Solving the Problem of Medical Device Poor Quality

Inadequate risk management by medical device providers is significantly impacting the safety of the customers they serve, the quality of their products and their profitability. Billions of dollars are being spent yearly in the medical device industry on the direct costs of poor quality. One would not expect this to be happening given that the medical device Industry is one of the most regulated industries in the world. The required steps and volume of paperwork required to obtain medical device approval is second to no other industry. The question that must be asked is if all this work is being done why are the direct costs of poor quality so high? This paper will show that the current methods used by medical device providers being driven by standards such as ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes [2] and ISO 14971:2019 Medical devices - Application of risk management to medical devices [1] are ineffective at managing risk because they are ineffective at defining the root causes of risk exposure. The reader will learn how a medical device provider can consistently comply with these standards while creating medical devices that will fail to meet the users' needs. The paper will introduce the reader to Risk Based Medical Device Lifecycle Management (TM) (Risk Based MDLM (TM)). Risk Based MDLM (TM) is very effective in reducing/removing the root causes of medical device poor quality through the systematic management of risk over the medical device's entire life cycle from definition of user needs through to decommissioning and disposal of the medical device if applicable. Risk Based MDLM (TM) uses tools many readers may have heard of such as Design FMEAs, Process FMEAs and Application FMEAs. Because of this some may come to the incorrect conclusion that there is nothing new in Risk Based MDLM (TM). Although they have the same names, the FMEAs used in Risk Based MDLM (TM) are fundamentally different than the FMEAs being used by 99% of the companies in the medical device industry. The paper will explain why the vast majority of FMEAs currently being performed by medical device companies are ineffective in managing risk and why the FMEAs used in Risk Based MDLM (TM) are the most effective risk management tools in existence. Existing medical device industry paradigms about the purpose of FMEAs and the steps required for their proper performance are the greatest barrier to the effective implementation of Risk Based MDLM (TM) and the significant benefits it can provide.

Automated summary

Inadequate risk management in the medical device industry is negatively impacting customer safety, product quality, and profitability. The current methods used by medical device providers are ineffective at defining the root causes of risk exposure. Risk Based Medical Device Lifecycle Management (TM) offers an effective approach to reducing the root causes of poor quality by systematically managing risk throughout the device's lifecycle. The existing paradigms in the industry hinder the implementation of this approach.