Boston Conference Aims to Demystify Medtech Outsourcing

Uncertainty abounds in today's medical device industry. While the world’s aging population is spurring demand for medical technology, the industry is also facing a number of hurdles. The supply chain is becoming ever more complex; the pressure to slash healthcare costs is intense; operational costs are up; navigating the regulatory climate—both in the United States and abroad—is often an exercise in frustration. And, domestically, there are concerns about how healthcare reform will ultimately affect the medical device industry.

June 28, 2012

3 Min Read
Boston Conference Aims to Demystify Medtech Outsourcing

Outsourcing can be used to help device companies meet these challenges as it can help them cut costs and redirect energy into adapting to the rapidly changing business climate. As Nancy Duarte-Lonnroth, director of quality and regulatory affairs for Celestica HealthTech, explains, "a strategic partner can offer a current and broad surveillance of the global supply chain and anticipate the latest technological developments or availability of components."

Yet outsourcing itself can pose its own challenges. For one thing, contract manufacturing only works if you find the right partner(s) for your particular needs, and, even then, your firm must clearly articulate your needs to them and that relationship is well managed. Examples of other considerations include intellectual property, supply-chain management, and cultural and operational matters when dealing with foreign suppliers.   


To help medical device professionals get the most out of outsourcing—and to better understand the evolving medtech market, MD+DI has launched an event titled “Medtech Supplier Relationships” that will be held August 22–23 in Boston. (Disclosure: I’ll be chairing the event.)

Following is a brief summary of the topics covered in the conference agenda along with mention of who will be speaking at the event:

 DAY 1

  • The shifting market for medical device supply chain. Mark Leimbeck, Quality and Training Program Manager, Underwriters Laboratories.

  • Key factors in supplier selection. Olen Chiddix, Director of Materials, Pathway Medical Technologies.

  • Building collaborative partnerships. Karen Conway, Executive Director, Industry Relations, GHX.

  • Creating a strategic polymer supply chain. Kathleen Murtagh-Galea, Sales Development Manager, Healthcare, Solvay Specialty Polymers.

  • Panel Discussion: Utilizing suppliers to add value to your devices. Yong Cho, Senior Technical Manager, Genentech; Mark Leimbeck, Quality and Training Program Manager, Underwriters Laboratories; and Mark Bonifacio, President, Bonifacio Consulting Services.

  • Intellectual Property (IP) issues and open innovation challenges when working with suppliers. David J. Dykeman, shareholder and patent attorney, Greenberg Traurig.

  • Case Study: Evaluating suppliers based on risk using an effective supplier assessment tool. Nicholas Pelletier, Product Development, Vention Medical.

  • Working internationally: Utilizing CMOs to gain market entry in new territories. Mark Bonifacio, President, Bonifacio Consulting Services.

  • Overcoming the cultural and operational challenges of working with international suppliers in emerging economies.  Yong Cho, Senior Technical Manager, Genentech.

  • Medical device supplier qualification and management. Edwin Lindsay VP of Quality & Regulatory, Vascular Flow Technologies.

 DAY 2

  • Supplier controls and validation: Maintaining quality agreements to manage and minimize risk. Michael B. Checketts, Director of QA/RA & Technology, Ametek.

  • Employing design controls to meet internal quality and external regulatory requirements. Paul B Wernke Jr. Principal Quality Assurance Engineer, Cordis Corp.

  • Panel Discussion: What will the FDA expect? Strategies to avoid supplier-based FDA warning letters. Michael B. Checketts, Director of QA/RA & Technology, Ametek; Paul B Wernke Jr., Principal Quality Assurance Engineer, Cordis Corp.; Steven Niedelman, Lead Quality System & Compliance Consultant, King & Spalding LLP;  Christopher J. Devine Ph.D., President, Devine Guidance International.

  • Undertaking supplier auditing and ongoing evaluation of suppliers to meet FDA and international requirements. Christopher J. Devine Ph.D. President, Devine Guidance International.

  • Establishing performance management systems and metrics to drive efficiency, reduce costs, boost quality and enhance supplier value. Dan O’Leary, President, Ombu Enterprises.

  • Undertaking robust process validation to ensure end-to-end quality across your supply chain. Scott Frederick Manufacturing Engineer, Bradshaw Medical.

  • Conducting a risk-based assessment and management of suppliers, Michael Weber, Director; R&D; Quality Assurance; Manufacturing, IT, Soluble Systems.

  • Creating continuous joint value by measuring effective relationships, Tom Hughes Executive Director, Strategic Marketplace Initiative.

Brian Buntz is the editor-at-large at UBM Canon's medical group. Follow him on Twitter at @brian_buntz.

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