MedTech Monitor: Advanced Manufacturing Minneapolis Edition
Welcome to a special edition of MedTech Monitor, dedicated exclusively to the Advanced Manufacturing Minneapolis show! MD+DI is thrilled to be an official media partner of this exciting event.
"The Midwest’s Largest Annual End-to-End Design and Manufacturing Event"
Bringing together Medical Design & Manufacturing (MD&M), Automation Technology Expo (ATX), Design & Manufacturing (D&M), MinnPack, and Plastec offering the latest insights and solutions spanning medtech, packaging, automation, plastics, and design.
Developing a Sound Strategy for Selecting the Right CMO
Representatives from Kimball Electronics gave their perspective on what OEMs need to do to find the right contract manufacturers during a session at MD&M Minneapolis.
By Omar Ford
The relationship between an OEM and a contract manufacturing organization has often been compared to dating with the intention of finding a suitable mate.
That’s because selecting a contract manufacturing partner is an important strategic decision that can impact a Medical Device Manufacturer for many years. Due to the long product lifecycle of regulated medical devices and FDA regulatory requirements, transferring to a different Contract Manufacturer later can be very time-consuming and costly.
On Wednesday, executives from Kimball Electronics doubled down on the relationship narrative during a session at MD&M Minneapolis titled “Contract Manufacturing Strategy: Cultural & Team Alignment.”
Lisa Butkovich Business Development Manager at Kimball Electronics and Patrick Prondzinski VP of New Business Development at Kimball Electronics were panelists at the session.
One of the most important steps in securing a strong relationship comes from the CMO. Prondzinski said CMOs must be upfront and see if the OEM is the right fit.
“We actually evaluate a relationship even before we start,” Prondzinski told MD+DI during the session. “We have a process that we go through … and it’s not just the xs and os, dollars and cents and things like that. There are some qualitative measures that we take measurement of.”
Butkovich noted another way to make sure a relationship between a CMO can work is having the OEM understand the people that work at the organization.
Butkovich?said OEMs should ask these questions:
“From an OEM standpoint, we talked early on in the session about doing your research and knowing who’s out there,” Butkovich told MD+DI. ?“I think that’s very important. You want to make sure the CMO is a [good] fit. And that’s not only from a product standpoint. You want to ask, does the CMO within our market, do they have the technology types that we’re looking at getting into? Do they have experience with these types of products?"
She added, “A lot of OEMs will come to us with expectations of wanting to engage -but maybe not understanding that they aren’t as developed yet. We tread very lightly and do extra research if it’s a startup right need to understand what that’s going to look like moving forward. I think the OEMs just need to understand the size of the company and does their product make sense to move forward with. OEMs will sometimes have unrealistic expectations of what they think they need or want and it might not align with what they really need.”
3D Printing Takes the Stage at Advanced Manufacturing Minneapolis
By Rob Spiegel
Whether it comes in the form of personalized medical solutions, tooling, or miniaturization, 3D printing has become a big part of the future of medical technology. So it’s no surprise the technology is well covered at Advanced Manufacturing Minneapolis on Oct. 16 and 17. While the show covers a wide range of emerging technology, it has long focused on the newest developments in medical technology.
The event gathers professionals in the medical design and manufacturing industry. Speakers and exhibitors include engineers, designers, and decision-makers who are on hand explore the latest innovations in MedTech, packaging, and automation. Advanced Manufacturing Minneapolis features the co-located shows Medical Design & Manufacturing (MD&M) Minneapolis, MinnPack, Automation Technology Expo (ATX) Minneapolis, Design & Manufacturing (D&M), and Plastec Minneapolis.?
The location says everything. Minnesota is known for its robust healthcare and manufacturing sectors.?The state is home to leading institutions like the Mayo Clinic and companies such as 3M and Medtronic. Advanced Manufacturing Minneapolis features over 530 exhibitors and offers more than 30 hours of free education sessions.?Keynote presentations and a seven-track conference program address a range of MedTech advances in additive manufacturing, artificial intelligence, product development, and more.
This year, the show reveals how 3D printing is taking a major role in emerging technologies.
One of the keynote presentations at IME Minneapolis will look at 3D printing:
The keynote Printing a Healthier Tomorrow: How 3D Technology is Shaping the Future of Medicine will be presented on Thursday, October 17? from 10:15 AM - 11:00 AM Central.
