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HERE’S WHAT WE SEE

What's the word on ethylene oxide?

he coronavirus pandemic has pushed a lot of news out of people’s minds, but medtech has other big issues to deal with. For instance, 8 months have passed since the FDA issued a public challenge for alternatives to ethylene oxide (EtO) as a sterilant for medical devices. As I write this editorial, the agency has not revealed them. Even if a new technology emerges, it would take years to build the capacity to sterilize the billions of medical devices that EtO does annually, not to mention the validation process that each device would have to undergo to make the switch.

"Even if a new technology emerges, it would take years to build the capacity to sterilize the billions of medical devices that EtO does annually." Ethylene oxide is a human carcinogen, but it also provides the most effective and costeffective form of device sterilization, decades after its introduction. Its ability to work at low temperatures makes it a viable option for devices made of multiple components and materials. It can also penetrate different types of device packaging, enabling sterilizers to process truckloads’ worth of devices simultaneously. After processing, devices have to go into aeration chambers to remove EtO residue, but the chambers don’t always do the trick. Georgia state officials in December ordered Becton Dickinson to apply for an air quality permit for a warehouse that housed EtO-sterilized devices. A report that BD submitted to the state revealed 0.65 lb per hour in “fugitive” EtO emissions from the warehouse, leading state environmental officials to conclude that the facility could emit 5,600 lb per year of the gas. Any facility that has emitted or may emit more than 4,000 lb per year of EtO must apply for a state permit to do so. EtO sterilization plants in Illinois, Georgia Michigan and Pennsylvania have become the targets of neighbors’ protests, state and local government officials’ attempts at regulation, and lawsuits alleging the gas caused illnesses and deaths.

Medical Design & Outsourcing

3 • 2020

The commercial EtO industry, of which medtech sterilization is a part, is also due for new regulations from the EPA in May. They’ll be the ﬁrst new regulations in 14 years and will come on the heels of much stronger controls the EPA issued for industrial EtO sources in November 2019. Most of the facilities they’ll cover are older, and upgrading their emissions-control technology will cost millions. Stay tuned. Also this month, executive editor Chris Newmarker details some of the latest news coming out of the 3D-printing industry. It’s not about printers, though; it’s about the software that enables them to churn out evermore amazing medical devices. Senior editor Danielle Kirsh tells the story of Otis Boykin, an African American engineer whose work led to the pacing technology that cardiac pacemakers have today. And ﬁnally, you can read how a former Medtronic senior project manager has raised millions to develop the Abilitech Assist, a device that allows people with limited use of their arms to independently perform tasks that most of us take for granted every day. Thanks for reading! Let us know what you think!

www.medicaldesignandoutsourcing.com

Nancy Crotti Managing Editor Medical Design & Outsourcing ncrotti @wtwhm e di a .c o m

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CONTRIBUTORS

HALBERT

MATTHEWS

SCHAIBLE

POLICKER

MAJNO KEITH HALBERT is a business unit director at Portescap (West Chester, Pa.), an Altra company. LORENZO MAJNO is VP of Dynaﬂo (Reading, Pa.), recently joining the company after 39 years in the laboratory instrumentation business with Instron. He holds a degree in mechanical engineering and materials science from Brown University. PETER MATTHEWS is senior technical marketing manager for Knowles Precision Devices, with more than 20 years of experience in technology sales, marketing and product management. Knowles produces highly engineered capacitors and microwave-to-millimeter wave components for use in military, medical, electric vehicle and 5G markets.

SCHMITZ

SHAI POLICKER is CEO of MEDX Xelerator, a partnership of Boston Scientiﬁc, Intellectual Ventures, MEDX Ventures and the Sheba Medical Center working under a license from the Israeli Innovation Authority. For over 20 years, he has led development, commercialization and investments in innovative medical devices. SANDI SCHAIBLE is the senior director of analytical chemistry and regulatory toxicology at WuXi Medical Device Testing (St. Paul, Minn.), specializing in extractables and leachables studies. She is a U.S. delegate and international delegate for ISO 10993 part 18 in chemical characterization, and also a U.S. delegate for ISO 10993 part 13 and the particulates committee (TIR42). JOHN SCHMITZ is president of Aberdeen Technologies (Carol Stream, Ill.), which provides plastic injection molding and mold tooling solutions to the largest medical device companies in the world. The company has been an insert molding provider for more than 25 years.

CONNECT WITH US! CHECK US OUT ON ISSUU! 8

Medical Design & Outsourcing

31 • 2020

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CONTENTS

medicaldesignandoutsourcing.com ∞ March 2020 ∞ Vol6 No2

• • • • • THE ENABLING TECHNOLOGIES ISSUE

COLUMNS 6

HERE’S WHAT WE SEE

CONTRIBUTORS

COMPONENTS

What’s the word on ethylene oxide?

Why non-magnetic capacitors matter in medical imaging

CORPORATE LAW

MOLDING

ON THE COVER SOFTWARE IS ENABLING 3D PRINTING INNOVATION: HERE’S HOW

How to prepare your medical device company for an exit Book molds have reinvented vertical injection-molding technology

The software that powers 3D printing keeps evolving, paving the path for even greater adoption by the medtech industry.

20 MOTION CONTROL

FEATURES

Selecting miniature motors for surgical robotics

26 PUMPS

46 ABILITECH AIMS TO ARM PEOPLE WITH INDEPENDENCE

How diaphragm pumps can work for sensitive devices

This startup is preparing to launch a device to help people with limited arm strength and mobility to independently perform many tasks most of us take for granted.

30 STANDARDS

What do big changes to ISO 10993-18 mean for medtech?

50 THIS COIN-SIZED PATCH COULD IMPROVE DIABETES TREATMENT Could treating diabetes someday be as simple as slapping on a patch? A UCLA research team thinks so and is seeking FDA permission to prove it.

32 STARTUP ACCELERATOR

How to cook up a successful medical device company

54 ETHYLENE OXIDE

34 TUBING TALKS

The medtech sterilization business faces battles on many fronts from the public and regulators.

What is the best tubing for medical device applications?

60 MEDTECH EVENTS

57 OTIS BOYKIN

How is coronavirus affecting medtech?

Through his work on multiple patents, this inventor laid the foundation for today’s pacemakers.

64 AD INDEX

Medical Design & Outsourcing

3 • 2020

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COMPONENTS

Why non-magnetic capacitors matter in medical imaging

The quality of an MRI image depends on the homogeneity, or uniformity, of the magnetic ﬁeld. Component material choice is paramount.

agnetic resonance imaging (MRI) equipment uses a strong magnetic ﬁeld and computer-generated radio waves to produce cross-sectional images of soft tissue such as muscle and fat. These images enable clinicians to investigate and diagnose without the need for more invasive procedures. However, a low-quality image may lead to mistaken diagnoses and, consequently, misguided treatment selections. That said, magnetic resonance applications have very speciﬁc needs all the way down to the component level. Peter Matthews | Knowles Precision Devices |

MRI basics Magnetic strength is measured in Tesla (T); by extension, Tesla indicates the strength of the MRI’s magnetic ﬁeld. The 1.5T MRI is one of the more common MRI scanners today, but 3T and 7T machines can produce even higher-resolution images. This level of detail is helpful for diagnosing more unique

Multilayer ceramic capacitors from Knowles Precision Devices

Image courtesy of Knowles Precision Devices

Medical Design & Outsourcing

3 • 2020

cases. However, once MRI scanners reach 7T and up, the magnetism is strong enough to cause complications for individuals with implantable devices, such as pacemakers. Healthcare professionals have the option to use a closed MRI or an open one. An open MRI is less claustrophobic for patients, but it doesn’t contain the magnetic field as well as a closed tube, so it produces lower-quality images. When thinking about the working principles behind MRI, it’s important to remember the basics: The MRI machines we are accustomed to are based on the principle of nuclear magnetic resonance (NMR). The name of the phenomenon provides the clue — it has to do with nuclei and magnets. The molecules that make up our body contain hydrogen. The nucleus of a hydrogen atom, a single proton, behaves like a magnet with a north and south pole. When a magnetic field is applied, their spins (a spin is a property of subatomic particles) arrange uniformly. When a patient is positioned inside the MRI scanner tube, the spins of the protons in their body’s molecules line up, facing the same direction like a marching band practicing on a football field.

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When a short, computer-generated RF signal is applied to a portion of the uniform ﬁeld, those protons receive a “nudge” and break formation. Imagine a scenario in which a stray football is heading for the marching band. After the interruption, the protons (the musicians in our analogy) return to their state of alignment. In the process of realigning, energy is emitted. That energy can be measured and used to distinguish between different types of molecules and their locations. A thorough grasp of MRI requires a deeper dive into quantum mechanics, but beginning to understand the process makes the output that much more amazing. The catch An MRI machine is designed to help us identify molecule types and locations based on measuring the behavior of their hydrogen nuclei. However, the quality of an MRI image depends on the homogeneity, or uniformity, of the magnetic ﬁeld. If there’s any variation, it’s more challenging to detect the impact of an RF signal interruption. Even with the slightest variation, those protons aren’t aligned the same way as the others and won’t respond the same way to stimulus. These differences confuse the detection algorithms. It would be like some of the musicians in our marching band were already out of step when the football struck. Watching all of this, how would we know where the disturbance caused by the stray ball happened?

In practice, excessive signal noise, or random variation in signal intensity, produces granular images. It’s much more challenging for a healthcare professional to rely on them for accurate information.

2.25”

Make good choices It’s important to look for high-purity metals that exhibit no measurable magnetism, because magnetic components inside the MRI scanner tunnel can alter the field’s homogeneity. Even the smallest trace of magnetism could affect the quality of the MRI image. Hardware components including fixed capacitors, trimmer capacitors, inductors, connectors and more must be non-magnetic. Take capacitors, for example: Many capacitors are designed with a nickel barrier finish to maintain solderability. Due to nickel’s magnetic properties, these capacitors are not acceptable for medical applications such as MRI. Commercial brass, a commonly used material, is also not acceptable for these applications. Coils also require inserts, pins and other special shapes with no measurable magnetism. This level of care in component selection prevents distortion and minimizes the need for image correction. Patients, caregivers and healthcare professionals all rely on MRI imaging technology. While components like capacitors are typically viewed as simple or uncomplicated, life-critical applications demand specialized attention in every aspect of design. M

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Medical Design & Outsourcing

CORPORATE LAW

How to prepare your medical device company for an exit It’s about sticking to the basics, growing — and much more. One of Greenberg Traurig’s top corporate lawyers shares his insights about leading a medical device company to an acquisition or IPO.

