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.