Though vaccinations began in late 2020, they’ll have a bigger impact this year and will push medical manufacturing and the world toward a new normal. In achieving herd immunity, McKinsey & Co. estimates the U.S could complete inoculations by Q3 or Q4 of 2021.

Analysts from Oxford Economics note that manufacturing remained stable at the end of 2020, with the ISM Manufacturing index rising for seven consecutive months to a new recovery high of 60.7 in December. New production orders signal solid future activity, and inventories rose for a third straight month. Looking ahead, evolving recovery dynamics could cause factory activity growth to slow in 2021. Potential headwinds include the virus’ recent resurgence, slower economic recovery, and ongoing supply chain disruptions.

Oxford Economics stressed that controlling COVID-19 now matters greatly because while the economy has recouped two-thirds of its pandemic output loss and 12 million jobs, gross domestic production (GDP) remains 3.5% below its Q4 2019 level, and the employment shortfall remains. Real GDP growth of 3.5% is expected in 2021, which also assumes broadly available COVID-19 vaccines by mid-year.

The recently released EY’s Pulse of the Industry: Medical Technology Report 2020, notes a 6.3% revenue growth in 2019, slightly down from 2018’s 6.7% growth. In the first half of 2020, however, roughly two-thirds of U.S. pure-play medtech companies and conglomerates with more than $500 million in annual revenue experienced a 5% aggregate revenue decline. Companies focused on elective procedures suffered the most, while companies focused on diagnostics benefited as the pandemic heightened demand.

Those in the personal protective equipment (PPE), testing swab, ventilator, or respirator market (and those able to pivot that direction) were extremely busy in 2020.

Virtual care and telehealth also grew during the pandemic, and that’s not going to disappear now that the convenience has been found. Frost & Sullivan is forecasting a 7x growth in telehealth by 2025 with a 5-year compound annual growth rate (CAGR) of 38.2%. Virtual visits and remote patient monitoring should propel the overall telehealth market, followed by mHealth and personal emergency response systems. Patients will benefit if data from remote patient monitoring are fully available to virtual visit providers, so we’ll likely see more of these integrated services.

The global outsourcing market was valued around $104 billion in 2017 and nearly $116 billion by the end of 2020. It should grow at a 10.4% CAGR to 2027, reaching more than $231 billion.

Within the outsourcing market, contract manufacturing held the largest market share of 55.8% in 2019 and is expected to dominate the market for the foreseeable future with an increased focus on reducing medical device costs. Several top players are determining their core strengths and outsourcing everything else.

Bottom line

The global medical device market for 2019 was $448 billion, 2020 should be around $443 billion, and the market should grow at a CAGR of 5.2%, reaching more than $671 billion by 2027. (To see what’s forecast for a range of medical sectors, turn to page 8.)

About the author: Elizabeth Engler Modic is editor of Today’s Medical Developments. She can be reached at 216.393.0264 or emodic@gie.net.

Stryker: Designing and manufacturing products for the future

By Josh Mix

Designing solutions for the future begins with developing a profound empathy for the caregivers who will use them. We must understand who these caregivers are, how they work, and what they need to take care of patients safely and efficiently.

Before we launch a new product, we spend time forging strong relationships and listening to the challenges our global customers face. This drives us to design solutions that will truly impact their lives – such as our newest bed innovation, ProCuity.

We have a rigorous process for discovering an unmet need, achieving a breakthrough, and, ultimately, bringing a solution into production. On the surface, our human-centered design process may not differ from other companies. But we believe the real difference for us is our talent and the connections we make with caregivers.

With respect to the future, it’s important to understand the macro trends within healthcare – such as shifts in care settings. COVID-19 has emphasized the importance of being adaptable and nimble in the face of rapid change, when customers’ needs are shifting.

Some of the biggest buzzwords in healthcare are data, artificial intelligence (AI), and its applications to improve the world around us. These technologies will enable us to bring profound solutions to the table. We will incorporate the tools around us, continue to evolve our process, and leverage it as we continue to focus on enhancing the lives of caregivers and the patients they serve.

Josh Mix is senior director of R&D, Acute Care, Stryker.

Flex Health Solutions: Devices for remote care

By Amy Boyle

The pandemic is an accelerant to digital transformation. Trends and developments we once thought would play out throughout a decade are taking root in months. This is especially true for medical devices, where many factors are converging to accelerate delivery of at-home care. Trends driving medical device evolution include:

Reducing non-adherence: Medical non-adherence leads to an estimated 25% to 50% of prescriptions in the U.S. not being taken as prescribed, causing ineffective or less effective therapy, higher hospital admission rates, lost productivity, and higher insurance costs.