Chris Newmarker | Executive Editor |

Wayne Elowe | G r e e n b e r g Tr a u r i g |

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s co-chair of Greenberg Traurig’s Global Life Sciences and Medical Technology Group and co-chair of the firm’s Atlanta Corporate and Securities Group, Wayne Elowe focuses on corporate counseling, crossborder and complex commercial transactions. He is especially involved in mergers and acquisitions, joint ventures, strategic investments, licensing and development deals, and other collaborative transactions, working with clients located in the U.S., Asia and Europe. Leading a young medtech company to a successful exit, according to Elowe, is all about sticking to the basics: identifying a target market, regulatory, intellectual property, not burning through funding too quickly and more. Entrepreneurs need to keep their company’s momentum going, attack and resolve their problems in the marketplace, and create a well-defined story. “When you get into the exit stage, your story should be welldefined. You should know what you’re presenting to the buyers,” Elowe recently told Medical Design & Outsourcing. Here are more insights from Elowe about the current state of medtech M&A and IPOs, as well as advice on how young medical device companies can make the most of the present environment. MDO: When it comes to getting a medical device company acquired, what is different now versus 10 years ago? Elowe: The fallout from what was coming out 10 years ago economically, the financial meltdown — that just brings a different kind of discipline into the deal-making world. People are going to be more careful when they’re spending their money. What that means, on the exit side, is people are looking at things more carefully. www.medicaldesignandoutsourcing.com

Photo by Michael Jasmund on Unsplash

CORPORATE LAW

We still are seeing very active markets generally, but to get there, companies are probably a little more careful than they were at one time, and then making sure that the targets check a number of boxes, in terms of things such as what space they’re ﬁlling, what is the strategic ﬁt to the buyer, do they have their IP in order, their regulatory path mapped out, all of these different factors that a buyer might look at in terms of evaluating a company. I think it creates some challenges on the exit side, but at the same time, it comes back to just being disciplined in how a company is going to operate itself from a very early stage going forward. It’s a highly regulated industry. You have to have your house in order from the beginning, or you’re not going to go anywhere.

of capabilities. A device might have AI or software capabilities behind it or add some big data applications. The strategic players are looking at devices from perhaps a broader perspective in terms of the value creation in the delivery of the healthcare service, and even more so in terms of how they’re trying to deliver their products and services into a broader spectrum of the healthcare service path for the patient. All of these things coming together in the industry create opportunities for companies to ﬁll needs or provide capabilities that at one time may not have been as prevalent in this industry. MDO: When it comes to young medtech companies with the goal of getting acquired, what are the biggest mistakes you’ve seen them make? Elowe: One of the things companies need to do early on, as they’re growing, is just grow the business. It sounds obvious on one level, but from an exit perspective that’s

MDO: Are there opportunities? Elowe: Strategic buyers are looking at a much broader range of devices and capabilities than even 10 years ago. There is this blending and convergence

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Another mistake, sort of a doubleedged factor — do you bring a strategic in as an investor into your company? An investment from a strategic can bring many benefits— industry experience, strategic interest and a cachet of having a big name investor. A lot of strategics however, will come in and want a right of refusal to buy the company if there is a sale or exit, and that can kill your ability to sell to others or at least impact your valuation to a third-party buyer. When granting these rights, you’re basically requiring a third-party buyer to be out there waiting to see if the strategic is going to exercise its right or not. When you negotiate an investment from a strategic, I think you have to be careful about trying to limit how many tentacles they have into your company and try and push off some of those more onerous rights like right of refusal. Otherwise, it may impact your valuation or ability to shop the company to other third party buyers. MDO: We’ve noticed over the past year that IPOs have made a comeback in the medtech space. What changed? Elowe: Right now, we’re in that economic period where there’s some open windows in the market for companies to get an IPO done. I think there’s also an appetite in the marketplace for the innovation that is coming out of the companies — this convergence of technologies that are coming together to deliver a healthcare solution. A lot of them are not raising billions dollars. Sometimes, they’re going out and raising less than a hundred million dollars in an IPO. I sort of scratch my head because you take on all of the regulatory baggage of being a public company, without the huge market valuation necessarily. But then again, you play the cards you’re dealt. … You can take a little money off the table, or you raise some money, then you fight the battle the next day of what are you doing as a public company — and operating in that environment too. Overall, if an IPO provides another funding route, despite the challenges, it’s a good result for developing companies if other funding sources are not available or less attractive. In the end, public or private, these companies will need to execute their business plan, develop and cultivate their avenues for exit if they seek the larger payouts to stockholders.

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MOLDING

How book molds have reinvented vertical injectionmolding technology Insert molding, especially on a vertical molding press, can hold tight tolerances and offer design flexibility. Book molding machines can run up to 12 different molds at the same time.

Image from Aberdeen Technologies

M John Schmitz | A b e r d e e n Te c h n o l o g i e s |

any of todayâ&#x20AC;&#x2122;s new and innovative medical devices are made from a combination of thermoplastic resin and specialty medical components, such as cannulae, tubing, wires, cables, stampings and delicate sensors. Advancements in molding technology offer the ability to mold delicate components directly into the devices, rather than incorporating them later through machining, gluing or ultrasonic welding. Reinventing the technology While this technology might not be brand new in and of itself, the process has been reinvented with the use of book molds. Most vertical molding equipment on the market is configured with the top half of the mold attached to the upper plate of the molding machine. The top then closes down with force onto the bottom plate. It is often difficult to hold delicate inserts in place during the injection-molding process, even more so with horizontal

Medical Design & Outsourcing

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molding machines. The possibility for delicate inserts to be interrupted or misplaced is often greater than manufacturing managers would like to admit. The inserts loaded in the bottom half must be held securely in place so that, when the top closes, neither the mold nor the delicate insert is damaged. Damage to the mold can be substantial, especially when the two halves close under high tonnage around steel or other rigid materials, so it is important to locate and carefully secure components in place during molding. Still, factors such as operator misplacement or shuttle/rotary table vibration can mean damage to the mold or the inserts. Book molds can help A solution that has helped eliminate these complications is using book molds mounted on a rotary table press. Book molds have become prevalent in the production of medical devices, specifically for medical injection molding. They differ from traditional molds as they are typically

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hinged to each other and open/close like a book (hence the name). These molds can be used on traditional vertical presses but are commonly found on vertical molding machines with rotary tables. How they work Book molds are mounted to vertical clamp/ vertical injection molding machines that have multi-station rotary tables. The molds consist of top and bottom mold halves that are connected by a hinge in the back so the top half can be lifted open. The hinge is the linchpin of the mold and ensures each opening and closing is exactly the same no matter what type of machine it is on. Like conventional molds, book molds may have taper locks to maintain alignment between both halves to avoid shifting. A tapered sprue bushing is located on the top of the mold so that, when the mold is opened, the sprue and runner will remain in the bottom half. Ejectors are installed in the bottom half to lift out finished parts along with the sprue and runner, so multiple cavities are often well-suited for book molds. A handle is often mounted on the top half for easy opening, which can be done manually by the press operator or with a stationary ramp. Another benefit One service that is best used with book molds is overmolding. Overmolding is often confused with insert molding because it is performed on the same injection-molding machines. Overmolding is a subset of insert molding. All overmolding is insert molding, but it does not go both ways. The term “insert molding” is often used when a pre-produced part is inserted into a mold and receives a mold around it. Overmolding is a similar process but is typically used when a part needs a second operation over the initial insert molding. It is still an insert-molded product, but the process is referred to as overmolding. Overmolding is also commonly referred to as “injection molding with a second operation,” or “insert molding with an overmolded sequence.” The manufacturing process should always be in the forefront of a medical device engineer’s mind as manufacturing costs quickly rise with the complexity of each part. The best way to keep manufacturing efforts efficient and affordable is to find a capable vertical molding manufacturer to help through the entire process. 3 • 2020

Medical Design & Outsourcing 19

ISO 13485:2016

MOTION CONTROL

How to select miniature motors for surgical robotics Surgical robotics leverages the same sterilizable brushless direct current (BLDC) motors used for decades in surgical hand tools. It’s all about torque, speed and reliability — as well as sterilization requirements.

This is a brushless dc slotless motor.

customized to both integrate with their tool and make the proper tradeoffs to optimize performance. Methods to maintain and preserve the sterile ﬁeld in the operating room to prevent infection, cross-contamination and the spread of disease are all critical concerns. Here are the most common approaches to achieve the required sterilization:

Image courtesy of Portescap

oday’s surgical robotics and robotically assisted surgical devices often require BLDC motors to meet demanding requirements. While motors and motion are core to all robotics, surgical robotics demand the capabilities of both traditional robotics and traditional surgical handtools. In addition, devices used in surgery must be sterile. Often these devices must reliably and consistently function despite repeated steam sterilization during reprocessing, in addition to demanding ﬁeld use. Beyond reliability requirements, surgical device designers must also ensure their end products satisfy exact speed and torque requirements, have the ability to withstand the high temperatures of sterilization, remain cool during operation, and meet extreme positioning demands. These device makers need motion components that are suitable for their application, and which have been appropriately

Keith Halbert | Portescap |

Medical Design & Outsourcing

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The disposable tool: In some cases, hospitals and surgeons elect to use disposable, single-use tools. These generally employ inexpensive motors (given long life isn’t required) and often plastic components. Such tools must be discarded after each surgery. While this approach simpliﬁes reprocessing and eliminates the requirements of tool maintenance, it also necessitates a consistent supply of tools be maintained and increases the amount of hazardous waste produced by the hospital. In addition, disposable tools aren’t typically the most economical option when considering the total cost to the hospital. Modular design for sterilization using non-sterilizable components: Another approach is to design devices so that exposed components are sterilized and others are not. Here, a design may house the motor, controller and battery pack inside an enclosure, and hospital staff remove the motor and battery pack from the tool prior to sterilization.

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MOTION CONTROL

This approach requires following a special process to ensure the reprocessed tool is properly sterilized, and may also require more durable electronic components and connections in the design due to repeated disconnection and reconnection of the motor and battery from the system. Protective barriers: Yet another approach is to cover the robotic arm or instrument with a (typically disposable) sterile barrier — for example, a plastic draping or plastic clamshell. When successfully executed, such barriers maintain a sterile field and eliminate the need for components outside the field to be reprocessed. This approach is common with large surgical robotic systems for which autoclaving of the entire system is impractical. The ergonomic requirements of robotic systems also differ from those of traditional handtools. More specifically, the motor may be physically located away from the surgical end effector and transmit motion via cable-drive, which may not

Medical Design & Outsourcing

3 • 2020

be feasible for traditional surgery when a surgeon must precisely manipulate a handtool to perform a delicate task. This design approach is also common for medical procedures having less stringent sterilization requirements, such as dental and tattoo applications, for example. But a downside includes complex draping schemes needing systematic removal and replacement, which can signiﬁcantly increase the time the operating room is engaged for a surgery. Draping can also be bulky and awkward and can reduce visibility in the surgical theater, in turn degrading the surgeon’s effectiveness. Autoclavable motors: Medical devices can also be designed using only sterilizable components, including the motors. The introduction of sterilizable BLDC motors 3 decades ago let tool designers produce high-power ergonomic tools that could be trusted to be sterile due to the entire tool having gone through the sterilization process.

