Design engineering is also being driven by the changing regulatory landscape. Medical device regulators in the U.S. and EU continue raising the bar to ensure device safety and effectiveness. With the new European Medical Device Regulation (MDR) now arriving in 2021, there will be greater consideration toward usability and risk mitigation throughout the design process.
“There is an increased focus on all facets of device design, especially usability engineering, driven by the European MDR that goes into effect in May 2021,” said Drew Calabrese, senior mechanical engineer at Goddard, a Beverly, Mass.-based provider of mechanical engineering and industrial design services for the medical technology and life science industries.
Design engineers must incorporate any important findings from human factors studies or formal clinical evaluations and mitigate any design risks revealed by these tests. They must also be extremely knowledgeable in the material selection and testing of a new product, “as the FDA expects more information on chemical compatibility and clinical toxicology than ever before,” added Ted Mosler, CEO for Gilero, a Morrisville, N.C.-based provider of medical device design, manufacturing, and regulatory consulting. “They must also brush up on statistics and sample size justifications, possess knowledge and techniques for test method validations, and demonstrate proof of data integrity.”
This is a perfect time for contract design engineers and product developers to show off what they can do—especially by providing turnkey, custom product development. As exciting as these opportunities are, however, many major corporations are applying the bulk of their R&D budgets toward risk mitigation, sustaining engineering, and incremental generational product improvements while partnering with startup entities to develop new and emerging technologies for down-the-road acquisition.
“This strategy relies on lean, cost- and time-efficient organizations to achieve milestones in development much faster, with no corporate risk to the OEM, ” said Philip Remedios, principal and director of design and development for BlackHägen Design, a Tampa Bay, Fla.-based provider of user-centered design and human-factors engineering services for the medical device industry. “Many innovators spend an entire career identifying and developing new opportunities in a symbiotic relationship with their M&A targets, spinning off new companies every few years.”
Innovation within the medical device industry used to be about increased functionality, speed, power, and cost integrated into standalone platforms. In today’s global economy, more than ever before, innovation is applied to networked devices that can provide essential functions for all markets, with much less engineering complication, risk, and per-case cost by also sharing functionality with other devices and the Internet of Things (IoT) via fast, reliable connectivity.
Many design improvements include advances in software. Design software is moving toward the cloud, enabling pre-designed work to be shared across engineering teams. “In software engineering, continuous integration and test-driven development are making their way into the medical device development environment,” said Steve Maylish, co-founder and chief commercial officer for Fusion Biotec, an Irvine, Calif.-based provider of engineering and design services for the medical device industry. “For legacy products and services, these are being converted into cloud-based services and interoperability models.”
A more holistic approach to design is being driven by more stringent regulatory requirements. Designs are no longer based only on one physician’s viewpoint—instead they take into consideration all stakeholder viewpoints, including patients and consumers, to collect a broader scope of feedback to determine the best design approach. This is especially true as the industry moves toward increasingly smart and interconnected medical devices and equipment—for example, implanted blood glucose monitoring devices versus mobile blood glucose monitoring kits, or mobile LVAD (left ventricular assist device) versus clinical heart-lung machines.
“Because of device complexity, functional integration is needed, which requires advanced design and solution competence,” said Ursula Nollenberger, global product line director for Trelleborg Healthcare & Medical, a provider of engineered polymeric solutions for medical device, biotech, and pharmaceutical applications with headquarters in Fort Wayne, Ind. “In addition, accelerated product design and development needs have brought advanced simulation techniques and additive manufacturing concepts to the forefront, which helps accelerate development times and availability of full functional prototypes.”
What OEMs Want
OEMs are looking to outsource non-core competencies, subject matter experts, niche areas such as artificial intelligence and data analysis, remote services, and converting internal and product services to the cloud. They want low total cost and low risk of ownership for a highly robust design, as well as unparalleled reliability in manufacturing and functionality. And, of course, rapid time-to-market is always a top priority.
