Medical Design & Outsourcing – SEPTEMBER 2020 by WTWH Media LLC

www.medicaldesignandoutsourcing.com SEPTEMBER 2020

HOW THE PRESIDENTIAL ELECTION COULD AFFECT MEDTECH ADAPTING A STROKE DEVICE FOR CORONAVIRUS A TOP RESEARCH LAB PIVOTS TO FIGHT COVID-19

2020

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2020

HERE’S WHAT WE SEE

Learning and innovating — what medtech does best

he medical device industry never stands still. There’s always so much to learn, not just from colleagues, but from others within your market segment and those working in completely different areas of the business. This year’s edition of MDO’s Medical Device Handbook can add reams of information to that knowledge. Pick a topic — device components, drug delivery, manufacturing, materials, regulatory, legal, software, sterilization, tubing — and you’ll be better informed. We address timely topics that affect the industry as well, including the presidential election and the COVID-19 pandemic. Senior editor Danielle Kirsh dove deeply into donation data to learn which presidential candidates medtech workers and their families are supporting with their dollars. We also report on expectations of how a Trump administration versus a Biden administration would affect the industry, federal regulations and patient safety. And we continue to cover medtech’s evolving response to the COVID-19 pandemic. If there is another spike in infections, will there be enough personal protective equipment for frontline workers? Chief among the array of facial and body coverings is the N95 respirator, designed to filter out 95% of airborne particles. Manufacturers continue to churn them out by the thousands, but the masks are supposed to be discarded after every patient. When that’s not possible, frontline healthcare workers may wear the same mask all day. When that’s not enough, those masks can be decontaminated, but which method is best at killing the virus, preserving mask shape and strap integrity so it will continue to protect the wearer? We report on some of the latest research on decontamination methods and an effort by a veterinary school to repurpose a building to decontaminate masks for healthcare providers and first responders. On the race to develop a safe and effective COVID-19 Nancy Crotti vaccine, executive editor Chris Newmarker tells the story of Managing Editor Medical Design & how a microarray patch made by Vaxxas may be used as a Outsourcing delivery platform for a major drug-maker’s vaccine candidate. We also bring you stories of how some of the brightest n c ro tti @ wtwh m e di a .c o m minds in device development recast their pre-pandemic projects to address the pandemic scourge. Harvard University professor Jeff Karp and colleagues are working on a gel that could kill SARSCoV-2, the virus that causes COVID-19, as soon as it enters the nasal passages. And Northwestern University bioengineer John Rogers and colleagues converted a device they designed to detect swallowing problems in stroke patients to a COVID-19 symptom detector for frontline healthcare workers. Not only can it alert physicians to cough, labored breathing and fever, it uses artificial intelligence to generate data that is furthering research on pandemic symptoms. Karp acknowledged the energy and passion that the pandemic has inspired among medtech innovators. “As problem solvers who have a lot of access to resources and incredible collaborators, we’re trying to think of everything we can to help in many different areas.” We at MDO hope that the information we provide in this Handbook will inspire you to continue innovating in this evolving industry. 4

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MEDICAL

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SOLENOID VALVES

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Medical Design & Outsourcing

SolenoidSolutionsInc.com 888.825.8405

2020

CONTENTS

medicaldesignandoutsourcing.com ∞ September 2020 ∞ Vol6 No5

• • • • • THE MEDICAL DEVICE HANDBOOK

COLUMNS 4

HERE’S WHAT WE SEE:

COMPONENTS:

Learning and innovating — What medtech does best DC motors, Valves, Interconnections, Minifactories, Power supplies, RF/ microwave components

2020

22 DRUG DELIVERY:

Tiny vaccine patches

26 MANUFACTURING & MACHINING:

Custom implants, Future factories, Metal injection molding, Diagnostic test production, Prototyping, Injection molding, Vascular stents

46 MATERIALS:

Anodizing aluminum, Laser inversion, Material substitution, Textiles for orthopedics, Synthetic polyisoprene

57 PRODUCT DESIGN & DEVELOPMENT:

Antenna placement, Custom-printed metal implants, Root cause analysis, Hiring freelancers, Warp-speed device development

REGULATORY, REIMBURSEMENT, STANDARDS & IP: In vitro diagnostics regulations, An innovation roadmap, Pandemic IP opportunities, Legal agreements, Testing requirements

80 SOFTWARE:

Developing for safety in robotics

82 STERILIZATION SERVICES:

Mask decontamination, Plasma treatment

86 TUBING:

Ablation catheter tech that mimics ﬁsh, Echogenic catheters, Nitinol tubing

Medical Design & Outsourcing

92 HOW THE PRESIDENTIAL ELECTION COULD AFFECT MEDTECH The federal government’s relationship with the industry has changed. Medtech insiders believe there must be a reckoning regardless of who ends up in the White House.

95 BIDEN IS GETTING MORE MONEY

FROM MEDTECH EMPLOYEES

Check out our breakdown of contributions from workers at 25 of the largest companies.

98 THESE RESEARCHERS ADAPTED A

STROKE DEVICE FOR COVID-19

An engineer and research scientist in Chicago retooled their wearable device to detect coronavirus symptoms in frontline workers.

102 HOW A TOP RESEARCH LAB PIVOTED TO FIGHT COVID-19

The pandemic brought regular work at the Karp Lab in Boston to a halt, and that’s OK, according to its founder and director.

104 AD INDEX 8

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2020

COMPONENTS

Miniature solenoid valves’ continued evolution makes them valuable and effective components for controlling the flow, direction and pressure of gases and fluids.

Paul Gant Emerson Automation Solutions

ith automated functions, excellent reliability and long life, it’s no surprise that gas and liquid valves are used throughout the medical device industry. They control the flow, direction and pressure of the gases or fluids used by a device. Miniature valves and the electronics that control them provide performance, longevity and dependability for oxygen concentrators, ventilators and respirators, anesthesia equipment, patient monitors, clinical diagnostics, DNA sequencing, surgical equipment and even dialysis. Recent improvements in solenoid-operated valves are helping medical device manufacturers use energy much more efficiently, allowing them to build more portable equipment while managing issues such as heat generation more effectively. Solenoid valves Solenoid-operated valves are commonly used in oxygen therapy devices because they offer value and reliability while providing excellent function. Pressures in medical device applications

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are typically lower than industrial applications — often 1 bar (14.5 psi) and much less. Proportional control, or the ability of a valve to vary its orifice size based upon the strength of a signal, gives further capability while enabling multiple uses. Combined with a “smart” electronic control system, these valves can deliver exacting solutions and may also perform different functions to expand the capability of specialized machinery. Isolation valves Isolation valves are used in applications in which fluid control must be efficient, precise and leak-free. These applications require the fluid to be contained and often be controlled without contamination from outside elements, including the valve itself. In many cases, a membrane is used to accomplish the isolation, with many different design elements and functions for the unique application. An alternative design is a pinch valve control, which allows fluid to flow through a soft tube while the valve controls the medium by “pinching” the tube. In this case, purity of the medium is ensured.

www.medicaldesignandoutsourcing.com

Image courtesy of Emerson

Gas and liquid valves can improve medtech performance and efficiency: Here's how

2020

COMPONENTS

Solenoid and other miniature valves offer medical device designers several technical advantages, including the following: Portability One of the leading reasons solenoid valves and other miniature fluidic components have long been used in medical devices is that they combine lightweight construction with a simple, compact design to enhance medical device portability. Newer solenoid valve technology provides manufacturers with the ability to custom-configure standard solenoid valve components to fit more readily into tight device configurations, reducing weight without sacrificing function.

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Scalability The compact, simple design of many solenoid valves makes them especially useful for manufacturers who are developing pilot projects and need the ability to scale the production run of the end product up or down. Solenoid valves can be easily integrated into manifolds and other electropneumatic control subassemblies whose production can be cost-effectively scaled. Electronics integration Medical device manufacturers can benefit from the integration of microelectronics during valve manufacturing to help make their devices more intelligent while also enabling them to use a variety of digital communications protocols, such as Ethernet/IP or Profinet. Miniature electronic proportional valves combined with the proper electronic controls and feedback can control pressure, flow and other variables in a medical device. These closed-loop systems enable the engineer to design complex system controls while still relying on the valve manufacturer to deliver a robust, affordable package. 12

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Power management Solenoid valves are electrically powered, leading to two important design considerations: power consumption and heat control. Newer solenoid valves are typically available in a broad range of power proﬁles. If a 3.3-volt coil is the best ﬁt for a particular valve, it is usually available as a standard variation. This means designers can better match the solenoid valve to the power capacity of the medical device, which can help extend battery life on portable devices and can also help control the heat generated within the medical device.

3/13/2020 1:33:33 PM

Medical Design & Outsourcing

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Smart technology The healthcare industry’s use of digital information from medical devices to help track and assess patient therapy outcomes continues to expand. Digital technology that is now incorporated into solenoid valves can help document how the operation of medical devices contributes to these outcomes. This information can become part of the digital record of a patient’s treatment, ultimately helping to ensure medical devices are properly providing the targeted therapy. Medical device designers can take advantage of these capabilities and use them to provide a competitive edge in their systems’ performance. Custom design support Many suppliers of miniature gas and liquid control valves have standard product portfolios. However, medtech manufacturers with unique design challenges such as portability, energy-

efficiency, scalability and use of digital data may benefit from working with suppliers who develop customized solenoid valve configurations. Such suppliers should have engineering resources available to quickly adapt standard products to custom configurations, familiarity with integrating electronics into miniature control solutions and experience with integrating solenoid valves into complete subassemblies. Paul Gant is director of business development, Analytical & Medical, for Emerson Automation Solutions. He previously served as director of global life sciences for Aventics and worked in sales management for Clippard for 19 years.

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Medical Design & Outsourcing

2020

COMPONENTS

How to select the best power supply for your stepper or servo motor application Stepper, servo, and DC Brush motors have unique power supply requirements. Here’s an analysis of the three primary power supply architectures and their pros and cons. Abe Amirana Te k n i c

f you need a DC power supply for your stepper or servo motor application, you have three types to choose from:

• Unregulated, “bulk linear” supplies. • Regulated, PWM switching-mode power supplies (SMPS or “PWM switchers”). • Hybrid, regulated “resonant mode” supplies. Motion control has many uses in medtech, including in blood analyzers, imaging, sample handling robots, highresolution microscopes, centrifuges and medical pumps. Motion control applications have two requirements that are particularly unique: a peak power demand that is typically very high relative to the average demand; and motors that often act as a generator, rather than as a load, pumping current into the power supply rather than drawing from it. (We’ll call this generator effect “regen,” short for regenerated energy.) Bulk linear supplies basically boil down to three components: a transformer, rectifier and large filter capacitor. They are fairly well-suited for motion applications but are big and heavy. Additionally, because they’re unregulated, their output voltage can drop significantly during high peak power demand. Regulated-switching power supplies are the most widely available of the three types and can have a low cost per watt of average power. But you need to put in extra work and money to ensure they can deal with the high peak power demand and regen

associated with motion applications. Hybrid, “resonant-mode” supplies — or resonant discontinuous forward-converter (RDFC) supplies — are newcomers to the motion control world but are better suited for the unique demands of motion control applications. Considerations for a servo or stepper DC power supply It’s important to consider the unique demands of a motion control application when selecting a power supply. During accelerations, motor drives can quickly draw large amounts of power. Motors can also act as generators, pushing current back into the power supply during deceleration, which means the power supply needs to handle the resulting increase in voltage. Highly dynamic motion applications — with large inertial loads, fast accelerations/decelerations and high peak velocities — place large and rapid demands for current on the power supply. Non-motion control factors Choosing the best power supply involves many other considerations that are not speciﬁcally related to motion control. Some of these considerations are especially important to OEM machine designers looking to minimize the cost of their product and provide reliable operation over a wide variety of operating conditions. Image courtesy of Teknic Servo Systems

Medical Design & Outsourcing

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COMPONENTS

The table below lists the main factors to consider when selecting a power supply.

Peak power Average (RMS) power (aka, continuous power)

The maximum output power for a short period (typically a few seconds). The output power that the supply can provide on average (root mean squared average, or RMS) over a long period of time. If the output power demand is constant, this could also be called the continuous power output — the power that could be supplied indefinitely. The average power is typically limited by thermal considerations.

Load regulation

The stiffness and stability of the nominal output voltage as the load current changes.

Line regulation

The stiffness and stability of the DC output voltage as the AC line voltage changes.

Physical volume

The x-y-z dimensions that make up the power supply volume, including required space for connectors, cables and ventilation spacing.

Weight Cost: ($/watt-peak) ($/watt-continuous) Regen control Additional features

In-rush current limiting Protection features

The total weight of the power supply, which drives packaging and shipping costs and can also affect mounting locations. The total cost divided by both the peak and continuous output power specifications. The power supply’s ability to handle returned energy from decelerating or gravitational loads. The range of special features for diagnostics, safety (e.g. LEDs with informative blink codes, rapid discharge of stored energy, etc.) The built-in circuitry to limit the instantaneous current draw when AC power is initially applied to the supply. In-rush limiting helps avoid nuisance trips of the AC supply circuit breaker. Short circuit protection, thermal overload protection, reverse polarity protection, etc.

Table courtesy of Teknic Servo Systems

This article is a brief introduction to the unique advantages of hybrid power supplies for driving stepper and servo applications. For all of the technical details, including performance graphs, carefully annotated speciﬁcations as well as real pricing comparisons, see our Selecting the Best Power Supply blog at www.teknic. com/selecting-power-supply. Abe Amirana has been with Teknic Servo Systems for over 24 years in various roles, including sales and applications engineering, technical marketing and general management.

Medical Design & Outsourcing

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Mini factories in containers help reduce mask shortages Decentralized systems from Mikron are helping to ensure supply in times of a pandemic. Festo is a key development partner. Mike Santora Fluid Power World

manufacturing system from Swiss company Mikron can produce 50 to 100 face masks per minute, depending on the version. With engineering support from Festo, Mikron developed this system in just six weeks. Mini factories in containers Mikron’s system fits in a 20-foot shipping container, which can double as a cleanroom. The factory-in-a-box could be located in front of a hospital, next to a shopping center or near a school. The integrated air-conditioning system with air purification filters makes production possible even in places with a high risk of viral contamination. With adequate raw materials, the system can operate autonomously for more than two hours.

Mikron’s system for producing 50-100 face masks a minute fits in a 20-foot shipping container. Image courtesy of Mikron

“This reduces the number of people required to operate the system, and as a result, lowers the risk of infection,” explained Nils Rödel, general manager of Mikron Berlin. “The mini factory can produce protective masks in remote areas or even in crisis zones where meeting hygiene standards is most challenging.” One system could produce 2 million masks each month. The masks are based on meltblown, non-woven fabric that consists of many layers of fine fibers to filter out particles such as bacteria and viruses from the air.

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“Using official statistics, we calculated that medical personnel in Germany alone need at least 50 million disposable protective mouth-nose masks per month,” Rödel said. “We could meet this demand with 25 containers.” Eliminating the need for transport makes the end product less costly. Depending on how it is configured, the system can make packs of 10 masks or individual ones, shrink-wrapped for cleanliness, and packaged in printed bags and boxes if required. “Packaging masks involves docking an automated station developed by pi4 robotics GmbH, Berlin, a project partner,” Rödel said. Reliable supply of system components Electric and pneumatic components from Festo enable transport, clamping, unwinding, shaping and folding of the non-woven fabric. An ultrasonic sealing station seals the edges. The servo drives CMMT from Festo for controlling the electric drives. EMMT are used in the application, because they can be easily connected to PLCs from major manufacturers, including Beckhoff, Siemens and Rockwell. The pneumatic components from the Festo core product range installed in the system, such as the compact cylinder ADN, the guided drive DFM and the round cylinder DSNU, are in stock worldwide and available for shipment within 24 hours. Global availability enables quick and reliable manufacture of systems for producing masks within a condensed timeframe. The pneumatic drives are actuated by MPA valves. The safety valve MS6-SV-E ensures that safety-critical system components are exhausted and de-energized as quickly as possible in the event of a sudden emergency stop. Independent, decentralized and virtual “Travel restrictions make it extremely difficult for commissioning technicians to go where the systems are to be built,” Rödel said. “Mikron came up with a digitized solution. We use Microsoft HoloLens, which enables commissioning to be done virtually using an interactive 3D projection.”

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Medical Design & Outsourcing 17

2020

COMPONENTS

Which type of motor is better for disposable surgical power tools? Motor technology is often a critical choice for design engineers working on disposable surgical tools — speciﬁcally the selection of either a brush DC or brushless DC motor. Clémence Muron Portescap

urgical power tool designers must choose whether to take a disposable or reusable design approach. Design and manufacturing improvements in both brush DC and brushless DC (BLDC) motors have reduced prices while increasing performance, making it possible to achieve a sufﬁciently low per-surgery tool cost with a disposable design.

Fully Integrated, Custom Fluid-Handling for In-Vitro Diagnostics

Motor performance requirements for single-use tools While motor performance requirements are similar for reusable and disposable surgical tools, the lifetime and cost requirements are vastly different. A motor speciﬁed for a reusable tool may have a lifetime requirement of hundreds or even thousands of surgeries and thus must use premium components and materials. A motor for a disposable tool needs to provide similar performance and often must be available in high volumes and at a competitive price. When specifying motors for disposable tools, design engineers should consider the possible advantages of conventional brush DC motors over the more advanced BLDC technology. The reliability advantages of BLDC do unfortunately increase costs, often making them unfeasible to specify for a disposable tool. Designers should work with a motor supplier well-versed in both technologies to identify the performance and cost trade-offs.

Creating optimized fluid-handling systems for in-vitro diagnostic instruments requires specific expertise. You need a system that delivers the right performance, does not involve a lengthy design process and can be easily assembled. At Emerson, we know what you’re up against. We will create a customized fluid-handling solution that meets your most challenging needs — all in a matter of days. Learn more at: Emerson.com/medicaldiagnostics or email Medical@Emerson.com

Brush DC vs. brushless DC motors If the goal of a new project is to maximize performance and reliability, a design engineer is likely to gravitate to BLDC technology. Brushless technology makes it possible to operate at high speeds (up to 100k RPM) over a long operating life. In BLDC, commutation is achieved without the use of mechanical brushes (e.g., via magnetic Hall sensors or a sensorless drive with a brushless motor controller) so the contact between the motor’s rotating and stationary components is limited to the ball bearings. This means the lifetime of the motor is primarily related to the longevity of the bearing, and the motor can operate at high

Medical Design & Outsourcing

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speed for an extended period. In a brush DC motor, commutation is achieved through mechanical brushes made of graphite or precious metal, making physical contact with the rotor to complete the electrical connection. The lifetime of the motor is primarily limited to the lifetime of the brushes, with higher speeds leading to premature wear. For a disposable tool, the higher speed may not be an issue given the short lifetime requirement. However, this will depend heavily on the duty cycle and speed requirements of the application. The design and materials used for a brush DC motor will also affect performance. Most lower-cost brush motors have an iron core, while a coreless motor’s rotor is only composed of a coil and a single shaft. The coreless design offers lower inertia, resulting in better acceleration and efficiency. It also eliminates detent torque (cogging torque), which can reduce rotation smoothness at slower speeds.

For reusable surgical tools, the lifetime and speed requirements often make BLDC the ideal solution. However, for some applications using a single-use design, a brush DC motor can provide an attractive solution.

A coreless brush DC motor Image courtesy of Portescap

Clémence Muron is an applications engineer for Portescap, a supplier of motor technology to surgical OEMs.

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COMPONENTS

How high-frequency interconnections affect microwave ablation systems Microwave ablation systems provide nonsurgical methods for treating internal cancers and tumors. This application requires the right cable assemblies to achieve optimum performance.

Radiofrequency ablation (RFA) and microwave ablation (MWA) respectively use electrical and microwave energy to heat precise areas and destroy abnormal cells.

Image courtesy of Times Microwave Systems.

Carrie Obedzinski Times Microwave Systems

Medical Design & Outsourcing

adiofrequency (RF) and microwave energy carry many modern messages as part of broadcast and wireless communications but are also potentially life-saving medical tools. Within ablation systems, radiofrequency and microwave energy can penetrate a patient’s body to heat and destroy tumors, avoiding invasive surgical procedures and long recuperation times. These systems feature advanced software and artiﬁcial intelligence (AI) methods to treat tumors with minimal damage to surrounding tissues, but they still depend on many different types of RF/microwave components. This includes coaxial cable assemblies and ofteninvasive antennas formed of coaxial cables. The performance of these cables is crucial because a life may depend on it.

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How they work Radiofrequency and microwave ablation systems use tiny antennas or probes projected onto a patient’s body to focus electromagnetic (EM) energy on tissues to be treated. To reach malignant tissue with adequate EM energy, small-diameter coaxial cables are used to form ﬁnely polished antennas or probes and to transfer the EM energy from a source to the antenna. Those cables should provide performance levels that help RF and microwave ablation systems destroy the targeted malignant tissues. Shielded coaxial cables with low loss at the target frequency are typically used to preserve as much of the high-frequency source energy as possible; high loss in these interconnection cables will result in RF/microwave energy lost through heating the cables rather than heating the tumor.