Rising remote monitoring: Improvements in sensor and connectivity technology, pressure to reduce healthcare costs, an aging population, growing demand for electronic health record interchanges, and the desire of patients and healthcare professionals to keep non-critical patients away from crowded healthcare facilities are driving non-contact patient monitoring. Patients want more access to their information and sophisticated consumer devices are enabling that shift by interacting with many medical devices.

Smartphone proliferation: Patients and healthcare providers trust smartphone apps to collect sophisticated data to manage most health conditions. Providers can reduce drug waste, monitor more health data, and capture detailed drug administration patterns to improve patient outcomes.

The pandemic didn’t start any of these trends, but it’s helped accelerate the movement. The telehealth genie is out of the bottle. These dramatic shifts mean that manufacturers are now tasked with developing medical devices capable of monitoring more – and higher-quality – data that can be quickly and securely captured, transmitted, and analyzed in real-time to create actionable information.

Integrating technology to improve remote patient care is complex, but it’s a necessary step for manufacturers in a post-COVID world. This requires working with technology partners in a multidisciplinary approach that creates an open and collaborative mindset while still delivering quality products within a strict regulatory framework.

Amy Boyle is vice president, Strategy for Flex Health Solutions.

We expect a notable increase in simulation and other patient-matched technologies that can economically improve the quality of care, despite the challenging COVID environment, such as these trends.

Personalization – particularly in orthopedics: Cost and complexity have been barriers to personalization, but technological advancements continue to minimize them. Software advancements enable virtual planning of increasingly complex cases and AR/VR-based simulation using patient-specific data in surgical training. Patient-specific, 3D-printed instruments and intraoperative navigation tools reduce operative time, errors, and spending on patient care.¹

Additive manufacturing (AM): OEMs and supply partners will likely continue converting subtractive supply chains to AM as quality, automation, ease-of-use, equipment, and consumables advance. AM should become more accessible for point of care providers, broadening their manufacturing capabilities. We anticipate more research to be published by universities and research institutes covering a wider range of indications, which will catalyze the adoption of this disruptive technology.

Point of care manufacturing: Providers recognize the benefits of in-sourcing production of key surgical planning tools, instruments, implants, and advanced therapy medicinal products. Facilitating access to these devices and shortening lead times can improve patient care and improve control of the supply chain for PPE, critical equipment, and patient-specific devices often desired on short notice.

Point of care manufacturing became acute in 2020 as the pandemic took hold. As we look forward, we expect this trend to accelerate. Providers must recognize the significant manufacturing quality and regulatory requirements that they aren’t readily equipped to abide by on day one. Implementing these complex solutions will require collaboration with industry experts. One example is the Veterans Health Administration (VHA) contract with 3D Systems to establish U.S. Food and Drug Administration (FDA)-compliant manufacturing facilities within their hospitals for medical device production at the point of care. Our team will collaborate with the VHA to streamline its supply chain and accelerate innovation.

Regenerative medicine: Headlines in 2021 will be a mix of heralded technical advances from several firms and consortiums, as well as the continuing arms race between major players that will spur large mergers such as the $400 million acquisition by Integra LifeSciences announced on Dec. 16, 2020. Accordingly, we expect that 2021 will be an important year in the continuing evolution of regenerative medicine and its impact on the future of healthcare.

Menno Ellis is executive vice president, Healthcare Solutions, at 3D Systems.

Okuma: Taking inventory of what we’ve learned

By Jim King

As we start to feel recovery, it’s time to take inventory of what we’ve learned and what technologies will enable us to compete post-COVID.

Virtual communication tools increase the speed of business. It’s not only possible to evaluate technology without sending high-value staff on the road, it’s sometimes more desirable. Even machine runoffs can be accomplished virtually.

Artificial intelligence (AI) has arrived and will have its place in the machine tool industry. Early stages will demonstrate the obvious applications, such as predicting unplanned maintenance events before they occur.

Digital twin is on its way, but still needs to undergo further development to be ready for significant market adoption. This technology will have an impact in the not-too-distant future.

Blockchain for manufacturing will provide a secure way to communicate amongst teams in a world with increasing cyber-attacks.