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The benefits carry over to robotically assisted surgical devices, most of which also necessitate sterile designs of small size, high power, durability, efficiency, low noise and long life. Autoclavable BLDC motor design for surgical devices Both traditional motorized handtools and robotically assisted surgical devices can use BLDC technology in either a slotted or slotless configuration. Note that slotted versus slotless refers to the lamination type in the stator of the motor. Both technologies have their strengths, and the application requirements dictate which technology is better suited to the design at hand. Slotted BLDC technology has been a proven solution in the surgical motor market for more than 30 years. In slotted motors, the copper coils are wound within the slots of the lamination stack and so are inherently protected. Additional insulation layers and molding

material can easily be added without affecting motor performance. This physical conﬁguration makes slotted BLDC excel in miniature motion designs rugged enough to withstand harsh environmental conditions, such as those seen in autoclave or during surgeries that expose the motor to saline and other contaminants. In addition, the slotted design provides: • • • •

•

Easy customization to electromagnetics (windings, lamination stack length and so on). Very high dielectric resistance (1,600 VAC hi-pot or higher). Improved heat dissipation and thus higher continuous torque. A small magnetic air gap to allow use of thinner magnets and a higher permanence coefﬁcient (which imparts torque stability over a large temperature range). Lower rotor inertia than slotless BLDC motors.

A N A U T O C L AV E C Y C L E ? Keith Halbert

Portescap

The most common sterilization method used in hospitals is autoclaving, also called steam sterilization. During autoclaving, surgical handtools are exposed to 100% humidity, 135ºC (275ºF) and pressure variations for up to 18 minutes. Most autoclaves also have additional vacuum cycles to facilitate steam penetration and kill viruses, fungi, bacteria and spores that can hide in microscopic cavities on the device. What this means for medical devices Repeated exposure to this environment is what typically causes signiﬁcant electrical and corrosion problems for motors and medical devices insufﬁciently designed to withstand these conditions.

Epoxy Cures Rapidly at Moderate Temperature

Slotless motors are the other BLDC motor technology. These motors are also very capable and may be wellsuited to the application. In slotless motors, the coil is wound in a separate external operation and is a selfsupporting subcomponent. This rigid coil is then inserted directly into the air gap during motor assembly. In this design, the magnetic induction in the coil is decreased since the air gap is large. Induction in such a motor is usually much smaller than in a slotted BLDC motor, so a larger and more powerful magnet is typically needed to compensate for the loss of induction.

Two Component EP62-1Med

This is a Portescap Size 9 brushless dc slotted motor Image courtesy of Portescap

• • • •

Thermally stable USP Class VI approved Long pot life Sterilization resistant

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3 • 2020

Medical Design & Outsourcing

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10:01 PM

MOTION CONTROL

While slotless motors can be designed to withstand steam sterilization through insulation and other protective coatings on the exposed electronic components, achieving long-lasting and dependable protection from harsh environmental conditions is inherently more challenging when compared to a slotted motor. If autoclavability or very high numbers of sterilization cycles are not needed, there are aspects to a slotless design that may be an advantage for a given application: zero detent torque (no cogging), smooth operation at very high speeds, increased motor inertia, and high peak torque capability. Some surgical procedures or device applications demand high-precision control of the motor. This is true of robotically assisted surgical devices using sophisticated sensors, vision systems, haptic feedback, or 3D mapping to target material manipulation at the sub-millimeter level. Successful execution of the surgery may need extremely high precision

CROSS-SECTIONS OF SLOTTED AND SLOTLESS MOTORS

LAMINATIONS

TRADITIONAL SLOTTED MOTOR

SLOTLESS MOTOR ... THE DESIGN OF THE PORTESCAP 16ECP

Shown here are cross-sections of slotted and slotless motors for precise motion control. Traditional slotted motors have the space for winding protection in the form of coating molding. Slotless motors offer other beneďŹ ts but allow no such room for winding protection. Image courtesy of Portescap

The Best Components Begin with the Best Material

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control of the motor output. The precision requirements may go beyond that which is delivered by traditional Hall sensors, which can detect rotor position in 60° increments. Using an encoder can provide feedback for control of speed and positioning of the rotor at increments far smaller than 1°. Encoders provide angular position measurements of the rotor shaft at a much higher precision than three Hall sensors can provide. Such feedback supports position control and better BLDC-motorcontrol accuracy than otherwise possible. From the position measurements the encoders measure, both acceleration and direction can be inferred. Tip: When specifying an encoder, ﬁrst determine required accuracy and resolution. The technology type must also be chosen. Optical and magnetic are the most common technologies in rotary encoders. In autoclavable applications such as surgical tools, magnetic encoders are typically a robust and reliable option. Incremental or absolute feedback are two common variations for communicating the angle value. If using incremental signals, an index pulse, once per revolution, and a counter are needed to calculate the absolute angular position. Otherwise the feedback is relative. Absolute feedback is typically serial communication such as SSI, SPI or BiSS to provide an encoded angle value between 0° and 360°. Options from Portescap include: • • • • • • •

Sterilizable option, designed and tested to more than 2,000 autoclave cycles. Hall sensor signals for 6-Step commutation (U, V, W). 10-bit incremental encoder (A, B, Z). 11-bit resolution absolute angle encoder. Absolute position output via SPI. Differential output for noisy environments. Off-axis mounting allowing for cannulation.

Modern surgical devices — both traditional handtools and robotically assisted devices — have extremely demanding and exact motion requirements. Those requirements can be met by working with a motor supplier with the necessary technologies and experience with both traditional surgical handtools and robotically assisted surgical devices. 3 • 2020

Medical Design & Outsourcing

LOW STRESS. SMOOTH. GENTLE. STEADY. CALM. The new KNF FP 400 combines the advantages of diaphragm liquid-pump technology with pulsation levels comparable to gear pumps. It’s self-priming, has run-dry ability and provides a long, maintenance-free lifetime under continuous-operation conditions. The pump produces low-stress, smooth pulsation of 150 mbar, with much lower levels achievable. It delivers gentle, low-shear flow of up to 5 L/min at 15 psi, with steady, linear control between 10% and 100% of nominal flow. The FP 400 is perfect for clinical diagnostic instrument tasks such as liquid recirculation, supply/replenishment, mixing /agitating processes, and temperature management loops. Learn more at knfusa.com/FP400

PUMPS

How diaphragm pumps can work for sensitive devices Diaphragm pumps work like bicycle pumps, with one intake and one output cycle per revolution of the drive motor, which produces an inherently pulsatile flow. Dynaflo developed one for the U.S. military that virtually eliminates this effect.

D Lorenzo Majno | Dynaflo |

iaphragm pumps offer a number of features that could be valuable to designers of products that require the movement of gases and fluids: They are relatively inexpensive; capable of flow, pressure and vacuum levels suited to mobile or stationary applications; and they are configurable, efficient and durable, with no sliding seals. These pumps are used in ventilation and could work in other compressorrelated medical applications that require non-pulsing input. One of diaphragm pumps’ biggest advantages is that the fluid path is completely sealed from the environment, making them ideal for handling sensitive gases and fluids. The smallest ones are about 30mm (1 in) long and fit in the palm of your hand, weighing only a dozen grams (under a half ounce) for moving or sampling small amounts of air or gas. Heavy-duty industrial diaphragm pumps can weigh

hundreds of pounds for process applications involving chemicals, fluids and gases. How they work The way they work is fairly simple: A variable-speed electric motor converts rotational motion to linear (pumping) motion by driving a connecting rod from an off-center location much like an automotive crankshaft and the connecting rod to a piston. The resulting displacement of the free end of the connecting rod is used to push and pull on an elastomeric diaphragm, much like pushing and pulling on one flexible wall of an otherwise rigid box. This box is commonly referred to as the “head” of the pump. The motion of the diaphragm causes a volumetric change in the head and thus alternately creates a vacuum (when the diaphragm is pulled outward) and pressure when pushed inward. An intake valve ensures that during the outward stroke

Image from Dynaflo

Medical Design & Outsourcing

3 • 2020

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PUMPS

of the diaphragm, the gas or fluid enters the head. On the inward stroke, the gas or fluid exits the exhaust valve. Thus, these pumps can be used to create vacuum or pressure, depending on how they are plumbed. They are also inherently self-priming. How they work Diaphragm pumps have a huge range of uses, from coffee makers to medical aspirators to air sampling systems and blood pressure measurement instruments. But they also have disadvantages: • Their output is inherently pulsatile. • They are typically noisy due to the rapid opening and closing of the valves. • They can vibrate if not properly balanced. • Their service life and operating efficiency depend on, among other things, diaphragm design. • Low-speed cogging of the motor can limit their dynamic range.

For most applications, the pulsatile nature of the flow is not an issue, but it is in medical ventilators, which assist patients who may not be able to breathe on their own. Dynaflo was presented with the challenge to design a compressor for a ventilator with the advantages of diaphragm pumps but without the pulsing, and with the ability to operate over a wide range of output flow to suit a wide range of ventilation patients. The solution was a multi-head diaphragm pump with 12 radially oriented pumps driven off of a central, common eccentric. This approach causes each pump to go through its usual cycle once per rotation, as in single-head pumps. However, with 12 heads connected in series, any of the 12 pumps is just 30 degrees apart from its neighbor at any point in time, thus creating a 12-point averaging effect on the output flow. The symmetrical, balanced design virtually eliminates

One of diaphragm pumps' biggest advantages is that the fluid path is completely sealed from the environment, making them ideal for handling sensitive gases and fluids. vibration and presents a relatively constant torque load on the motor. The pump’s radial 12 heads were optimized for the output flow and pressure required: 140 l/min (4.9 cfm) and 140 mbar (~2 psi), respectively.

MEDICAL DEVICEwww.arthurgrussell.com ASSEMBLY

This radial, symmetrical design effectively solved the pulsation and vibration issues, and made things easier for the implementation of the motor: a low-profile, long-life brushless DC motor that can operate over a wide range of speeds. Symmetrical loading of the motor also allows it to run more efficiently than it would against the uneven loading of a single- or dual-head design. The pump’s non-pulsing output flow and pressure also make it easier for closed-loop control, in which a downstream flow or pressure sensor can be used as input to a control circuit to carefully control how the patient is ventilated. This, plus its light weight (1.5 lbs./0.7 kg) makes it ideal for mobile applications in which battery-powered devices need to last as long as possible, especially in field-based medical devices such as ventilators. Efficiency counts Operating efficiency is critical for batterypowered applications. In diaphragm pumps, this means focusing the electric drive motor’s power on creating as much pressure or vacuum as possible, as opposed to overcoming mechanical impediments such as friction, accelerating masses, or stretching the diaphragm. Careful attention to the profile of the diaphragm also yields high efficiency: Instead of a flat elastomeric part that would have to be stretched for each cycle, the diaphragms are designed to flex by rolling instead of by stretching. This dramatically reduces the work required by the motor and extends the life of the diaphragm. Thousands of these compressors are deployed today in mobile ventilator systems for the U.S. military, and they may have other applications.

