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
X-ray image of a human chest showing bones in high contrast. A visible electronic device, likely a pacemaker or implant, is located in the upper left chest area. A bold red arrow points to the device with a label in black and white text reading “definitely not bone.”

Mark and Ariana explore the surprising versatility of barium sulfate—a material used widely in both diagnostic procedures and medical device manufacturing. While many recognize it as the contrast agent you drink before an X-ray, it’s also a key additive that enhances plastic components across the healthcare industry.

Gloved hand holding a test tube filled with red liquid, with a large red arrow pointing at the tube on a blue gradient background.

We explore a groundbreaking shift in how Alzheimer’s disease may soon be diagnosed. Instead of relying on invasive spinal taps or costly PET scans, researchers have developed a blood test that detects key proteins associated with the disease—offering a more accessible and patient-friendly screening method.

A bearded man in a denim shirt uses a handheld breathalyzer device. To the left, bold text reads: "How Breath Testing REALLY works," with the word "REALLY" emphasized in bright purple.

We explore how breath testing in medical devices is transforming diagnostics. Mark Drlik walks through how this technology supports everything from roadside impairment detection to gastrointestinal analysis.

A transparent capsule-shaped ingestible medical device is shown on the right, revealing internal electronics, circuits, and components. On the left, bold purple text reads “Ingestible Medical Devices” against a clean white background.

Mark Drlik and Ariana Wilson introduce the fascinating world of ingestible capsules—tiny, swallowable medical devices that are revolutionizing gastrointestinal health monitoring and targeted therapy.