device product development process. While at first the idea of bringing your technology to life might be daunting, in the end it all comes down to two things: Number 1: Make a plan. Number 2: Stick to the plan! 

For many innovators, working with a design and development partner who knows the ins and outs of these hurdles is an essential step in the process. Not only do we provide guidance to prepare you for the uphill battle, we’re there fighting right alongside you. The recent COVID-19 regulatory easements from the FDA include very helpful rulings for product developers in the remote vital signs monitoring and telemedicine space, which also includes remote ophthalmic assessment and psychiatric disorders. We urge anybody that is currently in development, or is planning future developments, to take a close look at the new guidance documents provided by the FDA to understand how these rulings could benefit you. Reach out to us to discuss your upcoming med tech developments and how an agile strategy can help you get to market faster in a safe and effective way. As a design and development partner, we can help you plan new technologies in combination with the new rulings and empower your medical innovation.

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2. Bring a Map to the Road

Bringing a med device product from concept to market is hard, and without a clear roadmap it’s even harder. Start the process with a market-facing focus! Key questions in the beginning will be, HOW are we improving patients’ lives and WHO is going to pay for it? Med device development is always a balance between human needs and a market focus. Exceptional usability and best-in-class human factors can not only improve the human interactions but drastically help in the mitigation of risk such as the device failing to perform the intended use case. Engage in Human Factors Engineering (HFE) early in the development! The HFE team will be looking at identifying key inputs like possible errors across users, environments, and typical workflows. Identifying these and the associated hazards early allows the team to build effective mitigation strategies, instead of chasing use errors late in the developments. This will guide the UX development process, but also lays the foundation for a rigorous, use error driven software development roadmap. From there, it can help inform user-facing instructions, such as a Quick Reference Guide (QRG), Instructions for Use (IFU) and label claim development strategies and 510K related usability testing.

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3. May the User be Your Guide

Who is the User? In the medical device development world, this isn’t just a question of establishing a target market. No, it’s a question of who is actually going to use the device as a tool, and whether they are a registered nurse or certified technician, or a patient self-administering home care. The steps to use the device might be the same, but the language used to explain the nature of the steps can change a lot based on who the end user is -- not to mention the environment they’re using it in (ex: hospital vs. home care). 

This leads us to the FDA’s next question: how will the user group interact with the product? While regulated product development relies heavily on the mitigation of all hazard-related use scenarios, use errors are still a disproportionately large contributor to the malfunction and recall of medical devices.  Understanding both the user workflow and how many user groups are interacting with the medical device are main contributors to the complexity of the UX development of a product, and they can also add significant time and budget to the research and FDA regulatory documentation steps. The FDA requires testing products with a spectrum of users with various abilities from various geographies to ensure safety and prove that the interface can be used by a range of users across the US. Ultimately, even as regulatory guidelines continue to evolve, fundamental process boundaries and risk mitigation practices are still in place. Safety first is still the order of the day. The task for us as developers is to balance speed and agility with a rigorous process leveraging new technologies and toolkits along the way. Remote testing, advanced simulations and the usage of “Digital Twins” are a few of the examples how to bridge that gap.

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4. We’re Not in Kansas Anymore

Doctors and nurses are busier than ever, and hospitals are being avoided for anything but the most urgent visits. It’s an interesting and exciting time for medical innovations and a definitive moment for the future of digital health. Telemedicine applications, remote diagnostic equipment, and patient monitoring systems are not only gaining acceptance in the industry, they’re helping keep medical staff safe AND reduce the cost of care. 

This of course comes with an increased level of complexity. Patient records have to be kept safe, the correct dosage has to be confirmed, technologies can’t fail, the applications need to be secured, etc. It’s a lot easier to deploy your technology in a hospital. Products used in hospitals can usually rely on a structured training plan and maintenance procedures, which helps in planning the initial deployments and familiarity with the products. 

In-home med devices, on the other hand, are mostly remotely deployed and cannot rely on sufficient training and instructions, these products need to be extremely intuitive and user friendly. They will need to be designed with the ability to guide users through steps with intuitive graphics and on-screen guidance systems. Consumer devices like tablets and smartphones have created best practice examples that medical solutions need to draw from for inspiration on advanced UX and ease of use. Choosing a development partner who not only understands the medical device space but also has experience in high value consumer products will be your best bet for success. While there is room for error and misuse, confidence in remote healthcare solutions is growing. The future is bright, and it’s digital.

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5. Lose Your Manual!

Everyone has experienced the frustration of a poorly written user manual. In the medical development space, the unfortunate byproduct of usability falling short is often tedious Instructions for Use (IFU), warning labels, and packaging instructions. We advise our partners to develop any required documentation in parallel with HFE user testing timelines, to ensure that the user’s voice is reflected in their narrative . Well-crafted shorter Quick Reference Guides (QRG) are sufficient for getting users familiar with the necessary and safe interaction steps, and can significantly shorten the learning curve of your developed innovation.

Don’t let your documentation or labelling strategies be your last step!

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