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3 • 2020

Medical Design & Outsourcing 29

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STANDARDS

What do big changes to ISO 10993-18 mean for medtech? Medical device companies need to become familiar with recent changes to ISO 10993-18, which sets standards for certain device testing. This includes when to schedule testing, how the analytical evaluation threshold functions and more.

T Sandi Schaible | W u X i A p p Te c |

Medical Design & Outsourcing

he International Organization for Standardization (ISO) released changes to standard 10993-18 in January 2020, affecting the way manufacturers will need to conduct chemical characterization and toxicological risk assessments on products. If your organization didn’t prepare between the announcement this change was coming and the ofﬁcial release of the standard, you will need to work quickly to strategize how you approach the update. In revising ISO 10993-18 (part 18), the ISO’s goal was to lend consistency to chemical characterization industry-wide. Tests must now be more sensitive and meet standard extraction requirements. As such, it will be more important than ever for you to understand the speciﬁcations required during testing and to partner with an external lab

3 • 2020

that can effectively incorporate these updates during its testing procedures. When to conduct tests New rounds of analytical testing will not necessarily be required for all medical devices and their components. Chemical information is important when performing risk assessments, but part 18 makes a distinction between information-gathering and information-generation as viable options for providing such information. Information-gathering involves collecting chemical information that already exists, including test results, while informationgeneration involves creating new information via new laboratory testing. When partnering with an external lab, you should present all existing information about the chemical characterization or

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composite materials of your devices. That way, the testing partner can assess the adequacy of the existing data as the basis for a toxicological risk assessment. If they determine that the existing information is insufficient to complete the assessment, they should recommend additional testing. Note that information on Safety Data Sheets (SDS) or technical specifications alone will likely not provide enough information for the basis of a risk assessment. If you have relied on these documents in the past, you should be prepared to conduct additional testing. The analytical evaluation threshold One of the major updates that testing labs need to take into consideration is the analytical evaluation threshold (AET). The AET ensures chemists and toxicologists are in sync with one another in designing studies. It also requires that toxicological information (including toxicological threshold and exposure assumptions) and information on extraction conditions inform the chemistry test design and execution. Since chemical characterization relies on an understanding of the level of sensitivity, and the toxicological risk assessment focuses on the threshold at which a chemical could present a risk to patients, collaboration between the two specialties is crucial. And while part 18 recognizes it isn’t always possible to achieve the required AET, you will need to provide a strong justification if the AET isn’t met. A change to the number of replicates Another change to note is that manufacturers will need to submit three replicates when they put their devices through chemical characterization testing. If you are unable to, you will likely need to provide additional justification. In the past, three replicates were often only required if you intended to apply for FDA approval in the U.S. However, with the implementation of the Medical Device Regulation (MDR) in the EU, the number of replicates will be standardized to three. Changes for prolonged-use devices Under the new standard, all medical devices that come into contact with the body for longer than 24 hours will need to undergo exhaustive extractions in the lab. This is another way that the standard will better align EU regulations with the 3 • 2020

Medical Design & Outsourcing

FDA’s. Exhaustive extractions will be relevant for companies that manufacture devices such as infusion sets, insulin pumps and permanent implants. What is not yet clear is how regulators will interpret the standard for devices that come in contact with the body for less than 24 hours. It remains to be seen whether the expectations for these limited-use devices will be applied universally or will vary by potential risk to patients (for example, testing catheters that have contact with circulating blood versus lower-risk products such as adhesive bandages). Standardizing key terminology Another change brought on by part 18 is distinguishing between the terms “leachables” and “simulated use extractables.” For years, “extractables” has meant an exaggerated, worst-case assessment of chemicals extracted, while the term “leachables” has referred to a more physiologically relevant extraction.

In reality, “leachables” is meant to be an analysis of extracted compounds in the matrix, such as drug product in a syringe. It’s often impossible to measure chemicals in the exact matrix (blood, tissue, etc.) for a medical device, so conducting a “simulated use extractables” study provides a third option. When an actual leachables study is not practical, a simulated use extractables study allows for the use of simulated solvents, such as saline or alcohol/water mixtures. ISO 10993-18 is a major revision that medical device manufacturers need to be aware of. However, despite its exhaustive level of detail, the standard does not offer a step-by-step set of instructions for conducting chemical characterization. Partnering with an external testing lab with extensive industry knowledge and experience can ensure your device submissions are adequately prepared for the current regulations and the higher level of scrutiny that will be applied to them.

STARTUP ACCELERATOR

How to cook up a successful medtech company New medical device companies need much more than money to get their businesses started. The leader of a medtech-speciﬁc incubator explains.

s we dive into 2020, the medtech sector will continue to offer tremendous opportunity for innovators and investors alike, with growth projected at over 5% every year and annual sales expected to reach $800 billion by 2030, according to KPMG. However, for every medtech startup that succeeds, how many will fail to get their devices into the hands of healthcare professionals or even reach clinical trial phase? Taking your ﬁrst step toward success depends upon the stage of your venture. For medtech startups raising their Series A funding, most investors expect to be served a perfect dish, with all the key ingredients accounted for in any pitch. For earlier-stage startups pitching to an angel or an incubator for seed funding, some of these will surely be missing. The right seed investor will be able to see beyond those gaps and help you bridge some of them — except for the ﬁrst key ingredient — a clear unmet clinical need.

Shai Policker | MEDX Xelerator |

‘Focus or die’ Oftentimes a great, skilled, even brilliant engineer who is unfamiliar with the clinical environment designs an advanced piece of technology with no clear application. In these cases, we hear entrepreneurs use words like “platform solution” and “multiple applications in parallel” to try and sell the innovation as the total solution to address many of the world’s health challenges. This makes investors nervous. 32

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“Focus or die” is the only advice we give entrepreneurs who think like this. The unmet need is the basic ingredient for success. This isn’t necessarily a medical problem without a solution, or an improved clinical outcome for a particular clinical condition. An unmet need can also be a solution that saves money or time compared with the standard of care. After identifying an unmet need, you’ll be able to start asking yourself questions like, “What is the minimal viable product that we can take to a clinical trial and to market?” and, “What specifications will be enough to satisfy an important part of the unmet need?” Once those questions are well addressed, you are more likely to define your plan and budget and get your idea off the ground with initial seed funding. However, to progress to a Series A raise, here are the five ingredients to add before trying to present it to investors: 1. Feasibility data Very few investors will be OK with just a concept, but a prototype with feasibility data will really make our hearts sing. Unlike with the “unmet need” element, entrepreneurs sometimes mistakenly believe that they (or their hired engineers) can reinvent the laws of physics or biology to address the problem. This is rarely the case. Those considering a serious investment need to see a certain depth in the solution relying on strong science and a mechanism of action that is backed by some good data.

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Photo by Gaelle Marcel on Unsplash

2. Intellectual property IP is a common “project killer” for us. But it’s important to differentiate between “freedom to operate” and “patentability.” In simple terms, if there is no way to build your product without stepping into a minefield of 100+ issued patents, then investors will blanch. However, if you are not at risk of infringing someone else’s patent but your idea is hard to protect with a patent, you may still be able to come up with strong IP in the development process or find another moat. Make sure you use a top-notch IP lawyer experienced in healthcare/medical devices. This is not the right place to skimp. 3. Business model and market potential Investors will want to see that you have a reimbursement strategy in place. In the world of value-based care, you must shape your project to fit well into an easy-to-evaluate clinical, as well as economic, value. Early-stage investors also want to see a market potential of at least several hundred million USD. Otherwise, even an early-stage exit will leave them with too small of a payout to take an initial risk with you.

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5. Strategic partnerships It’s crucial to validate commercial assumptions with someone experienced in selling in each of your target markets. An incubator may be connected to strategic players active in the right target markets who are happy to share commercial insights and data in exchange for getting an early glimpse into the new innovation pipeline of the incubator. Early-stage funding for medtech ventures isn’t always easy, but a team with the right solution for a large enough clinical unmet need should consider raising seed funds from an investor that can provide value beyond the funds to help them either fail fast or reach signiﬁcant milestones quickly and efﬁciently. This will position new medtech ventures well for a series A round with everything necessary to satisfy investors. M 3 • 2020

Medical Design & Outsourcing

9001:2015 9100D

4. An experienced team The quality of your team will dictate most of your chances to succeed. It’s always nice to invest in an idea that comes with a wellrounded team. However, an idea without a team also presents an opportunity to get the right people on board early on. An incubator with shared and very qualified resources spread among several companies is also a good way to run the first mile in a capitalefficient way. When it comes to securing funding for a Series A, however, you must have this A-list team already in place.

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TUBING TALKS

What is the best tubing for medical device applications?

Silicone tubing

Image from NewAge Industries

Alex Kakad for NewAge Industries

Device designers have to investigate application parameters while also dealing with the product’s regulatory and compliance requirements to choose the right tubing. Here is the process for selecting the right tubing product and supplier for a given application.

hen selecting a tubing material for your medical device application, the most important considerations are the key physical parameters of temperature range, pressure capabilities and chemical resistance to ﬂuids that the application will see. However, other important physical attributes of the tubing may be durometer or softness of the material, as well as bend radius, which will dictate the product’s kink resistance in application use. Lastly, cost is always a consideration when specifying a tubing product for use in an application. Another important factor is choosing a tubing supplier that has current data and validation information to back up its claims for the product, meets the quality and compliance standards set by the governing bodies involved with the application and has 34

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the breadth of product offerings to meet all the tubing needs for the application. A wide range of materials that can be used for fluid transfer in medical device applications. PVC PVC tubing has a long history of use in the medical industry. It’s a flexible, durable and relatively inexpensive product that resists a variety of chemicals. PVC is also lightweight and offers excellent abrasion and corrosion resistance. Depending on its formulation, PVC can also offer compliance with FDA, USP, NSF and other standards needed for compliance in certain medical device applications. Depending on specific application requirements, PVC may not have the purity needed. If leachables or extractables from the tubing are a critical element of

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TUBING TALKS

the design, PVC may not be the best option. For industries where high purity tubing is critical to typical applications, other materials such as silicones or TPEs are more typically seen. Silicone Silicone is an extremely pure material that processes into very ﬂexible, soft tubing, making it less prone to kinking than other materials. It handles a wide range of temperatures – from as low as -100 °F up to 500 °F – and many silicone products meet regulatory compliances related to the FDA, NSF and USP. Silicone is non-toxic, naturally translucent and free of substances of concern such as BPA, latex and phthalates. The tubing is also odorless and tasteless and can withstand repeated sterilization. Certain formulations of silicone also perform very well when used in a peristaltic pump. Silicone tubing is typically broken into two main categories, peroxide-cured silicone and platinum-cured silicone.

