Search results for: 3d printing

With the nicer weather quickly approaching, we have been told that Chicago, IL is the place to be from June 13-15. Is something special happening in Millennium Park? Are the Cubs playing the Cardinals at Wrigley? Do the ChiSox still exist?

We found something even better.  American Conference Institute, in collaboration with HP, are presenting…

This post is from the Reed Smith side of the blog only.

For well over a year, now Reed Smith has been engaged in an “initiative” concerning the innovative technology, “3D printing,” also known as “additive manufacturing.”  We’ve tried to stay on the forefront of the legal implications of 3D printing, particularly the product liability…

Several Reed Smith attorneys, including Bexis, will be presenting an hour-long webinar entitled (so creatively) “3D Printing and Tort Liability” next Thursday beginning at noon Eastern Time.  You can pick up an hour of CLE in a number of states.  Anyone who is interested can register here.  We’re biased, but we believe that the…

Another guest post today, this one by Reed Smith’s Matt Jacobson and Kevin Madagan on the draft guidance document released earlier this week by the FDA. With the 3D printing of medical devices at the forefront of the burgeoning additive manufacturing revolution − and inevitably to become the target, eventually, of product liability litigation – anything the FDA does to move the ball forward (or not) is of great interest.

As always, our guest blogger deserves all the credit (and any blame) for what follows. Take it away Matt.

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The blog is not a stranger to 3D printing, the cooler and slang term for the additive manufacturing process. See here, here, here, and here.

The U.S. Food and Drug Administration (FDA) is not a stranger to 3D printing either. It has already approved more than 80 medical devices and one prescription drug that are produced by 3D printing techniques. It also held a public workshop to obtain information and input about 3D printing issues on October 8 and 9, 2014. FDA brought together technical 3D printing expertise from various industries and sectors to help the agency develop an evaluation process for future submissions of medical devices resulting from additive manufacturing techniques. After the workshop, FDA was silent on 3D printing, well that is, until last Tuesday, when it released a draft guidance for Technical Considerations for Additive Manufactured Devices.

Although the FDA workshop was almost a year-and-a-half ago, it was not for nothing, as the draft guidance is based on the feedback from the workshop. According to FDA, the draft guidance is a “leap-frog” guidance to share FDA’s “initial thoughts regarding technologies that are likely to be of public health importance early in product development.” While the draft guidance is not meant to be a comprehensive document to address all regulatory requirements, it highlights the technical considerations and recommendations for design, manufacturing, and testing of medical devices that include at least one fabrication step using additive manufacturing.

FDA is careful to warn that the guidance does not apply to any devices that use bioprinting − incorporating biological, cellular, or tissue-based products into the additive manufacturing process.Continue Reading Guest Post – Highlights of FDA Draft Guidance on 3D Printing

Posted in FDA

Here is a guest post on an interesting case.  It’s the first decision that we’re aware of in which a 3D printed medical device (or any 3D printed product) has been the subject of litigation that involves product liability principles.  This post is submitted by Matt Jacobson of Reed Smith, who is particularly interested in 3D printing issues.   As always our guest blogger gets all the credit, and any blame, for the analysis that follows.

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October 21, 2015, the day Marty McFly, Doc, and their flux capacitor-charged Delorean arrived in the future.  The future was filed with flat screen TVs, self-lacing shoes, flying cars, cold fusion, Pepsi Perfect, and, of course, hover boards.  While the future is only a week away now, in the 1980s, when Back to the Future, Part II hit movie theaters, it seemed like a long way off.   However, a surprising amount of Back to the Future tech and non-tech (the Cubs are in the playoffs after all) are now part of our everyday lives—flying cars and cold fusion, not so much.  One thing, the movie did not predict was 3D printing.  3D printing is turning science fiction into reality, and as the technology continues to develop, we may soon realize the future really is here.

This blog is not a stranger to 3D printing, as we have posted about it here, here, and here.  But as the writers of Back to the Future could not actually predict the future, neither can we predict how courts will handle 3D printed medical devices.   A glimpse into that future may be found in Buckley v. Align Technology, Inc., No. 5:13-cv-02812-EJD, 2015 U.S. Dist. LEXIS 133388 (N.D. Cal. Sept 29, 2015)—which, as far as we can find, is the first even semi-product liability case dealing with a 3D printed product.Continue Reading Guest Post – First Contact – 3D Printing Meets the Learned Intermediary Rule

We’ve blogged before about the interesting product liability issues created by 3D printing/additive manufacturing, in particular the novel separation that these techniques create (at least potentially) between “manufacturing” and “design” of products.  With respect to medical devices, if an implant is custom produced from equipment owned by, and located at, the hospital where the surgery is conducted, who’s the manufacturer for product liability purposes if, say, the implant fails in some way?  Our prior post provided some legal analogies that we thought might be useful.  We didn’t claim to be comprehensive or conclusive.

It’s a “wild, wild west” legal issue, so we were predictably intrigued when the law review article, Park, “For A New Heart, Just Click Print:  The Effect on Medical & Products Liability from 3-D Printed Organs,” 2015 U. Ill. J.L. Tech. & Pol’y 187 (Spring 2015), showed up on several of the half-dozen or so searches we run to stay current in our field.  Continuing with our “we read law review articles so our readers don’t have to” philosophy, we took a look.

We were disappointed, not particularly by its pro-plaintiff tone (we’re used to that from the academy), but by its superficiality.  Unfortunately, the article doesn’t seem to “get” the true legal complexities of 3D printing.  From beginning to end, it remains mired in the traditional paradigm – a prescription medical product produced by a “manufacturer” who provides warnings to the treating/implanting physician under the learned intermediary rule.  The paradigm shift that 3D printing promises, the devolution of the manufacturing function to on-site locations neither owned nor controlled by traditional Restatement of Torts “manufacturers,” goes totally unaddressed.

Maybe we were expecting too much.  It’s a student, rather than a professorial, article.  The best part of this article is its factual discussion of 3D printing in the field of medical devices.  “New Heart,” 2015 U. Ill. J.L. Tech. & Pol’y at 189-93.  These sections seem pretty current in the research and cite lots of interesting stuff, collecting it in one place.  Unfortunately, it’s largely downhill from there.  The article focuses in the most complex form of 3D printed medical device – artificial organs – and treats that in an utterly pedestrian manner.

We waded through a wholly unnecessary discussion of organ donation regulation, which is presented as some sort of alternative to the FDA.  We’ve been around long enough that it’s blindingly obvious to us that 3D printing of medical devices (and drugs, which the article does not consider at all) is and will be subject to extensive FDA oversight.  Thus, we think that the organ donation alternative discussed, and properly discarded, by the article (2015 U. Ill. J.L. Tech. & Pol’y at 193-95, 198-99) is a makeweight issue not worth the time spent on it.Continue Reading Unfortunately Disappointing 3D Printing Law Review Article

The other day we read a thoughtful Bloomberg piece on 3D printing in the medical device context by a trio of Alston & Bird litigators.  We’ve given you the link, but it might be behind a paywall.

The article indicates that 3D printing of medical devices is already a reality.  3D printing is currently being used with implants where sizing is both critical and extremely patient specific – the article mentions tracheal splints, skull plates, hip cups, spinal cages, knee trays, and dental reconstruction devices. Here’s a cool slide show that we found on the FDA’s website showing some of them and discussing relevant 3D printing techniques.  Also according to the article, the FDA doesn’t have any specific 3D printing guidance available – which we confirmed on Westlaw (no mention of “3D printing” or “additive manufacturing” in any FDA guidance).Continue Reading Some Ideas About 3D Printing

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