The following post was authored by Dave Franchino, President & Principal, Design Concepts
We’re on the verge of a fascinating intersection—perhaps collision—as the world of Internet of Things (IoT) technology begins to deeply encroach into the world of medical device development.
We’ve all experienced the remarkable impact of mobile apps in our daily lives, but when the consumer-based IoT begins to intersect with medical devices, things are going to get interesting.
Apple’s new iWatch is the latest in a string of sensorbased, connected devices that offer exciting new platforms for medical device development. Developments in higher-performance sensors that are lower in cost and power requirements, combined with mobile platforms, cloud connectivity, and big data can enable the creation of truly novel devices and systems.
So what does this mean for the medically-focused design engineer? Big changes and new challenges.
Tantalizing new opportunities are available in connecting medical devices more broadly with patients, clinicians, health information, and the healthcare infrastructure. Mobile platforms and accompanying sensor-based connected devices offer the promise of unprecedented levels of information, access, and feedback. When coupled with medical devices, the opportunity to reduce costs, improve patient outcomes, and positively change behaviors is too great to ignore.
With this opportunity comes some peril and additional responsibility for the design engineer. What makes this particularly complex is how rapidly the technological, legal, security, privacy, and regulatory landscape is shifting.
Here are six things to consider when entering this brave new world:
1. Have a Reason to Connect Your Device
Start with deeply understanding the need and make sure you’re delivering a meaningful benefit.
Complexity and risk rise dramatically as you integrate your product so the advantages of doing so should increase accordingly. Given the hype surrounding IoT, companies risk rushing to connected products in an attempt to follow trends.
The most successful medical device IoT implementations will have compelling benefits including lowered cost of patient care, demonstrably improved patient outcomes, and reduced risk of error, misuse, or missed diagnosis.
Implementations based on the subjective promise of improved quality of life or user experiences are plausible, but might face uphill battles in the cost-constrained, tightly regulated medical market.
2. Use a Human Factors-Centered Process
Use formally designed and meticulously documented formative human factors studies and human-centered design principles to study users, tasks, tools, and environments. IoT medical devices may have completely new workflows, users, and user experiences. Too many firms wait until their design is finalized before studying usability and realizing that unseen risks are looming.
For many medical devices, user-related hazards often dwarf device-failure hazards. Putting additional data into the hands of patients and clinicians can be incredibly powerful, but creates new challenges and risks for accurate collection, interpretation, storage, and dissemination that must be clearly understood. A human factors-centered design process including formative studies helps drive lower-risk implementations and establishes a culture and documentation focused on risk mitigation, user benefits, and compelling experiences.
3. Don’t Fake the Risk Analysis
A careful hazard analysis should be the center of your development focus. Rigorously use tools, such as failure mode and effects (FMEA) and hazard analysis to provide a mechanism for the entire design team to identify, discuss, prioritize, and document use and device risks along with their severity and likelihood. Use the hazard analysis as a defining tool to galvanize the development and validation of your strategy.
4. Recognize New Risks & Adopt a Clear Strategy
While connected med devices can provide benefits, they also pose new and sometimes unexpected risks. Make sure you and your team have carefully thought through the risks associated with:
- New clinical risks and possibilities for compromised care.
- Data privacy, management, and integration.
- Device integration, interoperability, and continuity of service.
- Technology churn and obsolescence.
- Hacking and device security.
5. Be Informed & Realistic about New Regulatory Challenges
The Food and Drug Administration (FDA) is grappling with balancing the risks and rewards as it works to protect patients. Expect a rapidly shifting regulatory environment and be prepared to build a compelling case for your product’s safety, security, and efficacy. A pre-market human factors review with the FDA can identify approval risks and help determine testing, validation, and submission strategies.
6. Remember, It’s Still a Medical Device
The speed, fluidity, and flexibility of consumer product development practices is an alluring benchmark. This will lead to frustration at the perceived slow pace associated with medical device development.
“Go fast, fail early” strategies are extremely valuable for need-finding and conceptual design phases but strategies, such as the minimally viable product and ability to refine based on early adopter feedback can be problematic with medical devices. Discipline is required for the validation stages of a project. It’s the responsibility of the design engineer to ensure that development proceeds rapidly, but in a safe, careful and organized fashion.