One takeaway from the BoneFix pouch project is the role of risk management early in project planning. Initially, the project seemed easy with just sourcing a pouch. However, skipping a thorough risk analysis at the sourcing stage allowed a major issue (solvent odor) to surface late in the process.
If the project team had conducted a Failure Mode and Effects Analysis (FMEA) early on, potential material defects, odor issues, or vendor quality inconsistencies could have been identified before placing a full production order. Small sample testing or even requiring a Material Safety Data Sheet (MSDS) from CamTech would have allowed early detection of the issue. The cost of mitigating a 10,000-pouch odor issue is undoubtedly higher than the cost of performing early, preventative checks.
How can project teams maintain the discipline to apply formal risk management processes even when projects appear deceptively simple or low-risk at first glance?
I totally agree that Failure Mode and Effects Analysis (FMEA) should have been incorporated. This seems like an immense oversight in product development. I think the project and the project team need stricter protocols since it seems too relaxed. The project team should not take source materials at face value. If the vendor says "This material is great and it is just what you need", team personnel should not trust this assumption based off of just words. It is important to build trust with other stakeholders of a product, but team members need to be skeptical of potential problems in source material.
I think creating an atmosphere of preventative thinking in the workplace can also help these potential issues come to an abrupt end. If the team could have sampled this material and put it through some environment conditions that the pouch may be exposed to, they easily would have flagged this. Even though the project is super low-risk, there needs to be serious protocols no matter what.
Had the team spent even 30 minutes on a micro-FMEA, “residual solvent odor” would have arisen instantly (common with heat-sealed pouches). The stage-gate would then have required (i) a 10-unit pilot lot, (ii) a simple head-space GC/MS sniff test, and (iii) MSDS review—all before authorizing the 10 000-unit order. Total delay: ~3 days. Total cost: a few hundred dollars. Compare that with weeks of rework, potential field returns, and brand damage once 10 000 malodorous pouches hit the dock.
Bottom line
Discipline is less about individual vigilance and more about system design: short, mandatory checkpoints; visible metrics; and cultural reinforcement that preventing a failure is as heroic as fixing one. When those elements are embedded, even the “easy” projects automatically receive the level of risk scrutiny they deserve.
Early risk management in a project is critical for the successful development of medical devices. Identifying potential risks at the planning stage allows teams to create mitigation strategies before issues arise. This includes technical, regulatory, financial, and supply chain risks that could impact timelines or compliance. Conducting thorough risk assessments, such as Failure Mode and Effects Analysis (FMEA), helps prioritize risks based on severity and likelihood. Engaging cross-functional teams early ensures diverse perspectives are considered in identifying hidden risks. Establishing risk registers and updating them regularly supports ongoing monitoring throughout the project lifecycle. Early engagement with regulatory bodies can uncover compliance risks and reduce delays later in the process. Proactive prototype testing and validation can expose design flaws before they become costly problems. Ultimately, early risk management increases project resilience, ensures patient safety, and accelerates time to market.
