Arena Blog

Get the Med Dev 411 Before You Need 911

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emergency-red-phoneStreamlined product design processes are the heartbeat of every electronics manufacturer—especially medical device companies. Unfortunately, too many med devs suffer from clogged arteries because they operate with a siloed mentality in which departments fail to share information cross-functionality. This results in misdiagnosis of your processes resulting in product errors, scrap, rework, and shipping delays.

Without streamlined product development processes, even the smartest medical device companies will flat-line in frustration.

Beeeeeeeep. It’s too late. Your company couldn’t be saved from bankruptcy because you didn’t have the business intelligence necessary for early detection that there were matters of regulatory non-compliant parts, bottlenecks, end of life (EOL) parts and other ailments.

A new Arena whitepaper, “Why Integrated Cloud PLM Guarantees Product Lifecycle Visibility” explores how a holistic product lifecycle management (PLM) solution with both embedded tools and seamlessly integrated external solutions can give companies great visibility across the product lifecycle.

By adopting an embedded integrated PLM system, companies large and small can improve the efficiency of their operations, resulting in better-quality products with faster time to market. And with the ease of communications access provided by cloud-based computing, a truly holistic PLM solution can help any electronics manufacturer achieve new levels of success in new product development.

To beat a dead horse, think of an integrated PLM system as akin to Kaiser Medical’s “continuity of care” system in which every specialist has access to your latest medical records. The ability for physicians to see your medical history empowers them with knowledge to more accurately diagnosis medical problems.

Holistic PLM Approach Benefits Quality, Too

Integrated PLM solutions in­clude tools that make it possible to move well beyond the basic management of a product and pro­vide clear, visual insight into the design, development, and manu­facturing of a product, including component costs, availability, and factors affecting time-to-market—like when that pesky part may experience its ‘end of life.’

An integrated PLM system can not only improve a company’s efficiency in product develop­ment but, when tied to an embed­ded quality management system (QMS), it can yield new products that are constantly improving in quality. A holistic approach to quality can dramatically reduce product design errors. And wouldn’t it be nice to be able to collaborate effortlessly—and inexpensively—with your suppliers (and their suppliers) about complex electronics?

A PLM-based quality solution helps companies involved with products where quality is criti­cal, such as in the medical device sector, to better meet FDA regula­tions and product quality business processes, including: 21 CFR Part 11, 21 CFR Part 820 and CAPA (corrective action and preventive action).

As Peter Lucas, COO of Epic Medical Concepts & Inno­vations (EMCI), observed of the holistic PLM solution provided by Arena PLM BOMControl and Arena Quality, “We know when we change a specification on one part of one of our devices, we immediately know what other parts, products, proce­dures, and manufacturing processes are affected. We can jump straight from there into engineering and document change requests and orders, as those can interconnect with our CAPA pro­cess within Arena Quality.”

Lucas is a med dev guru who knows that this type of holistic approach to PLM results in continuous improve­ments in product qual­ity. Operating costs will decrease as product failure rates decrease both inside the company during product develop­ment and for customers outside the company.

By combining PLM and QMS practices, quality begins at the design stage of every product, with such factors as the selection of PCB materials and components for a new product based on tradeoffs between cost and long-term reliability. From engineering to procurement, every group can share in the water-tight quest for quality that comes with a continuous quality improvement platform that is embedded in an effective PLM system.

In the medical device industry, quality is not only important, but often a matter of life or death. A holistic approach to medical device product lifecycle, from regulatory compliance, to global monitoring, quality assurance (QA), risk management, and part nonconformance, can de­liver a single, integrated view that eliminates errors and builds better-quality products.

By integrating PLM and QMS ap­proaches, all members of product development teams and related departments can be part of a qual­ity improvement process. Imagine breaking down silos and collaborating, identify­ing problems before they become more serious, and participating in a “quality campaign” that will continue to drive the company to­wards achieving higher and higher quality goals.

Consider getting your copy of the “Why Integrated Cloud PLM Guarantees Product Lifecycle Visibility” whitepaper today and see how your medical device company can benefit from PLM.