SME’s MMI at RAPID 2016 – Exploring and Sharing Solutions in Medical Device Manufacturing

 

Medical and Biomedical represent two of the fastest growing application areas of additive manufacturing. This year SME will feature Medical Manufacturing Innovations (MMI) Series at RAPID 2016. The MMI series is dedicated to additive manufacturing use in medicine and supported by Wake Forest School of Medicine.

MMI at RAPID 2016
16-19 May 2016
Orlando, Florida 32819 USA

We caught up with Lauralyn McDaniel, Industry Manager, Medical Device Manufacturing at SME to learn about this year’s MMI series in an exclusive AMazing® Q&A conversation.

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AMazing®: Lauralyn, thank you for your participation. At this year’s RAPID, SME’s Medical Manufacturing Innovation Series (MMI) will feature a range of technical sessions and workshops that focus on the use of additive manufacturing in medicine. What can attendees to this year’s MMI expect to learn about the latest developments and trends in the use of additive manufacturing in medical device development?

Lauralyn McDaniel: In addition to new ways AM/3DP are being used in medicine, attendees will find more in-depth presentations on technical challenges including corrosion, cleaning, warping, regulatory guidelines, economic justification, and more. Applications covered include the full spectrum: anatomical models, surgical guides, implants, scaffolds, and bioprinting.

AAM_RAPID_Logo_CMYKMazing®: SME’s Medical Manufacturing Innovation Series, supported by the SME Medical Additive Manufacturing/3D Printing Workgroup, is sponsoring an initiative titled “Building Evidence for 3D Printing Applications in Medicine Initiative”. The goal of the initiative, as we understand, is to gather key stakeholders (e.g. clinicians, medical device manufacturers, technology providers and others) to begin the step-by-step process of proving that additive manufacturing in medicine is indeed better than conventional medical practices based upon clinical evidence. What is clinical evidence and why is the distinction important? How can attendees at this year’s RAPID benefit from the initiative, and perhaps, contribute to the program?

Lauralyn McDaniel: Evidence is based on patient outcomes including things like shorter surgery time, hospital stays, recovery time, quality of life, and in some cases, longer lives, as well as economic benefits. In individual cases or anecdotal evidence, clear benefits and even new ways to treat patients have been demonstrated. While AM has been used for many years in many areas of medicine, it is still not a standard of care which means it is usually not a reimburseable expense. By working together to develop a consensus on guidelines for gathering evidence, clinicians and device manufacturers can build on the work of each other to achieve the documented evidence that will lead to standards of care and reimbursement.

RAPID attendees will benefit from the outcomes of the evidence initiative, the guidelines released. To gain the most benefit, they should get involved, register and attend the evidence program. This will be the best way to make sure their particular challenges and needs are addressed. They can participate as a company or as an individual. The program at RAPID (www.sme.org/evidencemed) will be the face-to-face kick-off of the ongoing initiative. (www.sme.org/3dpevidence)

Video courtesy of SME

AMazing®:The current scope of “The Building Evidence for 3D Printing Application in Medicine Initiative” focuses on three 3D printed medical device applications: 1) anatomical models, (2) patient-specific guides and (3) implants. Why were these three medical device applications selected? How has the initiative progressed and what are a few “next steps”?

Lauralyn McDaniel: These three represent the broad categories of the most common ways AM/3DP is being used today and are in greatest need of guidelines and reimbursability to be able to impact more patients worldwide. We are anticipating that it will take a few years to have guidelines for all areas, with anatomical models being the first released. As the initiative progresses, I anticipate we will encompass more bioprinting applications including scaffolds and eventually tissues. The plan is to continue the discussion from the Orlando program throughout the year through a series of webinars/online meetings and conference calls, with at least one face-to-face meeting each year.

AMazing®: While the business potential for the production of complex, high-quality niche products in smaller series appears attractive, the undertaking is not without risks. What advice would you offer businesses attending RAPID, that are interested in the commercialization of medical additive technologies?

Lauralyn McDaniel: Get involved. Engage with the medical leaders at RAPID. They represent technology developers, device manufacturers, and the fastest growing group, point-of-care manufacturers or clinicians. Attend both the sessions focusing on the engineering aspects and regulatory challenges. Visit exhibitors with MMI stickers in front of their booths. These are the companies that are already serving the medical community. They’ll see a wide variety of services, AM/3DP technologies, as well as imaging and inspection technologies. Ask them for examples of how their technology is being used in medicine, keeping in mind that while every technology has valuable benefits, no one technology is good for every application.

AMazing®: Many industry experts suggest that in order for additive manufacturing to reach its full potential, advances in design, equipment, processes and materials are needed. What areas do you feel need to advance in order for medical device manufacturing to reach its full potential?

