Reducing Device Development Timelines: People, Process, and Tools
In this episode of MedDevice by Design, Ariana Wilson and Mark Drlik explore how teams can reduce the device development timeline without compromising quality or compliance. Drawing from real-world MedTech projects, they discuss how optimizing people, process, and tools can help accelerate time to market when speed is essential for business success.
Optimizing People for Faster Device Development
When a client needs a device delivered faster, the team structure can make a major difference. Mark explains that projects often start with one team, but organizations looking to accelerate progress may use multiple teams working in parallel. Similar to an XPRIZE-style challenge, this approach increases upfront effort but can yield faster innovation and more creative solutions. Smaller-scale “bake-offs” between teams can also reveal better ideas more quickly.
Streamlining Process and Scope
Ariana shifts the focus to process. Instead of trying to serve every market at once, she recommends narrowing scope. Focusing on a single regulatory body, such as the FDA, can simplify timelines. Reducing intended use or starting with a simpler device class also helps shorten review and approval cycles. They note that regulatory pathways like the Emergency Use Authorization or breakthrough designations can accelerate approval when appropriate.
Tools and Trade-Offs in Device Development
The discussion wraps up with tools. While sophisticated designs and full DFM can delay regulatory submissions, simpler builds can move faster. Mark highlights maintaining a comprehensive risk registry as a powerful tool to balance decisions between cost, scope, and speed. By tracking both risks and opportunities, teams can make informed trade-offs to optimize the device development timeline for their unique goals.
Enjoying MedDevice by Design? Sign up to get new episodes sent to your inbox.
Related Resources
Accelerated aging in medical devices is a testing method used to estimate how a product will perform over time by exposing it to elevated conditions, most often heat. In simple terms, it is a way to simulate months or years of aging in a much shorter timeframe.
In a recent article for MD+DI, StarFish Medical Software Manager Sean Daniel explores how remote medical devices reliability is becoming a defining challenge as devices move beyond traditional clinical environments into homes, workplaces, and public settings.
This medical vs wellness example shows how device classification can directly change functionality. Even when hardware is similar, what the device is allowed to do can be very different.
Modern medical devices are no longer confined to hospital settings. Wearable cardiac monitors, home respiratory systems, and remote patient monitoring devices now operate within broader digital health networks.