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How they differ The smaller wavelengths and higher frequencies of microwave ablation systems allow deeper heating penetration and wider area heating coverage than radiofrequency ablation. Ablation systems typically operate in the ISM (industrial, scientific, medical) bands at frequencies of 915 MHz, 2.45 GHz and 5.80 GHz and at power levels of 50 W (+47 dBm) or more. That EM energy is coupled to the antenna or probe by means of a low-loss coaxial cable assembly. Higher, millimeter-wave frequencies (through 60 and 70 GHz) have been used in ablation systems for special treatment, although the difficulty of generating EM power at these higher frequencies makes the component selection for those microwave ablation systems even more critical. That is, the energy loss of a coaxial cable increases with increasing frequency. Cable considerations The coaxial cables used in ablation systems and other high-frequency medical electronic systems are typically flexible cables capable of wide-band frequency coverage. They should be specified carefully according to parameters that can affect RF and microwave ablation system performance. Those parameters include loss/attenuation, phase stability, shielding, passive intermodulation (PIM) and velocity of propagation (VP). Cable loss or attenuation is a function of its dielectric and conductive materials, diameter, length and the operating frequency. Loss increases with frequency and excessive loss can cause the temperatures of the cable and ablation antenna to rise, resulting in unwanted heating of tissues along the signal path to the antenna. In some cases, it may require some form of cooling to offset the cable temperature rise caused by handling too much power with too much loss/attenuation. Cable loss is typically characterized in dB/ft. It decreases with larger cable diameters, although they are less likely to reach a patient’s malignant tissue area. Phase must be extremely stable along the EM power path in an RF or microwave ablation system to maintain a tightly focused energy beam on a malignant tissue. Multiple cables are used in phased arrays to create focused energy on the tumor. Phase deviations can occur with cable flexure and with temperature changes, which are usually measured and compared from cable to cable in terms of ppm/°C. Phase can also vary with impedance mismatches from a nominal 50 Ω, which are measured by variations in voltage standing wave ratio (VSWR) with frequency. Other performance parameters include the effects of propagation delays and velocity of propagation through the cables, passive intermodulation and its impact on signal integrity, and shielding effectiveness, which describes how well a cable assembly is isolated from surrounding electrical devices and energy sources. Shielding effectiveness is key because high energy levels could interfere with other systems using the same frequencies, such as WiFi. RF and microwave ablation systems make huge differences in the health and lives of many patients. Coaxial cable assemblies are among the high-frequency components that make RFA and MWA systems possible. When they perform properly, they can be lifesavers. Carrie Obedzinski is business development manager for Times Microwave Systems. She has more than 20 years’ experience in sales and product management, focusing mainly on interconnect solutions and management.

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Medical Design & Outsourcing 21

2020

DRUG DELIVERY

Vaxxas’ patch comes in a hockey-puck-shaped applicator with a foil seal. Image courtesy of Vaxxas

Could Vaxxas' tiny patches enable a better COVID-19 vaccine?

Vaxxas’ HD-MAP includes a 9-by-9 mm array of thousands of very short projections around 250 microns in length.

Tiny vaccine delivery patches could solve logistical challenges, but they face manufacturing hurdles. Here’s how Vaxxas is trying to overcome them.

Image courtesy of Vaxxas

Chris Newmarker Executive Editor

erck and Vaxxas announced earlier this year that the pharmaceutical giant was using Vaxxas’ high-density microarray patch (HD-MAP) as a delivery platform for a vaccine candidate. Vaxxas did not disclose what type of vaccine the patches might deliver and Merck declined to reveal it. But Merck is very much in the race to create a vaccine to protect against the virus that causes COVID-19. Meanwhile, German manufacturing equipment maker Harro Höfliger has agreed to help Vaxxas (Cambridge, Mass.; Sydney, Australia) develop a high-throughput, aseptic manufacturing line to make vaccine products based on Vaxxas’ HD-MAP technology. Initial efforts will focus on having a pilot line operating in 2021 to support late-stage clinical studies with a goal of single, aseptic-based line able to churn out 5 million vaccine products a week. Based on technology originally developed at the University of Queensland, Vaxxas’ HD-MAP includes a 9-by-9 mm array of thousands of projections around 250 microns in length. Invisible to the naked eye and coated with vaccine, the projections are designed to quickly deliver vaccine to immune cells. Vaxxas officials claim the technology can deliver vaccine more efficiently than a needle and syringe. The patch, which comes in a hockey-puckshaped applicator with a foil seal, is anchored on a serpentine ring with a powerful dome spring behind.

Medical Design & Outsourcing

9 • 2020

MDO’s sister site Drug Delivery Business News recently interviewed Vaxxas CEO David Hoey about the patch technology and how it could improve vaccine delivery. DDB: What kinds of challenges did you have to overcome to make the HD-MAP technology a reality? Hoey: Microneedles have been around for maybe 2 decades, but there are no products on the market. That’s a big question. The challenge from microneedle patches has not been so much that the immunological results haven’t been compelling, because there are hundreds of papers out of all sorts of institutions and companies that show that if you can deliver a vaccine effectively into the skin, you can get a much better immunological result. Where it gets tricky is if you take it away from being a science experiment and you have to start to impose sterile manufacturing requirements that you need for clinic. And how do you actually manufacture these things at an industrially relevant scale? So that ends up being the most challenging part of the entire equation. We’ve focused very, very heavily since inception on making sure that every one of the individual components that make up the device is manufacturable by technologies that are industrially scalable, and then they can come together in a system that will enable sterile production at a relevant scale.

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2020

DRUG DELIVERY

DDB: How is Harro Höﬂiger helping with manufacturing? Hoey: The work that we do is focused on making these device components and the design. The work that Harro is doing is how we get sort of the high-speed robotic handling of the individual components as they make their way through the aseptic line. We have to do a 100% QC [quality control] of integrity. So the patch has to be visually inspected to make sure that those thousands of projections are intact. We then have to dose vaccine onto the patch with the printing technology. And we then have to verify that the vaccine was printed onto the tips of the projections, not the base. So we have a whole series of QCs that are associated with any sort of medical product. The trick is, ‘How do you do that at line speed?’ And line speed for us is about 600 patches per minute. A production line could do about 5 million a week. So all of those steps you’re doing, you have to be able to do them in a fraction of a second. That’s the work with Harro. We’ve built a proof of concept line in Germany that shows that we can do the handling at that speed. We’re now bringing that proof of concept line into our labs. It’s the ﬁrst step toward the pilot line.

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DDB: What kinds of advantages could HD-MAP have as a vaccine delivery method amid a pandemic? Hoey: There are elements of the patch that make it ideally suited to build onto the greatness that is a vaccine. In the influenza vaccine study that we published a few months ago, we showed that going down to one-sixth of a dose of the vaccine on the patch produced the same result as full dose by needle and syringe. And so in a pandemic context, you can produce many more doses of the vaccine more quickly from the limited vaccine stocks. Once the vaccine is printed on the patches, it’s in a dry format, and the flu vaccine was stable for 12 months at 40 °C (104 °F) and we only went out to 12 months. You can have a device that essentially could make many more doses more quickly in a pandemic response. You’re able to use logistics like U.S. Postal, FedEx or UPS to distribute to homes where people could do self-administration. Self-administration is something that we were actually interested in examining — pandemic aside — in our next flu study.

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Medical Design & Outsourcing

9 • 2020

2020

MANUFACTURING, MACHINING & MOLDING

Bosch Rexroth’s ActiveMover is a ﬂexible transfer system based on linear motors, designed to increase productivity for small batch sizes with quick and precise positioning of workpiece pallets. Image courtesy of Bosch Rexroth

How to move manufacturing into the future

“Factory of the future” systems can enable expanded and more versatile automation solutions, allowing device manufacturers to build their process steps, speed and cycles around the system’s capabilities. Bryant Boyd Bosch Rexroth

edical device manufacturing processes tend to be highly regulated, requiring extensive documentation and rigorous quality control. They also need precise control, high levels of automated tracking and assembly processes that are as error-free as possible. Some medtech manufacturers are investing in new technologies such as material transport systems that can enable new kinds of automation to improve productivity and provide greater ﬂexibility. These new transport technologies may help medical device manufacturers evolve their operations to take advantage of the capabilities offered by the “factory of the future.” What is it? The factory of the future is an intelligent and agile vision for manufacturing that is rapidly being adopted across multiple industries. Also referred to as Industry 4.0 or i4.0, the factory of the future uses digitized and fully networked production systems to give plant operations and management real-time, in-depth information to maximize the value and

Medical Design & Outsourcing

9 • 2020

performance of every machine and production unit. Software collects, transfers and processes data to provide production transparency and answers to questions about production bottlenecks, inefficient workflows and equipment in need of preventive maintenance. Capabilities of current transport systems Standard conveyor systems typically include twinstrand conveyors or plastic chain conveyors, which can transport loads of 10 kg or less, satisfying the requirements for a broad range of medical device and medical kit production operations. Typical transport speeds are 10 to 12 meters per second, with diverters offloading products or components at workstations or assembly systems. While sufficient for some operations, these conveyors can limit companies that want Industry 4.0 capabilities. Most conveyors are powered by AC motors turning at a constant speed and moving in one direction. Products transported in totes or on pallets are delivered to set points along the length of the conveyor through mechanical or pneumatic stops or diverters.

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2020

MANUFACTURING, MACHINING & MOLDING

Tracking the products on the system often involves attaching RFID tags, either directly to the product or to a tote, which sometimes contains multiple items. Regulators may require medtech manufacturers to track and document how every component in every device was handled, integrated, and tested throughout production. Throughput with these standard conveyors is determined by the conveyor’s upper limit. If new products require adding an assembly station or an automated seal insertion machine, modifying the conveyor layout can require downtime and engineering costs. Advantages of Industry 4.0 transport systems New, i4.0-ready material transport systems are engineered to provide more flexibility and automation. They also support much faster throughput, more efficient use of floor space and easy tracking, and can communicate that

data to plant management systems for documentation and analysis. Systems that use linear motors to boost transport speeds and add precise stop points use a revolving linear motor with vertically mounted workpiece pallets. Each pallet’s motion can be individually defined, with repeatable, individual stopping points of 0.01 mm. The integrated measuring system allows for precise indexing of pallets, eliminating the need for additional lift-and-locate units. Stop positions can be configured in software anywhere around the system, even in curves, to increase process quality, productivity and efficiency. The system can also support transport speeds up to 150 meters per minute — significantly faster than many standard conveyors. Since each pallet is independently programmable, its position can be accurately tracked and documented. Changeovers from one product to another with changes to station stops are much faster and simpler.

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Some medtech manufacturers are investing in new technologies such as material transport systems that can enable new kinds of automation to improve productivity and provide greater flexibility.

Some of these systems have replaced multiple conveyors with a single linear transport system and saved nearly 40% of the plant’s floor space. They usually support interfaces for many high-speed automation busses, such as ProfiNet, Ethernet IP and EtherCAT. These interfaces allow easier integration with a manufacturer’s existing machine communications backbone, as well as connecting to edge-computing devices such as Internet of Things (IoT) gateways that can collect and integrate data from across the factory floor. Consider your factory transport options This new generation of material transport systems can become the foundation for expanded and more versatile automation solutions, enabling device manufacturers to build their process steps, speed and cycles around the system’s capabilities. One way to ensure success is to work with knowledgeable suppliers whose technology is fully aligned with factory of the future concepts. This includes understanding lean processes and principles and how to use technology within a lean operation to maximize the outcomes of continuous improvement processes. Bryant Boyd is a product engineer and senior electrical engineer with Bosch Rexroth. He studied electrical engineering at the University of North Carolina at Charlotte and has spent more than 5 years with Bosch Rexroth covering product management for assembly technology and linear motion technology products.

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Bending / Coiling - Eagle craftsmen working with state-of-the-art machinery supply uniformly smooth bends, meeting the tightest customer specifications. CNC Machining Centers - enable machining some of the most intricate parts imaginable. Working in diameters from .030” to 2”, we’re ready to meet your most demanding requirements.

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Medical Design & Outsourcing 29

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2020

MANUFACTURING, MACHINING & MOLDING

3 things you need to scale up when outsourcing COVID-19 test production Testing is one of the key eﬀorts to control COVID-19, and U.S. diagnostic test production capabilities are in demand. To respond to the pandemic with urgency, test developers need a highly ﬂexible, scalable supply chain that can move quickly, control costs and manage quality. Claudio Hanna and Jennifer Ponti Web Industries

f COVID-19 has taught us one thing, it is to expect the unexpected. Original equipment manufacturers (OEMs) must be ready to produce enough diagnostic tests amid uncertainty about how the virus may evolve. Outsourcing production to a contract manufacturing organization (CMO) can save an OEM time and money, giving device developers the flexibility to ramp up their test volume without taking on the long-term overhead of a greenfield factory or plant acquisition. When choosing a CMO, it’s important to consider a prospective partner’s current capacity, medical device experience (including work with specific technologies) and ability to expand its manufacturing footprint. Several core competencies influence a CMO’s readiness to scale, whether it is taking a new COVID-19 test concept from the laboratory bench to commercial production or duplicating an entire manufacturing plant. Here are three things a CMO must have to scale up manufacturing for one type of COVID-19 diagnostic device, the lateral flow immunoassay (LFI) antigen test.

Medical Design & Outsourcing

9 • 2020

Well-established technology transfer protocols Technology transfer entails a carefully controlled, stage-gated transition of a device from the developer’s blueprint to mass-scale production. This should involve documentation of the inputs and processes used to make prototypes or initial batches of the test. It also should include thorough documentation and discussion of the CMO’s plans for mass-producing the device, including how quality and performance will be validated. Expect the CMO to conduct a raw material assessment to ensure all materials are available in the quantity and format needed for high-speed commercial production.

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Expertise with robotics and automation Automation enables CMOs to increase throughput and meet high-volume requirements while ensuring products meet tight quality tolerances. For example, using continuous processes versus manual methods allows a contractor to reduce operator errors and decrease material scrap rates. Automated process control is critical at multiple points. Is the CMO using cameras, sensors, checkweighers and other inspection devices to remove subjectivity from visual inspections of finished LFI devices and decreasing risk for defects? Multifaceted capabilities and existing systems The more capabilities a CMO has under one roof, the more seamless and efficient it will be at scaling up COVID-19 test production. These should encompass all aspects of test device production, from incoming raw materials inspection to work-inprocess steps (chemistry preparation and deposition, etc.) to final device assembly and packaging. That’s not to say the CMO needs to make every single component and material in-house, but it should have the right systems, from quality control to the supply chain, in place from the start. A supply chain needed to produce a full COVID-19 test kit typically includes a variety of flexible materials, specialty chemicals, swabs, vials, plastic cassette housings and packaging. Similarly, the CMO should be able to produce a single component for a test or to format materials for use downstream by another contractor or the OEM. Systems must be primed and ready to accommodate diverse manufacturing needs and business models. As COVID-19 diagnostic test production continues, device developers and OEMs will be challenged to bring new products to market more rapidly than ever. CMO partnerships will play a key role in ensuring COVID-19 tests can be manufactured using reliable, repeatable and scalable processes. Diagnostic test developers and contract manufacturers can close the testing capacity gap. Claudio Hanna and Jennifer Ponti are business development managers for Web Industries’ medical division. Hanna has more than 20 years of experience in flexible goods, startup manufacturing and automation. Ponti’s professional background includes over 15 years of experience with lateral flow devices.

To efficiently mass produce COVID-19 diagnostic tests, a contract manufacturing organization (CMO) needs robotic assembly capabilities in a controlled clean room environment. Shown here is an automated production line for cutting test strips and inserting them into cartridges at Web Industries’ Lateral Flow Immunoassay (LFI) Center of Excellence in Holliston, Mass. Image courtesy of Web Industries

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Medical Design & Outsourcing 31

MEDICAL DEVICE CONTRACT MANUFACTURING

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emand for lightweight, disposable surgical devices has been increasing as hospitals see a distinct cost advantage for off-the-shelf, single-use products that don’t require sterilization. Disposable sterile devices can also help minimize risk of infection. CMOs and their original equipment manufacturer partners (OEMs) can work together to address changing market needs with innovative technology, and MIM can help manufacturers meet the increased demand. MIM doesn’t replace machining, but it offers distinct advantages for certain high-volume, high-precision projects where parts may be smaller and require more maneuverability along with strong mechanical properties. The MIM process MIM integrates the shaping capability of plastic injection molding and the materials ﬂexibility of conventional powder metallurgy to efﬁciently produce small, complex parts at high volumes, using high temperature and pressure. The process uses combinations of metal powder and plastic binders that are blended and compounded so

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Medical Design & Outsourcing

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2020

MANUFACTURING, MACHINING & MOLDING

that an injection-moldable feedstock can be produced to fabricate the green part. Using an injection molding machine, the parts produced are then subjected to a binder removal process. Depending upon the type of binder used, either thermal or solvent then thermal debinding is applied. After debinding, the parts go through a sintering process to ensure densification, alloying, optimal mechanical properties and correct geometry. Newly molded parts are the shape of the final part but larger. The sintering process allows controlled shrinkage, usually in the range of 15%, to achieve full density. The end result is a net shape part. Post-processing may be needed to arrive at the final part. MIM versus machining MIM and traditional machining each have advantages and disadvantages depending on each project scope and requirements. MIM allows

components to be produced in a single manufacturing process, but a mold is needed to make the green part. Machining and other technologies typically require lower tooling cost and shorter lead time but incur higher piece part prices due to processing times. MIM may have several advantages when considering the following: •

•

Volume — MIM is cost-effective when large volumes are needed and lends itself well to automation in which high volumes, tight tolerances and consistent quality are required. Machining is more cost-effective for lower production-volume runs. With MIM, the biggest cost is setup to create the mold, but the cost can quickly be recovered when amortized over high-volume runs. Material — MIM allows for a variety of materials and great ﬂexibility to customize material compositions to

•

meet speciﬁc attributes required by an OEM. Selecting the right materials and feedstock composition are critical factors for success. Some of the compositions are stainless steels, low-alloy steels, carbon steels, Ni-alloys, tool steels and tungsten alloys. The two most common in surgical instruments are 316 stainless steel and 17-4 precipitationhardened stainless steel. The choice is driven by the need for tempering, which is possible with 17-4 PH. 400 Series Stainless is used when hardness is the priority, but may lower resistance to corrosion and staining. MIM also produces less waste and scrap and requires smaller material inventories, which can help reduce costs. Properties — MIM is best suited for very small, high-performing precision products and parts with tight tolerances and consistent dimensions over high-volume runs. Components can achieve 95% to 98% of wrought material density at a much lower cost. Design complexity — MIM is ideal for producing complex-shaped components with complicated design geometry, eliminating the need for potentially high-priced machined components or welded assemblies. It also allows signiﬁcant design freedom that can be incorporated in one step.

Early collaboration An experienced CMO partner can help OEMs select materials, optimize designs and ensure uniform parts with dimensional repeatability. Collaboration early in the development cycle can ensure a component produced through metal injection molding meets the form-ﬁt-function requirements. Engineers with expertise in both MIM and machining processes can suggest design modiﬁcations and provide input to get the best performance out of a product no matter what technique is ultimately used. An experienced CMO partner can work with their OEM customers to factor in design considerations that can save time and costs. Steve Santoro is EVP of Micro, directing corporate technical and commercial teams. He previously held high-level operations, sales, engineering and general management positions, and is a charter board member of the School of Applied and Engineering Technology at the New Jersey Institute of Technology. 34

Medical Design & Outsourcing

9 • 2020

When does in-house prototyping make sense?

Image courtesy of Kaleidoscope Innovation

Medical device companies have increasingly outsourced prototyping over the past two decades. It doesn’t have to be that way.

