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
A patient lies with eyes closed while a clinician marks dotted surgical lines on her face with a skin marker. The patient wears a surgical cap. Overlay text reads: ‘More than a procedure?’ in bold font on a white highlight box.

Patient-Centered Field Research in Medtech

In this Before the Build episode, Eric Olson and Paul Charlebois reflect on the value of patient-centered field research—and how firsthand observation can reframe design priorities and impact outcomes in profound ways.

loved hand holding a blood vial in front of blurred Chicago skyline. Overlay text says ‘From vial… To Chicago?’ in bold white font on black background.

Laboratory Diagnostics Showcase at ADLM 2025

Each summer, the laboratory diagnostics showcase hosted by the Association for Diagnostics & Laboratory Medicine (ADLM) draws industry leaders to Chicago.

Thumbnail showing a vial of clear contrast agent on the left, with a red dotted arrow pointing to an X-ray image of a skull displayed on a tablet held by a person in a white coat. Overlay text reads “Not approved here?” in bold black and white text.

Understanding Contrast Agents in Imaging

Nigel and Nick explore how contrast agents in imaging support medical device trials and diagnostics. While bones appear clearly in standard X-rays, soft tissues like those in the nasal cavity often require contrast agents to become visible.

A hospital patient lies in bed with a blurred background of medical equipment; bold text reads “Empathy in Design” across the top.

Translating Emotion into Empathetic Medical Design

What does empathetic medical design really look like in practice? Eric and Paul discuss how emotional insight from field research can profoundly impact the design of medical devices