Developing a medical device has always been a complex process.
Many executives in the medical device industry — from the founders of startups to the heads of billion dollar public companies — have long felt overly burdened by what they consider unduly complex approval processes.
The only way to manage the entire medical device product lifecycle – from regulatory compliance, to global monitoring, quality assurance, risk management and part nonconformance — is through a holistic approach that brings all of these moving parts together into a single, integrated view. When quality, design control processes, and risk management are embedded as an integral part of the day-to-day product design and development cycle, OEMs can dramatically reduce supply chain oversights, employee missteps and product design errors.
But an alarming number of medical device companies go bankrupt due to misleading reports that promote “best of breed” solutions, so-called “linked” systems or even the traditional model of isolated systems. None of these bandaged together isolated systems deliver a truly holistic solution. Unfortunately, medical device executives, whose use of siloed systems has led to product delays, scrap, rework and risk exposure, often realize too late that everything they were told about design was…wrong.
And in the patient focused medical device industry, a failed product could mean your company was…dead wrong.
Arena’s new whitepaper “Everything You Know About Medical Device Design Is Wrong” demonstrates that when quality is embedded in the product design and development cycle supply chain oversights, employee missteps and product design errors can be dramatically reduced.
In this whitepaper, you’ll discover:
Before delving into buzzwords, such as “holistic solutions,” “complete quality pictures” and “enterprise-wide visibility”, this whitepaper highlights why product lifecycle management (PLM) is the first step in a medical device company’s plan to reduce risk and ensure quality in their design processes.
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.
Manufacturers must continue to drive innovation while facing ever-intensifying business challenges, including the onslaught of fierce competition, the difficulty of managing globally dispersed teams, and an increasing need to address quality and risk. On top of this already challenging state of affairs, OEMs must also comply with strict and ever-changing regulatory requirements imposed by differing governing agencies around the globe.
If you want to herd a bunch of “best of breed” solutions — go to a dog show.
If you want to win in the medical device industry, you need a holistic solution that ties quality to the product record. To learn more about how Arena helps medical device companies succeed, please download our new white paper “Everything You Know About Medical Device Design Is Wrong.”