Amy Alexander, unit head of the Mechanical Development & Applied Computational Engineering, Division of Engineering at Mayo Clinic, will explain how the future of healthcare delivery will become more precise, personalized, and accessible. Her view of the future will explore the transformative potential of 3D printing/additive manufacturing, 3D scanning, extended reality, and artificial intelligence in revolutionizing how we deliver medical care.
A number of individual presentations in Minneapolis will also focus on 3D printing:
The session Same Day PCBA Prototyping Using 3D Printing: The Puma Process will be presented on Wednesday, October 16?from?9:30 AM - 10:00 AM Central.
Presenter Dave Jones, president of DE Design Works, will explain how innovation in the speed of Iterative engineering design, build, and test can drastically reduce risks and time to market by catching engineering mistakes and requirement misses earlier. AI component sourcing, schematic generation, and cloud-based 3D PCB layout tools can also speed the development process.
The presentation Case Study — Utilizing Hybrid Metal AM for Rapid Production of Tooling will be presented on Thursday, October 17 from 9:00 AM - 9:30 AM Central.
Thomas Houle, director of LUMEX N.A. at Matsuura USA, will look at real-world examples of tooling - plastic injection and metal injection - produced via a metal hybrid additive manufacturing?process. The presenter will outline the many benefits that can be achieved through the use of this technology.?
The session Microscale 3D Printing: Implications & Applications for Healthcare will be presented on Thursday, October 17?from 9:30 AM - 10:00 AM Central.
Seth Hara, principal engineer in the Division of Engineering’s Mechanical Development Unit and manager of the Microfabrication Laboratory at Mayo Clinic, will explain how microscale 3D printing is rapidly transforming the landscape of medical device design, offering unprecedented precision and versatility in creating intricate structures from various materials. This session will explore some of the benefits and applications of microscale 3D printing, particularly its ability to produce components at a scale and complexity that conventional additive manufacturing and microfabrication techniques cannot achieve.
The session Additive Manufacturing for Production: Product Management, Economic & Technical Considerations will be presented on Thursday, October 17?from?11:15 AM - 12:00 PM Central.
Carl Douglass, CEO at DI Labs, will look at how products can be developed, launched, and managed more effectively and quickly with additive manufacturing. Douglass notes that we’re effectively leveraging 3D printing as a manufacturing resource (additive manufacturing) to produce hundreds to tens of thousands of components for end-use applications ranging from Class I and II medical devices to aerospace, defense, industrial, and consumer goods. He will look at?examples of additive manufacturing adoption for scaled production and the lessons on what it takes to achieve success.
The session Laser AM in Aerospace & Space: Mitigating Supply Chain Insecurities will be presented on Thursday, October 17?from?2:15 PM - 3:00 PM Central.
Eliana Fu, industry manager for aerospace and medical at TRUMPF, will look at advanced manufacturing processes that include laser additive manufacturing processes such as LMF (Laser Metal Fusion) and LMD (Laser Metal Deposition). These technologies are no longer a gimmick. They have become accepted methods of manufacturing in aerospace, particularly in space exploration applications.
The panel presentation New Material Options for Additive Manufacturing will be presented on Thursday, October 17?from?2:15 PM - 3:00 PM Central.
Steve Morin, instrument maker at Minneapolis VA Medical Center will join other experts in additive manufacturing materials to discuss new materials.
Meeting Medtech Motion Control Demands
By Daphne Allen
领英推荐
If you’re engineering medical devices these days, chances are you’re looking for solutions that support miniaturization and increase performance.
“A key trend in medical devices is miniaturization,” Dave Beckstoffer, Portescap’s senior industry manager, tells Design News. “Being able to reduce the overall architecture enables greater freedom for patients and medical professionals.”
And “a second key trend is performance as devices are continually being asked to execute more challenging tasks. Many medical devices, especially cardiovascular ones, require a motion control system that can achieve quite high speeds and torques,” he says.
Portescap will be showcasing its expertise in medtech motion control solutions at the upcoming?MD&M Minneapolis 2024?October 16-17. The company offers?brushless DC motors for cardiovascular applications; frameless motors for surgical robotics; and a Surgical Motion Solutions portfolio of motors, gearheads, encoders, and controllers that can be designed to endure 3,000+ autoclave cycles.?
