In today’s hyper-competitive medical device market, medical device companies must balance the need to meet increasingly stringent regulations with the continuing need to innovate quickly and be first to market. To succeed, medical device companies should ensure these quality best practices are followed:
- Processes complement one another: Manufacturing, engineering, quality control and compliance management must all work together and optimize as a whole to control costs and shorten development cycles so as to retain a ‘First Mover’ advantage.
- Compliance becomes part of the culture: Medical device developers must embed compliance into the day-to-day work life of all global teams; otherwise employees will never be able to keep up with, much less meet, the ever changing array of local regulatory requirements.
- Ongoing, global monitoring of risks: Organizations need to take a holistic monitoring approach to account for the diversity of risks a medical device OEM faces, including product lifecycle, part(s) EOL, compliance, multi-sourcing and inventory risks.
- Ensure everyone participates: If the quality process is relegated to a one-off team using an isolated system, it is almost a guarantee the product will face quality issues. Quality processes must be integrated into the day-to-day product record so that everyone, including members of the extended supply chain, can contribute proactively to producing the highest quality product.
LNS Research recently released the results of a quality management survey that showed medical device executives ranked the ability to “better manage operational risk” and “ensuring compliance” as the top two quality management objectives. The roadblocks that executives felt kept them from achieving those goals were “effectively measuring quality metrics” and “disparate quality systems and data sources.”
Fortunately, with a PLM-based quality management solution, processes are embedded into enterprise business systems and other external data sources, producing – as documented by this research — the following business benefits:
- Reduction of the cost of quality by up to 3X
- A 25% increase in operating margin and a 29% reduction in failure costs.
- A reduction of the cost of poor quality (COPQ), which increased earnings 10 to 15%
When organizations employ disparate systems to manage quality, risk and other key processes, in large part they fail to perform because there is no effective way to retrieve recorded notes in the aggregate or assess the interplay between siloed solutions, making prior corrective actions difficult to adjudicate and true up. Quality Digest discovered that up to “80 percent of quality issues are repeat issues for which a corrective action has already been identified but does not persist.”
Because of existing investments in engineering, many companies are implementing quality management systems (QMS) and associated functionalities, such as CAPA, as an extension of product lifecycle management (PLM). For engineering-intensive organizations, this helps to incorporate quality processes not only into the design phase, but also into manufacturing, sourcing and business operations.
Extending CAPA and other QMS functionalities with PLM strengthens the feedback loop, because it enables stakeholders to take advantage of critical information earlier in the value chain as well as providing downstream opportunities for more rapid feedback when integrations are tied into non-conformities on the factory floor. This rapid iterative process in new product introduction (NPI) results in better-formalized first versions.
With a modern PLM solution, medical device manufacturers can develop a unified information management system for engineering and quality, which creates a single point of entry for all product and quality information irrespective of function. Streamlining independent data sources into a centralized system delivers more accurate product information, improves knowledge sharing, supports better design processes, and provides improved visibility into quality information for all stakeholders. It also eliminates the duplication of data in various disconnected systems.
Arena invests heavily in R&D. In doing so our quarterly new releases have enabled us to scale from a PLM company to an all-in-one product development solution with embedded QMS and ALM functionality. The benefits are tremendous.