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Designing forINDUSTRY FOCUS:

Medical/Life Sciences

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FDA releases Medical Device 3D Printing Guidelines � � � � � � � � � � � � � � � � � � � � � � 3

More Choices for 3D-Printed Medical Models � � � � � 6

5 Ways 3D Printing Will Change Healthcare � � � � � 10

Automation: A Compliance Lifeline for Medical Device Makers � � � � � � � � � � � � � � � � � � 12

Rethinking the Stethoscope � � � � � � � � � � � � � � � � � 16

Designing Prosthetics: When Customization is Crucial � � � � � � � � � � � � � � � 20

Transforming Ankle Foot Orthosis with 3D Printing � � � � � � � � � � � � � � � � � � � � � � � � � � 24

Hyundai Wearable Robotics for Walking Assistance Offer Spectrum of Mobility � � � 27

Going Vertical with Engineering Software � � � � � � � 29

The Role of Digital Methods in Medical Device Development � � � � � � � � � � � � � � 32

Skin-Deep Sensors � � � � � � � � � � � � � � � � � � � � � � � � 36

Contents

When engineering and medical know-how come together, the results are nothing short

of amazing. Technologies used every day by

engineers—such as CAD, 3D printing, simulation and sensors—are potential cures to many of the medical industry’s most pressing problems. However, the specialized knowledge of engineering and the specialized knowledge of medicine aren’t always so easy to combine. Doctors may have ideas to improve the design of their tools or for new tools, but not have the design and manufacturing experience to turn those ideas into reality. Engineers are accustomed to building better products and machines, but the human body is a far different type of machine. Beyond the scarcity of expertise in both fields are safety and compliance concerns that require their own type of expertise.

Thankfully, medical device manufacturers have blazed a trail, often with the help of 3D printing. The medical and dental industries’ need for custom designs—from prosthetics to jigs to surgical models—helped expose more people to what is possible when modern design engineering is applied to medical uses. Now the FDA is embracing 3D printing as well as simulation to help bring medical and life sciences product development up to speed with other sectors.

Using technology to usher in huge advancements—such as the possibilities offered by personalized medicine or cybernetics—is still on the horizon. But formerly cutting-edge technologies are becoming increasingly commonplace. Ideas that a few years ago were seen as radical—such as exoskeletons to help people walk, implants that are quickly custom-tailored for each patient, or performing virtual surgery in advance of the real one using that specific patient’s data—are now a seen as matters of course.

You’ll see some great examples of the how engineering and medical professionals are coming together to solve real problems with technology in the articles collected for this special digital issue. We hope they inspire you to expand your horizons.

Welcome

Jamie Gooch

Editorial Director, Digital Engineering, Peerless Media, LLCComments? E-mail me at: jgooch@digitaleng.news

Engineering Medical Marvels

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Editorial StaffTom CooneyPublisher

Jamie Gooch Editorial Director

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Peerless Media, LLCBrian CeraoloPresident and Group Publisher

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Editorial Office111 Speen Street, Suite 200 Framingham, MA 01701-2000 Phone: 1-800-375-8015

ON THE COVER: Image courtesy of Thinkstock/chombosan.

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Titled “Technical Considerations for Additively Manufac-tured Medical Devices: Guidance for Industry and Food and Drug Administration Staff,” the document addresses design, manufacturing and testing considerations of devices only; other work in progress will recommend policies specific to AM of drugs and human tissue. (One example of the latter is the Emerging Technology Program run by the FDA’s Center for Drug Evaluation and Research (CDER). Under this pro-gram pharmaceutical companies can connect with the FDA early in their research efforts, which can include use of 3D printing to manufacture drugs.)

A Starting Point for ManufacturersThe FDA, an agency of the U.S. Department of Health and Human Services, is chartered with ensuring the safety, ef-fectiveness and security (among other things) of human and veterinary drugs, vaccines and other biological products for human use, as well as of medical devices.

To begin addressing these concerns within the emerging AM field, the FDA reviewed more than 100 devices currently on the market that were manufactured on 3D printers. These ranged from patient-specific knee replacements and cranial implants to medical instruments and surgical guides which may or may not be patient-specific.

This work has been underway for quite some time, begin-ning with a public workshop held in October 2014, titled, “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.” At that meeting, medical device manufacturers, AM compa-nies and academia tackled five broad themes:

1. materials,2. design/printing/post-printing validation,3. printing characteristics and parameters,4. physical/mechanical assessment of final devices, and5. biological consideration of final devices (including

cleaning, sterility and biocompatibility).Feedback from that workshop led to publication of a draft

version of this document being issued in 2016.Although designers and manufacturers with years of ex-

perience in AM may find some of the document’s informa-tion just confirmation of well-known factors in the full 3D-print process (regardless of exact technology), they will also find that this group has compiled a knowledgeable checklist of many process details. The report’s authors note, for example: “The innovative potential of AM may introduce variability into the manufacturing process that would not be present when using other manufacturing techniques,” and “In a powder bed fusion machine, the ratio of reused to vir-gin powder can affect melting properties, which affects the energy needed to create consistent bonding between layers,

DanaMed Pathfinder biocompatible ACL surgical device, produced with direct metal laser sintering in Inconel 718: an example of a 3D-printed medical device. Image courtesy of Stratasys Direct Manufacturing.

PAMELA J. WATERMAN

THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) recently announced the publication of a 31-page set of guidelines for manufacturers producing medical products via 3D printing/additive manufacturing (AM). Although this information is presented as non-binding recommendations, the agency says it is the first in the world to provide such a comprehensive regulatory framework.

FDA Releases Medical Device 3D Printing Guidelines

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which in turn affects final mechanical properties.”A particular aspect addressed for patient-matched devices

(PMD) is the number of factors involved in building parts based on imaging data. One such concern is simply the passage of time, as explained: “When the device is intended to match a patient’s anatomy, and that anatomy can change over time (e.g., with disease progression), the time that can elapse between when the patient is imaged and when the final device is used may need to be reflected in the expiration date of the device.” It then cites information to be included on final-product labeling.

Planning and Documenting the Full AM ProcessOther AM-specific topics include the possibility of errors intro-duced in file-type conversions of data (from imaging to CAD work to printer set-ups), the need for maintaining secure patient data, establishing build-volume control limits for repeatability, and documenting all post-processing steps (i.e., removing manu-facturing residues from the device, heat treatments of the device to relieve residual stress, and final machining.)

And, since the design and materials involved with any kind

of medical devices or implants is subject to improvements, the guidelines recommend: “Manufacturers should rely on existing FDA Guidance for their regulatory pathway when considering a change to a previously cleared or approved device that uses AM.”

Lastly, a key theme throughout the document is the need to establish an in-depth quality system. At a minimum, this should include software workflow, material controls, process validation, material clean-up and sterilization, and mechani-cal inspection and testing.

Evolving Recommendations“Today we are issuing new guidance to help advise device manufacturers on technical aspects of 3D printing that clarifies what the FDA recommends manufacturers include on submissions for 3D-printed medical devices,” states FDA commissioner Scott Gottlieb, M.D. in the press release ac-companying the new document. “These steps are part of our broader effort to help ensure our regulatory framework is properly matched to the unique attributes of the new technologies we’re being asked to review.”

All this information will be useful for manufacturers planning product submissions for FDA approval, and will improve the position of the U.S. in the worldwide AM medical-device marketplace. The FDA encourages interested manufacturers to work closely with the agency starting early in the design cycle. DE

Contributing Editor Pamela Waterman is an electrical engineer and freelance technical writer based in Arizona. You can send her e-mail to de-editors@digitaleng.news. This article was originally published Jan. 22, 2018 on DE’s RapidReadyTech.com blog.

Dental laboratory Protaico uses an Objet Eden260TM 3D Printer to create surgical guides that assist with pre-surgical planning and provide interoperative positioning verification. Image courtesy of Protaico.

INFO ➜ FDA: FDA.gov

➜ Stratasys Direct Manufacturing: StratasysDirect.com

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Watch “The 3Rs of 3D Printing: FDA’s Role” to learn how the FDA reviews and researches 3D printed medical products to protect the public health.

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Until a few decades ago, medical modeling—a centuries-old skill—relied on carving or molding materials like wood, ceramic and plastic. Such physical models, replicating both interior and exterior human anatomy, are extremely useful for training and educating medical professionals, or serving as test platforms for device manufacturers. However, they often lack unique details and material authenticity.

The evolution of additive manufacturing (AM/3D printing) is changing all that. While patient-specific AM models already help doctors visualize and plan the steps of difficult surgeries, another aspect of this field is emerging: that of medical models with realistic material properties, serving as tools for research-ers, educators and medical-device manufacturers. Stratasys, one of the pioneers in 3D printing, has just announced a new medical-modeling service to meet this demand.

Modeling True-to-Life Anatomical StructuresStratasys has developed what it calls BioMimics, a model-ing solution offered initially in North America through Stratasys Direct Manufacturing, the company’s manufac-turing division, and available immediately. BioMimics is launching with options that mimic the complexities of heart and bone structures, with a third application—vas-cular anatomy—scheduled for an early 2018 release.

Combining Stratasys PolyJet 3D printing with new materials and processing parameters, these functionally accurate replicas eliminate a number of today’s limita-tions in medical training, research and testing. “3D print-ing is already being widely used to recreate anatomy for patient imaging, but what’s been needed has been the biomechanics element,” says Michael Gaisford, Stratasys

director of marketing for healthcare solutions.The BioMimics approach produces models with highly

detailed complexities, from intricate microstructures to melded soft and hard textures within a single model.

PAMELA J. WATERMAN

A S MUCH AS BOOKS and websites teach everything from how to unbox a computer to how to assemble an IKEA desk, they still don’t present the full insight-potential of a physical part. There’s nothing like holding, turning and viewing a real-world sample to give someone a deeper understanding into an intricate part or device. And if that part happens to be a human organ or anatomical structure, the importance of a lifelike model goes up dramatically.