How to go smaller for miniaturization
Miniaturizing a medical device “starts with understanding the critical device output requirements and folding those back to the motion control system," Beckstoffer explains.?“It is key to tie the footprint of the motion control to the optimal device layout.
“For example, designs can reduce the diameter of the system to accommodate a smaller device height, but the system length will grow.??Alternately, a larger diameter system with shorter length can be customized for a handheld device,” he says.
When the Portescap team first sits down with medtech design engineers, the initial discussion focuses on the end user and market requirements as well as device features and benefits, Beckstoffer explains. “The discussion includes a review of the various motion control system options, culminating in a design path that includes standard product options for initial prototypes up to customized solutions for the final product,” he says.
How to go big on performance?
As mentioned earlier, many new devices are expected to offer heightened performance. Design engineers will need to identify components that can handle higher speeds and torque.?
“With operation at high speeds and torques, temperature rise can be a concern since the device may be held by the medical professional,” says Beckstoffer. “Portescap’s Ultra EC brushless DC platform, with its proprietary U-coil design, has designs optimized for speed, torque, or a combination of both. The slotless design reduces iron losses, providing a slower temperature rise and reaching an acceptable steady state temperature during continuous operation. The Ultra EC line has a breadth of diameters and lengths available, enabling engineering collaboration to select the ideal mechanical configuration together with the optimal performance.”
Moving toward the right motion control solution for your medical device
There's a lot of design and engineering support available for medical device design engineers. MD&M Minneapolis 2024 will feature several sessions on?medical device R&D?and?quality. Be sure to visit Portescap?at Booth 2614 and check out other resources?here.
“Designing a medical device can seem daunting but working with motion control experts results in a device tailored to the patient and to the medical professional needs,” concludes Beckstoffer.
Medical Design & Manufacturing (MD&M) Minneapolis is part of Advanced Manufacturing Minneapolis, which will be held October 16-17, 2024, at the Minneapolis Convention Center. The event also features the co-located shows MinnPack, Automation Technology Expo (ATX) Minneapolis, Design & Manufacturing (D&M), and Plastec Minneapolis.
How Medtronic Ensures Medical Plastic Implants Go the Distance
By MD+DI Staff
The pace of technology today moves at warp speed, and in a highly regulated sector such as medical technology, these advances can outpace the guidance documents established to outline the required testing to ensure the life-saving devices perform as expected. FDA developed the Medical Device Development Tools (MDDT) program to accelerate the integration of new and proven strategies for evaluating new technology without diluting regulatory oversight or patient safety. It was a welcome development that medical device giant Medtronic has used effectively in an accelerated test methodology to address the performance of new materials at long human implant times.
“Prior to this program, guidelines could take years to develop,” explains Dr. Kimberly Chaffin, Vice President, corporate technologist and Fellow, at Medtronic. “In many cases, the technological advances were outpacing the guidance document updates, giving a false sense of confidence to the medical device developer when the guidance was successfully applied to today’s devices.”
Previous guidance pegged implant longevity at less than five years
MDDTs have been qualified for a range of device types since the program was established in 2017, and it is a testament to its rigor that only 17 MDDT tools have been qualified by the agency thus far. Chaffin discussed with PlasticsToday the Accelerated Testing to Prove Long-term Materials Biostability MDDT that Medtronic uses to collect evidence to support device biostability over modern-day longevity expectations, which often exceed 15 years. “This tool serves to update previous FDA guidance, which is based upon assumptions established in an era when longevity expectations were less than five years,” she notes.
In previous guidance for proving long-term material biostability, the focus was on oxidation, explained Chaffin. “There are two dominant in vivo reactions —?oxidation and hydrolysis. In the predicate guidance, it was assumed that hydrolysis was slow compared to oxidation and expected implant times. This assumption was supported by the historical observation that most material failures were oxidative in nature, said Chaffin. New materials, thus, were developed for oxidative resistance, pushing out longevities and resulting in a transition to hydrolysis-based failure as the most observed failure mode. “The MDDT addresses the gap that exists in the predicate guidance for modern materials and device longevities, where a new material’s susceptibility to failure by hydrolysis is addressed.?The advantage of having this MDDT to augment the guidance is that the combination of the two testing strategies results in a more comprehensive assessment of a new material’s susceptibility to in vivo reaction, where the assessment can be performed in vitro and be relevant at decade-plus implant timeframes.”