D r. E l l i o t Fegelman Kaleidoscope Innovation

hether tinkering in the garage or at multispecialty design/build shops, product developers have traditionally built their own pieces and prototypes. As machining capabilities have gained sophistication and capabilities, however, this also became more expensive and consumed more floorspace. For example, a five-axis CNC machine requires expertise that a knee mill does not. With this increased specialization, many of the in-house “build” capabilities that were once the hallmark of product design have been outsourced to prototyping specialists. For those with the space and access to a workforce skilled in CAD and machining, however, an in-house rapid prototyping shop can still make sense. Here’s how: Turnaround time While the off-site prototype shops excel in rapid turnaround and shipping, there’s a greater efficiency created when engineers just need to walk down the hall to consult with a prototyping specialist, discuss the item and know it will go into the queue that afternoon. Consultation That visit to the specialist involves more than just handing over a CAD file. Using their skills in CAD and machining, the specialist can make suggestions to the design engineers on placing a radius, augmenting tooling efficiency and reducing touch. These www.medicaldesignandoutsourcing.com

prototyping recommendations can often be translated into the final manufacturing process to save valuable time in a complex schedule. Precision With the advent of 3D printing, designers and engineers have enjoyed rapid turnaround and true-toform pieces, but the tolerances or robustness of those pieces can be lacking. Machined parts made of true material make the integration between pieces more predictable and the tolerance for field stressors more robust. This method of prototyping also eliminates the oft-heard excuse of blaming 3D-printed parts for technical flaws that may or may not truly be mitigated by production-equivalent devices. Customer satisfaction The triple constraints of time, cost and quality are still alive and well, heightened by today’s speed of innovation. In-house prototyping shortens the iteration cycle, but more importantly, reduces the need for iterations. When the pieces fit and function the first time, the critical design improvements needed to enhance the product — not the prototype — are more easily identified, shortening the process. Business development For businesses that deliver value through innovative design and manufacturing processes, differentiation is critical. An in-house rapid prototype shop staffed by specialists, combined with 3D printing capabilities, offers clients an efficient and bespoke approach to meeting their needs. Some trends are best followed; many are best to lead. Sometimes it’s most impactful to buck the trend. Inhouse machining capabilities with multi-axis CNC lathes and mills, precision EDM wire machines along with the specialists to wield them, can add overall improvements in timelines, costs and customer satisfaction. Dr. Elliott Fegelman is a surgeon and chief medical officer and VP of medical affairs at Kaleidoscope Innovation, Cincinnati, where he offers clinical advice on medical product development and input on medical product risk assessments. Before joining Kaleidoscope in August 2019, he served as VP and therapeutic area expert at Johnson & Johnson Medical Device Companies, focusing on the Ethicon business. 9 • 2020

Medical Design & Outsourcing 35

2020

MANUFACTURING, MACHINING & MOLDING

Passing the test with vascular stents Pulsatile durability testing is a time-consuming part of the vascular stent approval process. Accelerated test designs can deliver a high throughput when every specimen counts. Pete Bailey Instron

Image courtesy of Instron

here are many quality controls applied to the design and release of coronary and other vascular stent devices, but a proof test of pulsatile durability, such as those laid out in ASTM F2477-19 (i.e. fatigue in diametral distension) is probably one of the most unavoidably time-consuming. This is a simple “test to success” methodology, but it ensures a clear benchmark result of pass/fail. The test must simulate the dilational loading of 10 years of service at 72 B.P.M., meaning that the device must survive 380 million cycles in saline or simulant fluid. To demonstrate statistical confidence that this is a guaranteed safe life, it is generally considered necessary to test a representative sample of 30 specimens, all of which must pass. Ways to speed the process There is a commercial imperative to accelerate this testing by higher frequency, so most workers aim to bring the test frequency up to at least 30Hz, as this reduces the test time to just under 5 months. With good quality equipment, it is often possible to increase that to as much as 50Hz, but higher frequencies tend to introduce unacceptable levels of uncertainty due to mechanical effects. The fact remains that this is still a huge number of machine-hours, so further gains in throughput are usually made by use of a carousel fixture to automatically test multiple specimens in parallel. This approach has been in use for over a decade, with jigs holding 6 or 12 specimens, but the state of the art now

offers carousels with 16 stations, each with individual adjustment, and fully synchronous individual measurements of force for all 16 specimens in parallel. This means that a full batch test can now be delivered reliably in under 5 months with 2 test machines. It is important to emphasize that over the last decade, the industry has widely adopted a more extensive “fatigue to failure” approach, such as that described in ASTM F3211. Especially in the early design phase, this means that a smaller sample size may be permissible, but also that a range of different loadings must be applied, such that some specimens will fail much sooner. This approach demands a much more thorough understanding of the structural loading distributions within the device and is expected to be combined with detailed finite element analysis models, effectively providing physical validation of the theoretical model. High standards apply An over-arching view of the expected body of testing and evaluation work is given in FDA Guidance Document 1545 Non-Clinical Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems (latest revision April 2010). Overall, there is a general expectation for the designer to demonstrate a rigorous understanding of both experimental and modelling data, from the component material response building up to the full device durability. High-quality test equipment and fixtures play a crucial role for competitive players in this industry, so it is important to understand your needs and develop a reliable laboratory set up. If you are entering the field or expanding your capability, make the most of your relationship with test equipment manufacturers. Pete Bailey is principal application specialist on fatigue and fracture testing at the Instron Division of ITW. He has a doctorate in materials science and a has worked on experimental methods in research and development for various fields, usually with a focus on durability and time-dependent phenomena.

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YOUR CUSTOM SOLUTIONS ARE CGI STANDARD PRODUCTS

Advanced Products for Medical Applications CGI Motion standard products are designed with customization in mind. Our team of experts will work with you on selecting the optimal base product and craft a unique solution to help differentiate your product or application. So when you think customization, think standard CGI assemblies. Connect with us today to explore what CGI Motion can do for you.

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MANUFACTURING, MACHINING & MOLDING

This osteoinductive material may eliminate negative effects related to current bone ďŹ llers, such as cements and bio-cements. Image courtesy of GE Additive

Diagnostic imaging plus additive manufacturing yields custom implants Combining diagnostic imaging technologies with the design freedom of additive manufacturing has opened up new opportunities in prosthetics, enabling custom patient devices and improving the eďŹ&#x20AC;ectiveness of diagnosis, planning, surgery and clinical outcomes. Leslie Langnau C o n s u l t i n g E d i t o r, Design World

urgeons mainly use custom implants when bone geometry is not within the dimensional range of standard implants, when there are special requirements due to disease, or simply when a tailor-made solution enables a better clinical result. For the successful use of custom prostheses, inter-professional cooperation and communication between the orthopedic surgeon and the implant designer are key. The implant designer may not be

familiar with anatomopathological, epidemiological, surgical or resection/reconstruction procedures, while the orthopedic surgeon may not have an in-depth understanding of the process of producing a physical additively manufactured model. Additive manufacture of custom prostheses Developing custom prostheses requires going through a series of steps.

The stages of making custom prostheses. Image courtesy of MT Ortho.

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From the outset, this process requires close cooperation between the surgeon responsible for the procedure and an implant manufacturer’s engineering team. The first step is a CT scan to make it possible to build a 3D model of the patient’s specific anatomical characteristics. The doctor and engineering team then discuss the intervention and identify access routes. Designers then determine the characteristics of the fixing systems, considering the resistance of the material. The surgeon reviews the prosthesis design for feasibility. Finally, the prosthesis is printed, often with a backup copy in case of unexpected events or problems. The prosthesis usually does not require any special post-treatment other than washing and final sterilization, which can take place at the source or in an autoclave at the destination hospital. Driving advances in cranioplasty Using its experience in distributing a range of medical-surgical devices and now in additive technologies, the Italian company MT Ortho is developing innovative solutions for orthopedic surgery, oncological orthopedics, neurosurgery and maxillofacial surgery. This includes a new line of custom cranioplasty prostheses now in use throughout Europe. The use of additive technology in cranioplasty makes the prosthetics process easier and more precise. In addition, the characteristics of the technology make it possible to achieve an optimal structure for osseointegration. The technology’s speed and precision make it is easier to carry out the so-called demolition/reconstruction operations of cranioplasty in a single step, according to the company. These interventions are based on a different surgical strategy that allows the most precise planning of the intervention, for which MT Ortho provides not only the prosthesis but also the cutting templates, following the precise mapping of the intervention area by a CT scan. In surgery, the removal of the area affected by disease and the insertion of the cranial prosthesis can take place during the same procedure, drastically reducing the post-operative hospitalization and recovery time and the risk of infection. This is particularly important for interventions in sensitive areas such as the ocular orbit or the cranio-maxillofacial region. 9 • 2020

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Custom solutions for bone cancer patients Until recently, only standard, conventionally manufactured prostheses, or in limited cases custom prostheses, were available for patients with bone tumors. When combined with digital image processing and artiﬁcial intelligence technologies, additive manufacturing can make it possible to prepare a 3D intervention plan for treating bone cancer through the fusion of several CT images. The design freedom offered by additive technology allows for the manufacture of custom prostheses that consider deformation and the need to adequately distribute loads. Using additive technologies, it is possible to perfectly reconstruct the bone anatomy of patients after demolition surgery to remove a tumor. Looking back and ahead MT Ortho had two decades of experience in the Italian clinical-hospital market for standard prostheses before it started to

embrace additive manufacturing in 2014. That year also marked a series of arrivals at the company — a recent graduate engineer, Simone Di Bella, who had specialized in additive manufacturing, and two GE Additive Arcam electron beam melting (EBM) machines. “Our goal was to become not only a distributor but also a manufacturer of medical devices,” DiBella said. “And our vision was to achieve this by creating new, innovative devices with unique features that were only possible by using additive manufacturing and were more compatible with the human bone than metals on the market at the time.” The team at MT Ortho initially focused on the production of custom prostheses for neurosurgical applications (custom cranioplasty) and oncological orthopedics (mega-prostheses reconstruction). At the same time, the company launched several projects to obtain the CE Mark for several neurosurgery devices.

Now MT Ortho is working to develop a kyphoplasty implant for the treatment of vertebral collapse. This device could make it possible to replace current bone ﬁllers, such as cements and biocements, with an osteoinductive material, eliminating negative effects related to the current technology in use, according to the company.

Our goal was to become not only a distributor but also a manufacturer of medical devices.

At OKAY Industries, we’ve built a culture of quality and continuous improvement that reigns over everything we do. Just ask Jim DeVecchis, Director of Manufacturing Engineering. Jim and his team make sure every component that leaves our facilities meets your exact design and performance specifications. Across our organization, quality means paying attention to the details – even details that are as thin as 0.006mm – like in this heart valve stent. Internally, we call our commitment to quality The OKAY Way. As our customer, you’ll call it peace of mind. What we manufacture is Part of Something Greater. Learn more about this project at okayind.com/king.

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Why having a skilled injection molding partner matters A holistic approach enables a molder to guide medical device manufacturers from prototype to production.

Justin Strike Tr e l l e b o r g Sealing Solutions

he road to full-scale production for a medical device can be arduous. The challenge becomes even greater when the device requires custommolded components. Collaborating with a molder experienced in medical device development can help device manufacturers navigate the process from concept to launch quicker, while avoiding common medtech manufacturing pitfalls. Experienced molders have expertise in details such as complex geometries, material selection, tight tolerances, applied stresses, scale-up and more. They will also consider the finished device, including all other components, to ensure the best fit, production quality, repeatability, ease of assembly and cost. The silicone-molded part is often just part of a device and the right molding partner should consider how other parts within the device integrate with the silicone part, address tolerance stack and potentially find more robust ways of making the device using advanced capabilities, such as 2K molding, overmolding and automated assembly. This holistic approach to the engineering of the component enables a molder to guide device manufacturers from prototype to production. Prototyping for successful manufacturing A prototype shop may be able to provide what a device manufacturer is looking for but might not consider opportunities to enhance the product or the ability to scale-up effectively. Creating a prototype without considering how it will translate to full-scale production can lead to increased costs, an extended time to production, and possibly the inability to ramp up to the multi-millionpiece volumes often required by the medical industry. An experienced molder will think beyond prototyping to the process that can enable large-scale production — designing tooling, locking in tolerance ranges and identifying potential flaws early in the process. A skilled injection molding partner can also reduce design complexities. www.medicaldesignandoutsourcing.com

Image courtesy of Trelleborg Sealing Solutions.

Liquid silicone rubber for custom injection molding Experienced molders can also recommend the optimal material for the application. Liquid silicone rubber (LSR) is highly viscous, fast-curing and biocompatible and offers easily altered durometers, varying textures, resistance to different types of sterilization, the inclusion of additives and more. Precise injection molding processes using LSR result in flash-free, waste-free parts that with consistency in product dimension, precision and quality. Silicone’s reliability, tensile strength and compression-resistance make it ideal for custom injection molded medical parts, especially those used in long-term implantable devices. Additives and silicone Because additives and fillers can alter the physical capabilities, appearance and performance of LSR, the proper balance must be determined. Additives such as different colors are mostly used to change the appearance of the final product to act as a visual aid and increase the ease of use. Radio-opaque fillers can also be added to ensure that the components are visible during surgery. When used with in-process X-ray, the surgeon can see exactly where the component is within the body. This 9 • 2020

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MANUFACTURING, MACHINING & MOLDING

is particularly useful to ensure proper device placement. Conductive ﬁllers, used to provide electrical connections within the molded form, are particularly important for some implantable devices, such as pacemakers. Experimentation with silicone additives — including active pharmaceutical ingredients (APIs) — continues to lead to innovations that improve device performance. Common applications include the addition of antibiotics to prevent infections, steroids to reduce inﬂammation surrounding implanted devices, and therapeutic drug doses that elute at a controlled rate over time in targeted applications within the body. By relying on the expertise of a molding partner, medical device manufacturers should expect the product to be designed for manufacturability. When approached correctly, this partnership can increase the performance of the product while reducing its time to market and the device manufacturer’s total cost of ownership. Justin Strike is product manager for Trelleborg Sealing Solutions. A mechanical engineer with a background in polymers and coatings, Strike has 20 years of experience in the industry.

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Metal injection molding can simplify the manufacture of complex parts The MIM process combines the design flexibility of plastic injection molding with the strength and integrity of wrought metals. Deepak Garg Indo-MIM

edical device manufacturers are designing and developing smarter, lighter and more intricate products, using and experimenting with hard-tomachine materials such as martensitic, austenitic, and precipitation-hardened stainless steel, titanium and nickel-free alloys. Instruments such as dissectors, conchotomes, knives, scalpels and spreaders for minimally invasive surgeries are becoming lighter and offer greater freedom of movement, but they are more complex.

Metal injection molding can offer innovative solutions, such as manufacturing a part with multiple materials, allowing for the development of the feedstock from material powders to achieve specific properties, having gradient porosity, etc. It is best suited for higher-volume production with hard-to-machine alloys for strength, wear and corrosion resistance. Extensive mold life enables the reproduction of hundreds of thousands of pieces while maintaining quality. It offers significant cost savings over the piece price, helps with reduction of parts count, and eliminates assembly time because complex or multiple features of a design can be incorporated in a single part. The MIM process is comprised of four unique processing steps: 1. Compounding The MIM process starts with feedstock preparation, also known as compounding. Ultrafine metal powders are blended with thermoplastic and wax binders in a precise amount. The blend is mixed and heated for binders to melt. The mass is cooled down and then granulated into free-flowing pellets (feedstock) for molding.

Image courtesy of Indo-MIM

2. Injection molding The pelletized feedstock is fed into an injection molding machine where it is heated and the binder melts before the feedstock injected into the mold cavity/cavities under high pressure. The molded part (“green part”) is allowed to cool and then ejected from the mold. The green part is approximately 20% larger than the final part, and precisely calculated to compensate for shrinkage that takes place during sintering.

Advantages of MIM Metal injection molding (MIM) meets the challenges of manufacturing complex medical device parts. Netshaping MIM technology has the distinctive ability to produce highly complex components with intricate surface details and custom textures. With the MIM process, parts can be manufactured using an array of off-the-shelf materials, including casehardened and tempered steel, tool steel, stainless steel, magnetic materials, tungsten and titanium alloys for strength, wear and corrosion application. www.medicaldesignandoutsourcing.com

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MANUFACTURING, MACHINING & MOLDING

3. Debinding During debinding or binder removal, solvent extraction removes most of the binder. The part (now termed a “brown part”) is now semi-porous, which allows the remaining binder to easily escape during sintering. 4. Sintering The parts are loaded into an atmospherically controlled sintering furnace which slowly heats them to drive out the remaining binders. Once the binders are evaporated, the metal part is heated to a higher temperature and

Material

the metal particles fuse. The part shrinks isotropically to its designed dimensions and transforms into a dense solid. The sintered part achieves >= 97% density of the wrought material. Based on the customer requirements, certain operations such as coining, machining, heat treatment, surface ﬁnishing, plating and coating may be applied to the sintered part. MIM molds can last up to 500,000 shots to produce parts with highly repeatable dimensional accuracy. It offers significant cost savings compared with traditional manufacturing

processes and can eliminate assembly processes because MIM can replace an assembly of parts with one single component. Deepak Garg is a senior manager of business development with IndoMIM. He holds master’s degrees in Engineering Technology and Business Administration and has more than 20 years of experience in mechanical components manufacturing, fastening and installation, materials, surface treatment and metal/ceramic injection molding.

Properties

Applications Minimally invasive surgery (MIS) Instruments: Laparoscopic and endoscopic jaws, graspers, scissors

MIM SS 17-4 PH - Precipitationhardened stainless steel

Heat-treatable, moderate strength, corrosion resistant

General surgical instruments: Scalpel handles, nippers, forceps and instrument mechanism parts, knives, cutting tools Orthopedic surgery tools (power & hand type): Mechanism part, bone drills Open-heart surgery instruments: Stabilizers, positioners and various other parts

MIM SS 316 - Austenitic stainless steel

High corrosion resistance, good ductility

Orthopedic & dental parts: Orthodontic brackets, dental instruments & implants Hearing aid parts: Metal hook, tube element and various other parts General surgical instruments: Scalpel handles and instrument mechanism parts

MIM SS 420 - Martensitic stainless steel

MIM Ti-6AI-4V Grade 5

Heat-treatable, high strength, low corrosion resistance

Lightweight, high strength, corrosion resistant, and bio compatible

Minimally invasive surgery (MIS) instruments: Laparoscopic and endoscopic jaws, graspers, scissors General surgical instruments: Scalpel handles and instrument mechanism parts General and micro surgical Instruments: Instrument mechanism parts Implants Hearing aid parts General surgical Instruments: Instrument mechanism parts

MIM CP-Ti Grade 2

Lightweight, moderate strength, high corrosion resistance and biocompatibility

MIM F75 Co-Cr-Mo alloy

Moderate strength, high corrosion resistance, and bio compatibility

Implants

MIM 80Ni-15Fe-5Mo

Good soft magnetic properties, moderate corrosion resistance

Hearing aid parts

Different materials are more suitable for some MIM applications than others. Graphic courtesy of Indo-MIM

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Precision Flow Control Designing efficient systems involves much more than simply understanding a few basic principles. There is a true art to balancing the specific requirements of an application in order to achieve the desired goals in the best possible way. Help us understand the unique needs of your application and together, we’ll develop something that surpasses what any of us could have done alone. Contact your distributor to learn more, or visit clippard.com to request a free catalog and capabilities brochure.

• • • •

Electronic Valves Proportional Valves Isolation Valves Precision Regulators

• • • •

Toggle & Stem Valves Needle Valves Electronic Pressure Controllers Pneumatic Assemblies

• • • •

Special Manifold Designs Pneumatic Circuit Design Cylinders Fittings, Hose & Tubing

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2020

MATERIALS

This rubber thermoset works well in fluid control components

Synthetic polyisoprene has become an important polymer for medical ﬂuid control components. Image courtesy of Vernay Laboratories

Bob Ferguson Ve r n a y Laboratories

atural polyisoprene (NR) and synthetic polyisoprene (IR) are rubber thermoset materials with useful properties for medical ﬂuid control components and device assemblies. These material properties include extremely high elongation, high tensile strength and tear resistance. They also exhibit excellent resilience, or the ability to quickly return or recover to the original shape after deformation.

Graph courtesy of Vernay Industries

What IR is good for Such properties make IR ideal for medical applications requiring the prevention of ﬂuid leakage around surgical instruments, ﬂuid control valves re-sealing against a seat or

E ff E E

Storage modulus Loss modulus f 2

ff 2

(E ) +(E )

interface, and pressure-regulating membranes. Speciﬁc uses include: • •

Catheter valves and seals. Laparoscopic introducer valves (trocars, sheath seals). Diagnostic slit septum valves. Ventilator ﬂapper disc valves. Guidewire seals. Non-return pressure-regulating diaphragms. Needless injection site valves.

• • • • •

All of these applications combine dynamic and static sealing requirements. Resilience is a good example, as it is a dynamic material characteristic.

Complex modulus

tan δ =

Medical Design & Outsourcing

E f E

Mechanical damping

δ f

E 9 • 2020

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PIONEERING INNOVATION

In process and product technologies That’s what differentiates Freudenberg from the other CMO’s. We invest annually in R&D to deliver innovations like conductive silicone, inline ID measurement for silicone extrusion, twisted lumen technology, and turnkey product solutions that simplify your supply chain and get products to market faster. Learn more about Innovation at Freudenberg. freudenbergmedical.com/innovatio n

Delivery Systems • Catheters • Hypotubes • Needles Extrusion • Molding • Assembly • Coating

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MATERIALS

A dynamic mechanical analyzer can quantify dynamic properties and enable comparisons of different rubber recipes in efforts to increase characteristics of resilience. For example, using the DMA allows chemists to quantify the dynamic complex modulus, the storage modulus and the loss modulus. Years of research have shown that increasing the storage modulus and lowering the loss modulus results in a more resilient recipe with reduced hysteresis. Think of the storage modulus as the spring component of the complex modulus. In some applications, it is preferred that the rubber part exhibits characteristics like an ideal spring — quick to respond and returning nearly all the energy (not absorbing or dampening energy). The characteristics of the rubber recipe are adjusted using various polymers, ﬁllers, plasticizers and other ingredients, speciﬁcally to adjust the ratio of elastic versus loss modulae. This allows chemists to match the resulting

rubber material properties speciﬁcally to the application and part criteria. A delicate balance In addition to the physical characteristics of the IR formulation, meeting speciﬁc industry regulations for medical applications is critical. These regulatory aspects include, but are not limited to biocompatibility (USP Class VI and ISO10993), lowextractable pharmaceutical and in some cases white-listed materials (FDA 21CFR177.2600). These regulations contain strict limitations on performance characteristics and laboratory tests that the materials must meet in areas such as cytotoxicity, hemolysis, mutation, sensitization, limitations on maximum ingredient ratios, restricted ingredients, etc. Translating these requirements into the science and chemistry requires further consideration of effects on material viscosity, rheology and resulting physical properties like modulus,

resilience and chemical compatibility. It’s a delicate balance. Material formulation and properties are important, but they are not the only factors. The elastomeric materials and molded parts depend upon a balance of three critical technical aspects: formulation material properties, part/tooling geometry and the molding process. Changes to any one will affect the remaining two. Although synthetic polyisoprene exhibits many beneﬁcial material properties and characteristics, it is important to consider and balance together the part geometry and molding process in order to produce a successful product meeting all of the application criteria. Bob Ferguson is the VP of global R&D for Vernay Laboratories. His expertise lies in rubber material formulation development, nanoparticles as additives, and magnetic and electrorheologic materials.

The Best Components Begin with the Best Material

Boston Centerless supplies material to every segment of the Medical Device industry from Spine and Trauma, to Orthopedic and Dental. With unequaled material quality for machinability, and supply chain management that ensures regulatory compliance, you get precision, perfection and peace of mind in every bar.