More Choices for 3D-Printed Medical Models

Stratasys BioMimics 3D-printed model of a spine section, made from multiple appropriate materials on a J750 AM system. The model’s material properties allow it to be used for training surgeons; here, a pedicle screw is being inserted. Image courtesy of Stratasys.

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This realism allows users of medical models to break free from the approximations of human anatomy offered by animal anatomies (different from human) and the lack of “live-tissue feel” found in highly processed cadavers. Moreover, a BioMimics model can include the details of a real-world, imperfect or diseased pathological system.

Creating these models starts with a dialog, says Gais-ford; it’s not yet an automated process, but there is value in tapping the expertise of the material specialists at Stratasys Direct Manufacturing. Users either provide an STL model of the structure in question or data from a CT scan or MRI, and a Stratasys designer will use that as guidance for defining the optimum, specialized BioMim-ics “building blocks” (set of AM parameters). This entails directing the PolyJet printer to print with a digitally blended material with specific characteristics, at every voxel location in the build file, generating model-specific color, texture and density.

Bones and Hearts, for StartersGaisford gives examples of how accurate and useful such models will be: “If you’re doing a spine model that you want

to be able to drill pedicle screws into, and have haptic feed-back of the trabeculae (tissue) within the vertebra, then we would overlay that particular BioMimics building block. Or, if you want soft discs on the model that the physician can remove in a practice discectomy, and have the nucleus come away like crabmeat, then we would apply those characteris-tics within the BioMimics bone building block.”

Even more customization is readily available, Gaisford notes, so that the printed model meets a specific clinical scenario. “If the customer says, it’s a spine model,” he ex-plains, “but they want it to be for an osteoporotic woman in her 70s, then we would take that BioMimics building block and adjust the bone density accordingly. When you place screws into it, or are probing it, it will respond as an osteoporotic patient would.”

This latter scenario would, for example, help the man-ufacturer of titanium pedicle screws test a new design targeted to that exact application, rather than to generic, dense “healthy” bone.

The second building block now available replicates heart tissue including functioning cords, annulus, valves and calcification with a range of properties, such as an

LEFT: Using a multi-material 3D-printed model for training a surgeon to perform a spinal discectomy: step one, an incision between sections of “bone” and “disc” material. The model was produced through the new Stratasys Direct Manufacturing BioMimics service.

RIGHT: Step two in the surgical training for a discectomy: removing “nucleus material” from the 3D-printed part. The texture and density accurately mimic those of an actual disc. Images of courtesy Stratasys.

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ultra-soft material. With these models, medical students can practice cutting, suturing, drilling, reaming, patching and device placement (e.g., pacemaker leads).

Advances in Hardware, Software and MaterialsAlthough the BioMimics program has been underway for some time, the Stratasys team really escalated its efforts

over this past year. Gaisford says that not only were new materials needed, but that developing the software to control voxel-level printing was critical. And, of course, it all depends on the capability of the Stratasys J750 AM system to combine six materials on the fly.

Components for additional building blocks are in the works, starting with the vascular anatomy version. Users have already noted how this will improve pre-clinical validation of new devices and support clinically realistic training simulators. Watch the video “Lifelike Vascular Environment” below to see work that has led up to the new program. DE

Contributing Editor Pamela Waterman is an electrical engineer and freelance technical writer based in Arizona. You can send her e-mail to de-editors@digitaleng.news. This article was originally published Jan. 22, 2018 on DE’s RapidReadyTech.com blog.

Heart model made of realistic 3D-printed material, used in surgical training at The Hospital for Sick Children, Toronto, Ontario. Image courtesy of Stratasys.

INFO ➜ Stratasys Direct Manufacturing: StratasysDirect.com

➜ Stratasys: Stratasys.com

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Watch how the Jacobs Institute uses 3D printing to combat vascular diseases.

To properly model radiofrequency tissue ablation, the simulation must account for electric current flow, heat generation, and temperature rise in the human tissue. This is where multiphysics simulation software comes in.

The COMSOL Multiphysics® software is used for simulating designs, devices, and processes in all fields of engineering, manufacturing, and scientific research. See how you can apply it to modeling tissue ablation procedures.

Designing RF tissue ablation devices involves multiphysics.

comsol.blog/RF-tissue-ablation

Visualization of temperature, size of completely damaged tissue, and current density between the electrodes of a bipolar applicator.

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The report, published by Dr. Jason Chuen and Dr. Jasamine Coles-Black of Austin Health in Melbourne, Austra-lia, outlines five key areas where 3D printing will likely have the biggest impact on healthcare.

Chuen, the director of vascular surgery at Austin Health and director of the hospital’s 3D medical printing laboratory, uses 3D-printed models of aortas to practice delicate surgeries.

“By using the model I can more easily assess that the stent is the right size and bends in exactly the right way when I de-ploy it,” said Dr. Chuen.

The five areas discussed in the report include:1. Bioprinting and Tissue Engineering: Scientists are al-

ready building 3D-printed organoids to mimic human organs at a small scale, and the report predicts that eventually hos-

pitals will be able to print human tissue structures that could eliminate the need for some transplants.

However, Chuen says that “Unless there is some break-through that enables us to keep the cells alive while we print them, then I think printing a full human organ will remain impossible. But where there is potential is in working out how to reliably build organoids or components that we could then bind together to make them function like an organ.”

2. Pharmacology: 3D printing of drugs could enable com-panies to create multi-drug capsules that release different com-pounds at different times. There is already a printed polypill that contains three different drugs for diabetes and hypertension.

3. Surgical Rehearsal: Using 3D printed models to pre-pare for surgeries is already in practice at some hospitals. While the modeling software and equipment can be expensive, for particularly complex surgeries this method of rehearsal can save valuable (and costly) time in the operating theater.

4. Customized Prosthetics: Again, there are already a number of companies and organizations creating custom-fit prosthetics for patients (and even for pets) around the world. This not only helps improve the fit and function of the pros-thetic, but can also reduce the need for additional surgeries.

5. Distributed Production: Rather than inventory large stores of drugs, prosthetics, and other equipment, hospitals could potentially create items on demand and on site. This would significantly alter the healthcare supply chain, but the report says there are still concerns around quality control and regulatory compliance.

“That represents a huge shift and we have to work out how it could work. But if we get the regulation right then it will trans-form access to medical products,” Chuen said.

You can read the report in the Medical Journal of Australia. DESource: University of Melbourne

Contributing Editor Brian Albright is a freelance writer based in Cleveland, OH. You can send him e-mail to de-editors@digitaleng.news. This article was originally published Sept. 14, 2018 on DE’s RapidReadyTech.com blog.

5 Ways 3D Printing Will Change Healthcare

A NEW STUDY of the potential for 3D printing in the healthcare industry predicts wide-ranging advancements and disruptions as the technology is adopted by more hospitals and manufacturers.

Doctors are already using 3D printed models (like this one of an aorta) to practice surgeries in advance. Image courtesy of Austin Health.

INFO ➜ Austin Health: Austin.org.au

➜ University of Melbourne: Unimelb.edu.au

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After nearly a decade relying on mostly manual pro-cesses, TransMedics conducted an internal audit and found its compliance efforts in need of some serious resuscita-tion. The paper-based processes provided little visibility into design changes or approval workflows, and action items associated with specific projects would often get lost

in a pile of documents or stuck in someone’s inbox. It was hardly a remedy for fast-tracking products through the FDA approval process and out to the open market.

“We decided that given the size of our company, the complexity of what we were developing, and our growth, it was time to move to an automated system,” says Progga

Automation: A Compliance Lifeline for Medical Device MakersBY BETH STACKPOLE

WHEN ORGAN TRANSPLANTATION is your business, it’s critical to stay on the leading edge. TransMedics, known for its next-generation Organ Care System used to transport hearts, lungs and livers in a “living state” outside the body as opposed to the traditional biohazard ice cooler, struggled to strike a balance between innovating under time-to-market pressures and industry requirements around compliance.

M-Files QMS includes built-in change request features, version history, audit trail and proofed evidence of document learning to ensure that employees adhere to policies related to compliance. Image courtesy of M-Files.

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Das, quality systems engineer at the medical device manu-facturer. “You can achieve much higher visibility when you have online systems.”

TransMedics, like so many start-up medical device companies, found documenting repeatable processes to meet regulatory compliance to be more of a struggle than designing and engineering innovative products. Trying to meet requirements for regulations like the FDA 21 CFR Part 11, for electronic signatures, ISO standards for qual-ity management and the CE Mark, to sell a product in Eu-rope, is a complex drill that is often enforced and managed by personnel who aren’t facing the same time-to-market demands as engineers.

Meeting the compliance challenge involves an array of formal processes and procedures along with documenta-tion and audit trails to prove everything has been kept in check. Manual processes, coupled with disparate design, quality assurance (QA) and homegrown systems, have been the norm. But with product complexity on the rise and a greater focus on quality, medical device makers are looking for a lifeline. They may have found it by automating com-pliance processes with document management systems and PLM (product lifecycle management).

“As an engineer, you always want to design the coolest products with the greatest feature set and you don’t want to waste time separating yourself from design to follow

some due diligence process for compliance,” says Chuck Cimalore, CTO of Omnify Software, maker of Omnify Empower PLM. “The question is how to maximize time doing design work while retaining the confidence that you’re not stepping outside of the due diligence boundar-ies so you won’t run into regulatory issues downstream.”

Eliminating the Busy WorkValidation is the key to any compliance initiative. Docu-ment management systems provide numerous capabilities, including electronic audit trail, workflow and electronic signature functions, that ensure processes are repeat-able and do so in a way that’s less time consuming and expensive than human oversight, says Todd Cummings, vice president of Research and Development at Synergis Software, the provider of the Adept engineering document management system. “We can take a lot of the details and busy work out of the process and automate it,” Cummings says. “That provides a massive leg up by allowing humans to focus on more creative thinking work.”

For example, version control, one of Adept’s features, keeps an audit trail of what documents or CAD models were checked in or out during the product lifecycle, en-suring everyone, not just engineers, are working off of the most current and accurate information, Cummings says. Electronic signatures, a critical piece of compliance directives, can also be streamlined in systems like Adept, through the use two-factor identification, which validates that a person signing off on something is who they say they are, he adds.

