Bio-Printing & 3D Printed Medical Devices – Navigating Today’s Regulatory Challenges & Opportunities
President & CEO
Over the last decade, the medical device industry has seen a rapid change in product development technology, specifically in the area of 3D printing. As of October 2014, at least 85, 3D printed medical devices have been cleared or approved by the FDA (many of these are orthopedic implants). The first 3D printed drug was approved by the FDA in August 2015. In addition, a collection of global, biotech companies have introduced products such as bio-printed liver tissue, breast tissue, and early stage human organs.
Product developers, manufacturers, and researchers are all eager to bring more of this advanced technology to market. However, the medical industry is faced with navigating a “cloudy” regulatory landscape. The FDA is still drafting final guidance documents related to 3D printing and bio-printing technologies (draft may possibly be completed by the end of 2015). Without a clear path to regulatory clearance or approval, companies are holding off on investing the financial resources and time required to expand this product development at a more rapid pace.
To help companies offset some of the regulatory confusion, Guideline Medical developed an innovative regulatory service called “3D Med-Make.” The service was initially designed to help answer the continuous stream of client questions surrounding FDA regulatory standards related to 3D printing. Companies were requesting more and more detail about how FDA regulations must be followed when manufacturing products like 3D printed orthopedic implants. The service was also introduced to entice companies to engage in the design and manufacture of 3D printed medical technology. Servicing companies based on this combination of factors helps remove the “unknowns” related to how 3D printed products can safely and effectively be manufactured and sold in the US market.
Guideline Medical sees the strategic importance of servicing this rapidly growing segment of the medical device space. With new bio-compatible materials, 3D printers, and software systems entering the market, it makes sense for manufacturing facilities to think about becoming the early adopters in this space. Patient specific products such as customized implants, drugs, and biologic matter like human tissue are the future of medicine.
A downside to being the early adopter of this manufacturing process is the complexity of validating an entirely new manufacturing system. Companies should expect that it will take two or more years to implement an operational, FDA-standardized manufacturing process. The entire process, including product design, software usage, machine validation, product testing, and materials certifications, is going to take more time than a traditional system. The obvious upside to implementing this system now is that early adopter companies will be ahead of the learning curve when the technology reaches mass market acceptance. This mass market acceptance is on the horizon.
Guideline Medical is excited to be offering such a unique service to the early adopters in this high-growth area.
About the Author
Michelle Bonn’s international business and medical manufacturing career has involved leading large-scale medical and industrial manufacturing projects across the globe. She has led a variety of projects including ISO-13485 certifications, medical device risk assessments, medical facility audits, medical 3-D printing and bio-printing services, and FDA regulatory clearances and registrations. Her manufacturing expertise is focused on FDA Quality System Regulations, ISO standards and Six Sigma Quality methods. Michelle has worked in China, Hong Kong, Singapore, Iceland, Italy, Mexico, and the US. She is a certified, Six Sigma Black Belt and holds an MBA with a focus on International Business. Michelle has successfully completed RAPS medical-device regulatory certificate programs.
About Guideline Medical
Headquarters: Amherst, NY
Guideline Medical simplifies the medical manufacturing and FDA process. The Guideline team acts as trusted guides for managing the complex systems of global regulatory affairs, medical device manufacturing, and 3D printed medical device compliance. Their mission is focused on helping companies place safe, compliant, and FDA-standardized medical products into the hands of customers.
NYS Employees: 1 – 5