A few words about the Medical Device Industry
Growth and innovation are driving the Medical Device industry into becoming an increasingly global and competitive marketplace. Digitalization in manufacturing, new relationships through outsourcing, mergers, acquisitions, expanded geographic markets, and increased regulatory scrutiny add complexity to the way forward.
At Kepner-Tregoe, we work with medical device companies to address the challenges of working in a highly regulated environment. In an industry where quality is indispensable and competition demands continuous improvement, medical device companies rely on KT to improve investigations, accelerate corrective and preventive actions, and proactively manage risk with rapid and effective issue resolution including regulatory reporting. Kepner-Tregoe’s structured approach to documented troubleshooting for root cause and risk analysis, helps client organizations gain confidence in the CAPA process and achieve status with regulatory authorities.
As expert troubleshooters and decision makers face endless datapoints and constant change, the KT analytic processes for solving problems and making decisions are used throughout medical device manufacturing and development organizations. Our structured methodologies quickly identify relevant data and help develop excellent skills in making the best decisions regarding highly complex issues including capital investments. Strong critical thinking skills help managers address multifaceted issues in new product development, and improve customer support by accelerating issue resolution.
To learn more about Kepner-Tregoe consulting and training solutions for the Medical Device industry, contact Kepner-Tregoe.
It is no longer acceptable to respond to audits and product recalls with CAPAs that only address short term concerns. It’s now all about aligning CAPAs and Continuous Improvement processes.
Integrating training into the workflow helps organizations apply new skills as they are learned to address current issues or meet new goals. Consider how this works in regulated, manufacturing, and service industries.
When human error is to blame, corrective actions often involve addressing the system itself—its balance of consequences, feedback mechanisms, targets and objectives. Consider five factors that influence human error and offer opportunities for improvement.
Controlling process change can be improved, KT methods support three key areas of process validation: planning, installation and qualification.
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