Quality, another big piece of compliance, can also be addressed more naturally within the context of a document management system, contends Greg Milliken, vice presi-dent of Marketing for M-Files, an enterprise document and content management system. As opposed to storing quality manuals on a shelf somewhere or in a separate siloed system where they are likely to be ignored, Mil-liken says moving that data and those processes under the domain of a document management system used every day is more likely to result in repeatable processes and as a re-sult, compliance.

“Our philosophy is to move away from a separate, siloed quality system to a system where it becomes day-to-day quality management,” he explains. “The first respon-sibility of maintaining quality is to document things that should be done to the best standards of the industry. Now imagine doing that within the same system that you’re doing everything else in.”

PLM and the Case for QualityWith the FDA shifting its compliance focus to quality, PLM vendors are making the case that their platforms are the best fit. Along with key industry partners, the FDA has

TransMedics’ OCS HEART delivers warm, oxygenated, nutrient-enriched blood to the donor heart and keeps it in a living state until the organ is ready to be transplanted. Image courtesy of TransMedics.

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been pushing the Case for Quality, an initiative launched in 2011 to identify and promote best practices for medical device quality after research revealed that the number of adverse event reports — particularly among cardiovascular and surgical devices — has increased significantly and is outpacing industry growth by a wide margin. The num-ber of recalls on medical devices has also escalated, with a third due to design flaws and another quarter related to is-sues in manufacturing, the FDA found. Improving quality measures presents an enormous opportunity to the medi-cal device industry — to the tune of about $4.75 billion to $6 billion, according to research from the McKinsey Center for Government.

Driven by DataAs opposed to a document-centric take on compliance, the new quality mandates require a data-driven approach, something only supported by PLM, notes Swapan Jha, PTC’s vice president of go-to-market for PLM. “When the design engineer or quality engineer is working on a 3D model of a medical device, a lot of data gets added to that model from a compliance and traceability perspective,” he explains. “Today, a lot of customers take that 3D model and create a PDF and all of that information that’s sup-posed to be tracked is lost and the dots are disconnected.”

With its model-based, product-centric view, Windchill PLM can provide access to the artifacts required for a quality initiative and for compliance throughout a prod-uct’s lifecycle, Jha says. With Windchill 11, PTC is mak-

ing compliance easier by providing out-of-box configura-tions for certain regulations — CFR Part 820 for quality system regulation, for example, as well as several of the ISO standards.

For its part, Aras is touting its model-based environ-ment as one of the primary reasons its PLM platform is gaining traction among medical device companies as a means to automate compliance, according to Doug Mac-donald, the company’s product marketing director. The flexibility of Aras’ modeling approach for customizing business processes, coupled with PLM’s ability to serve as a digital thread, providing traceability from a product sit-ting in a warehouse all the way back through manufactur-ing and to design, makes it much more effective in stream-lining compliance processes compared to any manual approach. “Without PLM, information could potentially be spread everywhere,” he explains.

A Layered ApproachSome Aras customers like Care stream Health Inc., are layering Aras on top of existing PLM systems to facilitate compliance and quality initiatives. Carestream, which manufactures medical imaging equipment among other health care-related offerings, uses Siemens PLM Soft-ware’s Teamcenter to manage engineering CAD and as-sembly files. However, the company has also brought in Aras PLM as the system of record for Device Master Re-cords (DMR), which capture all the drawings, documents, work instructions and processing information related to

Aras PLM supports Failure Modes and Effects Analysis (FMEA) procedures to help identify potential failure modes within a system, process, design or item while helping to design those failures out with minimum time and resources. Image courtesy of Aras.

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a particular device, along with the Design History File (DHF), which captures the complete record of design decisions.

“Aras gives us more flexibility to work with from a con-figuration management perspective,” says David G. Sher-burne, Carestream executive IT director. As for why PLM in general for compliance: “It helps us be more efficient while reducing compliance risk in a global environment — we want our cycles going into product innovation, not trying to figure out what version of the truth is out there,” he explains.

For TransMedics, Omnify PLM was the prescription for balancing compliance requirements with the need to accelerate time to market. The platform automates many compliance processes, including QA training to ensure manufacturing operators stay up-to-date. “It’s critical that we make sure they have training before completing a specific process and we’re out of compliance if it’s not documented,” Das explains. “Training was one of the areas we thought we could improve by managing it in Omnify versus having someone remember what person was trained in what and losing all of that closure.”

Specialized Service ProvidersWhile PLM and document management tools can auto-mate and streamline compliance, they can’t do so without knowledge of the regulatory landscape, which continues to evolve. That’s where specialized service providers come into play. Sterling Medical Devices, for example,

provides design and consulting services to medical de-vice manufacturers, including in the area of compliance, which is only going to get more complex as medical de-vice makers integrate state-of-the-art technologies like smartphones, the cloud and the Internet of Things (IoT) into their offerings.

The FDA is starting to adapt, but it’s a few years behind the technology, says Bruce Swope, vice president of En-gineering at Sterling. “The FDA, ISO and CE bodies are constantly coming out with new versions of regulations,” Swope cautions. “You could be designing for old standards and if you’re not done in time when the new regulations are out, you won’t get approval if you don’t meet the new regulations.” DE

Beth Stackpole is a contributing editor to DE. You can reach her at beth@digitaleng.news. This article originally appeared in the May 2016 issue of Digital Engineering magazine.

Omnify automates many quality and compliance processes, including training. Image courtesy of Omnify Software.

INFO ➜ Aras: Aras.com

➜ M-Files: M-Files.com

➜ Omnify: Omnifysoft.com

➜ PTC: PTC.com

➜ Sterling Medical Devices: SterlingMedicalDevices.com

➜ Synergis: SynergisSoftware.com

➜ TransMedics: TransMedics.com

/ / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / /

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In 1816, French physician Rene Laennec was embar-rassed to press his ear to a young woman’s chest, the pri-mary method of listening to a patient’s heartbeat at the time. As a more modest alternative, Dr. Laennec rolled up a stack of paper and placed one end of the cylinder to his ear and the other end on the patient’s body. Surprised by the clarity of sound, he later crafted a hollow wooden version with a brass tube insert. The stethoscope (named from the Greek words for “I see” and “the chest”) was born.

Although the materials have changed over the years, the general 19th century design has remained the same. And, respected voices in the medical community say the stetho-scope now belongs in a museum, not the doctor’s office; they argue that handheld ultrasound devices provide more accurate diagnostic screenings.

However, not all medical experts agree that the stetho-scope is ready for retirement. In a recent article for the New England Journal of Medicine, “Tenuous Tether,” cardi-ologist Elazer Edelman defends the traditional device as fundamental to the doctor-patient relationship.

“Laennec’s legacy lives on because it is not limited to a monaural tube, but includes the idea that we must in a sense become part of our patients, physically engaging them so that we can feel what they feel, sense how they suffer and fully comprehend what they are trying to tell us,” writes Edelman, the director of the Harvard-MIT Biomedical Engineering Center.

Also a professor at Harvard Medical School and a senior attending physician in the coronary care unit at Brigham and Women’s Hospital in Boston, he has been testing a new digital stethoscope called the Thinklabs One that can be connected to an external speaker and any com-puter, tablet or phone—turning the stethoscope from a “private hearing aid” to a “transcendent teaching tool.”

“Projected sounds also engage our patients, for they hear what we hear [often for the first time] and appreci-ate what we are doing [also often for the first time], which

binds them to us and us to them,” Edelman writes. “One patient with severe mitral regurgitation commented: ‘No doctor has ever offered to let me listen. Now I can hear what makes me feel this way, and for that I thank you.’”

Thinklabs: The Next Generation of StethoscopeThe Thinklabs One Digital Stethoscope was developed by electrical engineer Clive Smith, who introduced an electromagnetic diaphragm (the large flat side of the chest piece) using a high-intensity electric field (almost 1 mil-lion volts per meter) to measure vibrations. Instead of the traditional hollow tube, the sound is transmitted through high quality headphones.

The innovative design recently made the Thinklabs One the stethoscope of choice for emergency physicians treating African victims of the Ebola virus. Wiring head-phones into the protective medical suits was safer and more practical than the thick stethoscope tubes, which would have required cutting holes in the hoods, poten-tially exposing the ears and face to the virus.

“We decided to completely break the mold and do something very different and radical,” Smith says. “We’ve

RETHINKING the StethoscopeON THE 200TH ANNIVERSARY of the

stethoscope, is the iconic medical instrument in danger of becoming obsolete? Or is it about to experience a technological renaissance?

Thinklabs founder Clive Smith has infused electronics and digital technologies into a medical device that stayed virtually unchanged for two centuries. Image courtesy of Thinklabs.

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developed proprietary technology for producing extremely high-quality sound. The digital stethoscope has patented transducers and audio sensors that capture sounds from the body better than any other device.”

“You can barely hear anything when you use a regular stethoscope,” he adds. “The sound is very distant and faint. When you use our stethoscope, it’s significantly ampli-fied. Instead of saying: ‘Can I hear that sound? What is that sound?,’ you’re more focused on what IS the sound. What’s the diagnosis? There’s no reason in this age of electronics and amplification why doctors should struggle to hear what’s going on.”

Edelman likens the audio improvement to the differ-ence between AM radio and digital radio.

“It’s not that a seasoned clinician will make a diagnosis with the digital stethoscope that they couldn’t otherwise make,” he cautions. “It’s just that the ease of making the di-agnosis, the confidence of the diagnosis and the difference between understanding the diagnosis over a graded scale, is now tremendously enhanced. And the ability to engage col-leagues in making sure that they concur, and reinforcing your confidence in your diagnosis is made that much easier.”

