Application of 3D printing in medical devices New Product Development

Abstract

For Johnson & Johnson (J&J), a healthcare industry leader, speed to market is a valuable component of any New Product Development (NPD). This is especially so in its Medical Devices (MD) franchise increased salable lifetime, first mover advantage, customer loyalty, and company reputation for innovation are just some of the reasons that accelerating the pace of development is a priority at J&J. Despite the incentives to speed up the development process, a typical MD product introduction takes three years from initial prototyping to full launch. Over this period, the product is repeatedly refined, prototyped, and tested for reliability and safety prior to production at high volume to meet expected demand. Throughout this process, J&J has historically favored proven manufacturing techniques such as machining and injection molding, which are well understood by the company's designers and manufacturing engineers but lead to long development cycles and high costs when used iteratively, as in NPD. Because new products can improve patient care-which is at the core of J&J's Credo-the company is currently investigating methods to accelerate the NPD process. One way to accelerate development that is being explored is enabled by the burgeoning field of additive manufacturing, or 3D Printing. Traditionally used only for early prototyping and development, innovation in 3D Printing over the past decade and recent FDA guidance on the subject opens the opportunity for its use in late-stage development, tooling, and even end production healthcare products. The scope of this effort was to investigate how MD can use 3D Printing to shorten NPD time from early prototyping through launch, with a target of two months acceleration. Through literature review, expert interviews, and close work with three project teams at J&J over the sixmonth duration of this effort, a portfolio of technical and organizational improvements were identified to improve New Product Development speed in Medical Devices. The use of 3D Printing was found to have a positive impact on all phases of development, ranging from initial design through high-volume manufacturing, with a cumulative effect of over 8 weeks of project-dependent improvement. An organizational structure was proposed to speed adoption of any new technology by using a twofold approach, which focuses on improving both organizational knowledge and internal processes to optimize company value. Additional proposals for using 3D Printing to reduce time to market include: using Direct Metal Laser Sintering (DMLS) for improved injection molding tooling; increasing developer access to local 3D Printing technologies; establishing decision rules to determine appropriate investment in new technology; using polymer 3D Printed injection molds for improved prototyping; increasing minor design iterations to minimize major reliability tests; improving availability of cutting-edge high-volume additive manufacturing technologies; and developing Design for Additive Manufacturing (DFAM) guidelines to decrease the learning curve for engineers. In compilation, these proposals show significant potential to increase the rate of organizational learning around 3D Printing and accelerate the pace of NPD in MD. 3D Printing therefore has the ability to benefit not only J&J's financial position, but also the patients it serves through new products and improved clinical outcomes.