Part of PTC's approach to achieving that goal is extending its Windchill PLM platform with new capabilities in the areas of quality management, including corrective and preventive action (CAPA), along with requirements traceability and more robust document management functionality.
For example, PTC's acquisition of MKS Inc. added the Integrity requirements management and verification platform to Windchill 10.1, while its 2009 buyout of Relex delivered a risk analysis platform that can help engineering organizations identify potential areas of compliance risk early in the design process so they can be mitigated then as opposed to later when it is more costly, Lloyd said.
Even as a relatively small company, Livengood, which manufactures a mobile patient care environment, is feeling the weight of an increasingly complex regulatory climate. As a result, the company has put a number of new processes in place and is leveraging tools like PTC's Creo Direct to inject more rigor into its document control processes and to aid in the creation of DMRs and DHFs. "Being a startup and a small operation, we put in place controls that would get us the results we needed for the first edition (medical electrical equipment compliance standards)," Joe Livengood, the company's chief technical officer, told us.
Subsequent editions of the standard are upping the ante, requiring Livengood to consider making additional changes to its processes, potentially adding PLM over time as they scale to new markets and as the varying configurations of the product get more complex.
For Carestream Health Inc., a maker of medical, dental, and molecular imaging systems, PLM, and specifically Aras PLM, is an essential ingredient in its ability to establish and enforce well-documented, quality systems and manufacturing practices that are critical for meeting compliance. Yet that wasn't always the case.
Traditionally, the company met its compliance requirements using a variety of stovepipe systems and with manual processes. However, the ever-changing complexity of the regulations, coupled with its global operations base, made it increasingly inefficient for Carestream to continue doing compliance in this fashion, according to Dave Sherburne, the company's director of R&D effectiveness and engineering IT. He told us:
We'd control errors by throwing people at the problem. It wasn't that we were in danger of non-compliance, it was that we weren't getting as much innovation out of people. That kind of waste is invisible, it's dangerous, and it's frustrating to people, but that's what happens when you don't have good systems.
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.
Nice to see the quote from Hunter S. Thompson, Cabe. As for regulations, the medical industry was excused from RoHS, just as the military and aerospace industries were. Have those exclusions expired?
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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