I suspect the answer to your question is that it depends on who is adding the value and bringing the significant technology to the application. If a material supplier isn't bringing extra value they can be fairly compensated for, why consider an application where they might sell a couple of 50 lb. bags, yet be on the hook for large liability when and if something goes wrong. Lawyers do indeed go after whoever has the deep pockets.
Are the manufacturers willing to indemnify and hold harmless material suppliers for micro molding applications? Would that even make a difference when a jury is determining damages in the inevitable suits that will come?
I wouldn't hold my breath waiting for affirmative answers to those questions. In other words, I don't think material suppliers are necessarily the bad guys here.
Material suppliers have always stepped up and devoted personnel and money necessary to develop new, leading-edge applications where they can bring significant added value not available elsewhere. It seems that just isn't the case right now with the micro molding applications Doug is writing about.
Perhaps tomorrow's leading material suppliers are working on the micro molding applications of today. I wish them well.
This article demonstrates how doing pioneering work can pay off for a molder. Phillips Plastics is a good example of this. I recently had the chance to visit one of their facilities. While some other injection molders may leave development work to resin suppliers and/or customers, and have to be dragged kicking and screaminh into trying anything new, companies like Phillips invest the resources they need to do innovative work. This strategy seems to be paying off for them. I didn't see any idle presses when I was there. Hopefully other molders are taking notice.
The ability to perform micro molding is also driven by machine manufacturers. When producing micro parts, a standard IMM will not suffice. Innovations in processing technologies such as cavity pressure sensors and intelligent flow front control have allowed designers to tighten tolerances especially on extremely small parts.
Some resin companies have had blanket policies that their materials cannot be used in implants of any sort. I imagine that would exclude them from a lawsuit if someone used their resin for an implant. Although, as you know, tort law can take some weird twists and turns, particularly when deep-pocket chemical companies are involved.
The subject of where polymeric implant materials are coming from is interesting and refreshing. A whole new cottage industry of specialist compounders has emerged to serve the implant industry. In some cases these are captive to the OEM medical device manufacturer. In some cases, they are big companies that operate very quietly. As I indicated in the post, don't expect to every see any press release on these developments. They are very private and very proprietary. What's also interesting is that many of the implant materials are not your garden-variety polymers. They are often a very specialized class of bioresorbable materials that are often based on renewable roots and then completely disappear after use.
One exception is the PEEK materials used in cranial implants which I discussed at length in my story that ran as the cover of the June issue. But the price of medical-grade PEEK is extremely high compared to conventional molding-grade PEEK. The biggest supplier declined to discuss the topic with me, other than to say that special steps need to be taken to ensure high quality. I would imagine that liability insurance is also cooked into the pricing.
With specific respect to microfluidics, some of the early work is focused on products used in labs—not in the body. One interesting product I saw recently from Makuta Technics uses polypropylene, which may strike some engineers as surprising. It was chosen because it offered adequate rigidity with the exact flow characteristics required for the application. This will be an interesting area to watch because I'm expecting a big increase in implant microfluidics because of work being doing by great scientists like MIT's Robert Langer.
Interesting piece, Doug. A question on the legal aspect you raised. You mention that the resin manufacturers have bailed on medical because of liability. With microfluidics requiring these resins, what are the implications for availability of micro molded parts? In other words, the four suppliers mentioned at the end of the story will make micro mold parts for firms designing microfluidics products. So do the resin vendors get their hands into this as far as trying to prevent their resins from being used for such parts? Or are they shielded from liability? Or not, and they're indeed at possible risk at some point if something bad happens as a result of one of these products?
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