Developing medical devices is a high-stake endeavor. It’s not about building fun gadgets but about creating life-saving innovations. Without the right strategies, these common mistakes in medical device projects can hit roadblocks that, if left unchecked, can snowball into costly setbacks.

Take the Therac-25, a radiation therapy machine infamous for teaching the industry what NOT to do. In the 1980s, this device caused serious patient harm thanks to sketchy design controls, murky requirements, and slapdash testing.[1] It’s a textbook case of how missing the mark early can lead to catastrophe. Think of it like catching a small leak before it floods the basement.

Thankfully, we can now learn from these mistakes! Here’s a look at some of the most common mistakes that can trip up even the most promising medical device projects, and how to avoid them!

Common Mistake #1: Skipping QA/RA Until It’s Too Late

Imagine your medical device project is moving along smoothly, and then BAM!!! Regulatory roadblocks and unaddressed risks derail everything. What went wrong? The most likely culprit is that QA/RA wasn’t involved early enough.

Drawing on my personal QA/RA experience, delaying the involvement of the QA/RA department is a major common mistake in medical device projects that is hard to ignore.

Quality professionals are the unsung heroes of medical device development, playing a critical role in ensuring quality and regulatory compliance, identifying potential risks, and implementing mitigation strategies.

When QA/RA enters the picture late, they’re forced to prioritize damage control – fixing problems that could have been avoided – over proactive risk assessments and quality planning. This shift not only consumes more time but also increases the risk of non-compliance, delays, and product failures.

In fact, a 2023 FDA review of the warning letters highlighted critical compliance issues. Key issues among them were devices exceeding the scope of their marketing submissions or failing to implement corrective and preventive action (CAPA) procedures.[2] While these problems typically surface post-launch, they often stem from gaps during development – gaps that QA/RA, if involved early, could have mitigated.
Think of QA/RA like firefighters: involving them early equips the team with prevention strategies, while late involvement leaves them extinguishing fires. By weaving their expertise into the process from the start, projects are more likely to avoid costly surprises and stay on track.

Common Mistake #2: Ambiguous Product Requirements

Ambiguous product requirements are a recipe for disaster. It can lead to regulatory non-compliance, delays, recalls—and ultimately, a compromised product. To top it off, it wastes resources and complicates the entire compliance process.

The problem intensifies when teams lack a solid understanding of regulatory standards like FDA, MDR, or ISO 13485. Misinterpreting these requirements can derail a project entirely.

Additionally, as regulations evolve rapidly across regions, staying current becomes crucial.[3] Falling behind on updates only increases the risk of confusion and non-compliance.

This is where involving the right stakeholders early – such as QA/RA professionals – comes in. They can help define and clarify requirements, ensuring a smoother path forward.

Common Mistake #3: Weak Risk Management and Verification

Risk management isn’t just a box to tick before the launch – it’s a process that needs to be baked into every phase of your project. Neglecting it leaves the project exposed to safety issues, regulatory setbacks, and reputational damage, as key risks go unaddressed.

Regular updates to risk and benefit analyses, especially as design changes or new clinical trials are introduced, are critical to maintaining alignment with safety and regulatory requirements.

Risk management doesn’t stop at identifying hazards; it requires ongoing monitoring and adaptation. Without regular and thorough risk assessments, the likelihood of safety issues or adverse events increases, potentially exposing the company to legal liabilities and long-term reputational damage.[4]

Equally crucial is the role of verification and validation, which is deeply intertwined with effective risk management. These processes serve as the backbone of ensuring that the product works as intended and meets regulatory expectations.⁴ When verification and validation protocols are incomplete or testing phases are rushed, critical design flaws or safety concerns can go undetected. This not only jeopardizes patient safety but also undermines the integrity of the entire product development lifecycle.

By tackling risks head-on and investigating them through verification and validation processes throughout the lifecycle, projects can avoid unnecessary setbacks, ensuring both regulatory compliance and timely market entry.

Common Mistake #4: Poor Design Review

A strong design control process is fundamental to successful medical device development. Weak or inconsistent design reviews are a major red flag that can lead to problems down the road.

When design reviews aren’t thorough or properly timed in the product lifecycle, critical design flaws, safety risks, and regulatory issues can slip through the cracks. This can lead to costly delays, compliance failures, or even product recalls.

Design reviews aren’t just a formality – they’re essential to ensuring that the device meets safety standards, works as intended, and complies with regulatory requirements.[5] If reviews are rushed, skipped, or fail to include the right stakeholders, the project will be more vulnerable to serious risk. A consistent and thorough design review process ensures that potential issues are identified early, and the product stays on track with safety and regulatory standards. 

[1] Leveson, N. G. (1995). Medical devices: The Therac-25 story. In Safeware: System safety and computers (Appendix A). https://legacy.cs.indiana.edu/classes/c211/leveson-safeware-therac-25.pdf
[2] Fitzgerald, S. (2024, February 21). US FDA CDRH Warning Letters: A Review of 2023. Emergo by UL. https://www.emergobyul.com/news/us-fda-cdrh-warning-letters-review-2023?utm
[3] Majumder, A., Debbarma, S., Datta, P., Paul, B., & Debnath, S. (2024). Current trends and challenges in medical device regulation. Journal of Propulsion Technology, 45(2), 277-289.
[4] Gadhiraju, A. (2023). Regulatory compliance in medical devices: Ensuring quality, safety, and risk management in healthcare. Journal of Deep Learning in Genomic Data Analysis, 3(2).
[5] Justiniano, J. M., & Gopalaswamy, V. (2003). Practical design control implementation for medical devices. In Informa Healthcare. Retrieved from Practical%20Design%20Control%20Implementation%20for%20Medical%20Devices-Informa%20Healthcare%20(2003).pdf