Medical Design & Outsourcing – JULY 2020 by WTWH Media LLC

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THESE MEDICAL DEVICE INDUSTRY SUPPLIER INNOVATIONS ARE MAKING A DIFFERENCE HOW TUBING COMPANIES ARE SUPPORTING MEDTECH DURING COVID-19

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Medical Design & OUTSOURCING medicaldesignandoutsourcing.com ∞ July 2020 ∞ Vol6 No4

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HERE’S WHAT WE SEE

2020: Medtech to the rescue

s I write this, the coronavirus is picking up speed in parts of the U.S. where it hadn’t yet hit hard, where residents weary of staying home jumped at the chance to reconnect in public once elected officials felt they could safely reopen their economies. Some of those officials had to backtrack and order bars and restaurants to close again as infection counts mounted and hospitals filled with desperately ill patients. While the virus has sickened millions across the globe and killed hundreds of thousands, one thing that has remained steadfast throughout this difficult year has been the medical device industry. Once it weathered the first waves in Asia, Europe and the U.S. Northeast, the industry was better prepared for the next U.S. wave, which hit the American South and Southwest beginning in June and continued moving through Central and South America while spreading rapidly in Africa. It wasn’t easy, as officials of pulse oximeter manufacturer Nonin Medical and N95 maskmaker 3M attest in my feature story on COVID-19 lessons learned. Our team of editors detail medtech’s ongoing pandemicfighting efforts throughout this issue:

One thing that has remained steadfast throughout this difficult year has been the medical device industry.

• DeviceTalks editorial director Tom Salemi tells how Mayo Clinic responded to shortages in critical supplies. • Executive editor Chris Newmarker explains how medtech companies are rethinking their legal strategies in light of the pandemic. • Senior editor Danielle Kirsh details what tubing and extrusion companies are doing to keep up with demand for tubing that’s essential to devices that continue to be in high demand, including ventilators and infusion pumps. • Assistant editor Sean Whooley takes a look at what goes into a ventilator. (Hint: They do a lot more than just pump air.) • Design World executive editor Lee Teschler takes apart a pulse oximeter to show — and tell — how it works.

continues to evolve. We evaluated scores of startup companies before deciding which 20 are working on the hottest new technology and which ﬁve qualiﬁed as runners-up. We also cover innovations that medical device industry suppliers have come up with, from 3D-printed “anatomical twins” that allow surgeons to rehearse procedures to thick-walled, stainless steel tubing that’s inexpensive enough to make disposable orthopedic drills and reamers. Looking ahead, we can acknowledge that while medtech couldn’t save everyone, it has surely helped save many, many lives. Parts of the industry that aren’t involved in making critical equipment for COVID-19 — including orthopedic and cardiac device makers — are hoping for a stronger end to 2020 as elective procedures resume and customer orders return. For the time being, most of the events that usually bring the industry together to exchange ideas and showcase products are still on hold. However, you can keep up with the latest from the industry every week with our DeviceTalks Tuesdays online events and our DeviceTalks Weekly podcasts. Check them out. And in the meantime, stay safe and healthy.

This issue isn’t all about the pandemic, however. Our cover story illustrates how medtech

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7 • 2020

www.medicaldesignandoutsourcing.com

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

| | | |

CONTENTS

medicaldesignandoutsourcing.com ∞ July 2020 ∞ Vol6 No4

• • • • • THE CONTRACT MANUFACTURER ISSUE

COLUMNS 6

HERE’S WHAT WE SEE:

CONTRIBUTORS

CYBERSECURITY:

DESIGN:

PRODUCT DEVELOPMENT:

2020: Medtech to the rescue

How to protect connected medical devices What is a pulse oximeter?

ON THE COVER 20 OF THE HOTTEST MEDTECH STARTUPS OF 2020 Pandemic or no pandemic, medtech startups keep popping up and reﬁning their technology. Here are 20 that caught our eye, plus ﬁve more worth a mention.

Think hard before naming your medical device

22 PRODUCT LIABILITY:

5 legal trends coming out of COVID-19

26 TUBING TALKS:

FEATURES

How catheters are becoming increasingly complex and efﬁcient

43 INNOVATIONS FROM MEDTECH

INDUSTRY SUPPLIERS

OEMs would have a hard time without contract manufacturers and other industry suppliers developing new technology to include in their finished devices.