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How anodizing can make aluminum suitable for reusable medical devices Image courtesy of Florida Anodize System & Technologies

Neel Patel Florida Anodize System & Te c h n o l o g i e s

High-performance aluminum anodic surface treatments oﬀer medical device manufacturers greater options for sterilization-resilient medical devices.

luminum can be found in many areas of the medtech industry, from orthopedic fixation devices to scopes and robotic surgery equipment. However, and possibly because of its common use, it is a material that is often taken for granted, and the processes needed to make it useable in the medical device industry are not well understood. One of those necessary processes to transform aluminum from its raw state to a useable medical device is aluminum anodizing. What is it? Aluminum anodizing is the process by which the surface layer of an aluminum substrate is electrochemically converted into an aluminum oxide layer. Although a natural oxide layer can be found on aluminum, this layer is uneven, thin and offers poor protection against chemical corrosion and wear abrasion and is wholly unsuitable in a medical environment. The anodizing process allows aluminum components to have a uniform and regular surface layer, increasing component durability and protecting the underlying material from corrosion. Supplementary processes can add to the functionality of the anodic layer. For example, colorants, lubricants or even antimicrobial biocides can all be deposited into the anodic structure. Anodic coating standards While the concept of aluminum anodizing is fairly straightforward, various industry-dependent standards influence process parameters, which in turn, greatly affect final coating characteristics. Among the most often-used standards, especially in the United States, are those developed by the U.S. Department of Defense, namely specification Mil-A-8625. Among the anodic coatings it details are Type I — Chromic acid anodizing, Type II — Sulfuric acid anodizing, and Type III — Sulfuric acid hardcoat anodizing. The medical device industry has not developed its own unique anodic coating standard, but instead relies upon the military specification, with the most often used being Type II and Type III. While both offer protection, Type II coatings are generally more aesthetically www.medicaldesignandoutsourcing.com

pleasing, with Type III coatings having greater abrasion resistance at the cost of generally being less aesthetic. Validation of effective aluminum anodic coatings Even before COVID-19, the quest for effective sterilization — especially with a better understanding of hospitalacquired infections — led to the use of chemical sterilization processes that were quite corrosive to anodized aluminum. The color and anodic coating would quickly degrade after the first few sterilization cycles, thus decreasing the working life of an otherwise capable medical device. However, anodic techniques have been specifically developed to overcome this weakness, enabling medical device manufacturers to continue to use aluminum as a primary component for their devices. To create durable, reusable medical devices, a medical anodize must be able to withstand at least 50 to 100 cycles of vaporized hydrogen peroxide or peracetic acid sterilization, or the use of a high-alkaline cleaner without significant loss of color or coating integrity. Anodic coating that cannot maintain this minimal level of resiliency should not be considered a valid or effective anodic treatment for medical devices. Another important characteristic of an effective medical-grade anodic treatment is that it has a smooth and even finish without any local discoloration. Similarly, it should not appear dull or result in a grainy surface (unless that is the desired effect). A smooth and even finish allows designers to have a blemish-free background for markings, and enables device marketers to speak to the quality of all aspects of the medical device. Notably, a consistent surface finish also indicates that the anodic coating was evenly applied to the substrate and that there are no weaknesses in the coating that could lead to accelerated corrosion and device failure. Neel Patel is VP at Florida Anodize System & Technologies (FAST), an ISO 13485 provider of aluminum anodic coatings. He is the medical and surgical industry product line leader at FAST, specializing in anodic surface treatments designed to withstand surgical sterilization systems and surgical cleaners. 9 • 2020

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MATERIALS

How to successfully switch medical device materials Breaking the hold on single-source suppliers creates a less costly and more sustainable material supply chain for medical device manufacturers.

any medical device manufacturers are relatively “cemented into” using one material provider. Oftentimes, they are not aware of the full scope of materials available on the market that might ﬁll an application. In the prototype or early-launch stages of a product, the focus is not concentrated on the cost of every material used in a device. But as volumes increase, price becomes an issue and suddenly an OEM may ﬁnd it is being held captive by a single-source supplier. This may be the time to switch from a specialty material to a standard material.

Image courtesy of Freudenberg Medical

Lars Gerding Freudenberg Medical

Changes in the regulatory environment, such as a ban on certain material classes or ingredients in compounds, might also drive the need for material substitution. Reverse engineering steps in Finding the best match for a speciﬁc material begins with reverse engineering the part in order to match compatible materials. First, perform a micro-CT scan to digitally model the entire part. Relying on the drawings alone might not be enough, since the properties of the real part are most important. Next, feed the model into a 3D CAD program, and then adapt a ﬁnite element analysis (FEA mesh) to start 50

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simulating the entire part. Having the real part available allows you to characterize its mechanical properties depending on what is important in the component’s application. In some cases, this might be tensile testing; in other cases, force displacement might be the relevant criterion. This data will determine the target properties and is a crucial input parameter for the simulation, in addition to the 3D model itself. Finally, feed the simulation with material models from existing and available raw materials. It’s possible to select multiple materials, provided the mechanical data exists in a database. Otherwise, a good supplier can perform material characterization to determine properties. The simulation evaluates each material on the mechanical properties determined from the original part. The outcome will display the range of each material in regard to the desired specification. If the specification cannot be met just by substituting the material alone, a modification of the part geometry might be necessary. The benefit of having the 3D model set up for this is that it’s possible to quickly evaluate a potential modification without having to do expensive and time-consuming molding or prototyping. Of course, all materials must meet medical device standards. The determination of material properties in the elastomeric world requires very specialized knowledge. In this simulation, both material characterization and material modelling capabilities come together with the know-how of interpreting the simulation results. Device manufacturers reap the benefits Here’s an example of how a materials switch actually works: A medical device customer had a valve seal created from an isoprene rubber — in this case, a proprietary rubber formulation that only one supplier formulated and offered at a set price. In the beginning, this was not an issue, but now the manufacturer required more volume and simply could not get it from their material provider. The valve seal had to fulfill specific mechanical properties and have certain characteristics. First, the part was 3D-imaged and the force displacement characteristics were simulated based on existing part measurement data to determine if required characteristics were met. Using the same model, the material characteristics and the required parameters for liquid silicones were uploaded from

www.medicaldesignandoutsourcing.com

This graph depicts the behaviors of three different materials. The squares indicate the speciﬁcation window at each displacement. The target material will be between the squares. In this example, the purple line (Material C) is the closest match. Image courtesy of Freudenberg Medical

a different supplier’s database, enabling identiﬁcation of the material of choice from the silicone world. The process was done without actual prototyping or using the material in a mold. It saved the OEM both time and money. Not limited to one application Material substitution is not limited to molding; it also applies to extrusion. It is also not limited to classical rubber vs. silicone. However, using newer material like silicone will provide a lower cost and a faster cure process. Many medical device manufacturers are stuck with single-provider materials and are looking for less costly solutions that offer more price ﬂexibility. Using hard data, advanced technology and smart engineering, a skilled manufacturing partner can replace materials with similar principles and offer a valuable resource to improve margins, part manufacturability and sustainability. Lars Gerding is VP of technology at Freudenberg Medical, a global contract manufacturing organization for medical device and component manufacturing. He is focused on R&D and innovation in manufacturing processes and on new products.

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MATERIALS

Biomedical textiles can drive innovation in orthopedics Orthopedic OEMs are looking to medical textiles for minimally invasive approaches to applications ranging from soft-tissue tears to bone grafts to spinal stabilization — and more.

Jeffrey M. Koslosky Cortland Biomedical

n the orthopedic sector, demographics are noticeably shifting toward younger and more physically active surgical patients. Soft-tissue injuries, including damage to the ligaments and tendons commonly associated with sports injuries amongst a younger generation of patients, are becoming increasingly common. This phenomenon dovetails with the trend away from large-scale surgeries toward earlier intervention with less-invasive devices to reduce hospital stays and recovery times. Preservation of the patient’s range of motion and natural movement is a primary objective, particularly when it comes to spinal injuries. Medical device OEMs in this highly competitive orthopedic space are adapting by looking to medical textiles to offer minimally invasive approaches for applications ranging from soft-tissue tears to bone grafts to spinal stabilization and more. How textiles work in orthopedics Traditionally, braided textiles have been widely deployed as orthopedic sutures, often fabricated using ultra-high-molecular-weight polyethylene (UHMWPE) or other high-strength polymeric fibers. Often the goal of these structures is to enable an effective repair by allowing a surgeon to secure soft and bony tissue using a braid with a low profile and high tensile strength. Advances in braided textiles allow for additional design features, such as the inclusion of regions of variable density or the ability to branch off, creating a multiaxial structure with a common hub. These advances allow for improved handling characteristics, better knot retention and less mass of implanted material, which can simplify the procedure and facilitate a more durable surgical repair. Another benefit of biomedical textiles is their shapetransformation properties. Because they are inherently compressible and flexible, it is possible to use them in minimally invasive delivery applications — entering through a small hole and expanding in the body as needed. Fabric porosity can also be tailored by the type of textile-forming technology and by varying orientations in its geometry, ultimately eliciting tissue in-growth in certain areas while serving as a tissue barrier in others.

Medical Design & Outsourcing

9 • 2020

High-density braider

Image from Cortland Biomedical

One can engineer fabric-based biomaterial structures with specific porosity characteristics to control the flow of materials and to facilitate biologic healing in a localized treatment site. This offers an option to use a fabric as a containment vessel for orthopedic materials, such as bone cement, with advantages unrivaled by more common device materials. Recent updates More recently, woven and knitted biomedical textile structures have emerged as an optimal foundation for orthopedic implants and anchor points for attaching soft tissue. This is largely due to their strength, compliance and inherent capabilities for promoting tissue ingrowth. These textile structures can distribute load over a larger surface area and may be engineered to mimic the behavior of the ruptured tendons and ligaments they are intended to replace. It’s possible to tailor the mechanical and biologic properties of textile structures for specific uses, such as regenerative scaffolding or as partially resorbable structures that enable healing. This is especially useful in the surgical repairs of tissue that is minimally vascularized, as is commonly seen in joint repair. For tissue engineering applications, composite scaffolds can be created using hybrids of biologic and synthetic materials. Textile structures created from resorbable synthetics allow controlled resorption of the polymers aligned with the healing rate of the tissue, resulting in a more complete repair. The potential combination of synthetic biomaterials with osteoinductive materials can produce a multi-component scaffold structure with the ability to form new tissue using the body’s cellular response to biochemical signals, according to Steven M. Kurtz

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and Avram Allan Edidin in the Spine Technology Handbook. These biomedical textile composites have a high level of orientation and localized containment not possible with other common scaffold materials such as sponges, foams and porous metals, making them better suited for spinal fusion, long-bone fracture and bone-void applications. High-performance biomedical textiles represent an exciting opportunity to increase innovation in the orthopedic market and provide less-invasive surgical options for patients. The design ﬂexibility and shape transformation properties of medical textiles — as well as their compatibility with biologic structures and ability to be tailored to the needs of the particular application — mean that patients may beneﬁt from simpler procedures, faster healing times and less risk of complications or rejection. Jeffrey Koslosky is director of engineering and product development for Cortland Biomedical. He is experienced in biomedical product design and engineering and drives new business through the intersection of medical device technology and textile structure formation.

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How laser inversion enables multi-materials 3D printing Researchers invented a new technique that could transform additive manufacturing processes, potentially enabling the printing of circuit boards, electromechanical components, and perhaps even robots.

Nancy Crotti Managing Editor

printing uses digital manufacturing processes to fabricate components that are light, strong, and require no special tooling to produce. One of the most widely used manufacturing processes, selective laser sintering (SLS), prints parts out of micron-scale material powders using a laser to heat the particles to the point where they fuse together to form a solid mass. The catch is that SLS technologies have been limited to printing with a single material at a time — the entire part has to be made of just that one powder. That limitation has been haunting the industry and preventing it from reaching its full potential, according to Hod Lipson, a mechanical engineering professor at Columbia University.

Selective laser sintering traditionally has involved fusing together material particles using a laser pointing downward into a heated print bed. A solid object is built from the bottom up, with the printer placing down a uniform layer of powder and using the laser to selectively fuse some material in the layer. The printer then deposits a second layer of powder onto the ﬁrst layer, the laser fuses new material to the material in the previous layer, and the process is repeated until the part is completed.

Robotics to the rescue Lipson and his PhD student John Whitehead used their expertise in robotics to develop a new approach to overcome these SLS limitations. By inverting the laser so that it points upward, they invented a way to enable SLS to use multiple materials simultaneously. Their working prototype, along with a print sample that contained two different materials in the same layer, was recently published online by Additive Manufacturing and will be part of its December 2020 issue. “Our initial results are exciting,” said lead author Whitehead, “because they hint at a future where any part can be fabricated at the press of a button, where objects ranging from simple tools to more complex systems like robots can be removed from a printer fully formed, without the need for assembly.”

The challenge of multiple layers This process works well if there is just one material used in the printing process. But using multiple materials in a single print has been very challenging, because once the powder layer is deposited onto the bed, it cannot be unplaced, or replaced with a different powder. “Also, in a standard printer, because each of the successive layers placed down is homogeneous, the unfused material obscures your view of the object being printed until you remove the ﬁnished part at the end of the cycle,” Whitehead added. “Think about excavation and how you can’t be sure the fossil is intact until you completely remove it from the surrounding dirt. This means that a print failure won’t necessarily be found until the print is completed, wasting time and money.” The researchers decided to ﬁnd a way to eliminate the need for a powder bed entirely, setting up multiple

Our initial results are exciting because they hint at a future where any part can be fabricated at the press of a button.

The black material is the thermoplastic nylon 12, and the white material is thermoplastic TPU. Image courtesy of John Whitehead, Columbia University

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Medical Design & Outsourcing

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MATERIALS

transparent glass plates, each coated with a thin layer of a different plastic powder. They lowered a print platform onto the upper surface of one of the powders, and directed a laser beam up from below the plate and through the plate’s bottom. This process selectively sinters some powder onto the print platform in a pre-programmed pattern according to a virtual blueprint. The platform is then raised with the fused material, and moved to another plate, coated with a different powder, where the process is repeated. This allows multiple materials to be stacked into a single layer. Meanwhile, the old, used-up plate is replenished.

We think this will expand laser sintering toward a wider variety of industries by enabling the fabrication of complex multi-material parts without assembly. In the paper, the team demonstrated their working prototype by generating a 50-layer thick, 2.18 mm sample out of thermoplastic polyurethane (TPU) powder with an average layer height of 43.6 microns and a multi-material nylon and TPU print with an average layer height of 71 microns. These parts demonstrated both the feasibility of the process and the capability to make stronger, denser materials by pressing the plate hard against the hanging part while sintering. Potential uses “This technology has the potential to print embedded circuits, electromechanical components and even robot components,” Lipson said. “It could make machine parts with graded alloys whose material composition changes gradually from end to end, such as a turbine blade with one material used for the core and different material used for the surface coatings. The researchers are now experimenting with metallic powders and resins to directly generate parts with a wider range of mechanical, electrical and chemical properties than is possible with conventional SLS systems today. “We think this will expand laser sintering toward a wider variety of industries by enabling the fabrication of complex multi-material parts without assembly,” Lipson concluded. “In other words, this could be key to moving the additive manufacturing industry from printing only passive uniform parts toward printing active integrated systems.”

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2020

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3 pitfalls to avoid with your medtech root cause analysis Using root cause analysis to identify the source of a medical device malfunction is often slow and unproductive. Here are three common errors — and strategies to improve results. Don Baumgarten Product Creation Studio

hen a medical device fails to function as intended, the stakes can be high, potentially affecting patient safety and brand reputation and even leading to a recall. Malfunctions that rarely occur can be the most difficult to resolve and engineers are often directed to rapidly implement a solution. If the reason for the issue is not clearly understood, attempts to fix the problem won’t work. Root cause analysis (RCA) is often the best approach, because it can help determine the specific underlying cause for a malfunction. Here are the typical RCA steps: • •

1. Unfocused effort When a signiﬁcant medical device malfunction occurs, quick corrective action is needed. But engineers are typically already juggling multiple projects, and managers are busy, too. Fixing the problem often falls to one or two engineers with no timeline for action or adjustment to their other responsibilities, and little management support. The result is a cursory RCA effort with little chance of success.

Image courtesy of Anyaivanova | Dreamstime.com

• •

Clearly describe the device failure. Examine the device design, manufacture and instructions for use. Identify potential causes of the failure. Analyze potential causes until the root cause is discovered.

Simple, right? Deceptively so. Here are three common reasons that root cause investigations fall short, as well as strategies for success:

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Medical Design & Outsourcing

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PRODUCT DESIGN & DEVELOPMENT

To truly tackle the problem, formally create a project team as would be done for any other R&D project. Prioritize the RCA project relative to other projects according to business impact and resource it accordingly. Include the RCA project in regular management project review meetings. 2. Avoiding vital work If a device failure is harmful, the need to resolve the problem is urgent. Pressure to move quickly can cause the RCA team to neglect critical thinking and planning and to avoid crucial but time-consuming analyses. The hurried effort is inevitably haphazard and superficial. Despite the urgency, a systematic approach is critical to success. A systematic approach is thoughtful and efficient, with investigations of the most likely root causes conducted simultaneously to quicken the pace. A number of well-known problemsolving tools, including the fishbone diagram and process flowchart,

are recommended for root cause investigations. Familiar techniques, including dimensional inspection, microscopy, oscilloscope signal analysis and debugging tools are essential to analyzing potential root causes. 3. Faulty conclusions An assumption might seem smart: The injection molding process was validated, so that can’t be the issue. A single data point can be convincing: The circuit board worked after the capacitor was replaced, so the capacitor was the problem. But assumptions and conclusions based on scant data are often wrong, and that can be disastrous to an RCA effort. To avoid erroneous decisions, gather compelling data before ruling out a potential cause or declaring that the root cause was discovered. Conduct controlled experiments and use statistical analysis when needed. Avoid over-interpretation of data and conclude only what the data supports. Conclusions can rarely be

made with absolute certainty. Seek strong evidence to make sound decisions. For intricate systems, there may not be a single root cause. Instead, several contributing factors occur simultaneously to produce the malfunction. Usually two or three dominant factors cause the issue. The best way to show that the root cause was actually discovered is to reproduce the problem. Deliberately build devices that include the identified root cause and demonstrate that the devices fail. Such evidence will give you confidence that implementing changes to prevent the identified root cause will greatly reduce the failure rate. Don Baumgarten is the director of mechanical engineering for Product Creation Studio. He has participated in the design and manufacture of medical devices for companies ranging from startups to Fortune 500 companies. He’s worked with Philips, Boston Scientific, Pathway Technologies, Intellectual Ventures and more.

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4 ways that manufacturing can affect your medical device development Although manufacturing is fundamental to a medical device’s success, its influence is often not taken into account during development. Del Lawson and David Franta 3M

ot every medical device idea makes it to production, and manufacturing is often not considered early enough in development to help ensure this stage’s success. Why is it not prioritized sooner? The exact answer might be different for each project. Manufacturing’s influence spans the entire development process. The sooner teams start thinking about its potential implications, the more robust the design will be. Here are four areas worth addressing early in the development process.

2. Deciding on a sterilization method Specific sterilization methods may alter how some materials perform. Gamma radiation, for instance, can stiffen and degrade polypropylenes. Changes caused by sterilization could affect how materials perform during and after manufacturing.

1. Material selection for performance It can be challenging to know if you are prioritizing the right factors in material selection. Development teams typically prioritize how the device will look and function. Yet, these considerations cannot come at the expense of selecting materials that are incompatible with each other (if Manufacturing’s the device will have multiple layers) or with influence spans the entire development your desired manufacturing process. For process. example, not all materials are compatible or Image courtesy of 3M can withstand high speeds, friction or heat. To determine material compatibility, examine each option’s mechanical and chemical properties to determine if there are potential Consider how the sterilization method’s temperature sources of contamination from one layer to the next and and duration could alter each of the device’s whether they exist naturally or result from a different part components. Whether the device will be sterilized in its of the development process. package can also affect its outcome and performance. In determining material compatibility with your Discussing the potential impacts in advance can help manufacturing process, work to ensure your process is refine which materials are best suited for the project. truly attuned to your device. Test more than one lot of production-equivalent material and your device’s critical 3. Forecasting the manufacturing environment’s raw materials. Critical raw materials should relate to implications the final product’s design specifications. Their influence The manufacturing plant’s temperature and humidity affects your product’s ability to meet regulatory, safety, — which may change with the seasons — can affect efficacy and appearance needs. device performance. For instance, hydrophilic The best way to know if your materials are materials can be vulnerable to degrading over time compatible with your process is to test a near-final version due to exposure to moisture. of your product — something beyond a rough prototype. If your product will experience those changes Your material supplier can help vet, test and prevent during manufacturing, ask your manufacturing partner potential issues. Bring them into the development process and material supplier about incorporating different as soon as you can to help you select the best materials. process controls and standards. www.medicaldesignandoutsourcing.com

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4. Controlling costs Manufacturing directly influences the end product’s price. Equipment, labor and raw materials are all contributing factors. To help keep long-term costs down, develop a robust, repeatable process capable of running with different operators. Occasionally, development teams attempt to save costs by using the most inexpensive materials without considering compatibility with the manufacturing process. While material costs must be considered, material performance and total cost to produce should be a top priority. If incorporating a higher-cost material allows your manufacturing process to run more efficiently, your total product cost may be lower. Del R. Lawson leads new product development and commercialization for 3M’s Medical Solutions Division. He has over 25 years of experience at 3M in laboratory management, strategic product platform creation and Lean Six Sigma operations, working on the development of advanced analytics and sensors, biotechnology solutions and medical adhesives. David Franta leads the Microfluidics Global Business in 3M’s Medical Solutions Division. He has more than 25 years of experience at 3M in product and process development, business management, strategic product platform creation and Lean Six Sigma, and in creating biomedical sensors, biotechnology solutions and medical adhesives.

