Advancements in 3D printing technologies and build strategies have made it possible for medical device manufacturers to accelerate innovation—from concept to commercialization. Additive manufacturing (AM) has become more cost-competitive with traditional manufacturing thanks to new, more efficient 3D printers, expanded options for materials, proven validation processes, software with deep learning algorithms, regulatory master files, and more. Tipping the scale in AM’s favor is the ability to design more complex devices, integrate lattice structures to support bone in-growth, customize and even personalize devices, as well as scale up and down in response to ebbs in demand.
When it comes to expediting device development and clearance, two major factors have demonstrated the biggest impact: 1) customer-focused experts and 2) a well-defined, well-tested workflow. As medical device manufacturers consider integrating AM into their manufacturing workflow, there are some key steps along the path to market. For a successful AM implementation, it’s important to fully understand the goals for the new implant and/or instrument, and what the right solution will be to produce the device most effectively. Let’s explore more about what to expect:
1. Identify the Need
An in-depth understanding of the application is critical to the efficiency and ultimately a successful launch. It’s important to spend time upfront conducting a thorough screening and analysis to ensure there is a business case for additive manufacturing and formulate a plan for design and development.
2. Joint Innovation
In this stage, processes are customized according to the objectives defined for the device. Then, the right technology and material are selected for the application and the design is optimized. 3D models are finalized and plans for build optimization are drafted.
3. Pre-prototype/Prototype
Stacking build strategies for implants like acetabular cups helps minimize material waste while boosting productivity by reducing build times and post-processing steps.
4. Low Volume Production
During this stage, the device is tested against a series of pre-defined validation and qualification criteria to ensure the manufacturer has all the data needed for submission and to fuel market adoption once clearance is received. It is at this point that the manufacturer looks at the path to scale production.
5. Full Production or Tech Transfer
This type of flexibility allows device manufacturers to follow the path that makes the most sense for them and helps to accelerate, yet also de-risk, the investment into additive manufacturing solutions.
Move from Innovation to FDA Submission in Just 90 Days
The typical timeframe for engineering teams to move their orthopedic device innovations from market assessment and prototyping to documentation and submission is 12 months to two years. The industry-accepted average is 20 months. Yet each month of delay increases the risks of escalating costs and shifting requirements in today’s rapidly growing medical device industry. The key to shortening ideation and validation timeframes significantly, and expediting time to revenue, is partnership. For medical device manufacturers considering the integration of AM to produce devices, it is recommended to partner with a company that can bring not only technology solutions but expertise in medical device manufacturing and clearances. Partnerships such as this can help make the path to market as quick and easy as possible.
About Ross Attardo
With nearly a decade as an engineer in 3D printing for healthcare, Ross Attardo is now an expert consultant managing product realization with 3D Systems’ Application Innovation Group. Leveraging a wealth of knowledge through his previous roles at Johnson & Johnson, Attardo leads design, development, and production projects for diverse medical device applications, helping to ensure excellent quality and expeditious delivery.