Fluoropolymer tubing Image from NewAge Industries

Medical Design & Outsourcing

3 • 2020

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Both are widely used in medical device applications and offer a high level of purity compared to other material types. However, peroxide-cured silicone does have low levels of benzylic acid as a byproduct of its processing. If the highest level of purity is required, platinum-cured silicone is typically the best option. TPE Thermoplastic elastomer (TPE) tubing products are another good option if a high-purity, ﬂexible tube is required. A unique advantage to TPE tubing is that it can be welded or sealed to itself using a heat sealer for use in sterile applications. Many versions of this material also meet USP Class VI standards as well as FDA and NSF requirements. Combining properties of plastic and rubber, phthalate-free polyurethane tubing offers more resistance to pressure and vacuum than corresponding sizes of PVC or rubber. It provides abrasion and tear resistance, high tensile and

elongation values and virtually unlimited flexural abilities. Polyurethane offers good chemical resistance, and like silicone, its raw materials conform to FDA standards. Fluoropolymers Another set of tubing products historically used in the medical device industry is fluoropolymers, including FEP, PFA and PTFE. These products have a very high level of purity but are not as flexible or kink-resistant compared with the other materials discussed in this article. Fluoropolymer tubing products do have a set of very unique properties, including extremely high tensile strength and burst pressure, a wide range of chemical resistance, and a high spectrum of continuous operating temperatures (up to 500 °F). Choosing the right tubing for an application can be a daunting task, as there are almost limitless options available, but very few candidates will meet all the requirements. In order to

determine the most suitable tubing solution for an application, the best idea is to discuss your needs with a supplier that has a wide breadth of product offerings, an understanding of regulatory and compliance requirements, and a knowledgeable staff that can help recommend the most suitable tubing product to meet your individual application needs. Alex Kakad until recently was a product manager at NewAge Industries (Southampton, Pa.).

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3 • 2020

Medical Design & Outsourcing

With “a few mouse clicks,” a radiologist on GE Healthcare’s Advantage Workstation can now separate volume renderings into both organs (kidneys) and blood — exporting them into 3D-printable ﬁles. (Note: The ﬁles are not cleared yet for diagnostic use.) Image courtesy of GE Healthcare

Medical Design & Outsourcing

3 • 2020

Software is enabling medical

CHRI S N EWMARKER EXECUT I VE EDI TOR

printing innovation:

Here’s how

The 3D printers themselves get a lot of attention, but for 3D printing to become ubiquitous in the medtech space, software will have to play a key role.

3D printer without software to tell it where to place the material is a really nice, expensive coffee table, according to Scott Rader, a former Stratasys GM who has led GE Healthcare’s 3D-printing efforts for the past year. Still, there is a need for even more software advances if 3D printing is to drive widespread healthcare innovation — from surgeons training on patient-speciﬁc 3D-printed models to customized, printed orthopedic implants and other medical devices. “That’s why I came to GE Healthcare — to help connect the dots,” Rader recently told Medical Design & Outsourcing. Whether it involves spitting out a 3D-printable ﬁle off of a medical image, designing a more complicated 3D structure faster or ensuring that a 3D printer is truly printing to spec, there have been great strides in recent years in the software that powers the use of additive manufacturing in medtech.

(CIRCLE) It’s possible to take 3D-printable ﬁles from the GE Healthcare Advantage Workstation to create 3D prints from a range of materials — from color-encoded to clear to preserve “X-ray vision.” Image courtesy of GE Healthcare

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3D PRINTING

“It's inseparable because it is digital manufacturing. You can't separate the computer out of the digital manufacturing process,” said Dr. Jenny Chen, founder and CEO of 3DHeals, a community of healthcare 3D-printing innovators. Here are a few of the highlights of those software advances. Quickly creating a 3D-printable ﬁle from medical images The contrast-enhanced CT image showed two kidneys with vasculature — a complex 3-dimensional image that would normally end up lost in the bowels of a hospital’s servers after a radiologist produces a diagnosis report and accompanying PDF. But Rader at GE Healthcare — replaying to MDO a demonstration he made at last year’s Radiological Society of North America convention — showed how a radiologist using the company’s Advantage Workstation within seconds can select 3D models of the

right kidney and a particular branch of a blood vessel. Physicians use Advantage Workstation to “read” patient scans like CT and MRI; once the radiologist defines the anatomy of interest, they can within a couple of mouse clicks see it exported to a 3D-printable file. It could be one of the STL files that 3D printers commonly use, or an alternative file format such as OBJ or 3MF or even VRML for virtual reality systems. It’s been possible for years to create 3D-printable files from the Digital Imaging and Communications in Medicine (DICOM) output from CT or MRI scans. But the process involves interpreting the data on slices through the body, then segmenting organs, bones and vessels by outlining those structures in the slices. Manual segmentation processes are laborious, especially for a hospital radiologist trying to create the files amid a busy workday, according to Rader.

3D Reconstructed neurovasculature using Philips’ IntelliSpace Portal Image courtesy of Philips

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3D PRINTING

HERE’S SOME RECENT MEDICAL 3D-PRINTING NEWS Chris Newmarker

Executive Editor

June 2019 Digital manufacturing company Protolabs (Maple Plain, Minn.) rolls out metal 3D-printing production capabilities. Materialise announced FDA clearance for its Mimics Enlight cardiovascular procedure-planning software to create accurate 3D-printed heart models. July 2019 Axial3D closes a $3 million funding round to support its U.S. expansion. The Belfast–based company is working on automated algorithms to improve access to medical 3D printing for modeling and education in healthcare settings. September 2019 Protolabs adds the Carbon platform to its portfolio of 3D-printing technologies. Carbon boasts fast stereolithography printing with little or no mechanical impact on the growing part.

October 2019 Stratasys announces the launch of its J750 Digital Anatomy 3D printer meant to replicate the feel, responsiveness, and biomechanics of human anatomy in medical models. Adam — a young company with technology to 3D-print bone grafts made of ceramic bioglass and modified biopolymer — says its first human trials are coming soon. December 2019 GE Healthcare inks a medtech 3D-printing partnership with Formlabs (Somerville, Mass.), a fast-growing maker of relatively affordable stereolithography-based 3D printers. January 2020 The FDA clears 3D-printed, patientspecific stents developed by a doctor at the Cleveland Clinic. Dr. Tom Gildea developed the stents to keep open the airways of patients with serious breathing disorders caused by inflammation, trauma, tumors and other masses.

LEFT: Bone tumor modeling workﬂow using Philips’ IntelliSpace Portal RIGHT: Pediatric heart model using the 3D-modeling application on Philips’ IntelliSpace Portal 42

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Advantage Workstation has helped radiology departments streamline the workflow for diagnostic reports for more than 20 years. What is new is the ability to re-use the 3D diagnostic visualizations for 3D printing and beyond via a simple file export. “If you know manual segmentation and 3D printer interface software, you can do this today, but my hospital customers don’t often have a 3D-printing or engineering background,” Rader said. With the new GE Healthcare capability 3D Suite, he added, “you can simply, within three clicks, reuse the data you already generated to write the radiological report.” GE for now is launching the new capability for creating 3D-printed educational models to aid in physician team communication and explain conditions to people seeking care, with plans to seek FDA permission for diagnostic and training uses. “We have the ability to communicate in 3D,” Rader said. GE’s major competitors in the imaging space — Royal Philips and Siemens Healthineers — have also made strides in creating 3D-printable files from medical scans. When Philips launched the 10th version of its IntelliSpace Portal in 2017, it included an embedded 3D-modeling application meant to make it easier to generate and export 3D models for VR and printing as an extension of the clinical workflow. Philips already had algorithms that could, for example, create a 3D version

Images courtesy of Philips

3D PRINTING

of a colon for a virtual colonoscopy or 3D versions of the heart or lungs, so it was fairly natural to make the jump to creating models that could actually be printed, said Kevin Lev, marketing director of advanced visualization and AI solutions at Philips. “We have to remember that physical model creation is something radiologists are not necessarily used to doing on a day-to-day basis,” Lev said. “What we tried to do is make the process easy for the radiologist to do and transfer over to the surgical or intervention suite where there could be large benefits in surgical planning, potentially making a large difference for the patient.” Also in 2017, Siemens Healthineers announced a partnership with Materialise — the first company to win FDA clearance for 3D printing anatomical models for diagnostic use — to incorporate Materialise Mimics inPrint software into Siemens’ advanced imaging platform Syngo.via. “The easy workflows in the Materialise software make it easier for the radiologists and imaging technicians to prepare a file from the DICOM images to a 3D-printable file in a straightforward and easier way,” said Todd Pietila, who manages global business development for hospital 3D printing at Materialise. Radiologists can use the Materialise software from any Syngo.via access point installed anywhere in a hospital network, according to Katrin Ganser, Syngo global marketing manager at Siemens Healthineers. “We’re aiming to take the 3D printer to smaller hospitals that are not the traditional big research facilities,” Ganser said.

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Faster and more intricate design Innovation is also taking place on the design software front of medical 3D printing. For example, nTopology (New York) has design software that goes beyond traditional CAD by using mathematical equations to represent complex geometries, versus having to represent each complex feature separately. The result is faster design and smaller ﬁle sizes that are only megabytes in size, versus hundreds of megabytes or even gigabytes, according to Christopher Cho, senior application engineer at the company.

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3D PRINTING

Anterior lumbar interbody fusion (ALIF) spinal implant with digitally-applied surface roughness and gradient periodic gyroid structure, made using nTop Platform software from nTopology Image courtesy of nTopology

The 5-year-old company’s roots are in the engineering design industry. But nTopology has made inroads in medtech, especially in the orthopedic space where complex geometries inside implants have the potential to stimulate replacement bone growth. Irish Manufacturing Research (IMR), for example, collaborated with nToplogy and British engineering company Renishaw and its Renishaw RenAM 500M metal AM system to produce lightweight spinal implants that mimic the mechanical properties of bone. It’s easier to make changes and experiment with the software because the alterations can then flow through the overall equations behind the design, according to Cho. “They were able to use the software to explore more options that they could consider and test in a shorter amount of time,” he said of Renishaw and IMR. “We can give you a brand new, unique-looking structure, go to market with something that no one has ever seen before.” Additive manufacturing excels at creating complex technologies, so nTopology’s design software marries well with 3D printing. The company has partnerships with Renishaw, EOS and others to integrate nToplogy directly into their 3D-printing systems, versus relying on STL files and their limitations. “If we can avoid that digital step, work directly with the machine manufacturers … basically integrate the digital model workflow directly with them, we would be able to bypass this digital obstacle and really push the envelope on the design into the manufacturing process,” Cho said. The rise of in situ monitoring No matter what software innovation created it, a design will prove useless if the 3D printer doesn’t actually print to spec. That’s where sophisticated in situ monitoring — monitoring during the actual print — is coming into play.

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3D Systems, for example, has inprocess monitoring systems in metal 3D printing systems, including its DMP Flex 350, DMP Factory 350 and DMP Factory 500, with data analysis taking place post-process. Plans include releasing new software for automated monitoring analysis soon to aid users in assessing part quality, said Markus Reichmann, healthcare business development manager at the printer company. “We are really putting a lot of effort into automated monitoring.” 3D Systems uses a digital camera and a light diode that collects emitted light to tell exactly what is going on in the melt pool. “A next step will be to incorporate the online analysis that would run during the printing … and provide a feedback loop to the printing process based on the analysis results,” Reichmann said. A 3-year-old 3D printer company called Origin, based in San Francisco, boasts a 3D printer called the Origin One that monitors even more during the print. There are two optical cameras, three infrared cameras, humidity sensors, temperature sensors and more — as well as analytical software to better ﬁgure out what is going on, said Origin’s marketing director Finbarr Watterson.

