Pre-Clinical Lessons We Wish We’d Known

Resources

Pre-Clinical Lessons We Wish We’d Known

Topic: Webinar

What seasoned medtech developers would do differently — and why it matters

Pre-clinical studies and early-stage trials are some of the most challenging — and expensive — milestones in medical device development. Yet, many teams encounter avoidable setbacks that could have been prevented with strategic foresight and practical lessons learned from experience.

In the webinar “Pre-Clinical Lessons We Wish We’d Known,” three experienced medtech professionals — Joris van der Heijden (Concept Development Lead), Paul Hulme (Human Factors Engineer), and Nick Allan (Bio Services Manager) from StarFish Medical — share candid stories, real-world challenges, and the pivotal pre-clinical insights they’ve gained over decades of medical device development.

Key Takeaways from the Webinar:

  • Design with the drug container in mind — Why selecting or accommodating the right primary drug container is critical for pharma partnerships and market acceptance.
  • Minimizing use errors through user-centered design — How real-world user behavior and stress conditions impact device performance, and why early usability testing is essential.
  • Lessons in IFU reliance and training — Why you can’t count on users reading instructions, and how hands-on training and competency checks can mitigate risk.
  • Packaging and labeling pitfalls — Surprising findings on what users actually notice on packaging (and what they don’t) and how simple design changes can improve safety and compliance.
  • The risks of last-minute design changes before trials — A cautionary story from clinical research where small hardware adjustments led to major setbacks.
  • Pre-clinical validation strategies that work — How simulation models, imaging studies, and stepwise testing can reduce uncertainty before entering costly clinical trials.

Whether you’re an engineer, program manager, clinical lead, or regulatory professional, this webinar offers practical, hard-earned advice to help you avoid delays, reduce risk, and position your medical device for clinical and market success.

Speakers

  • Joris van der Heijden, Concept Development Lead, StarFish Medical
  • Paul Hulme, Human Factors Engineer, StarFish Medical
  • Nick Allan, Bio Services Manager, StarFish Medical

Pre-Clinical Lessons We Wish We’d Known

Insights to help you avoid costly mistakes — before clinical trials begin.

Watch the recording
Engineers conducting pre-clinical testing of a novel medical device in a controlled laboratory environment

The EU Breakthrough Device (BtX) Designation Program

For manufacturers of novel devices that can make a significant impact to patient health, the goal of the program is to offer a path to streamlined and potentially faster market entry without sacrificing the rigour around ensuring safety and performance.

Medical device data management displayed on a connected healthcare tablet

Data Management Is Now a Core Device Requirement

When I was starting out in medical devices, the discussion focused on the possibility of an internet of things and the promise of “big data” about everything.

Human factors and operational controls in a medical device cleanroom

ISO 14644-5:2025 Cleanroom Operations Explained

With the release of ISO 14644-5:2025, Cleanrooms and associated controlled environments, Part 5: Operations, the standard places increased emphasis on operational discipline, human factors, and contamination control behaviour.

AI-enabled medical device software interface illustrating FDA PCCP guidance for controlled algorithm updates

Understanding the FDA’s New PCCP Guidance for AI-Enabled Medical Device Software

This article outlines the core elements of the PCCP framework, the types of modifications it applies to, and how the FDA expects manufacturers to use it in practice.