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Unconstrained Manufacturing Freedom: How 3D printing and advancements in additive manufacturing are improving the development of medical devices, practices, and patient health.

In Japan, engineers and scientists have developed a sensor device that can be embedded into a human being that closely monitors beating heart cells. The team, composed of engineers and scientists from the University of Tokyo, Tokyo Women's Medical University, and RIKEN used a complex, nano-mesh sensor fabricated through a process called electro-spinning

that extrudes ultrafine polyurethane strands into a flat sheet, forming a spiderweb structure. This web is then coated with parylene, a form of plastic, to strengthen it. Cold is then etched onto certain areas to serve as sensor probes that transmit signals, without interference, to a visual graphical interface that resembles a cardiogram.

The embedded device is emblematic of how plastics engineering, combined with other science, is creating dramatic medical progress. New capabilities with additive manufacturing and 3D printing are changing medicine, our lives, and our world.

"Doctors are just scratching the surface of what's possible with additive manufacturing for the medical device industry," says Lee Dockstader, director of vertical market development for HP 3D Printing in Vancouver, Wash. "Many medical device manufacturers are looking for technologies and engineering solutions that allow for more reliability, design flexibility, and cost-efficiency. 3D printing enables technological advances that were not previously possible in the medical industry, influencing medical devices and anatomical models across practices and disciplines."

Aiding Surgical Procedures

Such influence is not just enabling the fabrication of devices such as nano sensors, prosthetics, and other objects, but also helps surgeons improve their craft. They are using 3D-printed surgical guides for everything from knee replacements to custom dental implants and titanium plate fixtures for complex fractures.

Fabricated jigs and tools help surgeons and physicians perform complex medical procedures where precision in paramount. By using available imaging data, surgical teams can produce models and create guides that expedite delicate parts of surgical procedures. They help skilled surgeons put their full skills to work.

"Tens of thousands of surgeries are now carried out using 3D-printed surgical guides, which not only shortens the length of an operation, but can result in less pain, fewer surgical revisions, and a better long-term outcome," says Dockstader. "3D printing can upgrade any medical device that needs to be individualized for patients, thanks to the efficient and accurate design process it provides."

For example, suppose a patient is to have a total knee replacement. A guide to aid the complex surgery may be tailor-made based on the unique physiology of the patient's knee. It helps the surgeon know exactly where to make incisions and how to position components of the knee replacement. It affords a precise fit and a more successful outcome. It enables the patient to not only undergo the procedure well but also recover more quickly than usual.

Fabricating Multiple Medical Devices

Medical devices span a spectrum of function, size, and use. Prosthetics may substitute as body parts, embedded devices, and other devices may supplement human functions, and wearables may be used in the course of routine care for patients as well as supporting medical professionals.

Wearable devices in particular are increasing in all sectors. Devices are integrated into clothing, glasses, and strap-on apparatus; many other types of wearables use sophisticated technology (often microtechnology) to transmit data and help users perform more functions by enabling their mobility and work.

"We're at an exciting point in the medical devices industry with the explosion in popularity of wearable devices. They are the future of monitoring health and wellness, and we're already seeing growth in the design and functionality of these products," says Gordon Styles, chief technology officer and founder of Star Rapid, located in Zhongshan, China.

Some wearable medical devices incorporate a biochemically active design to boost blood circulation, heal foot wounds, and protect against future injury. For instance, they are inserted into footwear and ensure good balance while relieving pressure at the point of a foot wound, protecting it from infection. These devices are uniquely powered by a rechargeable battery apart from the insert; the configuration prevents medical problems that were previously difficult to deal with.

It's still early to cap the capabilities and applications of wearables. Notes Styles, "Wearables are the future of monitoring health and wellness, and we're already seeing an influx in the design and functionality of these products. With new wearables constantly hitting the market, the aesthetics become critical to succeeding in such a crowded market. As this sector expands, it will be a major driver for the plastics industry."

Such aesthetics may be greatly enhanced with additive manufacturing. The utility of 3D printing in medical device manufacturing is not always about functionality; it also may contribute to the aesthetics of, say, a prosthetic. Dockstader cites the inspiring story of Christophe Debard. He used HP's Multi Jet Fusion for his Print-M-Leg project.

