“This democratization of manufacturing means no entry barriers and blurred lines between who is the manufacturer and who is the patient or user of the medical device. Traditional strict product manufacturing principles will not fit this new landscape and legal guidelines will need to be developed regarding regulatory and tort legal issues.”
Colleen Davies is a member of the Life Sciences Health Industry Group, practicing in the area of product liability, life sciences and commercial litigation. She has served on Reed Smith’s Senior Management Team as Global Chair of Litigation and as Global Head of Legal Personnel. She has also served on the firm’s Executive Committee. Colleen’s client base primarily consists of major pharmaceutical, medical device, software, hardware, electronic and consumer product manufacturers. While Colleen’s experience extends into various product manufacturing arenas, her specialty areas remain in pharmaceutical, medical device and consumer product liability defense. She also counsels product manufacturers on all phases of product development. Here, her work addresses manufacturing and marketing issues such as product warnings, design development, document retention policies, claims management, media relations and crisis management. Colleen is active in a number of legal defense organizations and is also a frequent lecturer and author on substantive issues relating to product liability defense. She will be a speaker at #3DHEALS2017.
Q: What is your vision on the intersection of 3D Printing and healthcare?
A: 3D printing will transform personalized medicine — and in the process, disrupt traditional legal principles. My vision is to be part of a legal team that is ahead of the curves this legal landscape develops.
Q: What do you specialize in? What is your passion?
A: I am a Partner in Reed Smith’s Life Sciences Practice Group with a specialty focus on product liability issues for medical device and pharmaceutical companies. My passion is team building — and for this reason, I joined a group of lawyers to form our firm’s 3D Printing Task Force. This team is a cross disciplinary group of lawyers who specialize in 3D printing legal issues — including product liability, intellectual property, environmental, insurance recovery and regulatory matters (including reimbursement issues).Our published white papers include: 3D Printing of Manufactured Goods: An Updated Analysis and 3D Printing of Medical Devices: When a Novel Technology Meets Traditional Legal Principles.
Q: What inspired you to do what you do?
A: My inspiration came from my cousin Dr. Redmond Burke, a pediatric cardiovascular surgeon at Nicklaus Children’s Hospital and a pioneer in the use of 3D printed models to assist in surgical planning and patient management. http://www.stratasys.com/resources/case-studies/medical/nicklaus-childrens-hospital His work prompted me to learn more about 3D technology and eventually question how the technology will challenge traditional legal principles of product liability for medical devices and other products.
Q: What is the biggest potential impact you see 3D printing having on the healthcare industry?
A: 3D printing will turn manufacturing as we know it upside down as every physician, hospital and even consumer will eventually have the ability to be a product manufacturer. For example, individuals have already used 3D printers to print their own dental products. This democratization of manufacturing means no entry barriers and blurred lines between who is the manufacturer and who is the patient or user of the medical device. Traditional strict product manufacturing principles will not fit this new landscape and legal guidelines will need to be developed regarding regulatory and tort legal issues.
Q: What challenges do you see arising in implementing 3D printing in healthcare sector in the next 5 years?
A: One challenge in the legal arena relates to the apportionment of potential liabilities should an injury occur. There are multiple challenges in accountability and traceability to determine whether the injury occurred due to a defect in the digital file; a corrupted copy of a model digital file; the 3D printer itself; human error in implementing the digital design; negligence in using the 3D printer and/or materials; or defective replacement parts.
Q: What is the best business lesson you have learned?
A: Nothing trumps listening.
Q: What is the biggest business risk you have taken?
A: Assuming a business position in Senior Management.
Q: What crucial skill should people aiming to work in this industry acquire?
A: Collaboration and teamwork are key skills given the cross disciplinary nature of the legal issues.
Q: How will accessibility of the technology affect the cost of procedures?
A: For medical device product manufacturers, eligibility for reimbursement by government or private insurance companies is a key legal issue. Manufacturers should assess early on how they can align their strategies with that of the medical payors.
Q: Where do you get the training required to make informed decisions?
A: I have been lucky enough to work at a global law firm that offers industry expertise across the life sciences field.
Q: How will 3D printing impact product liability?
A: As is typical with technology and innovation, 3D printing is moving faster than the la w and regulations that guide its use.In many instances, the consumer or even the hospital is the manufacturer — and this fact makes the application of traditional legal principles difficult. In the short term, the law is likely to develop on a case by case basis with regulatory developments occurring along the way.