Medical device manufacturers face enormous risks - regulatory, legal, and financial - based on their products and operating processes. The risks range from minor disruptions to operations caused when auditors spot non-compliance with legislation, to the loss of public trust and brand reputation that might result from successful litigation by claimants. We would expect risk analysis to be a top priority for shareholders, owners and senior executives. The purpose of this research was to assess the extent to which risk management is routinely employed within medical device companies as part of day-to-day development, procurement and manufacturing operations. We also identify weaknesses in current approaches and identify best practices.
What this research shows is that everyone is focused on risk management and analysis, but that the processes and practices may be somewhat incomplete. Strategies for mergers and product line proliferation are common, but it‟s not clear that companies‟ approaches are adequate for the task. Further, not all companies are truly focused on what their customers care about - which inherently raises the risks that the business might meet internal metrics yet fail to gain market share.
Some of the weaknesses in risk management processes include poorly managed product development and design transfer processes, low visibility among departments, sites and partners; incomplete risk and root cause analysis, cumbersome corrective action processes, inconsistent information, and manually processed compliance paperwork. These clearly create risk to both patients and the business‟ success.
Companies that enjoy growth in both revenues and profits understand that their success stems from issues customers value, namely product quality, customer service, and flexibility. These growth companies also have more formal processes to foster teamwork across departments and among trading partners. They are more likely to support these processes with application software for quality, regulatory, enterprise, manufacturing, and product management. As a result of these practices, they are more likely to make gains in quality, operations, and financial metrics.