The FDA Group’s CEO, Nick Capman, sits down with Paul Hakamaki, Vice President of Quality at Anteris Technologies, to explore the nuances of medical device supplier management in the medical device industry.
Discussion points include:
» Paul's journey from a supplier quality engineer to Vice President of Quality and his experience across various company sizes in the medical device sector.
» The critical importance of supplier management in the medical device industry, highlighting the necessity for clear expectations, risk management, and fostering partnerships beyond mere transactional relationships.
» A spectrum of supplier relationships, ranging from transactional for standard components to deeply involved partnerships for custom components, necessitating rigorous expectations and qualifications.
» The pivotal roles in supplier management, including purchasing professionals who handle business aspects and supplier quality engineers who manage the technical relationship, ensuring suppliers meet the company's stringent expectations.
» The extensive role of supplier quality engineers beyond conducting audits, emphasizing their importance in relationship building and technical liaison with suppliers.
» The Global Harmonization Task Force (GHTF) guidance document from 2008, which provides a six-stage process for supplier management, underscoring the significance of continuous improvement and proactive management in mature supplier relationships.
» The human element in supplier relationships, often overlooked in guidance documents, which is essential for building strong partnerships that involve personal relationships, understanding, and cooperation.
» The tangible benefits of strong supplier relationships, such as consistent quality, timely delivery, and reduced production issues, which underscore the importance of the human element in forming cooperative relationships.
Paul is a seasoned Quality Leader renowned for driving significant quality improvements through data-driven projects and the daily application of Six Sigma fundamentals. With a robust track record of achieving challenging results across various business units, Paul's approach to quality leadership is rooted in collaborative problem-solving and the innovative application of Six Sigma principles. His expertise has been pivotal in overseeing complex projects such as post-market product design changes, reorganizations, facility moves, and Quality System software implementations.
Before assuming his current role as Vice President of Quality at Anteris Technologies, Paul Hakamaki honed his leadership and quality management skills in several significant roles within the healthcare and medical device industry. As the VP of Quality at Colder Products Company, he led all Quality and Quality System functions, ensuring compliance with ISO standards and overseeing the Six Sigma program across three sites in Minnesota. His strategic vision was further exemplified during his tenure as Director of Global Supplier Quality at 3M's Health Care Business Group, where he developed and implemented a comprehensive supplier quality methodology compliant with FDA and ISO 13485 standards. Prior to 3M, at Medtronic, he led a team of 125 professionals in supplier controls, managing a broad range of quality assurance processes and upholding stringent regulatory requirements. His expertise also extended to American Medical Systems, where he spearheaded supplier quality functions and internal audits, successfully closing FDA-identified compliance gaps and re-engineering the CAPA process through Lean Six Sigma methodologies.
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