Automation will become a must in most shops. It’s not just robots. Bar feeders, pallet pools, and flexible manufacturing systems are some options that can increase productivity.

Get back to basics and make sure your foundation is sound. Control the things that are in your control.

The events of 2020 were all-consuming and made it difficult to plan. Now is the time to take steps to ensure a successful future. Focus on where you are in the continuum of automation, data use, and understanding the drivers in your business. 2021 will be a year of transition as we prepare for manufacturing to once again lead our economy out of darkness to new prosperity.

Jim King is president and COO at Okuma America Corp.

Stratview Research: Orthopedic composites

By Aniket Roy

Orthopedic medicine has been evolving throughout centuries with composite materials finding their importance in this field. Traffic accidents, sports injuries, osteosarcoma growth, and a surge in diabetes-related amputations are driving the global prosthetics and orthotics markets with the World Health Organization (WHO) noting 30 million people needed these devices in 2018.

Why composites? Composite materials are lightweight, durable, have excellent fatigue characteristics, and are corrosion resistant, however, the high costs act as a bottleneck for wider adoption.

COVID-19: Demand for composites in the orthopedics market fell more than 19% in 2020 as treatment for those suffering from non-COVID ailments (including orthopedic surgeries) took a backseat. The pandemic disrupted supply chains, leaving orders for required composites unfulfilled. The carbon-fiber lower limb prosthetics market has been tremendously affected due to postponing the Tokyo Paralympics to 2021.

However, Stratview Research predicts the demand for global orthopedic composites is likely to rebound to reach a market value of $316 million in 2026.

Attractive market segmentS: More than 80% of medical composites are used in lower limb prosthetics and orthotics, the former being the largest application. Lower limb prosthetics use will be propelled by high cases of lower limb amputations, improved global healthcare spending, and higher adoption of composite materials in artificial leg manufacturing.

Nylon fibers and acrylic resins are predominantly used in orthopedic composites. Other dominant materials include cotton, carbon fiber, glass fiber, vinylester, and epoxy. Though nylon composites have a higher market share, carbon-fiber composites, due to their excellent strength-to-weight ratio and corrosion resistance, are widely adopted in lower limb prosthetics. Hence, the demand for carbon fiber composites is estimated to grow with the highest CAGR throughout the forecast period.

North America and Europe are forerunners in adopting orthopedic composites, together accounting for more than 75% share in 2020.

Road ahead: As the world recovers from COVID-19, the demand for composites will regain its momentum. Regenerative prosthetic and orthotic designs that use artificial intelligence (AI) will steer the market for composites in a new direction. With 3D printing advancements, the possibility of anyone being able to easily design and print a prosthetic limb will soon become a reality.

Aniket Roy is the digital marketing team lead at Stratview Research.

The collaboration between Solvay and PrinterPrezz is aimed toward developing 3D printing selective laser sintering (SLS) solutions for implants and other medical devices.

“This partnership will allow us to combine our expertise in materials with PrinterPrezz’s unique offering for qualification of medical devices to accelerate the adoption of 3D-printed implants and medical devices using Solvay’s latest additive manufacturing (AM) powder technology for SLS,” says Christophe Schramm, AM business manager for Solvay Specialty Polymers’ global business unit.

“The range of services offered by PrinterPrezz, which includes engineering, clinical, and regulatory guidance, as well as access to 3D simulation software and state-of-the-art 3D printers, provides Solvay a gateway for the development and optimization of their high-performance polymeric additive manufacturing powders to advance the manufacturing of next- generation implants and medical devices,” PrinterPrezz CEO Shri Shetty says.

VELO^3D partners with GoEngineer

GoEngineer will operate as an extension of VELO^3D under their newly formed nationwide distribution partnership. GoEngineer will dedicate resources to educate designers about SupportFree technology for their designs, as well as sales and service expertise supporting the complete solutions portfolio including Flow pre-print software, Sapphire metal AM printer, and Assure quality assurance and control system.

“We are pleased to partner with VELO^3D to help manufacturing companies across the U.S. produce mission-critical parts for industrial use,” GoEngineer CEO Ken Clayton says.

“GoEngineer has gained the trust of thousands of customers with their rich expertise in additive design solutions. I see them as a strategic and invaluable partner in educating customers about the opportunity our technology brings to design and manufacturing,” VELO^3D Founder and CEO Benny Buller says.