"Thanks to the design freedom of 3D printing, Debard can showcase his personality by way of his prosthetic leg through stylistic adjustments," explains Dockstader. "His goal is to empower others to create and wear aesthetically pleasing prosthetics in order to proudly display differences can change how others view disabilities."

Fabrication has also gone mainstream with kiosks that allow consumers to have unique items fabricated at a point-of-sale or nearer to the place where they might acquire something like insoles for their shoes. 3D printing is unique in being somewhat portable. Molding and manufacturing in batch has traditionally taken up much floor space. However, the technology of composites and fabrication of materials and objects does not need much space. 3D printing is not just revolutionizing the speed and facility of fabrication and production of plastic and composite objects, it's also transferring this process to nontraditional spaces.

HP helped develop Fitstation, which should be scaling up in 2019. This footwear platform takes a 3D scan of your feet plus captures your dynamic gait by a pressure mat that you run or walk on. In fact, a 3D-printed consumer insole version is in 26 stores and marketed by Superfeet, a producer of insoles for athletes and others who seek supplemental insoles for their footwear. Dockstader explains that the medical insole version will be rolling out more fully in 2019; it represents a growing sector of composites manufacturing where the once-complex process of fabrication using plastics and composites is simplified: digital end-to-end solutions provide high-value, locally and in-store, by making available quality devices at a reasonable price.

FDA Compliance

Many developments in material chemistry and properties are being advanced in response to the demand for medical device manufacturing using additive processes. The Food and Drug Administration (FDA) has heightened its oversight of manufacturing devices as the enthusiasm of this new capability means more products from more producers, many of whom are making medical devices and products for the first time.

The FDA explains that their focus is on the approval of finished medical devices, not on the specific materials used in the manufacture of medical devices. This includes materials that may be used in the manufacture of 3D-printed devices.

In their own example, the FDA states that it approved spinal implants made from titanium alloy, but has not reviewed or fully approved the use of titanium in medical devices. "Materials used in formulating or constructing medical products are evaluated within the context of FDA's evaluation of the safety and effectiveness of the medical product for its intended use," they explain.

Their regulation looks at the final product, integrated with the material it is made from. Specifically, they approve a material as part of the finished device and its intended use. It is their determination that the device's intended use and technological characteristics, which includes the materials, are safe and represent a legally marketed device. They are also specific in clarifying that approval of a device with one type of material does not imply approval of another device using the same material. Again, the context of their approval is based on the device and its functionality using specific material.

Interestingly, new materials used in medical devices don't always require the rigor of FDA approval for new market use; the review process for most new products is traditionally comprehensive and stringent. The FDA states, "Devices with new materials may be cleared through the 510(k) premarket notification process provided that the new material does not raise different questions of safety or effectiveness, and the submission demonstrates that the new material is at least as safe and effective as those in an equivalent legally marketed device."

Materials and Fabrication Management

The complexity of the material itself--wear properties, safety, structure, and more--is evolving. Science is solving challenges in material properties to improve the utility of the end products. The challenge to plastics engineers and materials scientists is to be aware of the properties and qualities of any new material, as well as the effect that it may have on the overall device and its compliance with FDA regulations.

"It's important for plastics engineers to be up to date on the types of materials that can be used with additive manufacturing for medical devices," says Dockstader. "PA-12, for example, is a common polymer utilized in various 3D-printed medical devices today. It has very good mechanical properties and is naturally very biocompatible. In the future, PA-12 could also be suitable for producing plastic parts with embedded printed electronics or sensors."

At HP, new materials are constantly being developed through HP's Open 3D Materials Platform. The platform was created to leverage the strength of collaboration between companies and break down the barriers to advancing 3D printing adoption and innovation. The methods by which engineers and scientists are producing medical products are advancing and conjuring excitement. They are developing new processes that work conjointly with additive manufacturing to expedite fabrication.

"From a technology point of view, one of the most exciting processes to gain popularity is micro-molding," explains Styles. "Micro-molding is a form of manufacturing used to create very small, highly precise plastic-injection-molded parts. This emerging manufacturing technique is ideal for the medical industry as it allows for extremely tiny parts with unique and complex shapes to be designed with high quality and at a low cost. This can be used to create a variety of medical devices."

