Our 3D Printing task force prepared our first 3D Printing white paper, “3D Printing of Medical Devices: When a Novel Technology Meets Traditional Legal Principles” last month because we are thrilled at the prospect of 3D printing changing the future of health care for the patients who need new treatments, devices and drugs, and we … Continue Reading
Search Results for: 3D Printing
3D Printing of Medical Devices: When a Novel Technology Meets Traditional Legal Principles
3D printing is quite possibly the next greatest chapter in the industrial revolution, and the technology is moving rapidly. Reed Smith’s Life Sciences Health Industry Group recently launched its first 3D printing publication white paper – 3D Printing of Medical Devices: When a Novel Technology Meets Traditional Legal Principles. This paper explores unchartered legal issues … Continue Reading
3D Printing Medical Devices
3D printing is providing physicians with a steady flow of new options for medical treatment. Reports are constantly emerging about novel, life-saving procedures made possible through 3D printing. As one might imagine, however, 3D printing a medical device for use in humans carries particular challenges not present with 3D printing in other contexts.… Continue Reading
3D Printing Raises Novel Questions About Potential Product Liability
Over on the Drug & Device Law blog, Reed Smith partner Jim Beck (aka “Bexis”) offers his thoughts on the possible product liability implications of printing 3D medical devices. Specifically, Jim examines the question of what party (or parties) would be held liable as the manufacturer in a product liability case involving 3D printing. There are uncertainties surrounding each of the three primary parties who may be considered for liability: the hospital that owns the 3D printer used to produce medical devices; the manufacturer of the 3D printer; or the designer of the software used by the 3D printer to create the products. Jim’s post discusses the current issues around naming each of those parties as the manufacturer, and concludes that – at least for the time being – 3D printing presents an unusual situation in which it is feasible that no entity qualifies as a “manufacturer” under the Restatements for strict liability. Additional legal issues like this will likely emerge as 3D printing’s popularity continues to increase.… Continue Reading
As 3D Printing Emerges, Legal Considerations and Challenges Arise
The January 25, 2015 edition of the Pittsburgh Post-Gazette featured an article in which Reed Smith partner Chris Healy commented on the dramatic rise in popularity of 3D printing technology and the legal issues that have come about – and may arise in the future – as a result of this trend. The article, “3D … Continue Reading
Life Sciences and Health Care Industries Reap the Benefits of 3D Printing
The past few years have seen 3D printing – a process that involves the creation of a three-dimensional object from a pre-conceived design – evolve from a futuristic idea into a multi-billion dollar business, and few industries have benefitted more from this technology than life sciences and health care. 3D printing has been used to … Continue Reading
IEEE Developing New Standards for 3D Printers For Medical Uses
The Institute of Electrical and Electronics Engineers Standards Association (IEEE) is developing new interoperability standards for medical devices, 3D printers and other eHealth devices. IEEE P3333.2.5, Draft Standard for Bio-CAD File Format for Medical 3D Printing is intended to develop standard methods for the printing of 3D-printed prosthetics and medical devices. IEEE proposes to define … Continue Reading
FDA Presents Webinar on Technical Considerations for Additive Manufactured Medical Devices
On December 5, 2017, the U.S. Food and Drug Administration (FDA) released the final version of its guidance entitled “Technical Considerations for Additive Manufactured Medical Devices; Guidance for Industry and Food and Drug Administration Staff.” As a follow up to the Guidance’s release the FDA held a webinar on January 10, 2017, to present an … Continue Reading
