Medical Product Outsourcing features Forj Medical, with a look at how to manage failure points during custom electromagnetic sensor assembly for medical devices.
Excerpt from the article:
Custom electronic components—especially miniature electromagnetic (EM) sensors—present unique challenges for medical device OEMs. High-risk failure points can emerge at any stage of development, from prototyping to mechanization to scaling, and the stakes are high. Left unaddressed, these failure points can compromise patient safety, inflate costs, delay time to market, and jeopardize commercial viability—underscoring the importance of failure mode and effects analysis (FMEA) for medical devices.
While the types of failure points don’t necessarily change across development and production stages, how they’re managed must evolve throughout each phase to ensure success. Early detection is ideal, but even when issues are discovered during later stages, sound management practices can salvage projects and keep devices on track for success.
Following offers insights on how to recognize and manage failure points at every stage of custom EM sensor assembly, from initial prototypes to high-volume production.
High Stakes: The Cost of Poor Failure Point Management
Nearly every project has potential failure points. The key isn’t to simply anticipate them—it’s to identify them as early as possible, then properly manage and mitigate them. Poor management comes at a high cost, jeopardizing not only the project itself, but also patient safety and OEM reputation. The real-world costs of failure point mismanagement include:
- Financial Losses: Rework, lost yield, and scrapped product quickly add up, especially when you’re dealing with high-value components.
- Market Delays: Delays in validation, regulatory testing, and production open the door for competitors to gain a foothold in the market.
- Clinical Risk: Failure points that go unaddressed can lead to device malfunction, medical procedure complications, and compromised patient safety.
- Brand and Reputation Damage: Clinical end users could lose trust in the product or brand, impacting future revenue and credibility in the market.
Note that late-stage failures are exponentially more expensive and damaging than early-stage failures, underscoring the need for proactive failure point identification and management.