In micro-molding, a mold, formed in the shape of the desired part, can create tiny but precise parts with micron tolerances. It enables the finite accuracy and precision that more advanced medical devices require.

"Being able to use micro-molding techniques to quickly create parts that otherwise would be tedious to design and produce will advance the medical devices industry to new levels," predicts Styles. "As the medical industry continues to push the boundaries of minimally invasive procedures, micro-molding will play a key role for producing the tiny, yet complex parts needed for medical devices and implants."

Another development is in the production of sockets used for devices. Traditionally, sockets are made using plaster molds and plastic. Several sockets are frequently made before the final product is ready, which results in an expensive and timely process for the patient.

Dockstader cites technology developed by a prosthetic limb and device company, ProsFit, to accurately and successfully produce 3D-printed custom sockets for prosthetics. HP has teamed with them with great success. According to ProsFit, two out of every 10 sockets, historically, met specifications and requirements. Products did not meet patient expectations; the end product was likened to a prototype.

In their partnership with HP and fully employing 3D scanning, proprietary software, and HP Jet Fusion technology, ProsFit now supplies prosthetic clinics with a complete digital solution to help simplify the fitting experience and improve the manufacturing of prosthetic limb sockets.

"ProsFit has reduced the time it takes to make and deliver a socket from weeks to days," explains Dockstader. "But ultimately, ProsFit's goal is to improve the lives of the world's more than 20 million amputees by providing them with more comfortable and better performing prosthetic limbs. The ProsFit business model enables this by having very little upfront cost, cloud-based software, and distributed 3D printing by certified vendors. Again, driving the cost down will drive adoption up."

Socket improvement and micro-molding are just two examples of how process improvement occurred as a result of moving medical devices forward with the advancement of 3D printing. As new methods are developed and employed, quality products may be prototyped quickly, speeding time-to-market and enhancing the competitive capability of manufacturers. They benefit and so do patients.

"Additive manufacturing provides researchers and medical device companies with tools to accelerate progress with rapid prototyping solutions," says Stacey Clement, vice president of marketing for Fisher Unitech based in Detroit. "Producing prototypes with additive manufacturing allows organizations to quickly realize new products in real time, allowing researchers to take an idea from concept to production. Rapid prototyping also allows medical device manufacturers to gather feedback earlier in the development process by creating clinically relevant and anatomically accurate models for validation and verification testing."

The Healthy Horizon for Medical Devices

"Improving patient outcomes while making the healthcare system more efficient is top of mind in the industry," notes Clement. "Technology innovations are driving new tools to solve these problems while becoming more effective and productive. Additive manufacturing is one of these tools that helps inventors, educators, and researchers improve how they design, manufacture, teach, and perform research."

For our world's healthcare, there is a healthy horizon for medical devices. The genesis of additive manufacturing as a means to create and innovate still has more to give to the medical community. It will provide more alternatives and solutions that were not possible a decade ago. It provides health professionals with more options. It breaks barriers and constraints that restricted their treatment. 3D printing aids medicine, and most importantly, the patients who are in receipt of their solutions.

The improvement in surgical methods as well as other treatment methods makes the genesis of 3D printing for the medical device industry a very positive force. "The same technology has also benefitted healthcare providers with tools that can accelerate medical innovation, improve patient outcomes through patient-specific surgical planning models, and help train the next generation of physicians," says Clement. "While no tool is an all-in-one solution, 3D printing is a strong step in that direction, particularly in its most sophisticated forms. By adopting 3D printing, engineers will have almost unconstrained manufacturing freedom; one system can prototype a new application, create realistic anatomical models for training and surgery planning, and create custom research."

ABOUT THE AUTHOR

Jim Romeo is a freelance writer based in Chesapeake, VA. For more than 20 years, he has contributed numerous articles to various publications on the topics of logistics, engineering, software and supply-chain management. He earned his B.S. in mechanical engineering from the U.S. Merchant Marine Academy, and an MBA from Columbia Business School at Columbia University. Contact him at freelancewriting@yahoo.com.

By Jim Romeo
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Title Annotation:MEDICAL DEVICES
Author:Romeo, Jim
Publication:Plastics Engineering
Geographic Code:9JAPA
Date:Feb 1, 2019
Words:2461
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