Lauralyn McDaniel: Identifying and working to address challenges are the goals of the SME Additive Manufacturing/3D Printing Workgroup (www.sme.org/medical-am3dp-workgroup). Medical manufacturers have the same challenges you mentioned plus a few more including biocompatible and bioresorbable materials, biomarkers for segmenting medical imaging data, standards that integrate with existing medical imaging standards, file formats that accommodate patient privacy, and awareness, particularly for the new type of manufacturer, clinicians. Device manufacturers are very familiar, sometimes have whole departments dedicated to understanding and complying with regulatory requirements for manufacturing. Clinicians are new to manufacturing. With quickly developing bioprinting technology, I anticipate the amount of this point-of-care manufacturing will continue to increase.

AMazing®: Finally, what trade fair strategies and tips would you suggest to MMI attendees to explore the rich, diverse network of industries to maximize their conference experience? 

Lauralyn McDaniel: Use the App. Seriously. The app will allow you to filter both exhibitors and other activities to find things of greatest interest and schedule your time before arriving in Orlando. For those in the medical area look for the MMI designation. At the event, attend the kick-off session on Monday afternoon from 2:30 pm to 5:00 pm. This is where you’ll hear highlights of new technologies you’ll see on the show floor. Take advantage of the presentations in the SME/America Makes theater throughout the show and the Innovations Auditions from 12:30 pm to 1:30 pm on Tuesday. Visit the SME booth to participate in a beta test of a new AM/3DP standards database. This will be an opportunity to tell the organizations that develop standards, what you need. Above all, be curious and talk to people. Ask questions of exhibitors as well as your fellow attendees; about how things work and sometimes, don’t work.

This concludes our interview. Thank you very much Lauralyn for your participation. We are grateful to learn about SME’s Medical Manufacturing Innovations Series at this year’s RAPID, and overall commitment to additive manufacturing in medicine. For more information about MMI at RAPID, visit: www.rapid3devent.com/mmi

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Lauralyn McDaniel, Industry Manager, Medical: "Identifying and working to address challenges are the goals of the SME Additive Manufacturing/3D Printing Workgroup."  (Photo courtesy of SME)

Lauralyn McDaniel, Industry Manager, Medical: “Identifying and working to address challenges are the goals of the SME Additive Manufacturing/3D Printing Workgroup.” (Photo courtesy of SME)

About Lauralyn McDaniel, Industry Manager, Medical
Lauralyn McDaniel joined SME in February 1996 and currently serves as the industry manager of medical device manufacturing. In this role, she guides SME’s medical industry strategy development and implementation, identifying potential markets, products and partners, and becoming the medical industry resource among the SME team.

McDaniel has been involved in medical manufacturing since 2000, engaging with companies and activities surrounding additive manufacturing, micro-manufacturing, nanotechnology, and many other technologies.

This work has included identifying challenges and potential solutions for medical manufacturing, writing articles on innovative technologies and processes, and leading SME’s Medical Additive/3D Printing Workgroup. She also serves as Vice Chair of the America Makes & ANSI Additive Manufacturing Standards Collaborative Workgroup. Prior to joining SME, McDaniel held roles at IBA Health and Life Assurance Company and Southwest Michigan Commission. She has a bachelor’s degree in journalism from Oakland University and a master’s degree in business administration from the University of Notre Dame.

About SME’s MMI
The Medical Manufacturing Innovations Series is the place where you can explore and share solutions in medical device manufacturing. The focus is on manufacturing processes and technologies. Gain perspectives from different applications — how best to use the technologies you have and those you could have. – See more at: http://www.sme.org/mmi/#sthash.Prb14EXi.dpuf

About SME’s Medical Additive Manufacturing/3D Printing Workgroup
The SME Medical Additive Manufacturing/3D Printing Workgroup collaborates to identify challenges, develop resources, and to facilitate changes to support anyone using the technologies for medical/biomedical applications. The workgroup members represent medical device manufacturers, clinicians, technology providers and more to provide a multi-perspective approach to all projects and discussions. – See more at:http://www.sme.org/medical-AM3DP-workgroup/ #sthash.qN9GWMdv.dpuf

About RAPID
For nearly 25 years, RAPID Conference & Exposition, produced by SME, has defined the crucial role of additive manufacturing and empowered the establishment of an industry that continues to conceive, test, improve and manufacture new products at a faster, more cost-efficient pace. As the leader and authority figure in additive manufacturing, RAPID attracts buyers, sellers and end-users of design, prototyping, tooling and direct digital technologies to a world-class event for discovery, innovation and network

About SME
SME connects all those who are passionate about making things that improve our world. As a nonprofit organization, SME has served practitioners, companies, educators, government and communities across the manufacturing spectrum for more than 80 years. Through its strategic areas of events, media, membership, training and development, and the SME Education Foundation, SME is uniquely dedicated to advancing manufacturing by addressing both knowledge and skill needs for industry. At SME, we are making the future. Together.

Source: SME, AMazing

Republication or redistribution of AMazing content, including by framing or similar means, is expressly prohibited without the prior written consent of AMazing. AMazing® is a registered trademark of Amazing.

 

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