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.
What should be the perception of a product’s real-world performance with regard to the published spec sheet? While it is easy to assume that the product will operate according to spec, what variables should be considered, and is that a designer obligation or a customer responsibility? Or both?
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