Context of use
FDA qualifies MDDT tools within a specified context of use, and the context for this particular MDDT limits the tool’s application to polyurethane materials used as insulation on cardiac and/or neuromodulation leads, where the dominant reaction is hydrolysis, explained Chaffin. The tool does not replace the predicate guidance that is focused on a new material’s ability to resist oxidation, she added.?In theory, however, this MDDT could be expanded to all types of plastics, elastomers, and adhesives.?“In fact, a similar quantitative acceleration protocol is used in other industries,” said Chaffin, noting that she was first exposed to the strategy early in her career when she was working in the automotive industry.
In the medical arena, the careful application of accelerated testing can reduce the use of preclinical models involving animals. Conventional thinking has been that the biological environment is too complex to simulate through in vitro lab experiments. “This thinking suggests we must always utilize animals to assess the biostability of a new material, and because it is difficult to find an animal model that is capable of exposure times consistent with modern-day implants, we must always extrapolate statically noisy data to predict a material’s ability to perform over the service life expected for today’s implants,” said Chaffin. “Through the publication of this MDDT, we have demonstrated that we can accurately predict the long-term in vivo performance of a material, disproving the thesis that the biological environment is too complex to simulate.” Chaffin cites recent research on the reaction rate of a PDMS-urethane material used in the primary insulation on some cardiac leads, where human implant times out to 13 years.
MDDT process revealed material shortcomings
At Medtronic, the MDDT process is used to assess all new materials used in chronic implants. Even before the tool was qualified by FDA, the medical device manufacturer used it to cancel major programs that incorporated new materials that did not perform well at long times, said Chaffin. “In addition, we have used it to introduce new materials to our long-term implant development programs.?Through the incorporation of this testing, we have the added confidence that we will not face a material degradation challenge 10 years after implanting our patients.?We have a comprehensive publication in process demonstrating its applicability to a wide range of new material chemistries,” said Chaffin. Thus far, three papers have been published showing how the MDDT tool was used to assess materials, as follows:
“Influence of Water on the Structure and Properties of PDMS-Containing Multiblock Polyurethanes” in Macromolecules.
“Polyether Urethane Hydrolytic Stability after Exposure to Deoxygenated Water” in Macromolecules.
“Longevity Expectations for Polymers in Medical Devices Demand New Approaches to Evaluating Their Biostability” in ACS Macro Letters.
Take a deeper dive at Advanced Manufacturing Minneapolis
Chaffin will lead a session on material biostability for chronically implanted medical devices at Advanced Manufacturing Minneapolis during the Medical Polymers track. She will discuss the use of predictive accelerated testing of commonly implanted medical device polymers on Oct. 16 at 3:45 p.m. Advanced Manufacturing Minneapolis brings together Medical Design & Manufacturing (MD&M), Plastec, ATX (automation technology), Design & Manufacturing, and MinnPack under one roof at the Minneapolis Convention Center on Oct. 16 and 17, 2024.
More Advanced Manufacturing Minneapolis News ???
? Mayo Clinic & Philips to Keynote Advanced Manufacturing Minneapolis: Manufacturing’s premiere event returns Oct. 16th and Oct 17th at the Minneapolis Convention Center.
? How Vulnerable Is Your Medical Device to a Cyberattack?: An industry expert discusses how medical device companies need to have a shift in thinking when handling cybersecurity threats.
? Advances in 3D Printing Usher in the Next Wave of Orthopedic Casts: ActivArmor's founder and CEO explains why 3D printing is changing the concept of orthopedics.
? AI-Enabled Medical Devices: Regulatory Trends in the United States & Beyond: Attrayee Chakraborty, quality system engineer at Analog Devices, discusses how to prepare for the rigorous regulatory requirements surrounding artificial intelligence.
? Best Practices for Medical Device Material Selection: To keep pace with the evolution of medical device design and development, more materials insight is needed than can be found in generic spec sheets.
? Get Ready for a Deep Dive Into Medical Plastics at Plastec Minneapolis: Material science experts will discuss current and emerging applications for medical plastics during a daylong conference track.