3D printing’s breakthrough in the life science market
A new item is being introduced into the life science market and it’s getting wide recognition for being the first of its kind: 3D printing. There has been much talk regarding the world of 3D printing but it has not been previously connected with the life science industry. The FDA has approved the first 3D printing drug, produced by Aprecia Pharmaceuticals and its being made to treat seizures and epilepsy.
The 3D pill hit the market earlier this year and questions as to whether the same guidelines apply to the production are arising. When a new drug is introduced, there are several markers that the company must follow, what companies are wondering now is if the same rules apply for a drug that is being 3D printed. Will there be similar guidelines for equipment use and quality control? Quality assurance has been one of the biggest questions surrounding 3D printing in terms of products; with the product now being of a medical background the quality control guidelines are going to be strictly followed and monitored to be sure the product comes out the same as it would under a mechanically generated pill.
Underwriters are also questioning what will happen if there is a software glitch. They are well prepared for these types of inquiries when a product is mechanically engineered, however the 3D printing model might throw a wrench into that liability. Will it be operator error or mechanical error? These inquiries will continue to come up as most companies explore the dynamics of 3D printing. AJG will continue to monitor the situation and investigate the coverages that will be available to the life science industry.
About the Author
Ceiry A. Fox is an Area Vice President at Gallagher and a member of the Property and Casualty Group. Ceiry’s main focus is working with high profile Risk Management clients in the life sciences and technology sector.