“We’re seeing an accelerated ‘time-to-market’ push that we’re tackling with innovative design approaches to meet the needs of our clients,” said Michael Neidert, vice president of strategic development for West Coast client relationships for Ximedica, a Providence, R.I.-based provider of medical device design and manufacturing services. “For example, to get to clinical trials sooner, we’re expanding available manufacturing methods by adding controls and inspection.”
OEMs also want to work with contract manufacturers (CMs) experienced with the regulating agencies and the requirements for launching medical devices from concept through commercialization. In turn, CMs want to partner with their own suppliers who are equally talented and can contribute to design solutions.
“OEMs ask for dedicated teams, rapid prototyping, project management, pilot manufacturing, and a seamless transition to high-volume production, all backed by a robust quality system,” said Jim Kelley, vice president of R&D for cardio and vascular for Integer, a Plano, Tex.-based medical device contract manufacturer. “In many cases, OEMs are also looking for contract manufacturers to provide critical inputs into regulatory submissions.”
With such a long wish list, it can be challenging for CMs to provide end-to-end services, who will work when needed with their own carefully selected supply chain partners to meet tight timelines and provide valued expertise.
“OEMs want products that exceed all requirements, are differentiated from competitive products, are patented, cleared by regulatory agencies, and are delivered in their finished form—all of which present dichotomies for the design process,” said Mosler. “Design engineers must prove to customers, marketing departments, and patent authorities that their products are unique, different, and better. But to the FDA, clearance of a new device usually must include proof that it is substantially equivalent to predicates, or the device conforms to an accepted standard. That makes it hard on the design engineer.”
New Technology Trends
As medical devices get smaller and more complex, software is increasingly an important part of the designer’s toolbox—for example, finite element analysis and NTopology. Engineers are also turning to SaaS and cloud computing to accelerate design efforts, as well as artificial intelligence, machine learning, virtual reality (VR), and augmented reality (AR).
“We’re exploring the use of AR and VR to effectively collaborate with our clients on early phase design work,” said Jan Zukowski, director of digital products for Ximedica. “With AR/VR, we can readily share 2D and 3D designs with stakeholders—allowing them to view the design while it’s being produced—which helps us move the needle forward and stay ahead of the curve. Our project teams are also using Miro, an online collaborative whiteboarding platform, to ease remote interaction and spark early innovation anytime, anywhere.”
As a visual project management tool, Miro allows cross-functional teams at multiple locations to collaborate, brainstorm, and share project work and new developments. Users can add a variety of data, including mockups, images, prototypes, drawings, videos, sticky notes, and documents and files. Miro is ideal for remote work, planning, and design thinking.
Another software tool is Onshape, a mechanical engineering program gaining attention for generative design. Although CAD software is extremely popular, it can be limiting in the number of ideas that can be generated by a mechanical engineer. “Most of them are unimaginative, which can lead to over-built, heavy, and cumbersome final products,” said Jake Washam, a mechanical engineer at Very, a Chattanooga, Tenn.-based engineering design firm.1
Generative design uses mathematical optimization, combined with finite element analysis, to automatically create optimal part geometries. It uses the engineer’s constraints, including loads and fixed geometries as inputs, and creates hundreds of the lightest, strongest, and most intricate designs as an output. “With this new technology, a thousand different solutions to a problem can be revealed to the engineer, all within a few minutes,” he added. Many of these new designs are lighter and stronger, making Onshape an ideal approach for medical applications such as implants, wearables, tools, and instruments.1
Rapidly advancing capabilities in additive manufacturing (AM) create expanded design opportunities for engineers—who can sometimes create highly innovative products that can only be made with AM. “Additive manufacturing is quickly progressing as a means to not only produce prototypes, but increasingly serial and customized parts and devices that are difficult, or even impossible, to produce with more conventional production methods,” said Nollenberger.
For example, a designer can use AM to make components or assemblies with intricate features that would not be possible to make using traditional manufacturing methods. “Consider a living hinge articulation joint for an endoscope,” said Calabrese. “It’s very challenging to make an injection-molded, cast, or machined living hinge articulation joint that works for an endoscope. Additive manufacturing represents a solution to this challenge, especially with the continued development of available materials and processes.”