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How to go from zero to medical product in 20 days The rapid design and manufacturing capabilities of industrial 3D printing enabled development and launch of a new nasopharyngeal swab in less than 3 weeks. Steven K. Pollack Carbon

Resolution Medical used Carbon’s lattice design software and Digital Light Synthesis technology to swiftly create at least 18 different swab designs during the product development process. The ﬁnal product is shown on the far right. Image courtesy of Carbon

he COVID-19 pandemic spotlights the value of additive manufacturing in responding to just-in-time manufacturing needs in the life sciences. In this article, we describe taking a disposable diagnostic product from concept to market in the space of 3 weeks by using a digital industrial 3D printing technology. Early in 2020, Beth Israel Deaconess Medical Center (BIDMC), Harvard University and the U.S. Army assembled a team to address the short supply of nasopharyngeal (NP) swabs, a key component of the RT-PCR molecular assay for COVID-19 diagnostic testing. The team included several 3D printing companies and academics, all of whom believed that a digital industrial 3D printing technology could circumvent supply-chain breakdowns and enable new swabs to be designed, manufactured and clinically assessed rapidly. NP swabs used in the molecular assay for COVID-19 are a Class I medical device. They are required to be biocompatible, as they are introduced deep into the nasal cavity. To minimize patient risk, clinicians prefer that they be sterile. Finally, new NP swabs must be tested for compatibility with RT-PCR assays and perform as well as traditional ﬂocked swabs. There are no standards for the properties of NP swabs, so the team designed a 3D-printed swab by reproducing the mechanical properties of conventional swabs and their ability to capture a sample. Minnesota-based Resolution Medical, an experienced user of Carbon’s Digital Light Synthesis technology, collaborated with Carbon on the project, using software design tools to create open lattices for maximum surface area and sample capture. The swab’s shaft also needed to be ﬂexible enough to undergo a 180-degree bend and tough enough to withstand 10 cycles of 180-degree twisting during sample collection without breaking.

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Carbon identified Keystone Industries’ KeySplint Soft Clear resin, an FDA-cleared dental material for splints and other oral health appliances, as having the appropriate mechanical properties. The resin’s suitability also opened the opportunity for the large network of Carbon’s dental partners to rapidly use the material to print and supply swabs to Resolution for final assembly and distribution. Working first with BIDMC, non-sterile swabs were fabricated, packaged and assessed for compatibility with the PCR test. For expediency, the packaged swabs were validated for on-site autoclave sterilization while validation of pre-sterilized swabs progressed in parallel. Once PCR compatibility was established, a small clinical trial demonstrated the non-inferiority of the 3D-printed swabs to the conventional swabs. U.S. healthcare facilities then began ordering the Resolution Medical lattice swab for evaluation. A second-generation swab design yielded improved mechanical properties post-sterilization and improved flexibility without sacrificing sample collection efficiency. An institutional review board study at Stanford University evaluated the new design with more than 200 patients, determining it to be equivalent in diagnostic power to both the first-generation swab and conventional flocked swabs. The clinicians were also satisfied with the comfort level. These second-generation swabs have been widely sold to hospitals across the country since Resolution Medical launched them on April 8, 2020 — just 20 days after the first design efforts. In July, Resolution Medical launched a sterilized version of the lattice swab, alleviating the need for on-site sterilization at hospitals. These swabs have an extended shelf life and the same mechanical properties of the second-generation swab. This “sprint” from a medical need to fully validated product is a testament not only to the power of just-in-time digital design and manufacturing, but also the utility of additive manufacturing in expediting product development timelines in the life sciences space, whether or not in the context of a crisis. Steven K. Pollack is a science fellow at Carbon. He has worked in the medical device field for close to 40 years and is a former director of the Office of Science and Engineering Laboratories in the Center for Devices and Radiological Health at the FDA.

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5 factors to perfect antenna and wireless performance in medical devices RF tests are conducted in an anechoic chamber on phantom body parts.

For best results, the antenna’s location in a wireless medical device must be addressed early in the design process. Geoff Schulteis Antenova

he antenna is one of the most important components within a wireless medical device, so it must function efficiently. The antenna’s position is important to good wireless performance, so this should not be a last-minute decision. The antenna’s signal may also be compromised by the proximity of other components, affecting how well the device transmits and receives data. It is best to plan component and architecture layouts for good radiofrequency (RF) performance. Here are five factors to consider. 1. Location is everything Deciding the location of the antenna upon the circuit board should be the first step, before laying out any of the other components. Chip antennas are the most popular choice for surface-mounted designs, hence their short name, SMD antennas. SMD antennas require a ground plane to radiate. It’s important to consider shape and dimensions, as each antenna has its own unique radiation pattern and requirements. The clearance areas around the antenna need to be part of the design, as placing other components too close to the antenna can affect the antenna signal. Batteries, metallic components, LEDs and LCD displays can all create interference if they are placed too closely. Wearable devices can be tricky to design because the human body can block radio signals and cause an antenna to detune. The optimum position for the antenna in a wearable design may be on the side of the device facing away from the body to avoid signal losses. 2. Ground plane specifications Take note of how the antenna’s ground plane is designed. SMD antennas use a ground plane to radiate, and this must be the correct size and length. Follow the ground plane requirements stated in the manufacturer’s datasheet to be sure the antenna will perform as it should in-situ. Some SMD antennas are available in left and right versions and antenna designs for corner positions are available. One of these options may enable you to keep the antenna away from the person and accommodate the ground plane requirements better into a design. www.medicaldesignandoutsourcing.com

Image courtesy of Antenova

3. Isolation Often a design has more than one antenna, such as a Wi-Fi antenna and a Bluetooth antenna. To keep the signals from one antenna from interfering with or detuning the other, keep them separate. 4. Transmission lines and matching The antenna, its feed trace and the radio transceiver must all operate at the same impedance (typically 50 ohms) to ensure that the energy transfer from the radio to the antenna performs efficiently. If the impedance should vary along this path, it can be resolved with matching circuits, such as π-matching topology, which can be tuned using lumped element inductors and capacitors to bring the antenna and radio to the same impedance. 5. Prototyping and testing Bear in mind that even the smallest of last-minute deviations can affect the performance of a device. RF performance will also be affected by the environment and other devices in the vicinity. A metal housing is not recommended for a wireless device, and within hospitals there may be areas with no signal at all. Generally, these areas are rooms below ground or those that are screened for X-rays. RF specialists conduct passive tests in an approved anechoic chamber with phantom body parts to simulate how the device will perform in the real world. The tests will determine the antenna efficiency, gain, return loss, impedance and 2D- and 3D-radiation patterns. The design must then pass statutory tests for safety and regulatory compliance to meet U.S. Federal Communications Commission standards and CE standards in Europe. The final step in testing will be to conduct pre-certification “over-the-air” tests to measure the performance of the device and ensure it will provide a good user experience while assessing its readiness for commercial deployment. Geoff Schulteis is an RF antenna application specialist with Antenova. He specializes in over-the-air testing for wireless devices. 9 • 2020

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How to expand the medtech design conversation Engineering departments have long sought to expand industry partnerships, and medical school departments are following suit. One university oﬀers a new approach to industry-academic collaboration.

Interventional cardiologist Dr. Jason Bartos (right) explains surgical concepts to a Clinical Immersion group over lunch. Image courtesy of the University of Minnesota

John Bischof University of Minnesota Institute for Engineering in Medicine

he robust growth of industry-academia partnerships has helped drive the stunning explosion of the medical device industry over the past 25 years. And yet, most of us in the medical device space are too constrained in our thinking about academicindustry partnerships. We more or less know how to form collaborations to tackle a particular problem or develop a particular device. But we almost never think about cultivating the fruits that come from just spending time together. To put this another way, both academic and industry medical device professionals aren’t prone to ask each other, “What have you been thinking about lately?” Nor do we have venues to readily learn about each other’s worlds, even though we’d all beneﬁt enormously from both. There are several ways to spur academicindustry interaction at what could be called the “brainstorming” level of medical device development. The suggestions below are primarily based on the Clinical Immersion program managed by the University of Minnesota’s Institute for Engineering in Medicine (IEM), so a short description of that program is in order.

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IEM’s Clinical Immersion program The Clinical Immersion program, which began in 2015, embeds small groups from a company with clinical faculty and residents at the University of Minnesota Medical Center for 2 to 5 days. The industry groups observe and discuss everything the clinicians do: patient rounds, surgeries, clinical meetings, lectures and other day-to-day activities of clinical life. Initial groups focused on general surgery and cardiology; the program has since expanded to include neurosurgery, interventional radiology, wound care and nephrology. Occasionally, some time is reserved for discussion about a device made by the company. Making it happen The program’s success shows that there’s a hunger for focused yet informal interaction in both academia and industry. Here’s how medtech industry professionals can initiate more brainstorming collaborations: •

Foster personal academic connections. Cold calling won’t work — everyone in academia is too busy to answer unsolicited email — so start by building on existing relationships. You can deepen these relationships by hosting an informal idea-

www.medicaldesignandoutsourcing.com

•

generating session, a tour of your facility with open-ended conversation, or some other event. You can also ask existing academic connections to help broaden your circle of professors interested in medical devices. Get to know academic leaders. Every major research university has a technology commercialization ofﬁce that is eager to forge new relationships with industry partners. Look for institutes and centers that list medical translation and commercialization as a key mission. A commonly overlooked resource in universities is department chairs. Focus on learning, not producing. Academics in particular gravitate toward pursuing the “why” and conceptual possibilities of devices. Conversation along such lines, along with a serious dive into the biological and procedural nuts-and-bolts of patient care, is enough to shake

•

people out of well-worn mental paths associated with pushing along the development of a medical device. Forget proﬁt, even if just for a while. We need to remember that behind the competitive medical device world is a community of common purpose — namely, to improve health for all human beings. By cultivating that community at a conversational level, we all have a lot more to gain than to lose.

John Bischof is Distinguished McKnight Professor and Carl and Janet Kurhmeyer Chair of Mechanical Engineering at the University of Minnesota. He is also the director of the University of Minnesota’s Institute for Engineering in Medicine.

You may need to experiment before you ﬁnd successful approaches: perhaps something like Clinical Immersion, a local industry-academia day retreat or a presentation followed by discussion over drinks. Anything that brings you exposure to academics to begin real conversation about real needs will build the trust and long-term relationships that are the foundation of fruitful ideas and collaborations.

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PRODUCT DESIGN & DEVELOPMENT

The Mayo Clinic engineering team collaborates on the design and ﬁt of a mandibular implant. Image courtesy of the Mayo Clinic

Point-of-care additive manufacturing of implants is about to get real Surgeons want to quickly treat people who need unique patient-speciﬁc implants. Point-of-care generation of these devices will meet this need.

Mark Wehde Mayo Clinic

Image courtesy of Mayo Clinic

FIGURE 1

ngineers have long understood the value of reverse engineering as a technique for extracting knowledge from an existing design. There are many reasons to do so, but for the purposes of this article the best reason would be to develop an understanding of a legacy system, often to replace obsolete parts in order to return something to its previous level of functionality. Point-of-care additive manufacturing of implants is primarily an extension of this technique applied to patients. While standard orthopedic implants are appropriate for many procedures in which the implant size and shape can be standardized, such as hip implants, there is a signiﬁcant number of use cases where that simply isn’t possible. One of the most common uses of a custom implant is in craniofacial repair that requires a custom implant to match the patient’s anatomy. A patient might need craniofacial repair because of broken

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bones, a deformity or a tumor removal that also required the removal of a significant portion of the bony structure. These implants can widely differ due to the variance in the sizes and shapes of tumors or the damage that requires bone to be carefully pieced back together. Titanium’s biocompatibility, strength and durability make it one of the most commonly used materials for these types of implants. A typical implant for a mandibular reconstruction uses bone harvested from the patient’s fibula. An engineering team then uses CT scans of the patient’s anatomy to develop a custom metal brace or splint to align the implant to the patient’s jaw. Once the computer-generated model is created, it can be printed and fit-tested using a traditional polymer print of the patient’s jaw, as shown in Figure 1. This method is superior to the traditional method of bending and cutting to shape during the surgical procedure. Patient anatomy can be hard to match, and there are always concerns about sterility when the implant is handled and manipulated. The computer-generated model is much more accurate and precise. It allows the implant to be created, inspected, sterilized and packaged before surgery. Particularly challenging anatomy can be addressed before the patient’s arrival, allowing the entire surgery to proceed much more smoothly.

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PRODUCT DESIGN & DEVELOPMENT

printed anatomical models for presurgical planning has demonstrated the value of having the biomedical engineers and technologists working hand-in-hand with the surgeons and radiologists. Locating a facility within the surgical suite allows the surgeons to drop in between cases to consult on the implants being developed. This allows for rapid development of patient-speciﬁc implants that can be used almost immediately. Signiﬁcant work must be done before the printing of custom implants is a more widespread reality. Point-ofcare manufacturing of custom implants will not only create better results for patients but will yield much greater patient satisfaction. This will allow for better patient care and provide extensive training and educational opportunities for both clinical and engineering staff.

FIGURE 2 Image courtesy of Mayo Clinic

Figure 2 shows the metal brace printed using support material on an EOS M290 titanium printer. Unlike traditional polymer printers with easily removable support material, the support material for titanium printers is also titanium. Once the powder is vacuumed off, the implant must be separated from the support material using traditional machining techniques. Custom implants are commercially available. However, Mayo Clinic’s 14-plus years of experience developing polymer-

Mark Wehde is chair of the Mayo Clinic Division of Engineering, a member of the South Dakota State University Electrical Engineering Industry Advisory Board, and on the board of governors for the IEEE Technology and Engineering Management Society. Mark is also a juror for the Medical Design Excellence Awards, an afﬁliate for the University of Minnesota Medical Industry Leadership Institute, and a member of the FDA Center for Devices and Radiological Health Network of Digital Health Experts.

Mark Wehde led a team of Mayo engineers and physicians in a discussion of how 3D printing and other tech will help hospitals operate in the COVID era.

TUESDAYS

Watch the DeviceTalks Tuesdays On Demand presentation. https://www.devicetalks.com/devicetalks-tuesdays-on-demand-sessions/

ENGINEERING BETTER DEVICES. BUILDING BETTER COMPANIES.

Medical Design & Outsourcing

9 • 2020

www.medicaldesignandoutsourcing.com

Can you add connectivity to medical devices already in the field? You can, if you identify the right combination of business goals, customer needs and technology solutions. Piotr Sokolowski S3 Connected Health

any medtech companies require their devices to be connected to the internet. Connectivity can be added to the thousands of pre-existing devices in the field. Here are some guidelines to help you succeed. Identify your business needs You’ll need to identify a genuine business reason to justify the effort required from R&D, regulatory, operations and other functions. For internal stakeholders to back your project, explain how collecting data on the device will benefit the company. Offering tangible gains for particular departments is crucial for success here. Examples of areas that can achieve tangible improvements from device data include: • • • •

Preventive maintenance. Context-based technical support and user training. Remote firmware upgrades. Device and consumables tracking.

Start with areas that can directly translate into reduced effort for internal support functions, like maintenance and technical support, or lead to improved outcomes and efficiency for device users.

Often, after launching the first connectivity project and showing specific benefits, other stakeholders will see the value information brings and request other types of data to be delivered over your new connectivity mechanisms. This data can be used to direct future enhancements to equipment, improve product differentiation, establish more meaningful customer engagement and serve other stakeholders in the device ecosystem. These follow-on features can collectively deliver significant return on investment from the project. Get clinical customers on board Hospitals using your equipment may hesitate to allow modifications for fear of taking on additional work and adding to their risk of cybersecurity threats. After all, they are operating within the confines of established clinical protocols, strict IT requirements and overloaded clinical staff. To succeed and demonstrate the real value of connectivity, show how their real unmet needs can be addressed using data and strive to seamlessly integrate these upgrades into the clinical environment. The resulting benefits for clinicians and clinical managers can include: • • • • •

Reduced device downtime and increased use. Improved treatment set-up and patient preparation. Improved patient safety. Increased clinical performance. Reduced consumable use.

Practical considerations The final hurdle is introducing connectivity and datacollection technology into the device as seamlessly as possible. This means having the least possible impact on the equipment design and associated processes (e.g. manufacturing) and with minimum regulatory burden resulting from the change. The following aspects must be considered: • Impact on equipment design: The connectivity component (whether internal or external) will need to meet a number of diverse requirements related to aesthetics, mechanical, electromagnetic compatibility, power consumption, heat dissipation, hardware and software integration/separation, bill-of-materials cost, etc. It requires excellent engineering skills and innovative thinking; there is much less design freedom than in new designs.

Image courtesy of Adobe Stock

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Impact on manufacturing and operations: Adding connectivity will mean adding to an established component supply chain, manufacturing line and operations processes; be sure to minimize the impact of this. Re-using existing components and suppliers, complying with their design for manufacturability (DFM) and other design for excellence (DFX) rules, and, most of all, containing the design change within particular subsystems — they can reduce the impact. Selecting the right communication method: There is a wide selection of standards from Zigbee and Bluetooth through WiFi, LoRaWAN, cellular IoT, to WPANs and 5G. However, options will be reduced by the product constraints mentioned above and limited by the environment in which the device resides. Aspects not commonly considered include signal propagation through complex building structures; interoperability with existing protocols, especially WiFi; electromagnetic compatibility with existing medical devices; cellular network coverage or the need to install additional gateway devices; and the total running costs of connectivity, including cellular IoT data plans. Cybersecurity framework: The connectivity function must meet requirements in three key domains:

TUESDAYS

1. Technical, including end-to-end data encryption and other security controls. 2. Regulatory, including cybersecurity guidelines and patient data privacy standards. 3. Environment, including ﬁtting into customers’ cybersecurity frameworks to support ongoing security analysis, software updates and vulnerability management. •

Integration with internal and external systems: Connected equipment will be integrated with supplementary functions like identity management, secure operations, inventory management, customer care and others that guarantee secure and uninterrupted data acquisition from the entire installed base of devices. Without these processes, the connectivity project is likely to remain a limited pilot installation.

Adding connectivity to existing medical equipment is possible, but it requires combining business, clinical, regulatory and technology perspectives as well as meaningful engagement with all stakeholders. Piotr Sokolowski is head of services strategy for medtech solutions at S3 Connected Health. He has almost 20 years’ experience in designing medical devices and device-based services.

To see and hear more about S3 Connected Health’s work on expanding connectivity, watch this DeviceTalks Tuesdays On Demand presentation. https://www.devicetalks.com/devicetalks-tuesdays-on-demand-sessions

ENGINEERING BETTER DEVICES. BUILDING BETTER COMPANIES.

Medical Design & Outsourcing

9 • 2020

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Image courtesy of Science in HD on Unsplash

Hiring the right freelance consultant

Ramya Sriram Kolabtree

edical device manufacturers may not always have all the skills to successfully bring a device to market in-house. In these circumstances, manufacturers with smaller internal teams can look for these skills elsewhere. For example, an increasing number of working professionals, including medical consultants in a range of fields, now choose to work remotely or as freelancers to have more flexibility. Why hire a consultant? Freelance scientists and researchers can support medtech manufacturers in a variety of ways, such as developing a device’s design, troubleshooting problems or preparing documentation for the regulatory approval process. This help is particularly beneficial to smaller companies that may not have sufficient funds to hire a full-time team member. Instead, they can access expertise and hire them solely for the duration of the project. Using freelancers also gives manufacturers access to a wider talent pool because there are no geographical limitations to their collaboration. Find the right expertise However, introducing an external specialist to a project is not as simple as advertising a project and hiring the best fit. Manufacturers should carefully consider how to find the person with the best skills for the project while also protecting their property. Manufacturers that use an online platform to search for a consultant should post a clear explanation of the job. Including a brief project description —as well as details such as expertise required, project duration and budget — means that the right consultants will find the project and apply. www.medicaldesignandoutsourcing.com

Medtech manufacturers have access to a large talent pool of PhDs, post docs and others whom they can approach when needed to streamline the journey from product idea to market.

Protect your company Protecting intellectual property (IP) should always be a priority. Organizations may have concerns when working with freelancers or remote workers and feel reluctant to share sensitive data with someone who is not part of the company. If they manage the process properly, medical device manufacturers can confidently share proprietary information and ideas with others. Applying for patents or registering designs or trademarks can be a good first step to safeguarding products when working with external collaborators. How much information can you share knowing that some applicants will not work on the project? Manufacturers should look closely at the terms and conditions when looking for a freelance consultant on an online platform. These conditions should include a confidentiality clause that protects the client’s IP and gives freelancers the right to use only information or materials that are necessary for working on the project. The clause should also specify that the freelancer will return or destroy any information as requested by the client once the project is complete. Non-disclosure agreements (NDAs) can also lessen worry during collaborations. Manufacturers can ask potential collaborators to sign these documents before disclosing any information about the project. Once they’ve chosen a medical device consultant, manufacturers can discuss the project in more detail, feeling safe in the knowledge that they have protected their IP. Ramya Sriram manages digital content and communications at Kolabtree, a freelancing platform for scientists. She has over a decade of experience in publishing, advertising and digital content creation. 9 • 2020

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How to go beyond the regulatory requirements checklist Many manufacturers run into issues as they adjust their devices and testing plans to meet updated regulatory requirements. Using a risk-based approach to predict and mitigate risks can help prevent costly setbacks.

Sherry Parker W u X i A p p Te c

etween the EU Medical Device Regulation (MDR) delay and other regulatory bodies shifting priorities due to COVID-19, manufacturers are scrambling to stay up to date on regulatory changes and keep their products on track for compliance. Simply working toward the current requirements checklist could potentially lead to regulatory complications, which is why experts recommend taking requirements the extra mile. A thoughtful, risk-based approach can help ensure that nothing in the testing plan slips through the cracks and threatens submission success. Following certain steps below can help manufacturers gain conﬁdence in their testing plan. Documentation longevity Device documentation and testing information must be thorough and transparent enough for someone removed from the testing altogether to understand what was done and how it was done. Assuming that the next person to reference the documentation of completed testing will have adequate background knowledge and experience to understand it could cause signiﬁcant issues.

