SME is directly involved in several key initiatives to provide information that helps medical manufacturers navigate this complex market.
Working in manufacturing often means we have an opportunity to make an impact—not just for the workforce and companies, but for individuals that use our products. For those in medical manufacturing, this connection to life-changing and even life-saving opportunities is clear. From surgical clamps and tiny neural modulators to large medical imaging devices, there’s an incredible amount of enabling technologies.
Innovation is a key driver. While there may not be a direct connection between innovation and R&D, you certainly can’t innovate without investment to expand your capabilities. As a percentage of revenue, R&D investment by manufacturers serving the healthcare industry is said to be second only to the computer hardware and software industry, and double or even triple the percentage for automotive or aerospace manufacturers. Where are healthcare companies investing and how do all these different technologies fit together?
To help understand the trends and how enabling technologies and innovations fit together, SME developed the diagram below of Medical Manufacturing Innovation Enablers. The blue boxes at the top indicate major trends. The arrows show how each enabling technology connects to the trends as well as each other. Follow the arrows to see how innovations in different areas work together.
Over all of these “enablers” are both key software and design considerations. For example, the trend of precision manufacturing is enabled by the trend of point-of-care manufacturing, which in turn is enabled by additive manufacturing/3D printing, which also supports tissue fabrication; both AM/3D printing and tissue fabrication are enabled by the development of materials and nano technology.
As an organization dedicated to advancing technology and the workforce to support manufacturing, SME is supporting medical manufacturing through several programs. AM/3D printing is probably the most active. Since 1990, SME has worked with the AM community to address challenges and expand AM use. The combination of imaging data and the ability to build from those digital files resulted in medical applications becoming a leader in using AM for final products.
Today, SME’s Medical AM/3DP Workgroup provides direction and resources for anyone using the technology in medicine. The group brings together a broad collection of stakeholders, including technology developers, device manufacturers, clinicians and researchers to address needs for anatomical models, instruments, surgical planning, prosthetics, implants, wearable and active devices, and tissue fabrication. The workgroup has been involved in activities that include:
Manufacturing Innovations at RAPID + TCT: Through recruiting speakers, reviewing potential presentations, identifying key challenges, and developing workshops, the workgroup ensures the content at the annual event addresses the needs of the medical community. Issues addressed range from an introduction for point-of-care (hospitals) manufacturers and regulatory/quality requirements to the developing area of tissue fabrication and bioprinting.
File Format: DICOM (Digital Imaging and Communications in Medicine) standards set file formats for medical imaging files. With patient-matched applications of AM/3DP relying on these files, users had to develop ways to keep the build files connected to the imaging files, which aren’t always reliable. The workgroup’s efforts resulted in a collaboration with the DICOM committee to conduct a needs analysis and proposal to the DICOM Steering Committee to update the standards to integrate the needs of AM. Many workgroup (WG) members are now active with the DICOM WG-17 3D manufacturing to encapsulate STL and other formats within the DICOM file.
Standards: In a highly regulated environment, consistent and reliable processes are critical. The WG is supporting this in two primary ways. The first is the creation of an open, searchable Standards, Specifications and Guidelines database that provides publicly available information on standards developed by several Standard Development Organizations. Inclusive of all standards developed for or applicable to AM, the database is an easy-to-use tool for anyone using AM. The second effort is through the Additive Manufacturing Standardization Collaborative of America Makes and ANSI. With the goal of accelerating the development of standards, the AMSC published a standards development roadmap identifying gaps in existing standards, priorities for development, and possible organizations to develop each.
More AM/3DP Resources: All of SME’s resources for AM/3DP also support the medical community, including an additive manufacturing member community and Tooling-U/SME certification and online classes. A quick list of these can be found at: www.sme.org/medical-additive. Micromanufacturing is another area in which SME supports medical manufacturing. The ability to make active devices and surgical tools smaller allows device manufacturers to innovate. Skills used for macro-scale machining, molding, fabrication and metrology don’t necessarily translate to the microscale, where processing assumptions can differ. Through webinars, articles, and seminars, SME helps people understand these differences and the options to successfully use micromanufacturing technologies.
Smart Manufacturing includes a range of technologies and applications that are critical for the next generation of devices. In the diagram, this includes robotics, artificial intelligence, cyber security, sensors, and more. SME’s coordinated effort includes several efforts to bring together a cross-industry audience.
Smart Manufacturing Series: A series of one-day programs, the Smart Manufacturing Series addresses automation, digital transformation, AM, micromanufacturing and more.
Smart Manufacturing Experience: Scheduled for April 30-May 3, 2018 in Boston, the Smart Manufacturing Experience 2018 provides practical solutions for applying the latest advanced manufacturing technologies that drive results.
Smart Manufacturing Magazine: SME’s Smart Manufacturing magazine provides excellent coverage of smart manufacturing technologies. With all the efforts on advanced technology, SME continues to support core technologies critical to medical manufacturing. Need help to machine titanium? Measurement and inspection challenges? Other? Check the Advanced Manufacturing Media website, the SME technical paper database, and Tooling-U/SME’s online classes.
Also, Manufacturing Engineering regularly publishes Medical Special Sections, including the one you are reading right now. It’s all part of SME’s commitment to enabling access to accurate, up-to-date information for medical manufacturing.