AM is also used for tooling, test fixtures, handle concepts, and housings, reducing prototype lead times and improving engineering decision making. Continued development of advanced AM materials also allows designers to create new products that were previously constrained by the limitations of injection molding or machining.
Despite the overwhelming creative possibilities, AM is still a highly specialized application due to its high per-part cost and limited material properties. For some high-value, low-volume industries, however, like aerospace and large medical scanning equipment, the ability to combine many parts into one with increased sub-assembly reliability can offset the cost and material compromises, which has definite appeal in the medical device industry.
“With AM now approaching the accuracy of subtractive machining processes while supporting previously unmakeable geometries, the industry is embracing AM options with increasing enthusiasm,” said Remedios.
Internet of Things
IoT is increasingly about connectivity and interoperability. Connected devices must maintain safe use and patient/data security and require elaborate encryption and telemetry protocols and sophisticated control algorithms.
“There are data formats to be considered such as HL-7, medical imaging format [DICOM], retail pharmacy messaging [NCPDP], web service providers to review, and data analysis to consider,” said Maylish. “It is easy to underestimate the amount of effort involved in connecting, retrieving, depositing, analyzing, and making medical data available and actionable. This expertise was not part of product development in the past.”
Designing IoT-connected products requires extra skills and expertise. “When creating journey and story maps detailing user personas, we factor in that a user does not necessarily have to be a person,” said Zukowski. “We also consider all touch points that systems have with each other to create the user experience. For example, how edge devices interact with a person, how edge devices interact with a cloud infrastructure, and what data is being collected. These scenarios drive the overall user experience design and require thoughtful discussions with clients, architects, and development teams.”
Increasingly, IoT-connected devices and apps are becoming full-fledged medical devices. As such, verification and validation testing, especially software validation, cannot be ignored. “As medical device and pharmaceutical companies embrace these technologies, design teams must be prepared to integrate hardware and write software code that can pass these rigorous approaches to validation,” said Mosler.
Calabrese believes consumer-focused IoT-connected medical devices will be the next big medical market to develop. “Telemedicine is slowly gaining adaptation and will likely be spurred on by the COVID-19 pandemic,” said Calabrese. “I am not certain, however, that we have the tools to support it. This leads me to believe that a market for IoT-connected medical devices is headed for a boom.”
Right now, MDMs are intensely focused on meeting the requirements of MDR in Europe. There are also relatively new FDA requirements for submission based on usability reporting—making it important to combine patient outcome studies with clinical studies wherever possible.
MDR in Europe and the FDA’s move to align its regulations more closely with CE mark means there is a greater requirement to consider usability and use-centered design (versus user-centered design). “Additionally, as clinical requirements become increasingly stringent, it is critical that contract manufacturers be able to quickly and cost-effectively manufacture human-use clinical builds in a high-quality manufacturing environment,” said Kelly. “Dedicated pilot manufacturing lines enable rapid response and a seamless transition to high-volume production.”
The FDA recently acknowledged the regulatory pathway has become incredibly cumbersome and lengthy, particularly with Class III medical devices that require pre-market approval, to the point where innovators and startups struggle to raise the substantial investment required to launch these devices. “As a result, it becomes increasingly incumbent on the OEMs to either support their innovation partners or develop such technologies themselves,” said Remedios. “To spur innovation in the industry, the FDA is encouraging greater communication with development teams via pre-submission reviews to help guide the design and its test protocols early on, reducing risk for the device to be rejected during formal review.”
Security is also a top concern with wireless/electronic devices—MDMs must not let IoT-related product design, complexity, and multifunctionality outpace the security needed to protect these devices and the personal information they generate.
“From a digital design perspective, we’re focused on developing unique processes that satisfy the requirements of the Health Insurance Portability and Accountability Act and address cybersecurity concerns in order to mitigate any risk that may impact the patient,” said Zukowski. “While cloud platforms support multifactor authentication and a secure and encrypted communication layer for privatizing data, Ximedica works with its clients and other partners to ensure we address vulnerabilities that could be harmful to patients and their data, as medical device hacking is certainly on the rise.”