62 DEVICETALKS:

Mayo Clinic is engineering its way through the pandemic

48 HOW TUBING COMPANIES ARE SUPPORTING

64 AD INDEX

MEDTECH DURING COVID-19

Without the proper tubing — and enough of it — hospitals and healthcare systems could not care for desperately ill patients who need ventilators, infusion pumps and more.

52 WHAT IS A MEDICAL VENTILATOR AND HOW DOES IT WORK?

There’s a lot more to it than simply pushing air into a patient’s lungs.

56 COVID-19 LESSONS LEARNED

Two manufacturers, a healthcare system and a logistics company share their wisdom on the supply chain and more.

Medical Design & Outsourcing

7 • 2020

www.medicaldesignandoutsourcing.com

CONTRIBUTORS

TESCHLER

WOLFSON

LEE TESCHLER is the executive editor of the Design World network of websites, online resources and print publications — WTWH Media sister publications of Medical Design & Outsourcing. He holds a B.S. in engineering and a B.S. in electrical engineering from the University of Michigan, and an MBA from Cleveland State University. MARGARET WOLFSON is creative director of River + Wolf, a New York City-based brand-naming company she founded in 2014. In partnership with Mohan Nathan, River + Wolf recently opened a special division for medical device naming and messaging.

ROWAN

GOKHALE

JOE ROWAN is the president and CEO for the USA & Europe at Junkosha. He has experience in developing and proﬁtably growing global high-tech business, with a specialty in advanced ﬂuoropolymers for the medical device industry. VINAY GOKHALE has more than 30 years’ experience in the wireless industry. Prior to Thirdwayv, he was VP of global IC sales for Impinj, a provider of RFID solutions that connect billions of items from apparel to medical supplies in applications such as inventory management, asset tracking and item authentication.

CONNECT WITH US! CHECK US OUT ON ISSUU! www.medicaldesign&outsourcing.com

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Medical Design & Outsourcing

CYBERSECURITY

How to protect connected medical devices from cyberattacks Image from Thirdwayv

Today’s connected-health solutions have dramatically improved patient care. Ensuring that they simultaneously protect patients from hackers requires a closer look at their security.

N Vinay Gokhale | Thirdwayv |

o one doubts that connecting medical devices in the Internet of Things (IoT) has delivered many benefits that have dramatically improved patient care. These devices, from insulin pumps to heart-rate monitors, have become critical elements in the continuum of care. But their benefits risk becoming liabilities if the security of these connected medical devices is in doubt —an afterthought considered prohibitively expensive or, worse, assumed to exist when it does not. These issues become especially critical as the industry moves to the convenience of using commercial smartphones for command and control. The key to protecting any connected-health system, and especially those used with commercial phones featuring Bluetooth connections, is to fully understand threats and mitigate them through end-to-end, multi-layered security. Understanding the threat Many of today’s heart defibrillators, insulin pumps, glucose meters and other

Medical Design & Outsourcing

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devices can be wirelessly hijacked and reprogrammed. The FDA issued a safety warning about this issue in May 2019 when a type 1 diabetes patient landed in the hospital after exploiting a safety flaw in a commercially available, FDA-authorized pump. He used this flaw to re-program his pump for use with an unauthorized device so he could customize his treatment. The FDA warned that this type of customization could pose significant risks if not implemented correctly. Even more worrisome, this same type of safety flaw is an open door to hackers. Consider the consequences if hackers were to gain access to a pacemaker and disrupt a patient’s heart rhythms — or if they intercepted the device’s telemetry data during transmission to acquire sensitive information about a patient’s condition. These and other threats are well within the realm of possibility unless the proper security procedures are followed when deploying a connected-health solution. The latest solutions address this challenge by providing the building blocks for implementing multilayered, end-to-end security.

