AM fast-tracks devices to market

Advancements in 3D-printing technologies and build strategies make it possible for medical device manufacturers to accelerate innovation – from concept to commercialization. Additive manufacturing (AM) has become more cost-competitive with traditional manufacturing due 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 designing more complex devices, integrating lattice structures to support bone in-growth, customizing and personalizing devices, as well as scaling up and down in response to demand.

For 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 or instrument, and what the right solution will be to produce the device most effectively.

Here’s what to expect:

1. Identify the need – In-depth understanding of the application is critical to efficiency and ultimately a successful launch. It’s important to spend time upfront conducting a thorough screening and analysis to ensure there’s a business case for AM and formulate a plan for design and development.

2. Joint innovation – In this stage, processes are customized 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 – Next, a gap assessment should be performed against validated production protocols and the new application should be modified accordingly. Initial examples are printed and evaluated to confirm the part has the right look and feel and can meet the defined requirements.

4. Low-volume production – During this stage, the device is tested against a series of predefined validation and qualification criteria to ensure the manufacturer has all the data needed for submission and to fuel market adoption once clearance is received. At this point the manufacturer looks at the path to scale production.

5. Full production or tech transfer – Device manufacturers can introduce new products to the market quickly without requiring a costly manufacturing line setup by leveraging AM services from ISO-certified facilities. However, device companies may also choose to manufacture implants and instruments in-house. In this scenario, the additive manufacturer would transfer the knowledge, technologies, and production strategies to operate independently.

This flexibility allows device manufacturers to follow the path making the most sense for them and helps accelerate – yet also de-risk – the investment in AM solutions.

Innovation to FDA submission in 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 2 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’s recommended to partner with a company that brings the technology solutions and expertise in medical device manufacturing and clearances. Partnerships such as these can help make the path to market as quick and easy as possible.

About the author: Ross Attardo is an application development engineering manager with the Application Innovation Group at 3D Systems.