3D Systems’ DMP Flex 350 machine is equipped with the latest monitoring software for maintenance tracking, as well as in-process monitoring of the build quality. Image courtesy of 3D Systems

3D PRINTING

For in-situ process monitoring, the Origin One boasts two optical cameras, three infrared cameras, humidity sensors, temperature sensors and more — as well as analytical software to better ﬁgure out what is going on. Image courtesy of Origin

The reason for so many controls is that Origin grew out of partnerships with major materials companies such as BASF and Henkel, which are also important medical device industry suppliers. They wanted a printer they could ﬁne-tune to build the materials that designers in medtech and other advanced industries want to use. Henkel, for example, has silicones that are used in medical devices, although

silicones are notoriously hard to 3D print. “Not many [3D-printer] companies out there offer it because it's hard to do ﬁne features, but through our software controls, through the kind of tweaks, we're able to get the silicones working on our system when they’ve failed with every other resin-based 3D printer out there,” Watterson said. Using Origin’s print process, silicones can be printed within a 100-micron tolerance, and with rigid materials, a 50-micron or lower tolerance can be achieved. Origin, Watterson said, is big on data access and analysis. “We want to make everything open and accessible, create really good hardware and not try to do everything. … We want to broaden and work with companies to co-develop applications.” In situ monitoring and data access through software are crucial for medical 3D printing innovation, Chen said. “It's extremely important to remove the human element so that it's no longer an art, so it's not like one product can be studied differently from the other, but consistently deliver with quality.”

We're aiming to take the 3D printer to smaller hospitals that are not the traditional big research facilities.

Origin (San Francisco) created a 3D printer that partnering materials companies such as Henkel can ﬁne-tune to use with usually hard-to-print medtech materials, such as silicone. Image courtesy of Origin

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Medical Design & Outsourcing

Abilitech Medical consultant Rob Wudlick (left) has been working with CEO Angie Conley (right) and others on the deviceâ&#x20AC;&#x2122;s development.

Image courtesy of Abilitech Medical

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abilitech aims to arm people with independence

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

Some have dubbed Abilitech’s device “a wheelchair for the arms.” Its machined aluminum exoskeletal arm and breathable cloth vest use a spring counterbalance system and a “living hinge” that spreads the load, making it — and the arm — feel weightless.

ob Wudlick brushed his teeth on his own recently for the first time in 8 years. The 35-year-old industrial engineer is a quadriplegic as a result of an accident. He’s been working for three years as a consultant to Abilitech Medical (St. Paul, Minn.), a startup whose Abilitech Assist device enables wearers to use their arms to feed themselves, brush their teeth, comb their hair, turn on a light switch, open doors — activities for which they’ve needed help from caregivers. Before founding Abilitech in 2016, CEO Angie Conley was working for a nonprofit called Magic Arms, which was trying to develop a 3D-printed device powered by rubber bands for children with a congenital joint contracture called arthrogryposis. When she joined Magic Arms, the device was in the prototype phase, fundraising for further development was difficult and the nonprofit had not fit any patients. “I was a senior product manager at Medtronic, and I’ve worked on six different cardiovascular products,” Conley said. “I had the skill set to develop a solution but no budget and no staff – only a few volunteers with extremely limited capacity. We even struggled to pay for things like QuickBooks. It was a bake-sale approach every time I fit a patient.” Conley raised enough money over 18 months to fit 12 children. “I saw patients moving their arms for the first time ever, and their parents just wept in disbelief,” she said. “It was an incredibly moving experience.” Meanwhile, her inbox was filled with notes from people asking Magic Arms to help their adult loved ones who lived with multiple sclerosis, amyotrophic lateral sclerosis (ALS) or spinal cord injuries., But the nonprofit was focused on children with pediatric orphan conditions.

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ABILITECH

When the staff tried their device on a 90lb doctor who had a neurologic condition, the device broke. When it was clear that the Magic Arms device was not scalable and needed to be redesigned, Conley went back to the drawing board. She decided to develop new technology powered by springs and motors and to focus on a market that included adults. Aaron Fletcher, managing director of Fort Worth, Texas–based venture capital firm Bios Partners, was her first investor. His daughter, Maddy, now 10, was born with arthrogryposis. Although the condition affects Maddy’s legs rather than her arms, Fletcher was inspired by the need to help children affected with rare diseases. Bios Partners normally invests in biotechnology companies, but Fletcher saw an opportunity for a business that could do a lot of good if it could develop a smaller, more durable device that would be scalable for people of different sizes and eligible for insurance reimbursement. Bios Partners invested $2.3 million and participated in a follow-on raise. “Angie has been with us since the beginning, and it has really been just all the credit to her continual hard work on trying to get this developed,” Fletcher said. Last year was an important year for Abilitech. The company won the top two awards for startups in Minnesota: the MN Cup entrepreneurship competition and the Minnesota High Tech Association’s Tekne award for medtech. It also participated in the Texas Medical Center accelerator program in Houston, which provides free office space, business advisors and clinical study opportunities.

and has a lumbar sacral orthotic to secure it to the hips. “It is not robotically powered,” said Mark Oreschnick, Abilitech’s VP of R&D. “It just takes gravity out of the equation… We’re actually supporting their arm and the weight of the device for them – it’s like power steering for the arms.”

It is not robotically powered. It just takes gravity out of the equation... We're actually supporting their arm and the weight of the device for them it's like power steering for the arms.

‘Wheelchair for the arms’ Some have referred to the Abilitech Assist as “a wheelchair for the arms.” It consists of an exoskeletal arm with a machined aluminum shell and a breathable cloth vest made by Core Products International (Chetek, Wis.). It has a spring counterbalance system and a “living hinge” that articulates across the back and wraps around the chest to spread the load of the device and the arm so that they feel weightless. The vest’s plastic-and-aluminum structure is padded with formable foam for comfort 48

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The company is working with spring manufacturers R&L (Geneva, Wis.) and Century Spring (Commerce, Calif.) to provide the correct lift and to pretension the springs for each wearer, Oreschnick explained. The other challenge was making the arm portion as light as possible (up to 3.5 lb) but still strong enough to meet testing regulations. Abilitech was advised to use carbon ﬁber, but Oreschnick said it is not strong enough to withstand the 150 lb of force created by arm extension. The company went with 70-75 grade aluminum, the type used in the interior of an airplane. “It has a very good strength-to-weight ratio,” he said. “This is not as good as steel, but it is a close competitor. Going up a little bit in thickness, you can outperform steel and still be lighter.” Abilitech has worked with the rehabilitation services department at Gillette Children’s Specialty Healthcare and Regions Hospital in St. Paul for 3 years for input on design and functionality. Rehabilitation services director Marny Farrell said she appreciates being able to help the company problem-solve. “I think it’s the big litmus test to be involved with practitioners to see how it will work,” said Farrell, who witnessed one patient feed himself for the ﬁrst time since his injury. “It’s

Abilitech Medical CEO Angie Conley holds the startup’s ﬂagship device, the Abilitech Assist. Image courtesy of Abilitech Medical

ABILITECH

just amazing when it’s the right piece. It can change their quality of life.” Rob Wudlick, the engineer who’s been working with Abilitech, said the device allows him to move his hand to his face and helps him with range-of-motion. The vest provides him core stability to support arm function, and the latest iteration enabled him to independently feed

The Abilitech Assist

Image courtesy of Abilitech Medical

himself and brush his teeth. “Having the ability to do it on your own, it’s really nice,” Wudlick said. No more bake sales Conley has raised $11 million over the past three years to fund the device’s development and to support device testing, FDA registration, clinical studies and commercialization into 2021. Abilitech plans to enroll 75 muscular dystrophy patients in a clinical trial at the University of Minnesota and Gillette Children’s. The endpoints will measure how it helps users complete activities of daily living such as eating, drinking

and toothbrushing; quality-of-life improvements; and economic benefits. Abilitech Assist is designed for people over 5 feet tall and is Class I, FDA 510(k)exempt. The company plans to launch the right arm in June 2020 and follow with the left within a few months. There’s strong interest in using the device for rehabilitation, and clinical studies will be planned for stroke and spinal cord injury rehabilitation, according to Conley. A National Institutes of Health grant is funding the adaptation for use with children, fulfilling Conley’s mission at Magic Arms. She expects to conduct a pediatric clinical trial in the first quarter of 2021. “It’s motivating for our team to have a mission to restore independence for these people,” Conley said. “We will have a physical, social and economic impact that will make a profound difference in patients’ lives and in the lives of their families.”

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This coin-sized insulin patch c uld

improve diabetes treatment

COULD TREATING DIABETES SOMEDAY BE AS SIMPLE AS SLAPPING ON A PATCH? A UCLALED RESEARCH TEAM THINKS SO, AND IT’S SEEKING FDA PERMISSION TO PROVE IT.

C H R IS NEW MA R K ER EXEC U TIV E ED ITO R Researchers were able to preload enough insulin into the coin-sized adhesive microneedle patches to enable clinical use. Image courtesy of UCLA

research team led by UCLA bioengineering professor Zhen Gu claims to have overcome some of the technological hurdles to creating a patch that releases insulin based on the level of glucose in a person’s body. Their creation is a coin-sized (about 5 cm2), adhesive polymer patch with microneedles. The pyramid-shaped microneedles are about 400 microns wide at the base and 900 microns tall and penetrate the stratum corneum, the outer layer of the skin. When the interstitial ﬂuids in the skin reach hyperglycemic levels, the phenylboronic acid units within the polymer matrix promote swelling of needles and release the insulin preloaded into the matrix.

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Because the researchers created the patch through a molding and UV light-curing process that doesn’t damage the insulin, about a ﬁfth of the microneedles’ weight is insulin — enough to enable clinical use, according to the researchers’ paper in the Feb. 3 edition of the journal Nature Biomedical Engineering. Studies showed that the patches maintained the bioactivity of the insulin for more than 8 weeks at room temperature. “There’s a high amount of insulin inside, and we’re making the whole needle matrix glucoseresponsive,” Gu said in a recent interview with Medical Design & Outsourcing.