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Teams change, and it is crucial to set future colleagues up for success by providing a road map of past decisions regarding the device, the materials used, the testing history and more. Testing partners can help ensure your document includes the appropriate details, regardless of personnel changes. Device classification It is vital to be proactive when it comes to device classification. The new MDR guidelines have proven this to be an element of medical device testing that can change quickly and send a manufacturer back to the drawing board. Manufacturers must have a thorough understanding of their device’s classification. The potential classification offers a guide to what non-clinical testing work might be needed, along with possible steps for submission. For example, Class II devices generally require more testing than Class I devices, which can set manufacturers on a different trajectory and ultimately lead to delays if done insufficiently. It is also essential to test the final finished device, which may not be addressed by only testing materials and/or components.

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Image courtesy of WuXi AppTec

REGULATORY, REIMBURSEMENT, STANDARDS AND IP

Additionally, Class I (reusable) devices, such as surgical instruments, are under higher levels of scrutiny than ever before with MDR guidelines. It is essential to understand what it takes to prepare devices for submission to meet these regulations. Staying ahead of classiﬁcation regulations requires thorough research and a team of qualiﬁed experts. Consider what the regulatory landscape may look like for the entirety of the device’s lifecycle and work with the mindset of exceeding regulatory expectations now for more leeway later. Post-market considerations Strategically prepare for post-market successes and challenges when planning beyond regulatory submission. Surveillance throughout product lifecycle is not an area to cut corners. For example, if post-market monitoring reveals an unforeseen color change or chemical reaction, be sure to diligently investigate

this. Working with a testing partner can help determine the next steps. The work is not over when a regulatory body gives the stamp of approval. Listen to the end-users — patients and physicians — for feedback on how the device is operating outside the testing lab. Continuous monitoring will help improve the device and provide insight for future projects. Packaging and labeling While not high on the priority list, packaging and labeling must be considered early in the process to meet regulatory requirements and avoid submission delays. Ensure that the intended clinical uses and instructions are not only documented well in study data but also prioritized for packaging. Bringing in the marketing team early can help with this process. Also, don’t forget to test the device from its ﬁnal packaging to detect any potential leachables transferred to the

ﬁnished device. It might seem unnecessary now, but planning packaging and labeling during the device testing can expedite the process and keep the device on track to meet the submission timeline. Sherry Parker is senior director of regulatory toxicology at WuXi AppTec Medical Device Testing (St. Paul, Minn.). Parker also serves as a member of ISO TC 194, WG 11 and is U.S. co-chair for the ISO TC 194 Mirror Committee.

Investing in the Latest Technologies Medbio is committed to the reduction of part to part variation with the use of robots and automation

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Medical Design & Outsourcing

2020

REGULATORY, REIMBURSEMENT, STANDARDS AND IP

Look outside your company for IP opportunities during unprecedented times COVID-19 has caused many companies to hunker down, protect the status quo and embrace a conservative mindset. But some are taking this time to seek out intellectual property (IP) opportunities.

David D. Headrick McAndrews, Held & Malloy

Image courtesy of McAndrews, Held & Malloy

t is said that 80% of the information in patents is never published anywhere else. Despite this treasure trove of knowledge, many companies do not systematically examine patents others are pursuing. Patent mapping — sometimes called landscaping — allows one to use search terms, patent classes and a database to see what patents others are pursuing in a given field. Years ago, this effort would entail excruciating, costly manual work. But today’s cloud-based software makes collecting and visualizing such information easier. For a given field, one can determine who is filing for and obtaining patents, how quickly they are filing, and where such patents and applications are concentrated. The results can be surprising.

with IP counsel to locate and eliminate grey- and black-market goods that eat away at market share. • Organize a series of collaborations between your innovators and technical sales staff by videoconference or in-person, with social distancing, to overcome the drag on creativity that can accompany working at home. Consider enhancing, again under appropriate conditions, their collaboration with the kind of patent landscape analysis described above.

Who are your patent competitors? “Competitors” in a given patent space are not the same as they are in the commercial marketplace. Universities, startups and small companies file for and obtain patents in areas of interest to medical device companies. Other companies may be filing and obtaining patents that use technology of one field in another. These situations can represent opportunities to those who take the time to study the data. Patent landscapes can provide valuable opportunities for a company whether by license, acquisition or joint venture. This is particularly true now as many IP holders look for ways to raise revenue. Even if you make no acquisitions or enter no agreements based on your efforts, you can gain vital competitive intelligence as to what is going on in technical fields of interest. Patent landscapes can also help your company make strategic decisions and stimulate in-house development efforts. But consult with IP counsel as to how to appropriately share the details with your innovators.

Consider IP pledged to ﬁght COVID-19 The COVID-19 pandemic has not only spurred a worldwide research effort; it has led organizations to make certain IP rights freely available via “open licenses” to those working to develop products to ﬁght the virus. Open COVID Pledge (OCP) is one example of such an organization that seeks “to accelerate the rapid development and deployment of diagnostics, vaccines, therapeutics, medical equipment and software solutions in this urgent public crisis.” OCP claims that IP holders have pledged the freeuse of more than 250,000 patents to date — all of which are searchable on OCP’s online database. The term of the open license extends one year after the World Health Organization declares COVID-19 is no longer a pandemic. Obviously, a company should exercise care before implementing such open technology in any product it might develop. But efforts like this represent a massive IP resource that did not exist until a few months ago. These may be unprecedented times, but companies, particularly those that rely on design and innovation for their business, should consider the unique IP opportunities that are available.

Tap into technical sales With the COVID-19 pandemic limiting or even preventing in-person sales calls, sales staffs may have idle time. Here are a few ways a medtech company can exploit the situation: • Apply the sales staff’s technical knowledge to work 74

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Such initiatives will help ensure that the innovation pipeline continues to ﬂow even though we all may be working separately in the near term. They can also build team camaraderie.

David D. Headrick is a shareholder at McAndrews, Held & Malloy (Chicago) with experience in both intellectual property litigation and advising clients on strategic intellectual property matters. He is recognized by IAM Patent 1000, and his practice also includes client counseling, intellectual property licensing, clearance opinions, intellectual property due diligence and patent and trademark procurement.

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Navigating regulations for in vitro diagnostics Working through the regulatory requirements for IVD devices in your target markets can mean a successful launch into an industry segment poised for great growth in the coming years.

Claudia Sirch Intertek

Image courtesy of the National Cancer Institute

n-vitro diagnostic (IVD) devices help detect diseases using samples from the human body, such as blood draws or mucus swabs. Examining these specimens provides essential information to identify, cure, treat or prevent illness. As populations age and pandemics such as COVID-19, SARS and other infectious diseases sweep the globe, the IVD market is expected to grow, resulting in an increased demand for early and simplified diagnosis and rapid-test products.

IVD regulatory requirements Global regulatory requirements for IVD products vary and often differ from requirements for other medical devices. In the U.S., Canada and Europe, requirements depend on product classification, which is based on risk level. Additionally, in Europe, the In Vitro Diagnostic Regulation (IVDR) for placing IVD products on the market came into force in May of 2017, replacing the IVD Directive (IVDD), with the www.medicaldesignandoutsourcing.com

transition ending in May of 2022. Changes under the IVDR include an expanded scope, reclassification of devices, and more stringent requirements regarding clinical evidence and documentation. It’s possible to use local, regional and international standards to demonstrate compliance with specific regulatory requirements for IVD devices. Examples include: • IEC 61010-2-101, EN 13532 and/or ISO 15197 for safety of IVD medical equipment/self-testing devices. • ISO 13485 for quality management systems. • ISO 14971 for risk assessment. • IEC 62304, IEC 62366-1 for software and usability. • IEC 61326-2-6 for electromagnetic compatibility (EMC). • EN 556 & ISO 11137, ISO 13408 series for performance, including sterilization and microbiological methods. • Standards for labelling, metrological traceability and more. IVD and medical electrical equipment (MEE) standards Selection of standards must be made carefully, keeping in mind specific regulatory requirements in the target market(s). For example, submissions to regulatory bodies for point-of-use or home-use products sometimes reference standards for medical electrical equipment like IEC 60601-1, IEC 60601-1-2 and IEC 60601-1-11. The FDA does not currently list IEC 61326-2-6 — the international EMC standard for IVD equipment — as a recognized consensus standard to which a Declaration of Conformity is accepted, but in the EU, EN 61326-2-6 is harmonized. If manufacturers want to use a voluntary FDA consensus standard, the IVD device should meet the requirements of AAMI/ANSI/IEC 60601-1-2 for MEE to provide evidence for compliance with EMC requirements. Standards for MEE are in many aspects more stringent than those for laboratory equipment, so manufacturers of IVD devices should identify the appropriate standards and apply their requirements from an early design stage. The European Commission has asked the European Committee for Standardization (CEN) and its Electrotechnical body (CENELEC) to harmonize standards with the Medical Device Regulation (MDR) and IVDR, but the process has been slow. As a result, although the new IVDR supports the use of 9 • 2020

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harmonized standards, they may not be available in time. Some manufacturers will have to take a different route to proceed, e.g. via standards harmonized under the IVDD or other state-of-art international or European standards. An international standard for IVD medical equipment The Third Edition of IEC 61010-2-101 was issued in 2018 and has been adopted and published as a national standard in the U.S. and Canada. It is used in conjunction with the general requirements for laboratory equipment covered by the Third Edition of IEC 61010-1:2010 and its Amendment 1:2016. Both are listed as standards operated in the IECEE CB Scheme, which is an international certiﬁcation program that helps manufacturers to gain access to global markets. IEC 61010-2-101 speciﬁes the safety requirements for equipment intended for IVD medical purposes, including selftest IVDs. Its focus is on the risks related

to the exposure of hazardous chemical substances, aerosol vapors, radiation and ﬂammable liquids, which are addressed by speciﬁc requirements for construction, markings and documentation. For hazards not covered by the general and particular standards, risk assessment shall be carried out and documented using the requirements of ISO 14971.

product development cycle. These might include pre-compliance checks, process evaluations, independent testing and product certiﬁcation. Make sure all testing and results are well-documented for the regulatory bodies. Navigating these requirements well can mean a successful launch into a market poised for great growth in the coming years.

Regulatory success Given the number and variety of standards, the regulatory requirements for the growing IVD market may seem daunting at first. Manufacturers must first consider which market(s) they wish to take their products to, then identify the applicable standards and requirements for that market. Being familiar with the requirements for various markets will help. Partnering with a knowledgeable third party can also be beneficial. Once the products and markets are identified, be prepared to conduct various checks and tests throughout the

Claudia Sirch is chief engineer for medical, laboratory, measurement and control equipment and laser products at Intertek. She has over 25 years of experience in the testing and certiﬁcation business, and is a lead and technical assessor in the IECEE CB Scheme.

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The regulatory roadmap Image courtesy of MIDI Medical Product Development

Here's how you embrace regulatory controls to map medtech innovation Using a properly formatted “roadmap” can help a medical device development team realize that the regulations are structured to yield innovation rather than stunt it.

Christopher Montalbano MIDI Medical Product Development

he complicated process of satisfying FDA requirements gives many medical device developers pause. This stems from the FDA not only prescribing the detailed method for putting a medical device through its development process, but also requiring the company(ies) associated with the development to embed this process into their essential DNA — documenting it within the organization’s quality management system (QMS). The QMS should describe and provide a visual roadmap so an organization can consistently deploy innovation in its engineering development work. The best way to explain the roadmap and how it leads to innovation is to open up the map, view the entire scope and discuss the three key stops along this innovation journey. The maturity of a team’s medical device development program will determine if a company deploys extensive activities at each of these stops, or in some instances, pauses brieﬂy to check there is enough intelligence and collateral knowledge in place before moving on to the next stop. Stop No. 1: Market exploration & discovering opportunities The FDA guidance recognizes this as a quintessential activity for any business, yet makes it known that its regulatory controls such as Design Controls & Risk Management do not have to be performed at this point. In Stop 1, you set the stage for establishing a value proposition between the internal stakeholders (the corporation) and the external stakeholders such as doctors, patients, purchasing decision-makers and payors. It’s important to identify and explore external needs. This is often what unlocks innovation and makes your company stand out from the competition. Stop No. 2: The technology R&D process The emphasis at this stop is on iteration, testing and incorporating feedback between iterations, or “agile sprints.” Each sprint is an opportunity to advance the www.medicaldesignandoutsourcing.com

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device both iteratively and incrementally. The idea behind an iterative agile sprint process is to innovate, design and engineer proof of concept and minimum viable product (MVP) of the device and/or technology application. The express purpose is to capture feedback both internally and externally from multiple perspectives. MVP test results should indicate if the device meets the overall criteria set forth in the previous stop on the roadmap. This approach fosters a quality feedback loop for system function, reliability and throughput. Stop No. 3: Commercialization and implementation Now is the time the development team needs to pay attention to ISO-13485. I encourage medtech companies to view the standard not as a constraint, but rather as a guide to being systematic and well-documented, allowing you to standardize the process and free your teams to focus on implementing and commercializing their innovations. Standardizing the process requires a robust QMS to define in detail the work that needs to be done. The team now starts the process of capturing and mining user requirements to develop the more refined aspects of device innovation. It breaks the user requirements down into device requirements or specific feature definitions. User requirements must be decomposed into device requirements, or specific feature definitions. Mapping out goals and using customer-focused development can yield innovative device features, unlocking new intellectual property that can enhance device value. Chris Montalbano is co-founder and CEO of MIDI Medical Product Development. He is a member of the Stony Brook University Center for Biotechnology advisory board; has served as a guest judge for BiomedX at Columbia University and as a Texas Medical Center external innovation advisor. 9 • 2020

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Image from Prateek Katyal on Unsplash

2020

5 keys to stronger medtech agreements

It’s important to avoid missteps while protecting your medtech company’s innovations. Top Greenberg Traurig attorneys explain how. David J. Dykeman and Bethany A. Stokes G r e e n b e r g Tr a u r i g

hen entering into partnerships and collaborations, a medtech company needs to have strong protection of its intellectual property (IP), which is often the company’s crown jewels. Non-disclosure, joint venture, licensing and collaboration agreements are integral to a medtech company’s growth, but not without risk. Building collaborative relationships through the sharing of proprietary technology and confidential information can strengthen your position in the market. However, collaborative relationships may end unexpectedly, leaving parties in vulnerable positions unless their rights have been protected with carefully considered written agreements. In the worst case, the two parties wind up in court or arbitration fighting about the interpretation and intent of an agreement drafted many years earlier. Successful collaborations involve complex negotiations related to issues such as maintaining confidential information, controlling research and development (R&D), ownership of intellectual property,

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timing of payments and profits, and ultimately, termination. Although each collaboration is unique, medtech companies should ensure that written agreements address the following five key aspects to help protect IP and prevent the loss of rights: 1. Confidentiality Negotiating collaborations with third parties often requires disclosing confidential information to the other party, who may also work with your competitors. Prior to divulging any confidential information, parties should execute a written non-disclosure agreement (NDA) that prohibits sharing confidential information with any third parties or using confidential information for purposes other than its intended use. If a separate NDA is not entered into by the parties, it’s important to include comprehensive confidentiality provisions in the main agreement governing the collaboration. 2. Ownership of IP and improvements Innovators must ensure that they maintain ownership of IP and all improvements to the product that

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may result from a collaboration. Collaborations often have ownership rights granted in proportion to the contribution made to the invention, but rights are sometimes divided by technology ﬁeld or level of expertise. Any agreement governing a collaboration should include assignment of any improvements to the original innovator and grant a limited license to the collaborator only to the extent and time period necessary to complete the collaboration. It’s important to provide special consideration to pre-existing IP that each party brings into the collaboration and draft the agreement

companies need to consider whether agreements should be automatically assigned upon a merger, acquisition or change of control, or if prior written consent for assignment is required. Automatic assignment of the agreement without consent may result in a party working with a competitor or other party they did not initially intend to engage. 5. Termination No matter how successful, most collaborations will come to an end. Agreeing to the details of an orderly termination in writing before entering a collaboration is critical to avoid a

This article reﬂects the opinions of the authors, and not of Greenberg Traurig or Medical Design & Outsourcing. The article is presented for informational purposes only and it is not intended to be construed or used as general legal advice nor as a solicitation of any type. David J. Dykeman is a registered patent attorney with more than 23 years of experience in patent and intellectual property law, and co-chair of Greenberg Traurig’s global Life Sciences & Medical Technology Group. Dykeman’s practice focuses on securing worldwide intellectual property protection and related business

Learn “How COVID-19 is creating new IP and litigation challenges for medtechs” in this DeviceTalks Tuesday.

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On Demand presentation by Greenberg Traurig. https://www.devicetalks.com/devicetalks-tuesdays-on-demand-sessions/

ENGINEERING BETTER DEVICES. BUILDING BETTER COMPANIES.

to protect each party’s background IP. Any agreement should also address each party’s responsibilities regarding (1) ﬁling of new patent applications and maintenance of patents and (2) litigation obligations related to patent infringement lawsuits and disputes. 3. Payments, milestones and royalties Conﬂicts can arise when valuing the contribution of each party to a collaboration because it often determines the balance of power between the parties. Medtech agreements should clearly describe each party’s contributions, expected efforts and compensation. Upfront payments, milestone payments or running royalties can all be appropriate; negotiate them thoughtfully. Often one party provides funds to cover the initial R&D costs associated with the collaboration. Alternatively, it’s possible to use milestone payments to minimize the risk associated with upfront payments. 4. Assignment and change of control While present at the end of most agreements, assignment clauses deserve careful review and attention. Medtech

messy dissolution. Termination clauses should address (1) when a party may terminate the collaboration; (2) who owns patents and other IP rights upon termination; and (3) the circumstances of termination. Parties will typically agree to termination in the event of a material breach of the agreement, insolvency, change of control, force majeure (be sure to include pandemics) or failure to timely supply product. Parties should also require adequate notice of termination and agree on what, if any, contractual obligations will survive termination, for example conﬁdentiality, intellectual property and payment obligations. In particular, ownership and control of the designs, molds and manufacturing or regulatory documentation upon termination should be clearly addressed. Protecting IP through thoughtfully drafted written agreements is key to building a successful medtech company. Prior to disclosing conﬁdential information or addressing intellectual property rights, a medtech company should safeguard its interests with thoroughly negotiated written agreements that protect IP and support a successful collaboration. www.medicaldesignandoutsourcing.com

strategy for high-tech clients, with particular experience in medical devices, wearables, robotics, life sciences and information technology. Bethany A. Stokes is of counsel at Greenberg Traurig in Boston. She advises clients on procurement and enforcement of IP rights, including domestic and international trademarks. Stokes also focuses on technology licensing, including negotiating and drafting of licensing, joint venture, collaboration and other IPrelated agreements.

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Medical Design & Outsourcing

2020

SOFTWARE

Developing software for safety in medical robotics As healthcare robotics continues to evolve, well-designed software will be paramount to safety and consistent performance.

Image courtesy of MedAcuity.

Susan Jones MedAcuity Software

he use of robotics in medtech continues to grow. Whether it’s a cobot working alongside humans to automate manufacturing or a surgical robot in the OR, a single point of failure can cause serious harm. The incorporated software systems must take safety into account. IEC 61508-3 offers several techniques for developing software for safety-related systems, which the medical device software development community can draw on when designing and implementing risk-control measures as required by ISO 14971. Developing “safe” software begins with establishing a software coding standard. IEC 61508-3 promotes well-known techniques, including: • • • • • • •

Using modular code. Using preferred design patterns. Avoiding reentrance and recursion. Avoiding dynamic memory allocations and global data objects. Minimizing the use of interrupt service routines and locking mechanisms. Avoiding dead wait loops. Using deterministic timing patterns.

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Keep it simple There are other suggestions under the “keep it simple” principle around limiting the use of pointers, unions and type casting, and not using automatic type conversions while encouraging the use of parentheses and brackets to clarify intended syntax. A hazard analysis might identify that your code or data spaces can get corrupted. There are well-known risk-control measures around maintaining code and memory integrity which can be easily adopted. Running code from readonly memory, protected with a cyclic redundancy check (CRC-32) that can be checked at boot time and periodically during runtime, prevents errant changes to the code space and provides a mechanism to detect these failures. Segregating data into different memory regions that can be protected through virtual memory space, and using CRC-32 over blocks of memory regions or even adding a checksum to each item stored in memory allows these CRC/ checksums to be checked periodically. CRC/checksums can be veriﬁed on each read access to a stored item and updated atomically on every write access to these protected items. Building tests into the software is an important

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tool as well. Itâ&#x20AC;&#x2122;s a good idea to perform a power-on self-test (POST) at power-up to make sure the hardware is working and to check that your code and data spaces are consistent and not corrupt.

results in unexpected failures. Itâ&#x20AC;&#x2122;s possible to avoid these failures by controlling latency in the software. State machines, software watchdogs and timer-driven events are common design elements to control this.

What else can happen? Another hazardous situation arises when controlling and monitoring are performed on the same processor or in the same process. What happens to your safety system if your process gets hung up in a loop? Techniques that separate the monitor from the controlling function introduce some complexity to the software system, but this complexity can be offset by ensuring the controlling function implements the minimum safety requirements while the monitor handles the fault and error recovery. Fault detection systems and error recovery mechanisms are much easier to implement when designed from the start. Poorly designed software can experience unexpected, inconsistent timing, which

Keep an eye on communications Inter-device and inter-process communications are another area of concern for safety-related systems. The integrity of these communications must be monitored to ensure they are robust. Using CRC-32 on any protocol between two entities is recommended. Separate CRC-32 on the headers and the payload helps to detect corruption of these messages. Protocols should be written and designed with the idea that at any time, your system could reboot due to some fault. Thus, building in retry attempts and stateless protocols is recommended. Safe operational software verifies the ranges of all inputs at the interface where it is encountered; checks internal variables

for consistency; and defines default settings to help recover from an inconsistent setting or to support a factory reset. Software watchdog processes can be put in place to watch the watcher and ensure that processes are running as they should. By taking these techniques into account, software developers working on medical robotic devices can better address the concerns of safety-related systems. Susan Jones is engineering manager for software quality at MedAcuity. She has over 25 years of experience in various roles leading a high-technology organization.

