PLM to the rescue
While aiding in compliance has always been a part of the value proposition around Product Lifecycle Management (PLM), vendors in this space have stepped up their efforts as part of their evolving product pitch. Some, like PTC, have acquired technology to add functionality like requirements management and quality management to their suites. Others, like Dassault Systemes, have packaged up a set of components into a fully integrated suite that promises to deliver the end-to-end traceability that links compliance directly to innovation and design practices.
Consider Dassault's new Licensed to Cure, a packaged PLM offering introduced this fall based on its 3Dexperience platform and tailored specifically for the medical device industry. Touting a data-centric versus the more traditional document-centric approach, the Licensed to Cure experience ensures a single source of information for both the design/innovation process, as well as a fully transparent and fully documented change process for managing compliance, according to Jean Columbel, Dassault's vice president of life sciences.
Unlike today, where innovation and compliance are typically handled by different, siloed systems, Dassault, like other PLM vendors, proposed having the same PLM data source and workflow engine serve as the single repository and process orchestrator for both sets of tasks. Doing so, Columbel told me, ensures that information in the product development lifecycle can be stored, reused, and validated as part of the same process. In that way, teams can be proactive rather than reactive, while maximizing their reuse of intellectual property, streamlining the regulatory filing process, and removing barriers to innovation. Columbel said:
We're saying that any information created throughout the product development lifecycle should be stored and validated so it can be reused in any future regulation step. That way, companies don't work in a sequential model -- they work in a parallel way and support a more collaborative paradigm.
PTC, too, believes in enveloping compliance as the by-product of day-to-day design and development work -- not as an after-fact, when it is far more difficult to gather the evidence and document compliance. Moreover, as opposed to the end goal being to meet the minimum standards of compliance, an integrated compliance workflow can actually serve to improve product quality and foster innovation.
Ryan Lloyd, PTC's director of medical development strategy, told me:
Focusing on compliance alone will ultimately allow you to meet the requirements of a regulator, but it doesn't deliver a sustainable advantage for a company in terms of delivering products that are cost-effective and provide good value for the [patient] treatment.
My question is rather pointy, which is: what is the claimed value of having all of those records about every step pf the product design and development? Why should every design decision be placed where it can be second guessed? Most importantly, WHO will obtain the alleged value of all of this rather expensive and complicated to keep documentation? Is it being saved up as fuel for malpractice suits? Or as defense from them?
How about a truthful explanation of just why all these records are so very important.
About 20 years ago, Design News did a story about a new implantable defibrillator from Medtronic. For the story, Medtronic photographed one of its employees standing next to a pile of compliance documentation. The pile was a couple of feet taller than the employee, and I'm sure it has gotten much worse over the past two decades.
Life safety give certain organizations clout to demand whatever they want. Since, they can pull that card at any moment, of course medical design companies are getting mad. Since new tech is being created every day in the industry, regulation is a must. Otherwise, we would still have x-ray machines at the shoe store. Those medical companies bought the ticket, they take the ride. (Hunter S. Thompson quote)
People are lazy, without these regulation woes we'd all get hurt.
Great article with good information. It really is surprising how much PLM is in its infancy in this highly regulated industry.
naperlou you are correct, aerospace companies have relied on PLM for decades to reduce risk and track their development/compliance. These tools are very much needed for the medical community and hopefully companies can adopt these solutions to keep innovation moving forward.
Beth, the compliance issue is an important one. As many engineered products are used in life critical situations, compliance is important. It is important not just for satisfying some external authority, but for serving customers.
That said, this applies to many industries. Avionics is one obvious one. The standards for various industries are generally separate and generally very similar. Thus, PLM vendors, who typically work across industries, can bring this knowledge to bear on new areas of opportunity. Now, if the companies would be smart and look for people with a different, but similar, compliance problem, they might find it easier to comply.
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