Based in Colorado, Thinklabs was founded in 1991 in Smith’s garage. His initial research was funded by Agilent

Technologies. The company’s digital stethoscopes are now being used by clinicians at medical institutions around the world, including Brigham and Women’s Hospital, the Mayo Clinic, NIH Clinical Center, Massachusetts General Hospital and Johns Hopkins University Hospital. Heart recordings using Thinklabs stethoscopes are widely used by medical schools, teaching hospitals, online medical journals and electronic medical textbooks.

Why Full-Cloud CAD “Liberates” Design and ProductionFrom its conception to its commercial release, the devel-opment of the Thinklabs One has taken three years, fol-lowing more than a decade of feedback from the Thinklabs user community. As Smith continues to challenge con-ventional thinking in the medical space, he’s also adopt-ing new approaches to his design and manufacturing. All Thinklabs parts are made and assembled in house.

Although the company’s first digital scope was created with a traditional desktop-installed CAD system, Smith has since migrated to fully cloud-based CAD. His primary design tool for the next-generation Thinklabs stethoscope is now Onshape, the first browser-based professional 3D CAD system to run on any computer, tablet or phone.

Thinklabs is now creating an improved stethoscope headphone design in Onshape that includes new features requested by doctors. CEO Clive Smith says Onshape enables “our production people to do production design. They can design the production processes and improve it themselves.” Image courtesy of Onshape/Thinklabs.

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“Our company is all cloud-based. We’re running Chromebooks and Netbooks and now any one of our pro-duction people can use Onshape while they are building our product,” he says. “Let’s say they are building some-thing and they think: ‘You know, it would be really con-venient if we had a jig that holds the frame that holds the product in a certain way.’ They can just hop on Onshape and design something and 3D print it. They can print a tool that they need for production.”

“3D printing liberates the design of our products. And Onshape in many ways liberates our production people to be very creative,” he adds. “We’re no longer tied to one computer. The old way was being forced to share what one of my engineering friends calls ‘the shrine.’”

“You go to the powerful computer with the copy of in-stalled CAD software and you sit down and figure out who’s going to get a turn. We have a very open office plan. What happens now is that everyone can just pick any computer and say: ‘I’m going to design and 3D print this part and see if it makes our production more efficient,’” says Smith.

Smith says he manufactures parts with 3D printing rather than injection molding, allowing Thinklabs to rap-idly deploy design changes as they happen. “When I dis-covered Onshape,” he says, “I was absolutely blown away you could have this kind of powerful CAD run inside a browser. I thought it was revolutionary.”

Saving Money on CAD Support, IT and TrainingAs an Onshape Professional Plan customer, Smith says he values the option to pay a monthly subscription for his CAD system instead of paying a lump sum for software upfront plus annual upgrade fees.

“We’re already established. We’re in production; we’re selling products. But if I take my mind back to when we were a startup, the last thing I’d want to do is throw $5,000 at a mechanical CAD package in order to get started,” he says. “It’s much better to pay $100 a month, spending three

months doing some design and seeing if your idea has poten-tial. It allows companies to try something new without mak-ing a big commitment. That’s huge for innovation.”

“As for our own savings, we were first attracted to On-shape because it’s cloud-based. That’s extremely valuable because we now don’t have a need for any IT support. We don’t need anyone maintaining versions, maintaining computers, backing up our computers. Everything is in the cloud,” Smith says.

With many of the Thinklabs assembly workers having CAD backgrounds (and expected to think like designers), Onshape’s online training videos and webinars make it easy for them to independently learn at their own pace.

“I’m an experienced CAD user and was astounded by how quickly I learned Onshape,” Smith says. “I watched about six videos, each two or three minutes long, and then I just practiced on a random drawing to see what I could do. Within a couple of hours, I could do what I needed to do.”

“The learning curve on mechanical CAD is historically horrendous,” he adds. “If I’m trying to hire somebody, I’m no longer locked into one program. I can bring in an aerospace engineer who’s got a huge amount of experi-ence in SOLIDWORKS or Autodesk and I have absolutely no hesitation just throwing Onshape at them—knowing they’ll be up to speed in a matter of hours.”

What’s in Store for the Next 200 Years?Whether as a teaching tool or as a diagnostic device, Smith predicts that the digital stethoscope will forge new roles for itself alongside established and emerging medical imaging technologies.

“Stethoscopes are still very important in remote health care. When you can now connect the stethoscope to mobile platforms and interconnect and interoperate with other things, it makes it a much more useful medical device,” he says. “Here on the 200th anniversary of its invention, there’s actually going to be a renaissance with new applications that people have not even imagined until now.”

And full-cloud design tools will be part of that renaissance.“Onshape has become an integral part of our design-

production loop,” Smith says. “Really, I’m not easily im-pressed. I’m a skeptic. I became impressed with Onshape by using it.” DE

This contributed article originally appeared in the April 2017 issue of Digital Engineering magazine.

INFO ➜ Agilent Technologies: Agilent.com

➜ Onshape: Onshape.com

➜ Thinklabs: ThinkLabs.com

/ / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / /

The Thinklabs One can be connected to an external speaker and any computer, tablet or phone—turning the stethoscope from a “private hearing aid” to a “transcendent teaching tool.” Image courtesy of Onshape/Thinklabs.

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Despite its long history, 3D printing is just now flour-ishing in the medical sector, especially for generating prosthetics. Engineers and medical professionals are col-laborating on a new generation of technology and design processes based on the quick customization enabled by 3D printing.

“With the use of 3D printing, a designer and prosthetist can work together to design a prosthetic using modern tools in combination with age-old techniques like plaster casting, to create prosthetics faster and more efficiently at a lower cost,” says Ava DeCapri, industrial designer at FATHOM, a Stratasys 3D printer reseller and service provider.

For example, Travis Bellicchi, Maxillofacial Prosth-odontic resident at Indiana University’s School of Den-tistry, is working with a host of students and faculty to develop a new mandible prosthesis for a patient. They’re using a new digital workflow that includes 3D printing.

Knowing the final product would be produced with FDA-grade silicone, Bellicchi and his team decided to integrate 3D printing as part of the design process. “It’s easily iterative. If you’re working with plaster in the lab to make your molds, it’s quite easy to crack, fracture [or] get totally destroyed. There’s a real delicacy to a mold.” Additionally, there’s a higher resolution quality to some of the printing materials, which is especially important when figuring out how to place a prosthesis near a jaw or under skin.

To develop a new mandible, Bellicchi collaborated with the School of Informatics and Computing: Depart-ment of Media Arts and Science, School of Mechanical Engineering and Herron School of Art. Their work not

Designing Prosthetics: When Customization is CrucialBY JESS LULKA

TODAY’S PROSTHETIC APPLICATIONS are an example of the intersection of design, technology and science. Going beyond traditional molding techniques and labor-

intensive processes presents new opportunities for medical device design and patient data collection.

Naked Prosthetics uses 3D printing to create biomechanical prosthetic fingers, such as the PIPDriver, pictured here. Image courtesy of Naked Prosthetics.

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only created a new mandible, but also produced a digi-tal workflow that combined 3D scanning, CAD and 3D printing — something that’s relatively new to the field. “In the past, our work felt very traditional and bogged down in this analog process,” he says.

By being able to gather digital data and print multiple prototypes, Bellichi says his team was able to automate a lot of the time-consuming lab work by referring to patient data every time they wanted to tweak the design, instead of starting from scratch.

Collaboration is also helping to drive lower costs. “The largely open-source prosthetic 3D printing com-munity shares designs and concepts at high speed, con-stantly 3D printing, testing and improving available designs … leading to faster innovation in the industry as a whole,” FATHOM’s DeCapri notes. This type of open-source design can be seen through organizations such as e-NABLE, The Helping Hand Project, Open Bionics and others who are focused on providing affordable and free 3D printed prosthetics to those in need.

While one of the main benefits of using 3D printing for prosthetics is reduced cost, there are other benefits that might not immediately be considered. “There is less risk and lower cost involved in designing and creating 3D printed prosthetics vs. traditionally fabricated pros-thetics, so the technology allows for greater exploration of unprecedented design concepts. For the many people who have unique cases, traditional options [which may require surgery] can seem overwhelming,” says DeCapri.

Beyond the cost and time savings for digital develop-ment, Bellicchi hopes using tools such as 3D printing and basic design software could also help medical profession-als directly within hospitals. “There’s a missing link in healthcare [when it comes to] digital design. Day-to-day, there’s a need for more simplistic rapid prototyping that doesn’t necessarily justify the thousands of dollars of de-sign support, but still can be beneficial for patients.”

Getting Technical3D printing is just the beginning of offering customized medical devices. Affordable, accessible technologies are also ushering in an era of prosthetics and medical devices that integrate sensors for smart prosthetics and tailored feedback. Some examples include the BOOMcast from FATHOM and the limbU design. Both of these applica-tions focus around connecting technology and augment-ing the patient’s use of a prosthetic or cast.

“With BOOMcast, the FATHOM team saw the op-portunity as a challenge,” DeCapri explains. “How can we rethink a medical cast? What are the possibilities that haven’t been tapped into? What if this leg cast could actively facilitate the healing process and give doctors ad-ditional medical data?”

Some of the technology that was used in the BOOM-cast was implemented to gather technical data — includ-ing an accelerometer, gyroscope, magnetometer and an Intel Edison compute module. Because the wearer, Mike North, was constantly moving around the globe for his job, having connectivity allowed doctors assess his medi-cal state from afar and make adjustments as needed.

While the technology helped doctors monitor patient statics, it also served as a bigger part of the user experi-ence. Bluetooth-enabled speakers and LED lighting added

Comfort is Key in Prosthetics

When addressing form, fit and function in prosthetic design, “fit” is king for creating a device that will be used

every day.“We get a lot of customers who [have gotten]

prosthetics developed and they just end up sitting in a drawer,” says Tony Peto, senior engineer at Naked Prosthetics. “That’s not what we want.”

3D printing allows the fit to be customized for each patient. Peto says engineers at Naked work on a patient-to-patient basis to ensure that the design will be beneficial to its user once it leaves production.

