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Orthopaedic device manufacturers face increasing pressures related to the safety of raw materials used in implants and instruments. In order to achieve success in global markets, manufacturers need to consider how to navigate the changing regulatory and economic landscape. Shawn Shorrock, Director of Global Regulatory Affairs for Solvay Specialty Polymers’ healthcare business, provided perspective on this topic at OMTEC® 2014. She spoke directly to the opportunities in emerging markets like China and Brazil, the importance of developing strategy early and the evolving expectations of raw material suppliers.
BONEZONE® asked Ms. Shorrock several follow-up questions to her presentation, which can be downloaded at www.OMTECexpo.com.
BONEZONE: What questions should device manufacturers ask when determining raw material utilization for a new product?
Shorrock: Companies should ask: What is the history of use for this product in this type of device? What are the global regulatory requirements for my device, and will the technical and regulatory information available for this material adequately support my global registrations?
BONEZONE: What questions do global regulatory bodies ask regarding raw material utilization in medical devices? How should device manufacturers prepare to answer these questions?
Shorrock: The scrutiny on raw materials is increasing globally due to several well-publicized issues in recent years. For example, several regulatory bodies are asking, “How can you prove that the raw material in your implantable device is, in fact, the implantable grade and not the industrial grade?” Additionally, we continue to see focus on additives for all products, especially related to colorants. In many instances, the only way for a medical device company to adequately address the questions is to rely on their raw materials suppliers’ contributions.
BONEZONE: What raw materials used in orthopaedic devices and instruments are receiving more scrutiny than others?
Shorrock: We are definitely seeing increased scrutiny for all raw materials for implantable devices globally. In the U.S., there has been an increase in recent years on the materials for instruments, especially those in direct contact with bodily fluids and tissues, even if only for a short time.
BONEZONE: From a raw material supplier perspective, what growth opportunities do you see in the orthopaedic industry?
Shorrock: We continue to see interest in metal replacement for all types of orthopaedic devices. Additionally, markets outside of the U.S. and EU are growing quite significantly.
BONEZONE: What factors should device manufacturers consider when looking for a raw material supplier?
Shorrock: Companies should answer the following questions: Is this supplier simply interested in a transactional relationship, or can I count on them as a partner in my approach to the market? How will this raw material supplier support me from a technical and regulatory standpoint as I take this new product to the global market? Is the raw material supplier committed to the industry in terms of the quality and quantity of support, products, quality of materials, knowledge of my application and my market? Also, what level of change notification or control does my raw material supplier offer for their products?
BONEZONE: What question should we ask you that we haven’t?
Shorrock: What recommendations do you have for orthopaedic companies with respect to the actual sourcing process for raw materials?
We are seeing more orthopaedic companies include engineering in their sourcing decisions, and this certainly helps provide more than a pricing lens when looking at the sourcing process. However, we also strongly encourage these companies to include global regulatory personnel in that process. This helps to ensure a shorter, less-costly time to market.
Shawn Shorrock is Director of Global Regulatory Affairs for Solvay Specialty Polymers’ healthcare business. Ms. Shorrock graduated with a Bachelor’s Degree in mechanical engineering from the Georgia Institute of Technology in 1995. She joined Solvay in 2000 and has worked in the medical market since 2004. In her role with Solvay, she works closely with customers as well as testing agencies, regulatory bodies and all other aspects of the supply chain to support the use of polymers in demanding healthcare applications. She can be reached at shawn.shorrock@solvay.com.
