Med Devices Manufacturers Face Growing Challenge of Regulation

Medical Devices Compliance

Managing the environmental and regulatory performance of products is an increasingly complicated challenge for medical device manufacturers who face a myriad of requirements from regulators, consumers and customers to control and report on the toxicity, safety and overall environmental impact of their products.

Today’s medical device products are more complex technically and commercially. They have more variants than ever before and are designed to support global markets. Along with complex products, many medical device manufacturers have evolved to become less vertically integrated relying more and more on multi-tier, global partnerships for design and manufacturing.

At the same time, the sluggish global economy and pressure from developing markets have forced manufacturers to adopt aggressive cost targets, continuously look for ways to reduce cost, and try to manage unpredictable cost drivers such as wildly fluctuating commodity prices.

All the while, manufacturing leadership faces exponential growth in product compliance obligations including regional demands, scrutiny on conflict minerals, sustainability targets, and hundreds of new environmental regulations annually. The number of environmental requirements alone has grown significantly in recent years.

Designing great new products on-time, on-cost and on-compliance requires a tremendous amount of coordination and communication, such as communicating supply chain preferences to product designers as early as possible to help guide design and part selection decisions. It also requires collecting a tremendous amount of detailed information from a multi-tiered supply chain. Supply chain teams are responsible for gathering the necessary part data and supplier information required by engineers to make design decisions.

One great example of supply chain data collection challenges faced by manufactures is in the area of materials compliance. Traditionally, sourcing continuously bombards suppliers for disclosure updates so they can respond to ever changing government material compliance regulations like REACH, RoHS and conflict mineral regulation as new requirements are identified. Manufacturers must collect, process, and manage disclosures from potentially thousands of suppliers on hundreds of thousands of parts in order to understand the compliance status of parts and product.

This process is inefficient for suppliers and manufacturers alike. Today’s manual data collection processes are not only cumbersome, inefficient, and costly, they can result in inconsistent data quality. For example, many compliance regulations are not static. They change with time as regulatory bodies add new restrictions and alter the requirements. Two regulations in particular, REACH and RoHS, are evolving rapidly and present manufacturers with significant challenges as they struggle to stay up to date with the mandates.

REACH continues to evolve as new chemical substances are added to the Candidate List Substances of Very High Concern (SVHC). The European law requires that manufacturers of products distributed in Europe report if a product contains more than a specified amount of any SVHC. RoHS evolves as exemptions are added, change or expire. RoHS mandates that producers of certain categories of electrical and electronic equipment are not allowed to place products on the European market that contain six “banned” substances, unless they qualify for a valid exemption.

While managing product environmental and regulatory performance is critical for corporate strategy and product stewardship, it is also vital to ensure products can be legally sold in target markets. Non-compliance with regulatory mandates such as conflict mineral regulation, REACH, RoHS, ELV, RRR, WEEE, Battery and Packaging Directives can result in blocked shipments, recalls, fines and penalties.

Collecting full material data is the best way to understand detailed information about every material and substance used in product components. And while the task of collecting the necessary information may seem daunting, especially when considering the number of parts and materials suppliers provide, there is no need to feel overwhelmed.

You can learn more about the best ways to collect product material and compliance data by downloading our exclusive white paper. And stay tuned for our next post which will identify the six best practices for data acquisition strategy and governance.

About Howard Heppelmann

Howard Heppelmann is senior general manager, Supply Chain Management segment at PTC. He has worked in the PLM industry since 1993 and has extensive experience working with leading manufacturers to help them elevate their product development effectiveness.
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One Response to Med Devices Manufacturers Face Growing Challenge of Regulation

  1. Pingback: 6 Tips for Building a Compliant Product | PTC

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