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2020

STERILIZATION SERVICES

How decontamination could solve the COVID-19 mask shortage problem With cold and ﬂu season rapidly approaching, public health oﬃcials worry about a resurgence of COVID-19 and personal protective equipment shortages. Protecting frontline workers will likely include decontaminating face masks.

Nancy Crotti Managing Editor

spike in COVID-19 cases this fall and winter could leave healthcare facilities with renewed shortages of personal protective equipment — particularly masks. Hundreds of frontline healthcare workers have died from the virus since the pandemic struck in China in 2019, bringing the need for effective face masks into sharp relief. But despite the efforts of 3M and other companies worldwide to boost production of the most effective filtering masks — N95s — there still might not be enough. N95s, which filter out 95% of airborne particles, were designed for industrial use; for medical use, they should be discarded after every patient encounter, according to the Centers for Disease Control and Prevention (CDC). But pandemicinduced shortages have forced healthcare providers to wear the same mask for full shifts and for hospitals and clinics to seek ways to reuse them. A number of researchers have studied the efficacy of mask decontamination systems. As of September 4, the FDA had granted emergency

Medical Design & Outsourcing

9 • 2020

use authorizations (EUAs) for 10 decontamination systems, nine of which use vaporized hydrogen peroxide (VHP) and one that uses supercritical carbon dioxide — a ﬂuid/gas combination created by pressurization. The National Institute of Occupational Safety and Health (NIOSH) has also said that ultraviolet germicidal irradiation, VHP and moist heat have shown the most promise. Other methods under study include peracetic acid and ethylene oxide. Medical Design & Outsourcing talked to a researcher who recently studied mask decontamination methods for effectiveness in killing the virus and in not damaging masks or their straps. Co-lead investigators Dr. Anand Kumar, an infectious disease and critical care specialist at the University of Manitoba’s Health Sciences Center, and Jay Krishnan, senior biosafety ofﬁcer at the National Microbiology Laboratory of the Public Health Agency of Canada in Winnipeg, studied seven possible

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decontamination methods. The researchers have submitted the study for publication. “The study basically demonstrates which methods might be most effective and easily implemented,” Kumar said in an interview. “We basically found that a couple of them were particularly strong, and a couple that we had hoped would work didn’t.” Their conclusions: The best and most practical method is the application of moist heat at about 70 °C (158 °F) for an hour or so at about 25% humidity, which helps kill the pathogen. Moist heat decontamination can easily be done in bulk, and leaves no chemical residue that would require extra aeration time. It can even be performed in hospital blanket heaters, Kumar posited. “Most can be adjusted to 70 degrees, and if you put a large pan of water in it, you’d hit 22% humidity,” he explained. “That means you can do it in any ward in North America. Most of them have these blanket heaters.” Vaporized hydrogen peroxide is not as easily accessible, but the researchers found it to be effective. Peracetic acid fogging also worked well. “It’s not routinely used in most places, but it is a technique that can be quite easily performed,” Kumar said of peracetic acid. “You can set up to do it quite easily.” Ethylene oxide, which is widely used to sterilize medical devices, also worked well, but required 24-hour aeration to eliminate toxins. “Between the toxicity and the long cycle time, I don’t think it’s really practical,” Kumar said. Ultraviolet light (UVC), which has been touted as an effective decontaminant, failed in the Winnipeg study. “If you actually do the decontamination as suggested by some other groups and dissect the mask, you would ﬁnd a fair amount of virus still there,” Kumar said. “The ultraviolet light does not penetrate through the multiple layers of most of these kinds of masks.” Educational institutions including Duke University have received EUAs to set up mask decontamination equipment in dedicated spaces. Michigan State University’s Animal Care Program received one of the most recent EUAs for this purpose in July.

The animal care program in Lansing, Mich., has used vaporized hydrogen peroxide for years to decontaminate rooms between uses by different animals and projects, according to veterinarian Dr. F. Claire Hankenson, director of campus animal resources and a professor of pathobiology and diagnostic investigation. On March 31, Michigan’s governor and the university president contacted the veterinary center to ask if staff would consider mask decontamination. Hankenson co-authored a study on the efﬁcacy of vaporized hydrogen peroxide (H2O2) to decontaminate masks

the decontamination program will save users money. She has found that prices for N95 masks can range as high as $5 apiece, but the Animal Care system will be able to recycle them for about 25 cents each. “The most gratifying thing was just this incredible coming together of experts who were interested in doing whatever they could to help the community,” Hankenson added. “It was incredibly rewarding to work with everybody.”

If you actually do the decontamination as suggested by some other groups and dissect the mask, you would find a fair amount of virus still there.

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in an unused 20,000 ft2 building. H2O2 was delivered to rooms using robotic HaloFoggers, dispersing H2O2 vapor and increasingly concentrated microdroplets as a fog for a timed period based on cubic footage of rooms. Published in May in Applied Biosafety, the journal of the Association for Biosafety and Biosecurity, the peer-reviewed study determined that it’s possible to clear a variety of N95 respirator types and sizes of potential bacterial and viral agents using VHP in a controlled fog/dwell/exhaust cycle. Hankenson described how it works: After the prepared masks are loaded in the rooms, the VHP decontamination cycle takes six hours. Once complete and effectiveness is verified, the equipment is packaged and picked up by staff from participating healthcare and first responders’ facilities. The process is designed to reduce the possibility of crosscontamination and ensure each piece of equipment is returned to the original user. The Michigan State system can decontaminate up to 7,000 respirators daily, which the authors wrote “will address the predicted surge of COVID-19 cases in the state, and ultimately allow each respirator to be reused multiple times. There is no other public site in the region with our capacity to offset the continued supply chain issues for PPE needs.” In addition to helping keep frontline healthcare workers and first responders safe from COVID-19, Hankenson hopes www.medicaldesignandoutsourcing.com

How plasma treatment offers green, costefficient preparation of plastics Surface treatment to prepare medical device components for printing or bonding may require complex cleaning methods or harmful chemicals. Plasma etching for improved adhesion, once limited to low-pressure chambers, is now available at atmospheric pressure. Erhard Krampe Plasmatreat

Image courtesy of Plasmatreat

onventional methods of surface preparation, treatment and modification of medical devices made of PTFE, FEP and polyamide are usually expensive, harmful and very limited in their application range. Essentially, there are two processes. One operates with low-pressure plasma and enables surface pretreatment of a single or a large number of products in a batch process. In this case, a homogeneous treatment of the entire surface takes place in a low-pressure chamber. The other process allows for rapid, continuous treatment of a product within the production line under atmospheric pressure. Both plasma processes use process gases that are converted into an excited state. The excited molecules, ions and free electrons interact on contact with surfaces such as rubber, metal, plastic or ceramic and change the surface chemistry. Deep-cleaning fluoropolymers The fluoropolymers used in manufacturing catheters are largely resistant to conventional surface treatment methods, normally requiring extreme chemical treatment, such as sodium etching. This method is environmentally harmful and expensive. It may require the application of an additional primer or bonding agent and discolor the material, which is problematic for maintaining product aesthetics. In contrast, plasma pretreatment gently and reliably removes parting agents and organic contaminants from surfaces and subjects them to ultra-fine cleaning. During the same process step, plasma activation can also be carried out to enable adhesives and coatings to adhere later. Low-pressure plasma etching can remove contamination from the surface of PTFE in a targeted manner using defined process gases at the nanometer level. In a next step, the removal of functional layers www.medicaldesignandoutsourcing.com

allows the PTFE to be optimally prepared for permanent connections within a certain time window. Since this process is carried out under vacuum and with neutral gases, it is much more environmentally friendly and also much easier to handle. A recent study compared the adhesive bonding of the fluoroplastics FEP and PFA after plasma modification and after tetraetching. As expected, at the beginning almost no adhesion was achieved on an untreated surface. Both the tetra-etched and the plasma-treated samples showed a significant improvement in adhesion strength. The introduction of cost-effective plasma processes using a low-pressure or open-air plasma system, depending on the application, has largely eliminated the use of harmful chemicals, which has significantly reduced the amount of toxic process waste. COVID-19 test applications The same process attributes of plasma surface treatment may be used in other medtech applications, including the treatment of test kits for COVID-19. Demands for greater efficiency of these test processes are constantly increasing, including a requirement to use as little analysis substrate as possible to minimize the costs of individual tests. This can be achieved by a hydrophobic surface coating applied specifically in the area of the test that comes into contact with liquid. Super-hydrophobic coating, which is applied locally by an open-air plasma system, meets this requirement. These coatings, which are only nanometers thick, also fulfill the highest analytical demands with regard to optical transparency and sealing. As a dry-cleaning technology, plasma processes replace costly manual or wet-chemical/solvent-based cleaning processes, thereby meeting increasing demands for reducing volatile organic chemicals during manufacturing. They also reduce cycle times. The surface properties can be customized for different purposes, such as adhesive, oleophobic/ oleophilic, hydrophobic/hydrophilic and other desired functionalities. Erhard Krampe is head of Plasmatreat Academy & Market Segment Management Medical Technology. Krampe completed his studies in medical technology at the Technical University of Munich and at the RWTH Aachen â&#x20AC;&#x201C; Institute for Plastics Processing. 9 â&#x20AC;˘ 2020

Medical Design & Outsourcingâ&#x20AC;&#x192; 85

2020

TUBING

What's next for nitinol tubing? Complex extrusions open up design, quality and performance possibilities for medical tubing products, such as catheters, wound drains and hemodialysis tubing. Mark Broadley Viant

itinol has revolutionized the medical device industry. With its flexible superelasticity, shape memory and biocompatibility, nitinol has become a go-to material for medical devices. But this nickel/titanium alloy has its downsides. First, it’s relatively costly. So while an all-nitinol device may meet performance requirements, it may not be practical from a cost standpoint. As a result, medical device designers might specify nitinol for a specific component that needs flexibility, and spec another material, such as stainless steel, for adjoining components. But that’s the second downside: Nitinol is difficult to solder or weld, both to itself and to other materials. Currently, if you want to weld nitinol to stainless steel, you need an intermediate component of an alternate material that is compatible with both materials. For simpler product forms like wire, this may be a

Image courtesy of Viant

Medical Design & Outsourcing

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cost-effective approach. But for more complex product forms like tubing, the cost and lead time for the intermediate component as well as the more complex tube-welding method make this approach less attractive. Novel joining technique At Viant, we’ve developed a novel technique (patent pending) to mechanically join nitinol to other laser-cut metals — commonly, stainless steel. Let’s start with an analogy. As a kid, did you ever play with a small cylinder of brightly colored, woven bamboo called a “Chinese finger trap?” You put your index fingers in each end of the cylinder, and when you try to pull them out, it only tightens the trap. (You escape the trap by pushing the ends toward the middle, which enlarges the ends and releases your fingers.) The same principle is at work in this puzzle-cut, tube-joining technique. We cut a number of lobes around the circumference of the end of the nitinol tube, and cut lobes of a complementary size and geometry around

2020

TUBING

the end of the stainless steel tube. When we push the nitinol lobes into the spaces between the corresponding stainless steel lobes, the nitinol lobes spring back to their previous shape to mechanically engage and lock the joint, like connecting interlocking puzzle pieces, or like the finger trap holds your fingers. It’s quick and easy to assemble, with a satisfying snap. The benefits? First, you save cost by limiting the nitinol in your design to only the components that rely on its performance characteristics. Second, you eliminate the cost of the intermediate component, as well as the laser welding and the associated verification process, which mitigates risk. And third, you’re joining tubes of different materials together without a containment sheath or aligning wires. This allows a low-profile connection that doesn’t obstruct the inner lumen so that it can accommodate a wire for additional device functionality. In terms of technical considerations, it’s critical that the nitinol tubing has uniform wall thickness to avoid “whipping” when being rotated while bent. We perform 100% ultrasonic inspection of nitinol tubing to ensure uniform wall thickness around the circumference. In addition, welded stainless steel tubing is cold-worked and annealed during the manufacturing process to ensure homogenous dimensional and mechanical properties around the circumference. Material strength is also a design consideration. If a joint is designed for tensile loading, it’s important to have enough strength in the tube to withstand the load in both the nitinol and stainless steel lobes. This can be evaluated by performing an FEA analysis on a designed component and confirmed by functional device testing to ensure it meets mechanical requirements.

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Medical Design & Outsourcing

9 • 2020

Applications When we were developing this technology, we had been working with a customer on a robot-assisted, wristed endoscopic device. The design involved a nitinol actuator that transmits motion from a robotic device through the wrist to tools used to operate. When we priced out a nitinol actuation system, the cost was prohibitive due to the high cost of the long nitinol actuation tube. So we thought that if we could join nitinol with a less expensive material, like stainless steel, while retaining the nitinol only at the wrist, we could save costs. We estimate that using this puzzle-cut joining technique would have reduced the cost of the device by 30%. This technique could also be used for devices that need flexure but also need tension or torsion actuation through a flexing location, for orthopedic drives that require going around corners, or for a flexible drive that can transmit torque. Another application is catheter-based products that have a flexible section to enable the user to articulate around a bend or a curve. Limiting nitinol to just the section that needs flexibility — rather than using it for the entire length of the device — saves costs. Our initial development of this mechanical joint has focused on a basic symmetric lobe design, consistent with a push-together assembly method, cut into thin-walled tubing. Alternate lobe designs with tilting lobe geometries, consistent with a push-andtwist assembly, may allow the joint to transmit more torque in a preferred direction. Alternate tube designs with thicker walls will increase the strength of the joint under tension and torque as well as forces that would tend to misalign the joint. Mark Broadley is product solutions director at Viant. He provides technical support for Viant’s operations and commercial teams in metals and tube applications.

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How fish physiology is enabling Boston Scientific to help atrial fibrillation patients Company researchers developed cardiac ablation technology that mimics the navigation system of electric fish. Image courtesy of Adobe Stock

Nancy Crotti Managing Editor

cientists have studied electric fish for decades to determine how and why they discharge electricity. Recently, a couple of biomedical engineers at Boston Scientific realized that the way these fish use their electrical impulses to navigate around hazards could apply to treating atrial fibrillation (AF). The result is DirectSense technology, which the company uses in its Intellanav MiFi open-irrigated (OI) ablation catheter to measure local impedance — or the amount of resistance — in the tissue to the electrical current that the catheter is applying. Here’s how ablation works: One cause of atrial fibrillation is heart tissue that extends into one of four pulmonary veins that travel from the lungs to deliver oxygenated blood to the heart. This tissue can be irritable, releasing chaotic

What we're really doing here is giving physicians a little bit of light in a dark room. It makes their jobs just a little bit easier. www.medicaldesignandoutsourcing.com

electrical signals that reach the heart’s upper chambers and cause an abnormal rhythm. Cardiac ablation scars or destroys that tissue and restores normal heart rhythm. In the past, electrophysiologists looked at the mechanical connection of catheter to tissue in order to apply radiofrequency (RF) pulses to destroy tissue that they believed was causing the irregular heartbeat. However, they have never had a direct measure of the electrical coupling of catheter to tissue, which provides important insights, according to Dr. Kenneth Stein, SVP and CMO for Rhythm Management and Global Health Policy at Boston Scientific. Three miniature electrodes near the distal end of the Intellanav catheter provide data on the impedance around the catheter tip to measure the tissue’s ability to respond to RF energy before physicians deliver therapy. During ablation, DirectSense tracks the change in local impedance which, in conjunction with other measures, helps physicians understand tissue characteristics and how they are affecting that tissue. These insights may indicate temperature change in the tissue, helping to reduce the chances of over-ablation and avoid complications. Boston Scientific researchers did extensive modeling and preclinical experiments and some detailed human trials to determine if the data produced 9 • 2020

Medical Design & Outsourcing 89

2020

TUBING Image courtesy of Boston Scientiﬁc

by DirectSense were meaningful, according to Stein. Data from a retrospective analysis of the technology, presented at Heart Rhythm Society 2020 Science, revealed a local impedance decrease of ≥16.6 ohms with an inter-lesion spacing of ≤ 6mm and a ≥ 98% positive predicative value of durable pulmonary vein block at 3 months in patients with AF. In other words, if the spacing is less than 6 mm apart every time you move the ablation catheter, you can have a 98% assurance that you have a complete ablation with no gaps, Stein explained. The durability of the ablation lesions is critical to the procedure’s long-term success. “This is a safe procedure. It’s an effective procedure,” he added. “(But) no one wants to undergo it twice.” Boston Scientiﬁc launched DirectSense in the EU in 2018 and gained FDA approval for the technology in April 2020. The company waited until June 1, 2020 to launch in the U.S. because so few people were undergoing elective procedures

during the COVID-19 pandemic. The reception among physicians has been positive, according to Stein. Boston Scientific even made a video about how the technology was developed. In it, research scientist Jake Laughner explained how specialized cells in electric fish enable them to detect hazards. “Electric fish use electrophysiology

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Medical Design & Outsourcing

9 • 2020

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to actually navigate every single day,” Laughner said. “Why shouldn’t we be using this really elegant system and apply this to our catheters?” “What we’re really doing here is giving physicians a little bit of light in a dark room,” added fellow research scientist Matt Sulkin. “It makes their jobs just a little bit easier.”

What is an echogenic catheter? Echogenic catheters are designed to maximize visibility. Once the catheter is in the physician’s desired location, the needle can be removed easily.

Danielle Kirsh Senior Editor

ealth providers use echogenic catheters to improve visibility in a number of ultrasoundguided catheterizations. These catheters may be used in many applications. For example, echogenic catheter-overneedle systems can be used for continuous nerve block. There’s also a use for echogenic catheters in ultrasoundguided embryo transfer in in vitro fertilization programs. In a 2006 study, echogenic catheters enabled catheter identiﬁcation under ultrasound for the duration of the embryo transfer procedure. In a 2014 study pubished in the Journal of Ultrasound in Medicine, an echogenic catheter was used as a nerve block for a paravertebral anesthesia block. The results

Image courtesy of EpiMed

demonstrated superior ultrasound visibility of the entire length of the test catheter compared to a control. Echogenic catheters are designed to maximize visibility. Some catheters feature a touhy needle that includes etched imprints on the needle tip that reﬂect ultrasound for brighter visualization. Catheter tips can be purposely directed to an exact location without needing to thread. Once the catheter is in the physician’s desired location, the needle can be removed easily. There are several companies that make echogenic catheters, including B. Braun and EpiMed.

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Medical Design & Outsourcing

TI OT OR R Y C EDIT C N NA GING NA MA

Medical Design & Outsourcing

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t’s been a tumultuous few years for the medical device industry, with highs and lows that no one could have foreseen. President Donald Trump’s administration streamlined some FDA processes. The medical device excise tax, enacted during the Obama-Biden administration, was permanently repealed. But any normal state of affairs in the industry was upended by the coronavirus pandemic. COVID-19 disrupted supply chains, brought elective surgeries to a halt and attracted all sorts of businesses to jump into an industry that they knew nothing about. The pandemic also brought www.medicaldesignandoutsourcing.com

about unprecedented cooperation within medtech and between medtech and companies in other industries, such as automotive. Now medtech has to balance which presidential candidate would be best for the industry going forward. We asked a few observers how they foresee the effects of another Trump administration versus a Biden presidency. Here’s what they said: Shaye Mandle, president & CEO of the Medical Alley Association, the trade group for Minnesota’s medtech hub, said the industry has been fairly satisﬁed with changes at the FDA that began under President Obama and continued under Trump. But, he said, the pandemic may have changed the regulatory landscape for good. The FDA has been aggressively working to bring products to market to help COVID patients and those who care for them, and CMS has extended Medicare coverage for more devices. “The expectation in particular on the part of the American public and patients, to see the federal government being more focused on innovation and getting products to market because of COVID-19, I think is something that would be difﬁcult to walk back on for either president if they wanted to,” Mandle said. 9 • 2020

Medical Design & Outsourcing

PRESIDENTIAL ELECTION

He termed Trump’s support of business tax reform as “strong” but declined to speculate on whether a President Biden would push Congress to enact a new medical device tax. As far as tariffs are concerned, the industry has not been pleased with all of Trump’s decisions. Mandle found it difficult to predict what Biden would do about tariffs, but noted that the tariff situation was different under Obama than it has been with Trump. “The key for us is going to be seeing how the next administration works with industry to accomplish those goals that are in the national interest but also in the industry’s interest,” Mandle said. Patient safety activist Madris Tomes worries about the political and practical issues brought on by the pandemic. “Companies that have never produced medical devices before now are creating them. You have to monitor and do postmarket surveillance on those devices,” she said. Those companies may not know how to follow such guidelines for products that the FDA authorized them to sell during the public health emergency. “I haven’t seen anything put out by the CDC or the FDA to guide any of these newer vendors in this space,” added Tomes, CEO of Device Events and a former FDA public health analyst. She believes that the Trump administration is putting political pressure on the FDA not only to grant emergency use authorizations — which don’t require the usual amount of agency screening for safety and efficacy — but to speed a COVID-19 vaccine to market. If the agency approves an ineffective COVID-19 vaccine, it could fuel the anti-vaccine movement and lead to more cases of other diseases such as measles, Tomes said. The agency had many issues that needed fixing before Trump’s election in 2016, including a need for more money from Congress to increase postmarket surveillance of medical devices, she added, noting that more than 1 million medical device adverse events were reported to the agency in 2019. Whether a Biden administration would push for such funding would depend on the level

of advocacy for it, Tomes said. “It’s not an outrageous ask; it’s a very practical ask,” Tomes said. “They’d only need 10 scientists. It could save a lot of lives.” Brian Johnson, president of the Massachusetts Medical Device Industry Council (MassMEDIC), said the outlook for the FDA will depend on who’s in charge. Trump appointee Dr. Stephen Hahn is still in his ﬁrst year heading the agency, he noted. If Biden wins, FDA leadership will likely change. “We believe strongly that the FDA is a critical agency to the safety of the American people and believe that, no matter which party is in charge, the FDA should be given the resources necessary to keep America safe,” Johnson said. “In a time of great uncertainty, with the COVID-19 pandemic still a major threat to our country’s health, the FDA should not be used as a political football.”

