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.
The site managers explored opportunities to reduce the number of investigations as well as the number of days required to close their investigations. The plant did not have a standard, systematic approach to finding the root cause of manufacturing deviations.
Reduction in required investigations
Closings dropped to this level, compared with the previous year
The work plan to improve the investigation process and incorporate KT as the investigation methodology was completely developed and implemented in less than six months.
Gerresheimer, manufactures specialty glass and plastic products that support the highly regulated pharmaceutical and healthcare industries. Issues arose as the result of a material change-a component made of a soft plastic material had to be changed to a comparable material when the existing one was no longer available.
saved
The application of KT process yielded significant results beyond the hundreds of thousands of euros saved when the quarantined batches were released and shipped to the customer. Most importantly, product safety was ensured. The use of KT analysis and the confirmed root cause helped Gerresheimer to eliminate any risk to end-use customers and avoided the potential for recalls of product already on the market.
Novartis was developing a new process that was among the most complex ever introduced at NRL in terms of chemistry and equipment. Added to this was a crushing schedule. It takes several weeks to produce the API used in this drug. When the first batch was completed, the quality was to spec but the quantity was below target yield. The yield problem had to be fixed quickly in order to ensure supply to links further up the chain.
increase in sales
Sharing a strong commitment to resolving the yield problem, the team followed the KT's ATS process using data from a variety of sources including manual and electronic batch records and trends, development reports, and production shift logs. The problem was solved, and “fixes” were made. When the first fixed batch was completed several weeks later, it met standard yield. Validation was completed in record time. Novartis beat the competition to market, increased market share, and sales boomed, increasing 20%.
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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