Movement is another key requirement, especially for more advanced prostheses, according to Travis Bellicchi, Maxillofacial Prosthodontic resident at Indiana University. When generating solutions that are integrated into the jaw or face, for example, part of the patient experience is how movement affects the prosthetic material and positioning.

The form of the design is also important, but it’s not as challenging from a design perspective. “The aesthetic needs are actually quite [streamlined] for a prosthesis,” Bellicchi explains. “Both for internal characterization and external characterization, making it look lifelike is relatively straightforward.”

Making prosthetics look cooler than lifelike is also an option with 3D printing. For example, Open Bionics has teamed up with The Walt Disney Company to provide Frozen, Marvel and Star Wars inspired prosthetic hands to kids. Others are using the technology to create artistic prosthetics that are both lightweight and customized.

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a new layer of customization. But, it wasn’t entirely decorative; the speakers emitted low-frequency tones that re-searchers concluded did ultimately help heal the bone, says DeCapri.

The integration of different technol-ogies such as 3D printing, sensors and computer processors is just the begin-ning for prostheses.

“Despite promising advances in medical technology, prostheses that can match their biological counterparts are currently confined to the realms of sci-ence fiction. This limitation, however, does not restrict us from exploring new forms and functions for which the pros-thetic limb is uniquely situated,” says Troy Baverstock, designer.

Baverstock has designed limbU to push the boundaries of prosthetics and advance the current offerings. The device, which is a prosthetic add-on, currently sports a USB charger, stereo amplifier and speakers, GPS, microcon-trollers, barometer, accelerometer and gyroscope. Ultimately, the wearer will not only be able to monitor daily activ-

ity, but also their environment around them.“limbU seeks to redefine a wearer’s relationship with their limb by al-lowing the opportunity to co- create its form and function to suit their personal lives,” he says.

But, even with these advanced devices, Peto says that the technology for truly advanced prosthetics right now is currently ahead of the implementation. Still, with the lower costs of 3D printing methods and the trend toward connec-tivity, it’s helping more patients get better devices and pav-ing the way for even more innovative prosthetics. DE

Jess Lulka is DE’s former associate editor. Send e-mail about this article to de-editors@digitaleng.news. This article origi-nally appeared in the August 2016 issue of Digital Engineer-ing magazine.

INFO ➜ FATHOM: StudioFathom.com

➜ Formlabs: Formlabs.com

➜ Indiana University: IU.edu

➜ limbU: TroyBaverstock.com

➜ Naked Prosthetics: NPdevices.com

/ / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / /

The limbU prosthetic device integrates sensors and lights for data collection and customization. Image courtesy of Troy Baverstock.

Get Involved

Because open source is a large part of the 3D-printed prosthetic movement, organizations have popped up to take

advantage of the technology for philanthropy. If you’re interesting in helping, check out these causes:

• e-NABLE: One of the largest groups in the community, e-NABLE delivers prosthetics globally and its Raptor hand design has become mainstream for similar charities.

• The Helping Hand Project: Based out of UNC Chapel Hill, the group can make a prosthetic hand design for less than $40.

• Open Bionics: Going beyond 3D printing, this company has a developer community for users to help shape prosthetic designs and devices.

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24 DE | Technology for Optimal Engineering Design

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Traditional Ankle Foot Orthosis CostlyAn ankle foot orthosis (AFO), is a brace that is designed to treat foot and ankle disorders in children. AFO pro-vides a stable base of support for a child’s lower extremi-ties, thus allowing a child to develop the process of walk-ing and balancing. The current process of fabricating an AFO consists of several heavily involved steps including scanning, molding, vacuum heat forming, and form and fitting. This process normally takes as many as four

weeks and cost as much as $2,000 for most patients.Seeing the need to improve the process of designing

and constructing ankle foot orthosis (AFO) to cut time and cost, in late 2015, a group of students at the Gonzaga University started to research and develop a 3D-printed rapid prototyping process for fabricating AFO. The goal was to “create a simple, easily 3D printed AFO with the best composition and geometry to meet strength and comfort requirements for patients.”

Transforming Ankle Foot Orthosis with 3D Printing

PROSTHETICS AND ORTHOTICS are necessary for a variety of patients, but the current manufacturing process of these medical devices are time-consuming and costly for both patients and hospitals. Thanks to the large format 3D printing technology enabled by the 3D Platform and research effort by students at Gonzaga University, patients soon can expect high-quality 3D printed orthotics that are affordable and produced within an optimized time frame.

Traditional ankle foot orthosis (AFO) requires many costly steps. Images courtesy of Gonzaga University.

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3D Printing High-Quality, Affordable AFOCreating a simple, easily 3D printed AFO with the best composition and geometry to meet strength and com-fort requirements of the patients is Gonzaga University

researchers’ top priority. First, researchers used a 3D scanner to collect a patient’s ankle and foot measurement data, then a 3D model is designed for 3D printing the AFO. In addition to 3D printing the AFO design, research-ers also tested several types of 3D printing materials (including polylactic acid or PLA, polypropylene, carbon fiber PLA, PETG, nylon) to help determine optimal materials for 3D printed AFOs.

“We want to 3D print large braces (up to 18 in.), and we need to print with a variety of materials as we research the best de-

sign for the braces,” says McKenzie Horner, one of the researchers at Gonzaga University. “3D Platform helped solve the problem by providing a versatile large-format 3D printer that helps us with our materials research and AFO printing. We were able to print a full-scale proof of concept immediately, and the open platform software capabilities allow us to prepare a print easily from a doc-tor’s 3D scan of a patient’s leg.”

Researchers used a 3D scanner to collect a patient’sankle and foot measurements. Image courtesy of Gonzaga University.

The goal of the Gonzaga University students was to research and develop a 3D-printed rapid prototyping process for fabricating AFO. Image courtesy of Gonzaga University.

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A New Era for Ankle Foot Orthosis with 3D PrintingAfter extensive testing on the selected 3D printing materi-als’ tensile strength (Mpa), fatigue rating, printability, and repeatability, researchers successfully identified that PLA and PETG are the most optimal choices for use of 3D printing AFO, for both materials meet strength and func-tionality requirements while minimizing the material cost.

Four weeks vs. two daysBy 3D printing AFOs, researchers were able to cut down production time from up to 4 weeks to 2 days. The setup of the 3D model can take a matter of minutes, with the 3D print taking up to 16 hours on a larger model, the 3D printing process can cut production from a few weeks to a matter of hours.

Significant Lower Cost AFO3D printed AFO also costs signifi-cantly less to produce, thanks to the reduction of cost in materials and labor. Unlike the traditional heat molding process that has excess material wasted after trimming away from leg hole, 3D printing only uses the required material.

Students at Gonzaga University will continue to explore the possibilities of 3D printing AFO with more materials, and patients soon can expect high-quality 3D printed orthosis that is affordable and produced within an optimized time-frame. DE

This contributed article originally appeared in the May 2017 issue of Digital Engineering magazine.

Gonzaga University researchers identified PLA and PETG as the most optimal choices to use for 3D printing AFOs.

The Gonzaga University 3D Printing AFO Projectteam. Image courtesy of Gonzaga University.

INFO ➜ 3D Platform: 3DPlatform.com

➜ Gonzaga University: Gonzaga.edu

/ / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / /

Material Modulus (MPa) Score

Tensile Strength

(MPa)Score Fatigue

Result Score Printability/ Repeatability Score Cost

(per kg) Score Overall Score

Solid PP

1507�72 ---- 20�04 ---- infinite ---- N/A ---- $14�00 ---- ----

PLA 3930�26 4 42�66 5 13080 4

No warping, sticks to bed well, layers stick very well to each other, fast print speeds, very

repeatable

5 (tie) $27�00 5 4�6

CFPLA 6501�44 5 39�52 4 2620 3

No warping, sticks to bed well, layers stick very well to each other, medium print speed,

difficult to load, not repeatable (inconclusive)

3 $66�00 2 3�2

3DP PP 1316�54 2 16�89 1 N/A ----

Lots of warping, does not stick to bed, layers stick together

resonably well, very slow print speed, not repeatable

1 $50�00 3 1�75

PETG 2269�70 3 34�14 3 (tie) 400000 5

No warping, sticks to bed well, layers stick very well to each other, fast print speed, very

repeatable

5 (tie) $48�00 4 4

PCTPE Nylon

73�04 1 34�79 3 (tie) N/A ---- Requires baking before and/or after printing 3

$83�79 ($38 per pound)

1 2

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The SolutionUsing the LabVIEW RIO platform, including a Compac-tRIO embedded system and a real-time controller with an FPGA control architecture provided by Single-Board RIO, to acquire data from various sensors and control peripheral units, high-speed communication devices, and actuators; and using LabVIEW software to acquire reliable data by con-ducting real-time analysis and applying various robot control algorithms to dramatically reduce development time.

Full Case StudyThe Central Advanced Research and Engineering Institute at Hyundai Motor Company develops future mobility technolo-gies. Rather than provide conventional vehicle products to cus-tomers, this research center creates new mobility devices with

a wide range of speeds for a variety of people, including the elderly and the disabled. As our society ages, there is a greater need for systems that can aid mobility. Thus, we are develop-ing wearable exoskeleton robots with NI embedded controllers for the elderly and patients with spinal cord injuries to use.

In the field of wearable robotics, physical interfacing between the human body and a robot causes various engineering issues with mechanical design, control architecture construction, and ac-tuation algorithm design. The allowed space and weight for elec-trical devices is extremely limited because a wearable robot needs to be put on like a suit. Additionally, the overall control sampling rate of the robot should be fast enough that it does not impede human motions and can properly react to external forces. Also, many questions remain regarding human augmentation and assis-tance control algorithms for wearable robots, even though many of the endeavors of robotic researchers have resulted in successful performances of wearable robots. Therefore, our group mainly considered the following requirements for selecting a main con-troller for our wearable robots:

• High-speed processing of data obtained from various types of sensors

Hyundai Wearable Robotics for Walking Assistance Offer Spectrum of Mobility

THE CHALLENGE: Developing a system that can handle complex control algorithms to capture data remotely from various sensors simultaneously and perform real-time control of multiple actuators for a

wearable robotics device for walking assistance.