A tiny fiber-optic, light-based force center can measure miniscule forces to provide new insights for scientists, medical device manufacturers, and engineers who need insight into nearly imperceptible measurements.

Overcoming limitations of micro-electro-mechanical sensors (MEMS)-based force sensors could be useful for various applications, including medical systems and manufacturing.

“Applications for force sensing are numerous, but there is a lack of thoroughly miniature and versatile force sensors that can perform force measurements on small objects,” says research team leader Denis Donlagic from Slovenia’s University of Maribor. “Our sensor helps meet this need as one of the smallest and most versatile optical-fiber force sensors designed thus far.”

All-glass sensor

MEMS-based sensors can provide miniature force sensing capabilities, but they require application-specific protective packaging and multiple electrical connections, limiting applications. Without proper packaging, MEMS devices aren’t biocompatible and can’t be immersed in water.

To develop a more versatile miniature force sensor, the researchers created an all-optical fiber optic sensor made of silica glass formed into a cylinder 800µm long and 100µm in diameter – roughly the same diameter as a human hair. A special etching process the researchers had previously developed to create complicated all-fiber microstructures enabled the project. The micromachining process created a sensor based on a Fabry-Perot interferometer – an optical cavity made from two parallel reflecting surfaces.

The end of the sensor’s lead-in fiber and a thin flexible silica diaphragm were used to create the tiny interferometer. When external force is exerted onto a silica post with a round or cylindrical force sensing probe on the end, it changes the length of the interferometer in a way that can be measured with subnanometer resolution.

Researchers designed and fabricated the sensor’s structures to create an air-sealed cavity, protected from contamination and amenable for biochemical environments. It can be immersed in various liquids and can measure positive and negative forces, without additional packaging for most applications.

After evaluating and calibrating the sensor, the researchers used it to measure Young modulus – a measure of stiffness – of a human hair and a common dandelion seed. They also measured surface tension of a liquid by calculating the retraction force when a miniature cylinder was removed from a liquid. The researchers were able to measure force with a resolution of about 0.6µN and a force range of about 0.6mN.

“The force sensing tip can be made substantially smaller – down to about 10µm in diameter – and can be adapted to perform various force sensing tasks,” Donlagic says.

The team says the current version of the sensor is ready for use. However, improving the overload robustness, producing probe tips with other shapes, or adding miniaturized packaging could expand potential applications. The researchers are also working to automate the processes used to fabricate the sensor to make it more practical.

University of Maribor
https://www.um.si

If misuse of your medical device can harm patients or clinicians, human factors engineering (HFE) and usability engineering (UX) are important for products intended for the U.S. market. While most people working on medical devices are aware of the need, there’s less certainty about the method and decision points relevant to their unique device.

What should be considered when designing the user interface (UI) for your next medical device?

For context, it’s worth taking a step back to appreciate the broader landscape of HFE in medical devices. Many discussions start with health industry statistics describing the number of patients injured by complications arising from user interface interaction. But the most damning statistics are usually inferred rather than direct measurements of negative outcomes. It’s hard to isolate usability from dozens of other variables in the clinical setting, including patient variability, clinician judgment, and concurrent therapies and circumstances.

A different way to understand the problem is to focus on the pivotal shifts driving the U.S. Food and Drug Administration (FDA) when they released guidance on the topic in 2016. Applying Human Factors and Usability Engineering to Medical Devices is the FDA’s nonbinding set of recommendations to the medical device industry.

A prominent concept in the guidance is the term use error, which should not be confused with user errors. User errors are the fault of the user and are non-systemic to the medical device. This includes misreading a display, mental error, insufficient training, and lapse of attention.

Use error, a term coined in 1995 in a medical device trade periodical, inverts the blame from user error and asserts that the device is responsible for mistakes made by a user; even if those mistakes are made because of traits that we normally associate with human shortcomings, such as mental error or inattention.

Users and the complicated real-world environments in which they work, impose a permanent set of requirements on the medical device. Many such requirements are substantially addressable by design modifications – bigger, brighter displays; large input buttons, safety-aware workflows – avoid dependence on device training.

To demonstrate how strict the recognized standards are and how strongly the FDA feels about this, consider the following passages from the 2016 guidance:

“3.9 Use error: User action or lack of action that was different from that expected by the manufacturer and caused a result that (1) was different from the result expected by the user and (2) was not caused solely by device failure and (3) did or could result in harm.”

