3D Printing & Medical Technology: New Risks & Potential for Liability Joe Coray, Vice President Corey LaFlamme, Assistant Vice President The Hartford

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1 3D Printing & Medical Technology: New Risks & Potential for Liability Joe Coray, Vice President Corey LaFlamme, Assistant Vice President The Hartford

2 The Hartford Insuring Innovation Providing insurance solutions and keeping its promises to customers for more than 200 years 25+ years of experience writing technology & life science businesses of all sizes Since 1995, a strategic partner with Medmarc, serving the life science and medical technology community - 19 Years! for more information

3 Agenda What is 3D Printing and Additive Manufacturing? Processes, Components, Possibilities Application(s) of Additive Manufacturing in Medical Device and Technology Case Study: Oxford Performance Materials the First FDA Approved Risk Management, Product Liability Theories and Additive Manufacturing in the Medical Technology Industry Insurance Considerations and Conversations Questions, Comments, Insights from the Audience 3

4 3-D Printing Innovative Technology Definition: Process of making a three-dimensional solid object from a digital model using an additive or layering process under computer control; 3-D printers are industrial robots which layer materials to create objects Traditional manufacturing is subtractive removing layers, materials, etc., by cutting, drilling Technology developed beginning 1970s Focus has been rapid prototyping Moving now into consumer use and industrial production Computer software (CAD) creates 3-D model of object. 3-D printers read the file and lays down successive layers of liquid, plastics, powders, paper, etc., or using lasers, fuses or sinters metals into shape of the object based on the file. 3-D saves time, materials; more flexible in design shape. 4

5 Hype Cycle for 3D Printing 5

6 Types of Additive Manufacturing Common AM methods / classifications 3-D Printing Droplet Deposition Utilizes powder or liquid resin, deposited in layers, and cured with ultraviolet light and/or heat. FDM Fused Deposition Modeling A nozzle deposits molten polymer onto a support structure layer-by-layer. SLA Stereolithography - Photopolymerization Converts liquid plastic resins and composites into solids layer-by-layer using light. SLS Selective Laser Sintering / Melting (SLS/SLM) Fuses powdered material (polymer, metal, or ceramic) using a laser or electron beam. 6

7 Economics of Medical AM (USD Millions) 7

8 Additive Manufacturing and Medical Technology Significant opportunities Results Rapid Prototyping Surgical guides, especially in orthopedic, cranio, maxillofacial and dental surgeries Development of usable parts and products Hearing aids Dental implants Orthotics and Prosthetics Hip and Knee implants Reduced surgery times Faster recovery Less invasive and more accurate 8

9 FDA Personalized Medicine Doctors and medical manufacturing companies are increasingly teaming up to use 3-D printing to lower the cost of life-changing, personalized medical devices, which is currently a major focus at the FDA. The trend raises interesting questions about how the FDA will regulate an endless continuum of customizable devices and make sure the benefits always outweigh the risks. The scientists behind the regulation of 3-D printed devices with the FDA, however, said it s not much different than managing a normally-manufactured item. We are regulating 3-D printed devices the exact same way we regulate non-3-d printed devices, said Matthew Di Prima, a materials scientist with the FDA. During the review process we have a few additional questions about how the manufacturing process could affect device performance. But right now there s no difference in regulation. October 2014 Meeting 9 -

10 Univ. of Michigan/Akron Children s Hospital Case 10

11 Case Study: Oxford Performance Materials 11

12 Oxford Performance Materials A model for risk evaluation Tony DeCarmine Chief Technology Officer Risk Management starts with QUALITY QUALITY begins with PROCESS and CONTROLS ISO and IS FDA approved OPM s 510K Patient Specific Cranial Prosthesis OsteoFab in 2013 Approved OPMs Maxillofacial Patient Specific Device in 2014 OPM technology uses Additive Manufacturing 3D printer from Germany Built on COTS Software Their contribution is the material, medical polymer Poly-Ether-Ketone-Ketone (PEKK) OXPEKK 12

13 Oxford Performance Materials Process Sales Representative from distributor meets with surgeon Surgeon uses diagnostic scan, from clinical records, source usually a CT Scan, high resolution imaging Software engineers, work with file to complete a design to fit patient, return file to surgeon who has final approval DeCarmine Design must be surgeon s vision Manufacturing Process takes place in OPM s clean rooms Laser sintering process, which uses FDA inspected Current Good Manufacturing Practice (cgmp) OXPEKK powder Device is then shipped to surgeon; Sale Representative supports educational component; surgeon implants in patient What could go wrong? Where is there risk? 13

14 Other Examples of 3D Printing in Healthcare Virtual Surgical Modeling & Planning 3D Systems & Medical Modeling, Inc. Anatomical Models Hospital Based Use 14 What could go wrong? Where is there risk?

15 3D Bio Printing the (Near) Future 15

16 Risk Management and Products Liability Products Liability Claims arise from: Negligence Strict Liability Breach of Warranty Liability for a medical product defect could rest with any party in the product's chain of distribution, such as: The product manufacturer; A manufacturer of component parts; A party that assembles or installs the product; The wholesaler or intermediary; or The healthcare provider that sold the product to the patient. 16

17 Risk Management and Products Liability Injured by a 3D Printed Device? Possible Suits against: Creator/printer of the device Manufacturer of the 3D Printer Digital Designer or software engineer Healthcare provider Sales representative 17

18 Risk Management and Products Liability 18 Hobbyists are not commercial sellers Engstrom cites The American Law Institute s Restatement of the Law Third: Products Liability A product is defective if it has a manufacturing defect, a design defect or if its accompanied by an inadequate warning Commercial Sellers/Fabricators have exposure Manufacturer of 3D printer hardware/materials/software not strict liability Plaintiff must show that the 3D printer was defective at the time object was printed, and when the printer leaves the manufacturer s possession Digital Designer Software codes is, generally, intangible, is not considered a product under most theories of Strict Liability Content or Expression

19 Insurance Considerations It s All in the Underwriting General Liability/Medical Professional Liability for Healthcare provider(s) Products Liability, General Liability, and Technology Professional Liability for software/hardware maker General Liability/Products Liability AND Manufacturing Errors & Omissions or Technology Professional Liability for fabricator of the object Insurers and Agents and Brokers must help the insured assess their exposures and controls thoroughly. As Additive Manufacturing/3D Printing becomes normative the legal and risk environment will evolve. 19

20 Comments, Questions, Feedback Thank you! Joe Coray, Vice President Corey LaFlamme, Assistant Vice President The Hartford 20

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