BY DONGJIN HYUN

Life-caring exoskeleton in use. Image courtesy of NI.

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• Size and weight• Real-time data visualization for developing control

algorithms• Connectivity to other smart devices to provide more

convenient function

System ConfigurationThe real-time control and field programmable gate array (FPGA) hardware environment ensure reliability and stability by provid-ing I/O that is compatible with various robotic control devices. For instance, in the process of building our wearable robots, the overall control architecture drastically changed several times due to the replacement of sensors or changes in the control communi-cation method. However, the unique onboard combination of the real-time controller and FPGA features provided by NI products empowered our group to manage these changes promptly, which helped reduce our development period.

In addition, adopting the compact sbRIO-9651 System on Module (SOM) device helped us reduce the robot’s weight to less than 10 kg while maximizing battery efficiency through a low-power base system configuration.

Why We Chose LabVIEWThe number of sensors and actuators increases significantly to achieve more complex tasks in robotics, and the complexity of the control algorithms increases exponentially. Therefore, simultaneously processing all data from multiple sensors and sending instructions to multiple actuators becomes one of the most important challenges to address in robotics. LabVIEW sup-ports concurrent visualization for intuitive signal processing for installed sensors on robots and further control algorithm design in the experimental stages. Lastly, NI products are expandable and compatible, so we can possibly use smart devices as user interfaces (UIs) in the future.

Wearable Robotics for Walking AssistanceOriginally, the following types of wearable robots were built:

• Hip Modular Exoskeleton—A modular robot that provides walking assistance to people with discomfort in the hip area

• Knee Modular Exoskeleton—A modular robot that provides walking assistance to people with discomfort in the knee area

• Life-Caring Exoskeleton—A modular robot that c ombines the hip and knee parts to provide walking assistance to the elderly or people with difficulties moving the lower half of their bodies

• Medical Exoskeleton—A modular robot that combines the hip and knee parts to provide walking assistance to patients who do not have the ability to move the lower half of their bodies on their own

Following the demonstration of the wearable Life-Caring Exoskeleton for walking assistance for the elderly at NIWeek

2015, we unveiled a wearable medical robot for people with paraplegia, which was also designed using LabVIEW and Com-pactRIO. In a joint clinical demonstration with the Korea Spinal Cord Injury Association in January 2016, a paraplegic patient equipped with this Medical Robot succeeded in sitting down, standing up, and walking on flat ground. The patient who partici-pated in this clinical trial is paralyzed in the lower half of the body (injury at 2nd and 3rd lumbar vertebrae) with motor and sensory paralysis, but could walk successfully with the assistance of the wearable Medical Robot after a short training. Building on this achievement and current progress in development, we expect to manufacture a lighter and better product with added functions by 2018, and begin mass production in 2020.

Tapping IoT Technologies for Future DevelopmentWe have research plans for integrating smart devices into the UI to address future challenges. Currently, robots for people with lower body disabilities are designed to use crutches as wireless UIs for changing configuration, such as converting to walking, sit-ting, climbing or going down steps, or normal mode. Embedding smart devices into this kind of UI can help users conduct tuning of additional parameters including stride, time for taking one step, or depth/width for sitting on a chair. Also, data related to walking patterns or normal activity range is useful for treatment or reha-bilitation. Rehabilitation experts or doctors can configure more advanced parameters, such as forced walking time or adjusting joint movement, to continue to use them for treatment.

We started to develop the next-generation exoskeleton robot based on wireless technology to make gait analysis possible. When someone wears this robot, it is possible to identify intention and walking status by collecting data from an area between the ground and the sole of the foot. Technology that transmits this data through wireless ZigBee communication is already in place. This technology can be further expanded now using Internet of Things (IoT) technology. You can send information acquired wirelessly to a robot to make it assist with the walker’s movements. In addition, gathering relevant data can help users identify a personal range of activities and conditions based on location, and that information can be integrated into the robot and lead to more comprehensive service. If a patient wears this robot for rehabilitation purposes, doctors can monitor patient and robot conditions during rehabili-tation and deliver real-time training or adjustments to enhance ef-ficiency and effectiveness of treatment, a good example of imple-mentation of data information-based technology. DE

DongJin Hyun, Ph.D., is Convergence Technology Develop-ment Team Leader, Hyundai Motor Company. This contributed article originally appeared in the June 2017 issue of Digital Engineering magazine.

INFO ➜ Hyundai Motor Company: HyundaiUSA.com

➜ National Instruments: NI.com

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Interacting with a virtual heart in a virtual cave, made possible in Dassault Systèmes’ Living Heart Project. Image courtesy of Dassault Systèmes.

It’s quite different today. The drawing environment for AutoCAD Architecture — the version that Autodesk markets to the architecture, engineering and construction (AEC) industry — is tailored to help you parametrically draw adjustable windows, doors and walls. By contrast, AutoCAD MEP — for the mechanical, electrical and plumbing systems designers — comes with blocks and orthographic symbols specific to the intended field. And AutoCAD Electrical has a layout environment designed for creating schematics with electrical connections, volt-ages and circuits. A timeline chronicling the first releases of these special AutoCAD versions would offer good in-sight into the moments Autodesk decided to expand into new verticals.

Design software makers like Autodesk constantly weigh the pros and cons of emerging markets to explore. Some-times they acquire an established vendor in the target sector to use as their launch pad. Other times they spinoff a new edition or flavor of an existing product. When the needs of the new market are too eccentric (like the physics required to simulate fabrics in fashion and apparel, or the

surface-modeling features needed to design prosthetics), vendors face a dilemma: Make radical changes to the core product to appeal to the new users, or leave the field open for someone else to tackle.

Forging a Path into New VerticalsEarlier this year, Autodesk decided its product offerings had grown too complex. The company offered a number of suites, each targeting a specific vertical: Building De-sign Suite for AEC; Product Design Suite for mechanical design and manufacturing; Entertainment Creation Suite for content creators, game developers and filmmakers; Factory Design Suite for factory designers; Plant Design Suite for plant managers; and so on. But many suites were also subdivided into Standard, Premium and Ultimate edi-tions containing varying degrees of functionalities.

“[The suites] gave customers a lot of choices, but also created a lot of confusion,” says Carl White, Autodesk’s se-nior director of Business Models. The company’s strategy was to reduce its bundles to three Industry Collections, reflecting the three core verticals it historically serves:

Going Vertical with Engineering Software

BY KENNETH WONG

IN THE BEGINNING, AutoCAD was the same. Whether you used it for architecture, industrial design, mechanical design or electrical design, you used the same 2D drafting and drawing features. Working with a product built for the widest possible horizontal, you learned to come up with creative solutions (or clumsy workarounds) to accomplish the tasks unique to your discipline, domain or niche

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• Architecture, Engineering and Construction Collection• Product Design Collection• Media and Entertainment CollectionAbout the new collections, White says, “We’re trying to

put together the greatest number of relevant products at the right price point for most customers.” The new Indus-try Collections are not subdivided into three tiers like the predecessor suites.

“We do go after verticals, but we tend to pick the broadest vertical we can go into,” White adds. The com-pany’s acquisitions of HSMWorks in 2012 and Delcam in 2014 laid the foundation for its expansion into the computer-aided manufacturing (CAM) market, considered to be closely tied to the company’s core businesses in CAD and computer-aided engineering (CAE).

Though the company shows no interest in straying too far from its core competency, it has begun to encourage others to develop products for the underserved industries using Autodesk Forge, a set of cloud services that con-nects design, engineering, visualization, collaboration, production and operation workflows. Forge is a set of APIs (application programming interfaces) that allow developers to tap into the modeling, drawing, visualiza-tion, simulation, and data-management technologies from Autodesk. It’s the same platform used by Autodesk to build its own products. (Editor’s note: See page 7 for more information.)

The Heart of the StrategyHistorically a CAD and product lifecycle management (PLM) company, Dassault Systèmes took bold steps to expand its life sciences footprint into the biomedical field with the acquisition of Accelrys in 2014. The San Diego-based Accelrys specializes in biological, chemical and material modeling, simulation and production domains. Among its 2,000 customers were Sanofi, Pfizer, Unilever NV and L’Oreal SA. In May of 2014, Dassault Systèmes launched its new brand BIOVIA, described as a combina-tion of its “own activities in BioIntelligence, its collabora-tive 3DEXPERIENCE technologies, and the leading life sciences and material sciences applications from the recent acquisition of Accelrys.”

This is expanding into new territories for Dassault Sys-tèmes, mostly known for its solutions and experience with automotive and aerospace manufacturers. “We offer a full range of solutions to support innovation from pharmaceu-ticals to medical device to healthcare companies, leverag-ing the power and collaboration benefits of the 3DEX-PERIENCE platform and the integration with BIOVIA applications,” says Jean Colombel, VP of Life Sciences at Dassault Systèmes.

One of Dassault Systèmes’ notable offerings in this field is The Living Heart, a 3D digital realistic model of a

Another Way to Combat Complexity

T raditionally, the use of simulation revolves around general-purpose simulation software packages. The level of expertise required by this

approach limits the pool of candidates who can use the technology. Focusing on specific industries allows software vendors to cut through complexity and focus on the features engineers in those trades use most, but there’s another way to simplify software. The “app-ifi-cation” of simulation — the movement to encapsulate repeatable simulation tasks as simple, template-driven apps — broadens the playing field. It also leave room for simulation app developers — a new type of vendor.

AltaSim’s HeatSinkSim exemplifies this trend. It also illustrates the complex relationships and partnerships that must exist to support the new usage paradigm.

In the creators’ own words, the app analyzes heat transfer “using conduction, convection and radiation. Two levels of analyses are available: Level 1 analyzes a range of heat sink designs to identify optimum heat sink designs; Level 2 provides a detailed analysis of

the optimum heat sink design and is automatically recommended when predicted temperatures approach component operating limits.”