Medical device designers and engineers will continue to use innovative new tools to add more value and functionality to their products. For example, systems on a module enable data crunching and analysis on remote sensors. “Sensors processing large amounts of data—for example, an EKG—can analyze and report back only the data of interest, and not all of the data, saving data transmission, power, and ultimately, time,” said Maylish.
User-centered design is increasingly important in making the safest possible products and meeting regulatory requirements. It does, however, add cost and lead time to conduct meaningful and disciplined research. New technologies such as VR and AR can make this easier to accomplish and help keep costs down.
“Virtual reality and augmented reality technology and tools are converging to the point where iterative usability testing throughout the design process can be rapid, effective, and affordable,” said Remedios. “Integrating usability engineering holistically throughout the development process—thereby replacing inaccurate ad-hoc measures—continuously informs the design direction which results in a commercial product that maximizes market value, penetration, and relevance.”
“Design engineers are the bridge between design and engineering activities,” said Joe Gordon, vice president of innovation for Ximedica. “This facilitation role has increased in importance as products have progressed from stand-alone entities to being integrated into complex ecosystems. This requires the development of advanced system tools such as 3D modeling, scanning, and prototyping, which offer an almost unlimited ease of access, propelling collaboration and design in innovative new ways.”
Mark Crawford is a full-time freelance business and marketing/communications writer based in Madison, Wis. His clients range from startups to global manufacturing leaders. He also writes a variety of feature articles for regional and national publications and is the author of five books.
Paul Mulhauser • President, FactorsNY
As COVID-19 now ravages the nation and world, doctors and medical personnel who are severely lacking sufficient quantities of proper N95 masks, gowns, eye gear, and tests, are heroically risking their own lives on the front lines of a pandemic to diagnose and treat the daily onslaught of infected victims.
Shortages of basic personal protective equipment (PPE) and ventilators have sent hospitals and medical care facilities—as well as cities and states—scrambling to find, and competing to purchase, the same products. All are calling upon the same finite pool of distributors, themselves already short of the needed products, which are produced by a limited pool of already backordered manufacturers, many located in countries already confounded by the same pandemic.
Over the past 20 to 30 years, many U.S. manufacturers have evaporated; others purchased, merged, and consolidated; others converted into service companies. Still others are producing fewer domestic products by shifting manufacturing offshore or out-sourcing. Meanwhile, other countries have embraced the opportunity to expand their manufacturing bases.
Outsourcing has unquestionably reduced overhead and increased profits. However, today, there’s an unanticipated price to be paid. Today we’re out of luck. This pandemic has caught us empty-handed. Lives are being lost as desperately needed quantities of commodity products and critical care equipment are unavailable and out of reach. While outsourcing is a powerful resource, today we’re not feeling that power. Our supply chain has broken down.
As medical product designers and engi-neers, we are committed to creating safe reliable products to high standards and certainly to “do no harm.” Yet, today, emergency responders are at serious risk, facing profound product shortages as the pandemic’s trajectory curves veer upwards around the world and across U.S. cities. Effective response, safety, and lives are lost to unreliable and inadequate outsourced supply channels.
It is bluntly evident that our medical prod-uct outsourcing standards must change. Domestic manufacturers must be fortified. It is time for the U.S. to unabashedly make what we need locally; to physically produce products that we and the world need and to invest in expanding robust, domestic, world-class, mass-production manufacturing capabilities.
Domestic medical supply manufacturers must accelerate their ability to spontaneously scale-up capacity in response to a crisis. In the absence of time-ly federal guidance, medical manufacturing industries must themselves become independently prepared for the next inevitable pandemic.
Building domestic production capability is vital to supplying the many essential ultra-high-volume single-use disposable PPE that are used on a daily ba-sis throughout every hospital, med-care, medical manufacturing, pharmaceutical, technical lab, and research operation. Otherwise, today’s shortages and crisis outcomes are potentially destined to further cas-cade throughout medical device industries.
Paul Mulhauser is president of FactorsNY, a consulting company in New York City that specializes in medical and technical product design and development.