8TH SEMI-ANNUAL RISK BASED MEDICAL DEVICE SUPPLIER QUALITY ASSURANCE CONFERENCE

JUNE 11-12, 2018 | MINNEAPOLIS, MN

MILLENNIUM MINNEAPOLIS HOTEL

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DAY TWO | TUESDAY, JUNE 12

8:30 REGISTRATION AND WELCOME COFFEE

8:55 CHAIRPERSON’S OPENING REMARKS

9:00 MASTERCLASS: COMMUNICATING SUPPLIER QUALITY RISK TO NON-QUALITY EXECUTIVES
For many executives outside of quality assurance positions, it can be difficult to understand the inherent risks associated quality, the far-reaching consequences that non-conformity can have on the product lifecycle; from delays in manufacturing due to corrective or preventative action, to potential worst-case recall scenarios, as well as the impact of cost-saving measures on the ultimate quality of the end-product. The skill required to effectively render highly technical quality risk assessments into clear and rational summaries for non-quality executives is one where deep experience and strong cross-functional understanding of business needs and priorities is essential. Talking the language of executives from executive leadership to financial, supply chain and procurement to drive forward supplier quality initiatives is a unique but incredibly valuable skill.

  • Calculating the cost of quality for medical devices
  • Communicating value of supplier risk management
  • Effective translation of quality risks into tangible costs

Robert Steele, EVP Regulatory and Clinical Affairs, CONVATEC

 

9:45 EXECUTIVE PROCUREMENT PANEL: UNIFIED APPROACHES TO MAINTAINING PRODUCT QUALITY
Throughout the medical device industry, executives responsible for supplier quality are often challenged in working alongside internal procurement and strategic sourcing partners, and find a level of disconnect between priorities including cost-containment and quality assurance. Creating a unified approach to material and component sourcing which aligns all priorities and creates a streamlined approach to both sourcing and supplier quality will ultimately create the greatest efficiency across the organization, but can be difficult to achieve. Moderated by a seasoned supplier quality executive, direct procurement and strategic sourcing panelists will share lessons learned and best practices in communicating and balancing priorities between these two critical organizations.

MODERATOR:
Spiro Atieh, FREUDENBERG MEDICAL

PANELISTS:
Marti Everett, QUEST DIAGNOSTICS

Rajesh Shreekumar, GE HEALTHCARE

Shibu Korula, COORSTEK MEDICAL

 

10:30 COFFEE & NETWORKING BREAK

 

11:00 LEGAL PERSPECTIVE: RISK-BASED APPROACHES TO CONTRACTING & SUPPLIER QUALITY AGREEMENTS
Quality agreements are a crucial component of contracting with suppliers, but an area that is often rushed and ill-considered by purchasing and sourcing executives when structuring contracts, with many either integrating too stringent of criteria, beyond the capabilities of the supplier, or on the opposite side of the spectrum, not enough quality monitoring, resulting in a lack of control. Striking the delicate balance between overly cautious and expensive quality system controls or a lack of controls requires careful consideration of the priorities of the OEM as well as the capabilities of the supplier to ensure expectations are reasonable and achievable. Reducing a supplier base due to over caution will only cause challenges in ensuring a robust supplier marketplace, thus underscoring the importance of quality agreements that take a risk-based, rational approach.

Paul Gadiock, Senior Attorney, ARENT FOX LLP

 

11:45 MEDICAL DEVICE SUPPLIER DIVERSIFICATION: ENSURING BUSINESS CONTINUITY
In light of recent natural disaster devastation felt collectively around the globe, business continuity management remains to be mission critical for medical device executives that are responsible for supplier management. Virtually any setback within a medical device organization whether caused by natural disaster, equipment failure, insider threat or terrorist can prompt a series of cataclysmic financial and systematic consequences. By establishing a plan of action for suppliers based in categorized high risk regions and acknowledging the need for supplier diversification, organizations can begin to take proactive measures to avoid disruption of operations while maintaining the organizations financial viability.

  • Identifying supplier risks from a regional standpoint
  • Analyzing the impact of operational disruption
  • Proactive and reactive measures for risk mitigation

Tim Sanken, Senior Manager and Business Continuity Expert, MEDTRONIC

 

12:30 LUNCHEON FOR ATTENDEES, SPEAKERS, & SPONSORS

 

1:30 SUPPLIER ROUNDTABLE: SUPPLIER MONITORING & OVERSIGHT OF SUB-TIER SUPPLIERS
Throughout the medical device supply chain, component and material suppliers work with a host of sub-tier suppliers that provide parts and materials used in components and finished products, and which contribute to the overall quality and consistency of the medical device. As such, monitoring sub-tier suppliers for quality assurance must be conducted in a robust manner, and initiated from the outset of partnerships to ensure an alignment of both quality expectations as well as reporting responsibilities. Successful suppliers to medical device corporations recognize the necessity of oversight and the development of auditing practices to ensure that the highest quality components are manufactured and used for the healthcare industry.

  • Opportunities in sub-tier supplier quality agreements
  • Methods for oversight & auditing sub-tier suppliers
  • Aligning sub-tier supplier and OEM quality expectations

MODERATOR:
Steve Niedelman, KING & SPALDING

PANELISTS:
Spiro Atieh, FREUDENBERG MEDICAL

Shibu Korula, COORSTEK MEDICAL

 

2:15 ROUNDTABLES: SUPPLIER SCORECARDS: DEVELOPMENT, EXECUTION & QUALITY IMPROVEMENT
Often utilized to provide a rubric for supplier analysis, supplier scorecards have become a defacto tool for quality monitoring throughout the medical device industry, with the effectiveness in implementation and utilization varying across the industry. As there is such a high variability in scorecard use, analyzing best practices from differing organizational structures, taking into account alternative measurements of risk and success will allow participants with an opportunity to gauge current efforts and consider different uses for this important tool. Attendees are asked to bring one or more scorecards currently utilized for comparison and contrast with others in the industry, with small groups of up to 10 executives sharing best-practices and current initiatives.

 

3:00 CASE STUDY: TACTICAL MANAGEMENT OF NONCOMPONENT OR MATERIAL SUPPLIER PARTNERS
In an effort to create robust supplier oversight and monitoring procedures, many medical device firms are extending the traditional responsibilities of supplier QA executives to include atypical supplier partners, including internal service providers as well as external providers of components such as medical device software. Breaking away from the traditional mold of contract manufactured components or raw materials and considering the methods used for monitoring and managing suppliers of alternative items is a unique and growing trend worthy of investigation. With differing risk-associated considerations, supplier quality executives must consider a different set of tools, from initial quality agreements to ongoing monitoring and oversight strategies in order to ensure ongoing quality.

Spiro Atieh, Senior Quality Engineer, FREUDENBERG MEDICAL

 

3:45 CLOSING REMARKS AND CONFERENCE CONCLUSION