HeatSinkSim is an app — a repeatable simulation operation — built to run on COMSOL Multiphysics. When a user puts in the input parameters, the app uses COMSOL software to compute the answer in the back-ground. This allows novice users with limited multiphys-ics simulation software expertise to bypass the need learn COMSOL software to set up the problem correctly.

COMSOL, the company behind the popular COMSOL Multiphysics software, also encourages the app-ification with the release of its COMSOL Server, which functions as the host for simulation apps.

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human heart. “We have partnered with over 100 medical experts in the field of cardiology, working in collaboration with clinicians, designers and regulators,” Colombel says. “The first model we built is based on a healthy human adult and we can create other models from this one. You can use The Living Heart straight out of the box. If you’re a medical professional or a medical device researcher, you could use it, for example, to develop a new kind of cardiac valve and test it in silico. We provide a predefined set of characteristics related to the human body. You can then also customize [the digital heart] further with results from your own research.”

For blood flow and muscle movement simulation, The Living Heart uses SIMULIA, the same Dassault Systèmes technology deployed by car and plane manufacturers, but with a twist. “On top of SIMULIA, we put a layer specific to the design of heart valves and medical devices. And we make sure we use the right medical properties,” says Colombel.

In November 2014, Dassault Systèmes signed a five-year collaborative research agreement with the U.S. Food and Drug Administration (FDA). The joint announcement explained the company and FDA “will initially target the development of testing paradigms for the insertion, place-ment, and performance of pacemaker leads and other car-diovascular devices used to treat heart disease.”

Targeting a specialized industry like medical device makers requires a good understanding of their workflow, and tailor-made features to meet their regulatory needs. “Medical device manufacturers have to organize knowl-edge around what’s called a design history file (DHF) when they ask for market registration to comply with regulatory demands,” says Colombel. “The same type of information exists in the software for automotive or aerospace, but it has to be organized, named, captured, collected and presented in a specific way for Life Sciences DHF filing.”

DHF change management is part of Dassault Systèmes’ project management offerings under the 3DEXPERI-ENCE platform. It’s described as “advanced project man-agement capabilities for medical device companies to … coordinate project activities and deliverables to ensure completion of design control deliverables and automati-cally populates the resulting DHF.”

Open Opportunities for PartnersSome verticals will inevitably be too vertical, too narrow a niche for industry leading vendors to pursue. “If we have to make radical changes to the way our product work, and the market is so small, then it doesn’t make sense to us,” Hemmelgarn says. So pockets of opportunities are left to third-party developers and software partners with suffi-cient domain knowledge.

For example, OPTIS, a Deluxe partner of Siemens PLM Software, offers light simulation and prototyping solutions that “help businesses and people to optimize per-ceived quality and visual signature of their future product.” The software’s integration with NX, Siemens PLM Soft-ware points out, offers “advanced light and optical simu-lation directly integrated in their overall product design process.” Most people don’t associate Dassault Systèmes’ CATIA design program with architecture, but it is the foundation for Gehry Technologies’ Digital Projects, an architectural modeling program.

Sandip Jadhav, CEO of simulationHub, develops and markets a series of simulation apps based on Autodesk’s Forge APIs. The selection is currently available as beta versions. It features ventilation analysis for conceptual houses, flow simulation for butterfly valves, and turbulent flow analysis for cyclone separators. The preconfigured templates allow people with limited expertise in simulation to conduct specific types of analysis without learning or purchasing a general-purpose computational fluid dynamic (CFD) package.

As a general-purpose design product gains widespread adoption in a certain industry, the industry’s special needs and eccentricities begin to reshape the product itself. Thus, many CAD, CAM and CAE software vendors find themselves at a crossroad as they begin exploring indus-tries beyond their principal domains — automotive and aerospace manufacturing. The opportunities in emerging fields like IoT, biomedical, life sciences and medical de-vices beckon. But to pursue them, developers would need to put in significant code refinement and UI changes.

“We think it absolutely requires tailoring the software to specific industries. We really got down to the nomen-clature and verbiage,” remarks Siemens PLM Software’s Hemmelgarn. DE

Kenneth Wong is DE’s resident blogger and senior edi-tor. Email him at de-editors@digitaleng.news or share your thoughts on this article at digitaleng.news/facebook. This article originally appeared in the August 2016 issue of Digital Engi-neering magazine.

INFO ➜ AltaSim: AltaSimTechnologies.com

➜ Autodesk: Autodesk.com

➜ COMSOL: Comsol.com

➜ Dassault Systèmes: .3DS.com

➜ Siemens PLM Software: Siemens.com/PLM

➜ simulationHub: simulationHub.com

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Mahesh Kailasam, Ph.D.

Thornton Tomasetti’s Applied Science practice has an almost 70-year history of pioneering and engineering practical solutions to various challenges in multiple industries by performing re-search, modeling, physical testing and analysis for clients around the globe. The company has now expanded its practice into life sciences, tapping Mahesh Kailasam, Ph.D., to lead the initiative from the firm’s Silicon Valley office. Dr. Kailasam has more than 20 years of experience in the deployment of modeling and analy-sis techniques in emerging technology sectors.

He most recently led the commercialization of the technology developed in the Living Heart Project, and previously worked on pioneering modeling and simulation-based approaches for explo-ration and production methodologies in oil and gas production. As vice president of Thornton Tomasetti, Dr. Kailasam will lever-age Applied Science’s expertise in modeling and simulation to accelerate innovation in the worlds of high tech and life sciences, and the growing intersection of the two.

Dr. Kailasam was recently interviewed about the role of digital design tools in meeting the FDA’s challenge to speed product development in life sciences. He was joined by Steven M. Levine, Ph.D., senior director of life sciences at Dassault Systèmes SIMULIA, and Thomas Z. Scarangello, chairman and chief ex-ecutive officer of Thornton Tomasetti.

Q: What are the most acute challenges faced by life sciences/medical device developers/manufacturers today?

Mahesh Kailasam, Ph.D. (MK): Our clients face three pri-

mary challenges today. The first is the challenge of cost—how do you develop new products in a cost-effective manner, especially as the costs of medical treatment are rising everywhere? The second challenge is to make sure that whatever solutions are developed are applicable for the targeted patient population so that treat-ments are effective. Historically, solutions have been developed in a generic sense, but applied in an individualized sense using experience and observation. The challenge we face now is getting to a point where devices and treatments are personalized to an individual’s characteristics—while keeping the first challenge of cost in mind—so that the treatment works as intended both in the near-term and in the longer term. The third challenge is time, the need to develop solutions in a timely manner.

When you consider these all together, it is clear that the heavy reliance on traditional processes, including bench-top experiments, animal testing and typical clinical studies, is just not suited for the challenges the industry is facing right now. Digital technologies will be key to accelerate the transforma-tion that is needed.

Steven M. Levine, Ph.D. (SL): What we are hearing is that the single biggest way to reduce the skyrocketing costs in the health-care industry is to lower the volume of post-treatment care. This has two components, (1) getting the treatment right the first time, and (2) shortening recovery time with less invasive treatments. The former often is characterized as “precision medicine,” but it basically means that we need better ways to analyze a given condi-

The Role of Digital Methods in Medical Device Development

THE FDA’S DECISION TO ENCOURAGE new methods of modeling and simulation to accelerate the pace of innovation in life sciences is likely to have far-reaching consequences for product design, development and regulatory approval in that industry. Digital design tools have emerged as a key contributor to a manufacturer’s success in this environment.

Steven M. Levine, Ph.D. Thomas Z. Scarangello

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tion and select the best treatment. The use of digital technologies will be transformational in this, from using real-world data and in silico models to develop better physiological models of patients, to conducting virtual treatments to optimize outcomes. The lat-ter involves providing physicians with a more targeted approach in situations where they have less ability to see what is happening inside the body. Once again, virtual reality and realistic digital representations of the patient and procedure are critical to make this happen. Also, incorporating real-world behavior as part of the diagnostic or follow-up can dramatically improve success while achieving cost-saving goals.

Q: What is the FDA doing to support, yet regulate, the industry?

MK: The FDA has been encouraging the adoption of new modeling and simulation technologies for effectively evaluating different solutions and accelerating the pace of innovation. Si-multaneously, in order to make sure that such adoption is done in a consistent manner, there are emerging guidelines, such as for verification and validation, to ensure that this is done in a systematic and controlled manner rather than an arbitrary way. In addition, programs such as MDDT (Medical Device Devel-opment Tools) are helping the industry develop virtual human and animal models to evaluate medical devices with greater con-fidence than before.

SL: I understand the challenge the FDA has in maintaining their need to oversee the introduction of safe medical devices,

while at the same time accepting responsibility to help lower the speed and cost barriers without compromising safety. To meet this challenge, the FDA has invested, through internal R&D as well as extensive collaborations, in understanding new methods that could achieve both goals. They have evaluated the various sources of evidence, animal models, clinical trials and computational mod-els and concluded that, in many instances, as much as 50% of the time the computational models could be a better source.

As such, they are actively working internally and through collaborations with organizations such as the Medical Device In-novation Forum (MDIC) and projects such as the Living Heart Project (LHP) toward a future where half or more of the data submitted for regulatory approval comes from computer model-ing, virtual patients or virtual clinical trials. Moreover, they are publicly sharing this mission, publishing guidelines such as the V&V40, and encouraging what they have called a “Simulation Revolution” in medical devices.

Q: Why are digital tools essential at this point?MK: Digital tools allow us to virtually try out multiple solu-

tions to any challenge and do it all efficiently. This is certainly relevant at the earlier stages of design evaluation via virtualized benchtop tests, where companies ranging from the largest medi-cal device makers to hundreds of startups can use simulations to effectively zoom in on designs that have the most promise. These tools are also very relevant, and perhaps more valuable, in later stages where digital models of organs like the heart or skin can be

Eye-optimal device. Images courtesy of Thornton Thomasetti.

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used to assess effectiveness of devices in virtual populations and tailor the solutions to different population segments. Information from such virtual studies will allow clinical studies to be more ef-fectively designed, giving device developers greater confidence in their outcomes; this will lead toward virtual clinical trials in the near future.

