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In a recent episode of our podcast, The Life Science Rundown, The FDA Group's Nick Capman spoke with Paul Hakamaki, Vice President of Quality at Anteris Technologies, to explore the nuances of supplier management in the medical device industry.
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A few key points from the discussion:
Medical Device Supplier Management
Paul emphasizes the critical nature of supplier management in the medical device industry, underscoring the necessity for clear communication of expectations, rigorous risk management, and the cultivation of partnerships beyond mere transactional relationships. He points out that the spectrum of supplier relationships varies; standard components may involve more transactional interactions, while custom components require deeper partnerships due to the heightened expectations and qualifications involved. He insists on the importance of these relationships, as suppliers can significantly impact a company's performance, either by being a saving grace or a potential risk if they fail to deliver.
A few action items to consider:
Clarify Expectations: Develop clear documentation and communication channels to ensure that suppliers understand the specific expectations and requirements of the medical device company.
Risk Management: Implement a robust risk management process that includes risk identification, assessment, and mitigation strategies for suppliers.
Partnership Development: Move beyond transactional relationships by fostering partnerships with suppliers, especially for custom components, to ensure alignment and commitment to quality and performance standards.
Roles in Supplier Management
In supplier management, Paul identifies two pivotal roles: purchasing professionals and supplier quality engineers. The former focuses on the business aspects of the relationship, while the latter manages the technical relationship with suppliers. He advocates for the critical role of supplier quality engineers, who are responsible for more than audits; they are essential in maintaining the technical relationship with suppliers and ensuring that the company's expectations are consistently met.
A few action items to consider:
Role Definition: Clearly define the roles of purchasing professionals and supplier quality engineers, ensuring that both business and technical aspects of supplier management are adequately addressed.
Empower Supplier Quality Engineers: Recognize the importance of supplier quality engineers in the technical management of suppliers and provide them with the necessary authority and resources to perform their roles effectively.
Approach to Suppliers and Supplier Management
Paul references the Global Harmonization Task Force (GHTF) guidance document from 2008, which provides a six-stage process for engaging with suppliers. This process includes understanding requirements, qualifying suppliers and components, and establishing control plans for ongoing production. He emphasizes the significance of continuous improvement and proactive management to maintain a mature supplier quality relationship.
A few action items to consider:
Adopt GHTF Guidelines: Familiarize the team with the Global Harmonization Task Force guidelines and integrate the six-stage process into the supplier management program.
Supplier Qualification: Establish a thorough supplier qualification process that includes rigorous evaluation and approval of suppliers and their components.
Control Plan Development: Create detailed control plans for ongoing production that ensure the consistency and quality of components supplied.
Human Aspect of Supplier Relationships
Acknowledging that while guidance documents offer a structured approach, Paul notes they often overlook the human element of relationships. He stresses that building a strong partnership with suppliers involves more than business dealings; it requires personal relationships, understanding, and cooperation. This human aspect is crucial for developing trust and a successful, long-term partnership with suppliers.
A few action items to consider:
Build Relationships: Encourage team members to build personal relationships with suppliers, recognizing the value of trust and understanding in fostering cooperation and partnership.
Communication and Cooperation: Promote open communication and cooperative problem-solving with suppliers to address issues proactively and collaboratively.
Cultural Alignment: Ensure that the company culture and values are communicated to suppliers, and seek suppliers whose values and business practices align with those of the medical device company.
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.
Before 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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