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INSULIN PATCH

Controlled studies on diabetic minipigs showed the patches could maintain the pigs’ glucose levels in a normal range for more than 20 hours, according to the paper. Glucose challenges conducted on both diabetic mice and pigs showed the patches could bring down glucose levels within 1 to 2 hours. Zenomics, the startup Gu cofounded, is applying for FDA approval for a human clinical trial. The biomedical device company MicroPort Scientiﬁc Corp. invested $5.8 million in Zenomics in 2017. “The microneedle patch provides such a convenient, painless way to apply a glucose-responsive insulin delivery system to people with diabetes,” Gu said. “It could potentially enhance the health and quality of life of people with diabetes.” Gu’s work on smart insulin delivery goes back a decade to his time as a postdoctoral fellow at the Massachusetts

The microneedle patch provides such a convenient, painless way to apply a glucose-responsive insulin delivery system to people with diabetes. It could potentially enhance the health and quality of life of people with diabetes. Institute of Technology lab of medtech innovator and serial entrepreneur Robert Langer, a co-author of the recent paper and a member of Zenomics’ board. Langer had a grant available for diabetes research, and Gu had some interest in the subject because his grandmother back in China — now passed away — had Type 2 diabetes. “I understand their pain, and I understand their inconvenience,” Gu said of people with diabetes. Langer said of Gu’s work via email: “It has been a pleasure to see the terriﬁc progress by Zhen and his team. It could someday lead to new ways of treating diabetes and other diseases.” Work continued during the years Gu spent as a biomedical engineering professor at the University of North Carolina at 52

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Chapel Hill and North Carolina State University. It was there that he began to collaborate with another paper co-author, Dr. John Buse, whom the American Diabetes Association has recognized for his work on hundreds of clinical studies and dozens of epidemiologic analyses and translational projects. Buse said of Gu: “He's the brains of the operation, and I just try and keep him focused on how to develop this into something that works in patients.” The microneedle patch, according to the paper, boasts some improvements over similar concepts because it doesn’t rely on complicated chemical reactions that could irritate the skin. Because it is nondegradable, a person can remove it entirely after treatment. Gu declined to disclose how they did it, but he and his colleagues also ﬁgured out how to incorporate an adhesive without interfering with the microneedles’ ability to deliver insulin. Buse thinks the patch could provide a potential alternative — or at least a backup — to the continuous glucose monitor/ insulin pump combinations that major medical device companies such as Medtronic, Abbott, Dexcom, Insulet and Tandem Diabetes Care are touting. “The genius of this is if you could have something that was relatively unobtrusive, like a patch, which fundamentally is like a Band-Aid, and the patch would release insulin in response to glucose levels,” Buse said of Gu’s concept. “You basically would solve the diabetes problem in many ways.” It’s even possible to personalize the patches to release varying levels of insulin, either by varying the ratio of the monomers making up the polymer or by changing the size of the patch, according to the paper. “You might have one that you would wear all day that basically takes care of things when you're not eating a meal. And then you would slap on a big patch because you're going to have ice cream and cake at a birthday party — or a small patch because you're going to have a salad,” Buse said. “We don't know yet what the patches are going to be capable of,” he added. “In an ideal world, it'd be one patch a day or one patch a week. It’s going to take a while before we ﬁgure out what's really possible.”

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The medtech sterilization business faces

battles

on many fronts AS THE EPA PREPARES TO ISSUE

N A NC Y C R OTTI M A NA G ING ED ITO R

NEW REGULATIONS FOR THE CARCINOGENIC STERILANT GAS ETHYLENE OXIDE, THE INDUSTRY MUST DECIDE WHETHER TO INVEST IN EXPENSIVE EMISSIONSCONTROL UPGRADES, SWITCH STERILIZATION PROCESSES OR

— IN THE CASE OF SOME SMALL STERILIZATION COMPANIES — EXIT THE BUSINESS.

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n the next few months, the U.S. Environmental Protection Agency will update its rule governing emissions of the most commonly used substance for sterilizing medical devices: the carcinogenic gas ethylene oxide, or EtO. Although it’s been in use as a medtech sterilant since the 1960s, EtO has really only been under heightened scrutiny for little more than a year. EtO sterilization plants have shut down in Illinois, Georgia and Michigan over concerns about emissions. The FDA has warned about device shortages (although few have materialized). Concerned citizens have formed protest groups and filed

lawsuits against sterilization companies. And state and local governments have been wrangling over who has the right to regulate sterilization plant operations. The bottom line is that medtech sterilizers may have to spend a lot of money to upgrade their facilities to meet the new EPA standards, and possibly settle lawsuits or pay judgments to people who claim that they or their loved ones became ill or died from ethylene oxide exposure. At least 76 lawsuits have been filed against Sterigenics on these grounds, relating to its nowshuttered EtO plant in Willowbrook, Ill. B.

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Braun was just sued over emissions from an EtO plant in Hanover, Pa. Alternatives to EtO exist, but experts say none can sterilize as many types of devices in as many types of packages as EtO. The gas can penetrate paper and cardboard, doesn’t discolor or harm plastics used in many devices, and can sterilize truckloads at a time. Some of those experts, including Dennis Christensen, have been working with the FDA to determine the path forward.

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Medical Design & Outsourcing 55

ETHYLENE OXIDE

Christensen has been involved with medtech sterilization since 1967. He has sat on the Association for the Advancement of Medical Instrumentation (AAMI) 11135 EtO sterilization standards committee since 1984 and worked on the design, construction and operation of EtO sterilization facilities in the U.S. and abroad. Christensen also owns SVC, a contract EtO sterilization facility in San

Jose, Calif., and recently participated in a two-day FDA meeting on the status and future of medtech sterilization. The conclusion, he said at a DeviceTalks West panel in Santa Clara, Calif., in December 2019, was that the industry will have to spend the next decade reducing EtO use and emissions as well as residual EtO left on packages after processing. “We have to do everything we can to reduce the amount of (EtO) and reduce the amount of exposure and get as much out the device that we can,” he said. Many existing EtO sterilization plants are older and need extensive — and expensive — upgrades, according to Christensen. Some of those upgrades are underway. Becton Dickinson is spending $8 million on emissions controls at two medical device sterilization plants it operates in Georgia. Medline Industries is putting $10 million in emissions controls into its Waukegan, Ill., plant to comply with new state regulations. Sterigenics was working on upgrading its Willowbrook plant when the landlord decided not to renew its lease. Viant Medical closed an EtO plant it acquired in 2015 from Integer in Grand Rapids, Mich., after a run-in with state environmental regulators.

EtO is vital to the continued availability of tens of billions of safe and effective medical devices every year, and the medical technology industry is committed to its safe and responsible use as we look for alternatives and ways to reduce EtO emissions. The FDA recommends that medtech companies reduce the amount of paper (such as the labeling and instruction manuals) included in a sterile device package and deliver that information electronically. A large amount of paper in an EtO sterilization chamber hinders the gas getting to the device and results in higher EtO usage, the agency said in November. The FDA recently told Medical Design & Outsourcing it is working with applicants on a pair of challenges it issued 56

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in July to accelerate the development and review of new sterilization methods. The agency also began a voluntary pilot program in November to expedite its approval of certain changes that medtech manufacturers make to ethylene oxide sterilization methods, processes and facilities, and to streamline the reporting method that manufacturers of high-risk devices use when sterilizers make those changes. Meanwhile, the EPA is reviewing its National Emissions Standards for Hazardous Air Pollutants (NESHAP) for ethylene oxide commercial sterilizers. The agency received 97 comments from the public and the industry on the topic from December 12, 2019 through Feb. 10, 2020, including a statement from 11 state attorneys general arguing NESHAP fails to adequately protect workers and communities from the harmful effects of EtO. The medtech trade group AdvaMed urged the EPA to reassess its risk assessment value for EtO, arguing that the threshold is neither practical nor based on the latest science. Pursuing it could pose an increased risk to public health through what the group termed “supply chain and distribution threats.” “EtO is vital to the continued availability of tens of billions of safe and effective medical devices every year, and the medical technology industry is committed to its safe and responsible use as we look for alternatives and ways to reduce EtO emissions,” said AdvaMed president and CEO Scott Whitaker in February. “The agency’s failure to address these valid scientiﬁc concerns surrounding their value threatens not only the medical technology supply chain but the tens of millions of American patients that rely on EtO-sterilized devices. We ask the agency to follow its own scientiﬁc recommendations and develop a revised EtO risk assessment standard that will effectively protect the public health and not disrupt patient access to needed medical technology.” The EPA is due to come out with its new proposed rule covering commercial EtO operations in May 2020. Christensen, who said he has visited just about every EtO operation in the world, predicts the industry has a lot of work ahead of it. “They’re going to have to improve the technology if they are going to stay in business,” he said.

DAN I ELLE KI RSH SEN I OR EDI TOR

INVENTOR:

OTIS BOYKIN Otis Boykin

The man credited with laying the foundation for today’s pacemakers

Most people in medtech know of Earl Bakken's contributions to pacemakers

Otis Boykin ﬁled a patent for a resistor in the 1950s that could enable pacemakers to have a time base at a much smaller scale.

Image from the National Inventors Hall of Fame

and cardiac rhythm devices. But without Otis Boykin, pacemakers wouldn't have the pacing technology they do today.

n African American inventor and engineer, Otis Boykin had a special interest in resistors. His mother died from heart failure when he was 1 year old. Thirty-one years later, he filed a patent for a resistor that paved the way for his most notable invention, the pacemaker control unit. While working at Lisle, Ill.-based CTS Corp., Boykin filed a patent (U.S. Patent No. 2972726A) for a high-precision, wire-type electrical resistor that could be readily adapted to different space requirements and configurations. According to the patent, the resistor was designed to combine minimum inductive properties with minimum capacitive effects. It could also provide tolerances

as low as required and could withstand “relatively great accelerations and shocks and great temperature changes” without breaking the ﬁne resistance wire or causing other detrimental effects. In the patent ﬁling, which lists CTS as the assignee, Boykin said the resistor was made of lengths of resistance wire between 0.0006 in and 0.010 in in diameter and had resistance values of 0.05 ohm to several megohms. The patent also says the resistor could be made cheaply and quickly without wire strain. Most importantly, the highprecision, wire-type electrical resistor could enable pacemakers to have a time base — the repeated sending of uniform signals — at a much smaller scale.

