"Serious adverse event reports related to medical device use have outpaced industry growth by 8% per annum since 2001.
An analysis of root cause data reveals that failures in product design and manufacturing process control caused more than half of all product recalls." 
The reliability challenge for most medical device manufacturers today lies in the hampered ability to effectively evaluate product design given the multiple interactive subassemblies and process complexity of modern medical technology—varied boards, externally supplied components, connectors, assorted separate housings, plastic casings, software—much less facilitate a fast, effective process control program to weed out manufacturing-induced flaws, inferior supplier substitutions or, even worse, counterfeits.
Qualmark’s COE has in-depth experience in working with medical product designers and manufacturers to help successfully deflect FDA recalls, avoid litigation, reduce warranty incursions and elevate brand reliability.
SUCCESS PROFILE: Bedside Monitor Manufacturer
A leading hospital bedside monitor manufacturer turned to Qualmark’s COE for help as they struggled to find a solution for one of their devices experiencing a large number of field failures. This new device’s design called for measuring multiple points of patient data simultaneously, which presented a multi-layered complexity in attempting to identify the design (or possible manufacturing) cause(s) of the failures.
Under 483 scrutiny, quick resolution was paramount for avoiding FDA and financial consequences. Weeks of effort had already been exhausted by the manufacturer to determine a solution when they reached out to Qualmark.
Based on information gathered from this manufacturer’s product SME’s (Subject Matter Experts), Qualmark’s COE team developed a strategic approach that enabled rapid identification of the key product issues.
RESULTS: Within 30 hours of implementing Qualmark’s solution, Qualmark was able to identify to the customer the solder issues, component mount issues and software timing issues that were severely compromising this product’s field performance. Following root –cause analysis and corrective action, this manufacturer launched a highly successful, safe and profitable product.
The Return on Investment (ROI) from Qualmark COE solutions is proving to be quite substantial.