Thomas Scarangello (TS): Our firm has a long history of using digital tools for modeling and analyzing large and complex systems, including the effects of underwater shock on submarines and ships, ground-borne seismic waves and shock on structures, and environmental loading on structures like supertall skyscrap-ers, stadiums and arenas. These tools have created tremendous efficiencies and have been proven vital in speeding the pace of in-novation and the delivery of new solutions for our clients in these industries, and they will play the same role in helping our life sci-ences clients accelerate their success as well. Many of the methods we have been using are directly applicable to life sciences, particu-larly when you relate the underlying physics—whether they are structural, thermal, CFD and so on—to the problems at hand. Digital tools are perfect for capturing the interactions between different aspects of any complex system, whether it is the behavior of submarines underwater or stents experiencing blood flow in-side vascular systems.

Q: What are some examples of successful projects already being achieved in the industry?

SL: Five years ago you would have been hard-pressed to identify more than a few examples where simulation was on the critical path to commercial success of medical products. However, there were several showcase examples, such as cardiovascular stents where simulated fatigue prediction has become necessary to ensure not only the safe lifetime of a new design, but also the

regulatory approval of the FDA. Today, nearly every device can be MRI-safety certified virtually, and the FDA even has a formal program called MDDT (Medical Device Diagnostic Tools) to precertify computational methods that can speed regulatory ap-proval. I also believe the FDA has sent a clear message to the de-vice community when they joined the LHP to lend their support to introduce this technology into the regulatory process.

More importantly, the LHP, now entering its fourth year, has demonstrated that physics-based simulation, once the exclusive domain of mechanical devices, is equally applicable to biological systems such as the human heart. Using a consensus methodol-ogy among the now 100+ members, models and methods to vir-tually design and test new devices have been developed. These methods offer the potential to test and refine new device designs in a fraction of the time and cost of current methods that are based on a combination of bench and animal testing, and over time to be more predictive of clinical performance. Using the LHP as a basis, Dassault Systèmes is now working on models for other medically important body systems such as the brain, knee, spine etc.

MK: Digital tools are being used successfully in many areas, including where personalization is important. As an example, digital modeling and analysis were already being used to develop high-quality implants, but now many solutions (knee or hip replacements among them) are being designed to match an indi-vidual’s lifestyle choices, such as athleticism, as well as his or her physical characteristics, on a far more granular level.

In addition, these digital tools also are enabling production of high-quality, patient-customized implants using additive manu-facturing (3D printing). These solutions are not only being of-fered by large medical device companies but also by a whole cadre of smaller startups, including several that are able to recommend strategies for surgery and treatment based on simulated estimates of post-treatment outcom

Similarly, in other domains such as vasculature and blood flow, digital tools are being used to develop models of the vasculature from imaging data, which can then be used for a variety of ap-plications—ranging from 3D printing of realistic blood vessel network models to simulating the behavior of devices inside these models, and to even assessing various disease conditions that may hinder blood flow or risk the integrity of the vasculature.

Q: Why has Thornton Tomasetti (TT) decided to expand its life sciences capabilities at this time?

TS: Our decades of leadership in virtual modeling and simula-tion to enhance designs translate perfectly into the biomedical field, especially as the FDA and other agencies are also promoting simulation as a means of safely accelerating approval cycles. Many of the tools and modeling capabilities that TT has been develop-ing and honing since 1949 are at the cutting edge of some of the principles that are now being promoted by the FDA and increas-ingly being adopted by the life sciences community. For example, I expect that our experience with stochastic and probabilistic as-sessments of various types of events will allow us to offer methods

Skin needle penetration.

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that are quite relevant to life sciences, considering the variations in population or disease characteristics.

MK: Yes, our development and use of vibration and piezo-electric methods has played a key role in improving ultrasonic imaging solutions and is already being used by leading medical imaging companies. Another example is the development and pioneering adoption of constitutive models for soils, which at first glance doesn’t appear relevant to life sciences until you realize that the same constitutive models are used to simulate the manufactur-ing of pharmaceutical tablets. Overall, the firm’s commitment to driving innovation is at the heart of all we do, and is directly trans-latable to what we are able to bring to the life sciences arena.

Q: Mahesh, tell us a bit about your background and why you’ve joined TT Applied Science.

MK: I’ve spent the last two decades promoting the adoption of modeling and analysis techniques in a variety of industries, including life sciences, high tech and energy sectors, and helping identify and develop new methods. I was doing all this from the point of view of getting customers to adopt specific digital tools and less from the point of view of actually helping them use these tools to solve their pressing challenges.

Today, at Applied Science, my priority is to solve our clients’ problems and to transfer the methodologies to them for future reuse. In fact, the primary mission at the core of all of TT’s work is to embrace and solve the toughest challenges of our clients and to make lasting contributions for their benefit. Working with a team of gifted engineers, I am now able to show our cli-ents how digital tools can solve some of the challenges they’ve been facing for years. The opportunity to work with clients in this manner, and TT leadership support to build an even stronger team to expand our reach in life sciences, are the main reasons I joined the company.

Q: Why is TT Applied Science particularly qualified to con-tribute in this arena, and what are your capabilities?

MK: TT Applied Science has been using digital modeling and simulation for longer than most companies—it’s in the DNA of our firm. We’ve used modeling and simulation to solve problems and analyze complex systems in a number of other industries, and there are many similarities between TT’s historic uses of modeling and simulation to the current needs of the life-sciences world. We have also been active with various ASME committees for computational modeling, such as V&V 10 (Solid Mechan-ics), V&V 20 (Fluid Mechanics and Heat Transfer), V&V 50 (Advanced Manufacturing, covering additive manufacturing) and more recently have started engaging with V&V 40 (Medical De-vices) as well.

In terms of capabilities, we have expertise with a wide variety of physics modeling solutions, covering everything from solids and fluids to thermal and electromagnetic simulations. We also have the capabilities to research and develop new material models, develop bespoke test fixtures and carry out physical tests to help with validation, and to develop and automate new or existing methodologies, such as for probabilistic assessments or optimiza-

tion, for our clients.We have expanded and are

continuing to grow our team of engineers with specialized skills in bioengineering. This allows us to provide virtual human modeling and simulation solutions cover-ing a range of devices and organs, using both already available virtual models or, when needed, starting from imaging data to develop sim-ulation-ready virtual human mod-els, and then performing needed simulations. After the simulations and assessments are completed, we help our clients prepare thor-ough reports for submission to the FDA or other regulatory bodies, including necessary evidence of the efficacy and validity of the simulations. If they are interested, we also provide them with effective visualization solutions such as realistic rendering or VR approaches.

We have established strong partnerships with companies like Dassault Systèmes and others to leverage the best available digital tools and bring to bear our expertise on addressing our client’s individual challenges.

Q: Mahesh, what directions do you see life sciences product development taking in the future, and what are your goals for your own division?

MK: The challenge that I’ve seen out there is that there are lots of offerings from both software and solutions perspec-tives—with everybody solving a piece of the puzzle. From a so-lutions perspective, one company may be able to create human models from imaging data, another might be good at assessing the structural behavior of a device, and yet another may be able to look at probabilistic assessments, and so on. But few entities can pull and synthesize all the key elements together, and do so in a rigorous manner. At Applied Science, our goal is not only to help our clients solve specific pieces of a puzzle or workflow, but also to support them in building complete end-to-end solutions that can be automated and reused efficiently. We have the exper-tise within TT to make a real difference for companies large and small in the life sciences world, in every step of the engineering and regulatory process. DE

This article was contributed by Great Ink on behalf of Thornton Tomasetti. It originally appeared on DE’s website on Feb. 8, 2018.

Hip personalized bone implant stress.

INFO ➜ Dassault Systèmes SIMULIA: SIMULIA.com

➜ Thornton Tomasetti: Thornton Tomasetti

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In Advanced Materials, professor Michael McAlpine pub-lished a description of the technology that can help enable new types of wearable technology and surgical techniques.

“For surgical applications, giving surgical tools [a] sense of touch so doctors don’t have to just rely on looking at a screen,” McAlpine said. “Or imagine you’re a soldier on the field. You have this printer in your backpack and need some chemical sensor in chemical warfare. You would be able to print this device for your body.”

McAlpine’s team printed the sensors using $50,000 print-ers developed at the university. The printer uses nozzles to create a base layer of silicone, two layers of electrodes form conductive ink and a coil-shaped pressure sensor, and a “sac-rificial layer” holds the top layer in place while it sets. This final layer is washed away at the end of the process.

The sensors can stretch up to three times their original size, and the ink can set at room temperature.

“This is a completely new way to approach 3D printing of electronics,” McAlpine said. “We have a multifunctional printer that can print several layers to make these flexible sen-sory devices. This could take us into so many directions from health monitoring to energy harvesting to chemical sensing.”

The technology could also allow robots to “feel” using tactile sensors.

“This stretchable electronic fabric we developed has many practical uses,” said Michael McAlpine, a University of Min-nesota mechanical engineering associate professor and lead researcher on the study. “Putting this type of ‘bionic skin’ on surgical robots would give surgeons the ability to actually feel during minimally invasive surgeries, which would make surgery easier instead of just using cameras like they do now. These sensors could also make it easier for other robots to walk and interact with their environment.”

The researchers printed sensors on the curved surface of a model hand. Theoretically, the printer could print sensors directly on a human finger. DE

Brian Albright is a freelance journalist based in Columbus, OH. Send e-mail about this article to de-editors@digitaleng.news. This article was originally published June 15, 2017 on DE’s RapidReadyTech.com blog.

BY BRIAN ALBRIGHT

THERE HAVE BEEN 3D-printed sensors and 3D-printed medical implants, but researchers at the University of Minnesota have taken things a step further with new sensors that can be printed

directly on a person’s hand.

INFO ➜ University of Minnesota: Twin-Cities.UMN.edu

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Skin-Deep Sensors

This 5X speed video shows 3D printing of stretchable electronic sensory devices developed by University of Minnesota researchers.