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3 • 2020

Medical Design & Outsourcing

OTIS BOYKIN

Pacemakers are small devices that help the heart beat regularly by delivering a small electric stimulation that controls the heartbeat. The control units help identify the number of pulses per minute needed for each individual patient and the pulses become the number of beats per minute for the paced heart. “Essentially, it helps to control a patient’s heart rate,” Gabriel Mouchawar, divisional VP of product development at Abbott, told Medical Design & Outsourcing. “The invention of the resistor and later the capacitor was essential in setting the time base for electronic devices, so the work of Otis Boykin was incredibly important to advance the technology.” The earliest pacemaker devices were external and needed to be plugged into a wall while patients used them. By 1957, Medtronic co-founder Earl Bakken, an electrical engineer by trade, developed

the first battery-operated wearable pacemaker. Dr. Walton Lillehei, a pioneer of open-heart surgery, asked Bakken to build the pacemaker after a child who was connected to an AC-powered pacemaker died during a power failure. The first pacemaker implantation surgery took place in Sweden in 1958. Innovations continued, many of them enabled by Boykin’s contribution. “Pacemakers today are powerful devices with a number of benefits for patients. Many have computing power similar to early personal computers and can last more than 10 years on their internal battery,” Mouchawar said. “But all technology starts somewhere, and Otis Boykin’s work set the technology on a path that led us to where we find ourselves today.” Boykin graduated from a Dallas high school as valedictorian in 1938. He went on to attend Fisk University and worked

as a laboratory assistant in an aerospace lab, the National Inventors Hall of Fame reported. There, Boykin started to work on aircraft controls and various electronic resistors and became familiar with electrical components. He later moved to Chicago and worked in the P.J. Nilsen Research Lab where he eventually met Hal Fruth, with whom he would later start his Boykin-Fruth business, according to the Lemelson Program at the Massachusetts Institute of Technology. In 1952, Boykin-Fruth filed a patent with the U.S. Patent and Trademark Office related to a non-adjustable metal resistor made of wire or ribbon that could be coiled, woven or formed as grids arranged to reduce self-induction, capacitance or variation with frequency, according to the patent filing. It was the start to a line of as many as 27 electrical device patents and eventually the resistor that would become a part of the pacemaker’s control unit.

www.medbioinc.com 58

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OTIS BOYKIN

“Otis’s work was instrumental in making the components of the pacemaker longer-lasting and manufacturable at a lower cost, which in turn helped increase access to the therapy to improve patient care. For companies like Abbott, the devices we offer today stand on a foundation built by

people like Otis who made a remarkable impact on the ﬁeld,” Mouchawar said. Abbott (St. Jude Medical), Boston Scientiﬁc and Medtronic lead the way in pacemaker development today. Abbott has a number of cardiac rhythm management devices in its portfolio, including pacemakers, insertable cardiac

Boykin’s pacemaker control unit patent ﬁling

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monitors, quadripolar LV leads and CRTDs. Medtronic has four pacemakers in its current offerings with seven others in its past and Boston Scientific has five of its own pacemakers on the market. “Boykin’s work was critical to developing a pacemaker generator that was efficient, compact and resilient over time. Several decades of iteration on his foundational work have brought us rate-adaptive pacing, the ability to track the atrium and address complete heart block and rate responsiveness features that augment heart rate commensurate with physical activity,” Katie Schur, a spokesperson at Boston Scientific, told Medical Design & Outsourcing. Because of Boykin’s invention, companies have also been able to develop leadless pacemakers, which are less invasive and 90% smaller than transvenous pacemakers, according to the American College of Cardiology. While leadless pacemakers only provide single-chamber ventricular pacing and lack defibrillation capacity, they eliminate complications that arise with transvenous pacemakers and leads, including pocket infections, hematoma, lead dislodgment and lead fracture. Pacemakers are getting smaller and less invasive and the future of the device is on track to becoming even smaller with new power options and remote monitoring. Boston Scientific projects that there will be more opportunities in the future for modular rhythm management with multiple device communicating with one another. Pacemakers could also be implanted at different time intervals as a patient’s condition changes. Moreover, the company predicts that pacemakers could become energy-harvesting, meaning that instead of relying on batteries, they could use the motion of the heart or blood chemicals as a power source. Mouchawar at Abbott thinks the next generation of pacemakers offered to patients will be smaller, last longer and offer new remote monitoring capabilities through Bluetooth connections to a patient’s smartphone. “How the devices deliver care will offer one set of advancement, while new ways for patients to stay connected to their hospital or clinic will offer another avenue for companies like Abbott to continue improving outcomes.” 3 • 2020

Medical Design & Outsourcing

MEDTECH EVENTS

How is coronavirus affecting medtech? Company stocks are down, events are cancelled, but the industry could still bounce back.

T To m S a l e m i | D e v i c e Ta l k s E d i t o r i a l Director |

Medical Design & Outsourcing

he coronavirus (COVID-19) storm swamped the medtech industries along with the rest of the U.S. economy, but the sector is showing some resilience. And, in a few rare cases, it may offer investors a more secure place to invest their capital. In an interview with DeviceTalks Weekly — a new podcast produced by WTWH Media, which runs the DeviceTalks events and publishes MassDevice and Medical Design & Outsourcing — Jefferies analyst Raj Denhoy said medical device stocks may be tracking ahead of other industries. Denhoy said a leading medtech stock index dropped by 21% during the week of March 9 while a comparable biotech index dropped 26%. The S&P meanwhile fell 26%, so medtech performed well. “Generally speaking, we fared a little bit better than the broader market,” Denhoy said. “And healthcare overall fared a bit better than the broader markets, but we haven’t been immune by any stretch.”

3 • 2020

A primary weak point in medtech’s armor could be seen in the demand for so-called “elective” surgeries like hip or knee implants. As hospital systems began shifting resources toward responding to the COVID-19 cases, they were unable to accommodate those patients requiring non-emergency surgery. By March 10, nearly one-quarter of surgeons polled by Jefferies reported seeing a slowdown in elective surgeries. In China, that figure rose to 80–90%, Denhoy said. But there is good news. Medical device companies remain largely debt-free, giving them a strong ﬁnancial foundation upon which they can weather the storm. “For the most part, medical device companies are in good shape,” he said, adding that Jefferies is trying to steer clients to invest in companies selling devices used in critical procedures. Denhoy said Edwards Lifesciences’ transcatheter heart valve makes it an attractive investment target.

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MEDTECH EVENTS

While the impact of COVID-19 on publicly traded companies may be manageable, the threat of the disease has wiped out opportunities for investors, entrepreneurs, engineers, physicians and other critical parties to meet and share ideas. The March 5 cancellation of the Healthcare Information and Management Systems Society (HIMSS) 2020 Global Health Conference & Exhibition was one of the ﬁrst examples of the reaction to the outbreak and the domino effect it may have. Conversely, Biogen (NSDQ:BIIB) hosted a company meeting the same week in which up to 175 people could have been exposed to the virus after three employees who had tested positive for COVID-19 were in attendance, raising concerns over the potential knock-on effect of meetings, conferences, shows and more. Here at WTWH Media’s MassDevice, we’ve started a running tally of canceled medtech and medical device events. Here is our list of canceled or delayed events, as of the writing of this article in mid-March:

Medical Design & Outsourcing

3 • 2020

AAOS • The American Academy of Orthopedic Surgeons announced that it is canceling its annual meeting, scheduled for March 24-28 at the Orange County Convention Center in Orlando, Fla. • The academy expected the meeting to host 479 presentations in 250,000 net square feet of exhibit space with 27,000 attendees from around the world. • AAOS said it plans to share details soon on how it will “work to bring the substance and spirit” of the meeting to those who had planned to participate. ACC.20/WCC • The joint meeting of the American College of Cardiology and World Congress of Cardiology was scheduled for March 28-30 in Chicago. The ACC announced that it will not be held amid worries stemming from coronavirus. • More than 18,000 attendees from 108 countries were expected to attend.

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•

“With an ever-increasing number of ACC members on the front lines of preparing and reacting to the COVID-19 outbreak, we believe it is in the best interest of everyone to cancel the meeting and ensure our members are able to do what they do best — help and heal,” ACC president Dr. Richard Kovacs said in a prepared statement. “This is a ﬁrst for us. We have never not held an Annual Scientiﬁc Session live and in-person in the last 69 years.” Kovacs noted that there are virtual presentations in the works as the ACC seeks to recognize award winners and deliver some information intended to be shared at the meeting. The ACC plans to share more information regarding refunds and options in the coming days.

AdvanSE Life Sciences Conference • Southeast Life Sciences announced that it intends to hold its inaugural AdvanSE Life Sciences Conference as planned from May 26-28 at the Wild Dunes Resort in Isle of Palms, S.C.

• In a news release, Southeast Life Sciences told potential attendees that it plans to monitor the state, regional, national and international responses and recommendations and to quickly communicate any decision to postpone the event. BIOMEDevice • Informa’s BIOMEDevice Boston Design & Manufacturing event has been moved to Sept. 16–17. • Those who have registered will have their attendee registration automatically transferred to the rescheduled date, and no action is needed at this time, according to a release. • Anyone who booked hotel rooms in the event block will receive information regarding rescheduling dates and the process of canceling the existing room and reserving a new one. • Updates will be posted on the event website as they become available. Design of Medical Devices 2020 • The University of Minnesota canceled its Design of Medical Devices 2020 conference due to the coronavirus outbreak. • The event had been scheduled for April 6–9 in Minneapolis. • According to a news release, planners are in the process of setting up a one-day DMD 2020 event later this year so that artificial intelligence and medical device emerging technology forums may be held, along with other topics. More information on that is expected to come soon. • Those who registered for the event will receive information about refund options. DMD 2021 is set for April 12–15 next year. DeviceTalks • Registration remains open for DeviceTalks Minnesota (June 1-2) and DeviceTalks West (June 23-23). • Conference organizer WTWH Media (which also owns MassDevice and Medical Design & Outsourcing) has instituted a policy to ensure sponsors and attendees are financially protected in the event of a cancellation.

• WTWH Media will monitor the situation and decide if the conferences should be postponed. The decision will be made in April. • DeviceTalks Boston (Sept. 24–25) is proceeding as scheduled. That will take place at the Hynes Convention Center alongside the Robotics Expo and Healthcare Robotics Engineering Forum. • Any questions or comments can be sent to Tom Salemi, editorial director, tsalemi@wtwhmedia.com ECR 2020 • The European Society of Radiology postponed its annual ECR congress to July 15-19 in Vienna, Austria. The event was previously scheduled to take place from March 11-15. • Registration fees and online services remain in place for the new date and registration remains open. ESC Acute Cardiovascular Care conference • On March 4, the European Society of Cardiology called off its Acute Cardiovascular Care conference, scheduled for March 7–9 in Athens. At the time of cancellation, the CDC had confirmed eight cases of coronavirus in Greece. • ESC was expecting more than 1,000 participants from over 70 countries, and said it will be looking into the possibility of rescheduling for a later date. • “Your health and safety are of the greatest priority to us,” Acute Cardiovascular Care Association president Susanna Price said in a news release. “You have a vital role to play throughout the year but especially now, during the spread of the coronavirus. Most of the reported deaths from COVID-19 have been in patients with underlying cardiovascular disease.”

Non-medtech events These events may not be directly related to medtech, but could influence the growing domino effect that these cancellations are causing: • SXSW • Mobile World Congress trade show • Facebook F8 • Google I/O • Sports: NBA, NCAA, MLB, MLS, European soccer • At the time of the writing of this article, the federal government guidelines called for banning of large gatherings across the United States. Go to MassDevice (www.massdevice. com/tag/coronavirus) for more updates of events impacted by the coronavirus outbreak. Assistant editor Sean Whooley contributed to this story.

MDIC • The Medical Device Innovation Consortium postponed its Patient Engagement Forum scheduled for March 26 in Washington, D.C., citing advisories and restrictions imposed by the CDC and WHO. • MDIC said it is monitoring updates and recommendations and will notify registered attendees of a new date once it is confirmed . www.medicaldesignandoutsourcing.com

3 • 2020

Medical Design & Outsourcing 63

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