The first clause, “a result that was different from the result expected by the user” is pretty sweeping; how often do devices do something that we don’t expect? This doesn’t just apply to the device actions but also the lack of device actions. If this wasn’t broad enough, the phrase “...did or could result in harm” obligates the manufacturer to address both observed problems and theoretical ones.

From IEC 62366, Annex A

“…use errors are the direct result of poor user interface design”

As for who is culpable, this statement puts the blame for missed expectations directly on interface designers.

Use errors causes

How does the concept of use error motivate our thinking when designing medical device interfaces? Consider the causes of use errors, such as:

1. Managing user cognitive load

Is the user multi-tasking? Will the user be interrupted in the middle of a workflow? Is the information being presented (at every step in the workflow) too broad? Is the information being presented too superficial?

2. Accounting for untrained users

Can a manufacturer guarantee that all users will be trained? If not, will untrained users make use errors? To what extent can the medical device mitigate the potential harm from an untrained user?

3. Allowing for urgent usage

Are there high urgency use cases? If so, does the device support immediate use? Can information collection be performed at the end of, or outside of a workflow?

4. Accounting for novel use or streamlining

Will an experienced person use the device differently from a novice? Sometimes, physicians will use the device differently than other users, for example by disabling therapeutic limits. Should the device tolerate these novel uses? How will the device make these novel uses safe?

5. Balancing device security with access and workflow

Is device security and user authentication balanced with the needs of the user environment? For example, in a hospital’s ER, is urgent use balanced by the need to prevent unintended users? Is device security cumbersome to the extent that it is disabled or defeated by clinicians?

6. Compensating for user variation (height, hand size, color-blindness, visibility, audibility)

Do small buttons lead to key entry mistakes? Is the minimum font size visible at a distance for a user with corrected vision?

7. Accommodating a physically encumbered user

Do the requirements of a sterile environment conflict with the means of inputting data? Is the touchscreen sensitive to users wearing double gloves? Does the clinician have a free hand available to manipulate the device while performing other tasks?

Safety premium

Fortunately, preventing harm is a pretty well defined standard that can be addressed with design. It’s also consistent with the normal risk management practices that are incumbent with medical device design. What might be less clear is a framework for eliminating use errors.

The FDA recognizes an international standard for dealing with human factors and usability engineering – Medical Devices - Part 1: Application of Usability Engineering to Medical Devices (also known by the designation IEC 62366). The standard describes a process of risk mitigation that closely mimics the process outlined in risk management standard IEC 14971.

At a very high level, the general steps of IEC 62366 are:

1. Define the intended use, users, and environment

2. Itemize and analyze the hazards associated with use

3. Prototype solutions to the risks

4. Conduct user studies and evaluate performance

© ICS | https://www.ics.com/

Figure 1 presents a simplified flowchart showing the steps in more detail and how they iterate. The process is practiced and repeated until a predetermined threshold of safety has been achieved.

IEC 62366 contains in-depth guidance on how to perform each step in this process. A key part is declaring a documented description of the use environment and conditions that can support analysis. A useful component that supports analysis is a model for how a user interacts with an interface.

The diagram in Figure 2 is a good model for segmenting the responsibilities that compose interaction with a user interface. The interesting pieces often taken for granted are on the user side. They allow us to separate Information Perception from Cognitive Processing and efforts at control.

Decomposing the interaction this way allows risk management to handle limited solvable problems. For example, when considering the UI visible when therapy is applied, Information Perception prompts the question ‘is the clinically relevant information immediately available? If it’s not, but only available on another screen within the UI, this requires the user to navigate to it. The design-time awareness that this implies another six-step cycle of interaction for the user to access the clinically-relevant information is motive enough to seek an alternative means of access or display. Using this type of model to uncover and address interaction challenges is a great tool for anticipating use errors and optimizing the user interface.

Use errors, the chief consideration

While designing a pleasing user experience has benefits in providing a clean and appealing device interaction, the highest priority for medical devices is designing to minimize use errors. Use errors are strongly correlated to patient harm. Thus, tools and considerations leading to the detection and mitigation of use errors will always have the highest value in – and be the chief consideration for – medical device interface design.

Integrated Computer Solutions

Boston UX

About the author: Milton Yarberry is the director of medical programs at Integrated Computer Solutions (ICS) and Boston UX. He has more than 15 years of experience working with large and small medical device and IVD manufacturers. Yarberry may be reached at milton_yarberry@ics.com.