The key for us is going to be seeing how the next administration works with industry to accomplish those goals that are in the national interest but also in the industry's interest.

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National medtech industry trade group AdvaMed remains apolitical, according to CEO Scott Whitaker, who declined to comment on the election's outcome. But speaking as CEO of Stryker, AdvaMed chairman Kevin Lobo said in a September 11 news conference that both campaigns' promises to "reshore" medical device production to the U.S. due to pandemic-induced supply chain problems must be reconciled with the complexity of medical devices themselves. “We operate a global supply chain, as do many other medtech companies," Lobo said. "There are products that we export, there are products that we import, there’s components that we www.medicaldesignandoutsourcing.com

import and components that we export. “Medical devices are complex, they're not sort of singular items, and so any kind of challenges that are presented by any nationalistic policies, whether they’re in the United States or whether they’re in China or whether it’s other countries, are things that we will work through, and we’ve been able to do that throughout this pandemic to keep our supply chains operating very, very well," Lobo added. "That’s kind of how we operate, and we expect to continue to be able to operate in the future. The key is to be able to make sure that devices are available. That’s why the (national) stockpile is so very important an initiative to make sure that the right products are available through the pandemic. We’re optimistic at being able to continue to operate the way we do today with global supply chains.”

PRESIDENTIAL ELECTION

M E D T E C H E M P L O Y E E S V O T E W I T H T H E I R WA L L E T S Medtech company employees and their families have donated $289,533 to former Vice President Joe Biden, versus $190,570 to President Donald Trump’s campaign, according to OpenSecrets.org. Check out our breakdown covering 25 of the largest companies. Danielle Kirsh

MEDICAL DEVICE COMPANY EMPLOYEES’ preference in the U.S. presidential election appears to be clear: They’re providing more money to the Democratic presidential nominee Joe Biden, according to campaign contribution data compiled by the nonpartisan, nonproﬁt Center for Responsive Politics’ Opensecrets.org.

Senior Editor

The difference is even starker when adding donations to other Democrats who failed to secure the nomination. As of June 30, employees and their families at 25 major medtech companies had donated nearly $1.1 million. Biden received 26.6%, Bernie Sanders received 21.6%, Trump received 17.5%, Elizabeth Warren received 11%, Pete Buttigieg received 9.6%, Amy Klobuchar received 8.6% and Andrew Yang received 4.8%. Kamala Harris, Cory Booker, Tulsi Gabbard and Beto O’Rourke received too few donations to be included in the analysis. Biden beat Trump among employee donations at 19 of the 25 companies. As the COVID-19 pandemic continues, Biden has campaigned on shifting production of medical equipment and other products back to the U.S. to create jobs and bolster the domestic supply chain. Biden on his campaign website said he wants to reinforce stockpiles of a range of

critical products on which the U.S. is dangerously dependent on foreign suppliers. He also said he plans to build toward “ﬂexible American-sourced and manufactured capability to ensure we are not vulnerable to supply chain disruptions in times of crisis.” President Trump, on the other hand, announced in early August that he would ensure essential medical supplies are produced in the U.S., according to a White House press release. During his term, Trump approved legislation permanently repealing the medical device tax, which was enacted as part of the Affordable Care Act in 2010. Biden also could have an advantage among medical device company employees because the U.S. medical device industry is based in more progressive states, including California, Massachusetts and Minnesota. All three states had a U.S. senator seeking the Democratic nomination this year. Here’s how much employees at 25 of the largest medical device companies in the world donated to presidential candidates as of June 30.

TOP: Former Vice President of the United States Joe Biden. Image courtesy of Gage Skidmore on Wikimedia Commons

BOTTOM: President of the United States Donald Trump

Image courtesy of Gage Skidmore on Wikimedia Commons

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PRESIDENTIAL ELECTION

M E D T E C H E M P L O Y E E S V O T E W I T H T H E I R W A L L E T S (continued)

Medtronic Klobuchar: $65,824 (29%) Biden: $44,317 (19%) Sanders: $40,263 (18%) Trump: $25,819 (12%) Warren: $19,565 (9%) Buttigieg: $16,199 (7%) Yang: $10,087 (5%) Total: $222,074

Cardinal Health Sanders: $14,372 (25%) Biden: $14,328 (25%) Trump: $8,809 (16%) Warren: $7,583 (13%) Yang: $5,210 (9%) Buttigieg: $4,458 (8%) Klobuchar: $1,723 (3%) Total: $56,483

Zimmer Biomet Trump: $11,407 (47%) Sanders: $4,513 (19%) Biden: $3,110 (13%) Buttigieg: $2,572 (11%) Warren: $1,428 (6%) Yang: $727 (3%) Klobuchar: $462 (2%) Total: $24,219

Stryker Biden: $7,572 (40%) Sanders: $3,492 (18%) Trump: $2,246 (12%) Buttigieg: $1,998 (10%) Warren: $1,842 (10%) Klobuchar: $1,320 (7%) Yang: $649 (3%) Total: $19,119

Johnson & Johnson Biden: $76,825 (43%) Trump: $29,258 (17%) Sanders: $21,387 (12%) Buttigieg: $19,582 (11%) Warren: $17,223 (10%) Yang: $8,941 (5%) Klobuchar: $3,515 (2%) Total: $176,731

Philips Sanders: $15,652 (29%) Biden: $12,727 (23%) Trump: $8,665 (16%) Warren: $7,035 (13%) Klobuchar: $3,739 (7%) Buttigieg: $3,625 (7%) Yang: $3,268 (6%) Total: $54,711

Edwards Lifesciences Biden: $6,289 (28%) Sanders: $6,150 (27%) Trump: $3,530 (16%) Warren: $2,863 (13%) Buttigieg: $1,852 (8%) Yang: $1,079 (5%) Klobuchar: $606 (3%) Total: $22,369

Hologic Warren: $5,793 (31%) Sanders: $5,396 (29%) Trump: $2,962 (16%) Biden: $2,504 (14%) Buttigieg: $1,343 (7%) Klobuchar: $296 (2%) Yang: $231 (1%) Total: $18,525

Abbott Sanders: $26,158 (27%) Biden: $21,982 (23%) Warren: $15,177 (16%) Buttigieg: $13,830 (14%) Trump: $11,088 (11%) Yang: $7,560 (7%) Klobuchar: $1,859 (1%) Total: $97,654

Danaher Biden: $10,984 (34%) Warren: $7,042 (22%) Sanders: $4,934 (15%) Trump: $4,002 (12%) Buttigieg: $3,228 (10%) Klobuchar: $1,265 (4%) Yang: $694 (2%) Total: $32,149

Henry Schein Biden: $9,476 (46%) Sanders: $3,686 (18%) Trump: $2,704 (13%) Buttigieg: $2,396 (12%) Klobuchar: $1,130 (5%) Warren: $953 (5%) Yang: $207 (1%) Total: $20,552

Smith+Nephew Trump: $3,904 (26%) Buttigieg: $3,363 (22%) Sanders: $3,064 (20%) Biden: $2,802 (19%) Warren: $934 (6%) Yang: $610 (4%) Klobuchar: $408 (2%) Total: $15,085

Fresenius Trump: $35,779 (42%) Sanders: $19,487 (23%) Biden: $12,629 (15%) Warren: $7,909 (9%) Buttigieg: $5,035 (6%) Yang: $2,731 (3%) Klobuchar: $1,340 (2%) Total: $84,910

Siemens Healthineers Sanders: $9,418 (31%) Biden: $5,809 (19%) Buttigieg: $5,717 (19%) Warren: $5,306 (17%) Trump: $2,628 (9%) Yang: $986 (3%) Klobuchar: $525 (2%) Total: $30,389

Baxter Biden: $6,993 (34%) Sanders: $5,437 (27%) Buttigieg: $2,198 (10%) Yang: $2,033 (10%) Warren: $1,759 (9%) Trump: $1,565 (8%) Klobuchar: $433 (2%) Total: $20,418

Varian Biden: $4,258 (28%) Trump: $3,359 (22%) Sanders: $2,979 (20%) Buttigieg: $2,275 (15%) Warren: $1,125 (7%) Yang: $681 (5%) Klobuchar: $325 (2%) Total: $15,002

Boston ScientiďŹ c Sanders: $19,080 (25%) Biden: $16,537 (22%) Trump: $13,406 (18%) Warren: $9,446 (12%) Buttigieg: $7,448 (10%) Klobuchar: $7,207 (9%) Yang: $3,323 (4%) Total: $76,447

Becton Dickinson Biden: $8,676 (33%) Sanders: $8,612 (32%) Trump: $2,963 (11%) Warren: $2,662 (10%) Buttigieg: $2,356 (9%) Yang: $967 (4%) Klobuchar: $358 (1%) Total: $26,594

Intuitive Surgical Biden: $6,090 (31%) Sanders: $5,521 (28%) Buttigieg: $3,627 (19%) Warren: $2,163 (11%) Yang: $1,309 (7%) Trump: $843 (4%) Klobuchar: $0 (0%) Total: $19,553

ResMed Trump: $9,642 (69%) Sanders: $1,829 (13%) Biden: $1,675 (12%) Warren: $520 (4%) Buttigieg: $140 (1%) Yang: $78 (0.5%) Klobuchar: $0 (0%) Total: $13,884

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PRESIDENTIAL ELECTION

M E D T E C H E M P L O Y E E S V O T E W I T H T H E I R W A L L E T S (continued) Steris Biden: $4,131 (36%) Sanders: $3,205 (28%) Trump: $2,122 (19%) Yang: $707 (6%) Buttigieg: $533 (5%) Klobuchar: $391 (3%) Warren: $319 (3%) Total: $11,408

Insulet Biden: $7,295 (78%) Sanders: $784 (8%) Warren: $472 (5%) Buttigieg: $335 (4%) Klobuchar: $245 (3%) Trump: $100 (1%) Yang: $73 (1%) Total: $9,304

Owens & Minor Sanders: $1,141 (46%) Biden: $676 (27%) Trump: $372 (15%) Warren: $135 (5%) Buttigieg: $100 (4%) Klobuchar: $78 (3%) Yang: $0 (0%) Total: $2,502

TeleďŹ&#x201A;ex Trump: $3,347 (35%) Sanders: $2,885 (31%) Biden: $1,174 (12%) Warren: $787 (8%) Buttigieg: $637 (7%) Klobuchar: $495 (5%) Yang: $128 (1%) Total: $9,453

NuVasive Sanders: $6,451 (72%) Yang: $863 (10%) Biden: $674 (8%) Warren: $577 (6%) Buttigieg: $151 (2%) Klobuchar: $135 (2%) Trump: $50 (1%) Total: $8,901

Total donated to candidates: $1,088,436 Total Total Total Total Total Total Total

Biden donations: $289,533 (26.6%) Sanders donations: $235,896 (21.6%) Trump donations: $190,570 (17.5%) Warren donations: $120,618 (11%) Buttigieg donations: $104,998 (9.6%) Klobuchar donations: $93,679 (8.6%) Yang donations: $53,142 (4.8%)

* Percentages may not add up to 100% due to rounding.

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Image courtesy of Northwestern University

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These researchers adapted a

STROKE DEVICE patient

Designed to detect speech and

for COVID-19

swallowing problems, the device has found a new use in tracking cough frequency to alert healthcare providers that frontline workers may need to be tested for SARS-COV-2.

NA NC Y C R OTTI MA NA G ING ED ITO R

esearchers in Chicago have adapted a ﬂexible patch they developed to monitor stroke patients for swallowing trouble to detect symptoms of COVID-19. They’re hoping it can help physicians decide whether frontline healthcare workers have developed symptoms of the novel coronavirus so they can prevent the illness from worsening. In their “Lost on the Frontline” series, Kaiser Health News and The Guardian have reported 922 U.S. healthcare worker deaths that likely stemmed from caring for COVID-19 patients. The device that might help identify the virus is a postage-stamp-size wearable that adheres to the skin at the base of the neck — an indentation known as the suprasternal notch — and generates data for up to 40 hours straight without needing to recharge. Northwestern University biomedical engineer John Rogers had been working with Arun Jayaraman, a research scientist at Shirley Ryan AbilityLab, on developing the device to detect speech and swallowing problems in stroke patients and convey the data it collected to the patients’ physicians. Chicago-area healthcare providers who knew about their research asked if they could adapt the device to detect COVID symptoms. www.medicaldesignandoutsourcing.com

9 • 2020

Medical Design & Outsourcing

ADAPTED STROKE DEVICE

“When COVID hit, we were overwhelmed by requests from the medical community here to adapt and customize that device to assess the key symptoms of COVID-19, which are fever, shortness of breath and cough,” Rogers said. Rogers and Jayaraman ﬁgured that if the device could detect swallowing from placement on the neck, it could detect coughing. The COVID version of the device monitors coughing intensity and patterns, chest wall movements (which indicate labored or irregular breathing), respiratory sounds, heart rate and body temperature, including fever. It wirelessly transmits data to a HIPAAprotected cloud, where automated algorithms produce graphical summaries tailored to enable rapid, remote monitoring. “We anticipate that the advanced algorithms we are developing will extract COVID-like signs and symptoms from the raw data insights and symptoms even before individuals may perceive them,” said Jayaraman, who is leading the

algorithm development. “These sensors have the potential to unlock information that will protect frontline medical workers and patients alike — informing interventions in a timely manner to reduce the risk of transmission and increase the likelihood of better outcomes.” Once the worker removes the patch at the end of a shift, the device sends the data to the physician to evaluate for COVID symptoms, according to Rogers. The device, which Rogers and colleagues have been manufacturing in a Northwestern lab, is in use in healthcare

The nurse wore the patch at home for two more weeks after discharge from the hospital. There, it picked up very brief but extreme tachycardia events and apneas that were previously undiagnosed, Rogers said. The researchers have $1.5 million in federal funding from BARDA for device development and continue to refine its capabilities. They have applied for FDA clearance rather than an

When COVID hit, we were overwhelmed by requests from the medical community here to adapt and customize that device to assess the key symptoms of COVID-19, which are fever, shortness of breath and cough.

TUESDAYS

settings and also in home settings for people who’ve been discharged after a COVID-related hospitalization. “The nighttime recordings are really important,” Rogers said. “A lot of people aren’t aware of how often they’re coughing during the night. Those recordings, along with other features of the data, have provided some very important health insights.” For example, a nurse who caught the virus from her husband was admitted to Northwestern Memorial Hospital, where she agreed to wear the patch. “We were able to supply her with a device shortly after she was admitted,” Rogers said. “She came very close to being transferred to the ICU and placed on a ventilator but recovered to an extent that eventually allowed her to be released from the hospital.”

emergency use authorization, which would only last for the duration of the public health emergency. For now, they’re producing up to 100 devices per week, but they have a company in place, Sonica Health, that can take over that aspect of the work if the FDA clears the device. The initial target markets are frontline workers, patients, military and elderly populations. “There's been a lot of interest,” Rogers said. “We’re trying to be responsive to requests rather than marketing the devices. We’re funded at levels that allow us to reﬁne and develop and customize the technology at a high level, but our orientation is not around maximizing revenues and proﬁts and related business aspects, but rather toward providing something of value to the broader community.”

John Rogers gave a tremendous presentation on the state of wearable technologies on this DeviceTalks Tuesdays on Demand. https://www.devicetalks.com/devicetalks-tuesdays-on-demand-sessions/

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TUESDAYS Working remotely is going to get a little less remote.

• •

Each week, the organizers of DeviceTalks conferences will bring a lively, informative and enjoyable opportunity to catch up with medtech colleagues, gain insights on our evolving sector, and make new essential connections to help you move forward.

• •

Working with medtech leaders, our DeviceTalks team will bring together medtech professionals for a 90-minutes to discuss pressing issues of the day in these ﬁve critical areas in our industry.

•

INNOVATION & FINANCE PROTOTYPE & PRODUCT DEVELOPMENT MANUFACTURING & SOURCING REGULATORY, REIMBURSEMENT & MARKET DEVELOPMENT NEW TOOLS AND TECHNOLOGY Each DeviceTalks Tuesday will kick off with a quick briefing from the Editors of MassDevice and Medical Design and Outsourcing. These presentations will give attendees insights on what trends will be moving medtech in the days to come.

Next, Tom Salemi, host of DeviceTalks Weekly, will interview medtech leaders and facilitate discussions or presentations tackling critical areas within medtech. Attendees will leave with new contacts, fresh perspectives and a critical connection to our dynamic DeviceTalks community. Join your medtech colleagues every Tuesday afternoon.

ENGINEERING BETTER DEVICES. BUILDING BETTER COMPANIES. presented by:

devicetalks.com Sponsorship opportunities are available for future DeviceTalks programs.

@DeviceTalks

For more information, contact Mary Ann Cooke. 781.710.4659 | maryann@massdevice.com

How a top research lab pivoted to fight

COVID-19

A top medtech research site, the Boston-based Karp Lab has responded to COVID-19 with a virus-fighting nasal spray, better mask straps and much more.

N AN CY CROT T I MAN AGI N G EDI TOR

Biomedical engineer Jeffrey Karp in his eponymous lab at Brigham and Women’s Hospital, Boston.

OVID-19 completely disrupted the work at Jeff Karp’s medical engineering lab at Brigham and Women’s Hospital in Boston. That’s not necessarily a bad thing. One company that was planning to do research with Karp and his students pulled out; Canadian undergraduate students were called home by their government and couldn’t ﬁnish their experiments; postdoctoral students whose work was scheduled to end in June and couldn’t ﬁnish had to move on

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Image courtesy of Brigham and Women’s Hospital

Medical Design & Outsourcing

to other commitments. Undergraduate summer interns couldn’t start work because the hospital had imposed a hiring freeze. Karp has chosen to look on the bright side. “There's a lot of challenges that we face but at the same time there's a lot of opportunities that are arising,” said the Canadian-born bioengineer based at the Brigham and a professor of medicine at Harvard Medical School. “There are multiple new projects that have come out of this.”

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KARP LAB

The urgency to help patients and healthcare providers during the pandemic has enabled the Karp Lab, which has launched several companies over the years, to churn out technology that normally would have taken years to reach patients. “With the pandemic here, everybody understands what the problem is and there are many aspects of the problem that need to be addressed and there’s an immediate need,” Karp said. “There's been a loosening up of how quickly you can move things forward. It’s a big motivator to help people. “There's a lot of energy and passion. It's easy now to ﬁnd collaborators and bring people in and develop momentum on projects,” Karp added. “As problem solvers who have a lot of access to resources and incredible collaborators, we’re trying to think of everything we can to help in many different areas.”

their masks and their faces, Karp said. As a bonus, the gel would hydrate the nasal lining to help people breathe through their noses rather than through their mouths, leading to less fogging of glasses and perhaps more mask-wearing. “We’re still in the process of putting together the data and will ﬁle a patent soon,” Karp said of the virus-killing gel research. “We envision this can have a relatively quick trajectory to get into use.” The nasal spray research attracted $200,000 in funding from the Gillian Reny Stepping Strong Center for Trauma and Innovation at the Brigham. Plans are for it to be sold over the counter, so it wouldn’t need to undergo clinical trials, Karp said. The lab does, however, need a commercial partner to launch it. Earlier in the pandemic, the lab team worked with athletic shoe manufacturer New Balance to ﬁx the straps on 50,000 donated masks for use

There's a lot of energy and passion. It's easy now to find collaborators and bring people in and develop momentum on projects. As problem solvers who have a lot of access to resources and incredible collaborators, we're trying to think of everything we can to help in many different areas. For example, Karp and his team were already working on developing a nasal spray to create a physical coating that can deliver therapeutics. They pivoted that work from a different formulation to one that can kill SARS-COV-2, the virus that causes COVID-19. Made of items from the U.S. FDA’s Generally Recognized as Safe (GRAS) list of materials, the spray would form a hydrogel barrier on the nasal mucosa to capture the virus and release virucidal agents to deactivate it. Unless they’re wearing an N95 mask, which ﬁlters out nearly all airborne particles, people could use the gel to neutralize virus particles that enter their noses through gaps that form between

by frontline workers at the Brigham and its sister institution, Massachusetts General Hospital. Karp is now on different teams working on a COVID-19 detection approach, on how to re-purpose FDA-approved drugs to reduce the severity of COVID infections, and on developing a better non-medical-grade mask. The team has also begun to plan for normal lab activities to resume and to launch new, non-COVID research projects. “I think it’s one of these things where people, in the front of their minds, are kind of hopeful that COVID will be gone in 6 months,” Karp said. “Probably — realistically — we’re going to be dealing with COVID for several more years to come.”

Jeff Karp will discuss the future of innovation on DeviceTalks Tuesday.

TUESDAYS

Go here to register to watch the discussion. https://www.devicetalks.com/devicetalks-tuesdays-on-demand-sessions

ENGINEERING BETTER DEVICES. BUILDING BETTER COMPANIES.

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2020

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