Solving the Problem of Medical Device Poor Quality Costs

In 2017, McKinsey & Company estimated the 2016 Direct Costs of Poor Quality in the medical device industry at $18 to $22 billion. The question that must be answered is “Given the considerable time, effort and money spent during the development of the typical medical device, why are medical device Direct Costs of Poor Quality so high”? In his presentation, Mr. Harpster identifies the systemic causes of the high medical device Direct Costs of Poor Quality and their solution.

Mr. Harpster covers the following topics:

1) The current state of medical device Direct Costs of Poor Quality.

2) Two medical device Quality Management System tools commonly used by most medical device companies and their weaknesses.

3) How ISO 13485 and ISO 14971 compliant Risk Based Medical Device Lifecycle Management™ (Risk Based MDLM™) can significantly reduce Medical Device Poor Quality Costs while reducing the time to market and improving manufacturing productivity.

4) The five core risks facing all medical cevice companies and the four core tools of Risk Based MDLM™ used to manage them.