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CYBERSECURITY

Three key security layers A solid security strategy starts with the communications channel between the smartphone app, the medical device and the cloud. This application layer augments existing security mechanisms that are already built into operating systems such as Android and iOS and overcomes the security vulnerabilities of Bluetooth, NFC, LTE, Ethernet and other protocols. While these protocols do mitigate some breaches, other threats are far less contained. A secure channel gives connected-health solutions greater resistance to a variety of malware and wireless channel cybersecurity attacks. The second security layer ensures that only authorized and trusted sources are sending information and issuing commands. This layer facilitates authentication of the smartphone app, cloud and any associated devices that are connected to the solution’s communication system. A unique digital cryptographic identity is given to all system elements, and each element can validate the authority

and privileges of the other elements, also known as attestation. This creates a “root of trust” within and between all components in the system, protecting it against the risk of attack through connectivity to its cloud services, smartphone apps and other IoT devices. The platform validates the phone and app integrity while ensuring hackers cannot gain “root access” to privileges that enable them to modify the device’s software code or install other software. The authentication layer is most effective when a hardware security module (HSM) is provisioned at the factory to each medical device for storing and managing cryptographic keys and digital certificates. The trusted cloud infrastructure uses the HSM to verify the integrity and authenticity of all smartphone apps and medical devices, issues digital certificates over the air that identify them as trusted and handles all associated identity lifecycle management. The third layer of security ensures the high level of “always on” data

availability and device control that is required for safety-critical applications. A combination of gateways is used, including traditional fixed gateways as well as having the smartphone itself serve as a soft gateway. This ensures that the system can always receive the most recent data that it needs to immediately change device operation based on patient requirements.

Many of today's heart defibrillators, insulin pumps, glucose meters and other devices can be wirelessly hijacked and reprogrammed.

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Simplifying security Rather than being prohibitively expensive or complex, critical security measures can add just a few pennies to the cost of a patient’s insulin pump or other connectedhealth solution when deployed using today’s third-party IoT cybersecurity offerings as opposed to creating a solution from scratch. These capabilities are implemented in a building-block fashion that minimizes cost while simplifying the process of embedding connected-health solution security. While it is always better to build security into a connected-health system from the ground up, today’s building-block solutions are flexible and simple enough for robust measures to be effectively retrofitted into legacy designs and infrastructures. The solutions also facilitate continuous improvement, which is a cornerstone of good security practices. As an example, if manufacturers are not using an HSM to protect keys now, they can incorporate the use of an HSM later. Today’s IoT security solutions make it much easier to protect connected healthcare products and systems from increasingly dangerous cybersecurity threats. These solutions also create the opportunity for providers to meaningfully differentiate their connected-health products based on the strongest possible safety levels, at low incremental cost. Making this investment also enables healthcare providers to minimize the substantial expense of breach remediation and, most importantly, the likelihood of a breach-related injury or death.

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DESIGN

What is a pulse oximeter? If you’re recovering from a respiratory problem, chances are you had your oxygen levels checked with a pulse oximeter. Design World executive editor Lee Techsler took one apart so he could describe how it works.

ulse oximetry is the non-invasive measurement of oxygen saturation (SpO2). Oxygen saturation is deﬁned as the amount of oxygen dissolved in blood, based on the detection of hemoglobin, Hb, and deoxyhemoglobin, HbO2. The typical pulse oximeter is a device that clamps on one of your ﬁngers. Home-use oximeters are often battery-powered and self-contained, with the oxygen level displayed on a built-in LCD along with heart rate. That’s the kind we tore down, made by Veridian Healthcare in Illinois. Before we get into how it works, some background on how a pulse oximeter works is in order. Pulse oximeters use two different light wavelengths, 660 nm (red light) and 940 nm (infrared light), to measure the difference in the absorption spectra of HbO2 and Hb. Hb absorbs light at 660 nm and HbO2 at 940 nm.

L e e Te s c h l e r | Design World |

A photodetector in the sensor gauges the non-absorbed light from the LEDs. This signal is typically inverted using an inverting op amp, and the result is a signal that represents the light that has been absorbed by the ﬁnger. It is divided into dc and ac components. The dc component represents the light absorption of the tissue, venous blood and non-pulsatile arterial blood. The ac component represents the pulsatile arterial blood. The pulse oximeter analyzes the light absorption of two wavelengths from the pulsatile-added volume of oxygenated arterial blood and calculates the absorption ratio using:

(AC660) / (DC660) (AC940) / (DC940) SpO2 is typically taken from a table stored in memory calculated with empirical formulas. A ratio of 1 represents a SpO2 of 85%, a ratio of 0.4 represents SpO2 of 100%, and a ratio of 3.4 represents SpO2 of 0%. Another way to calculate SpO2 is to take the ac component and determine ratio using:

SmartHeart Economy Pulse Oximeter Image from Veridian Healthcare

Medical Design & Outsourcing

7 • 2020

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SpO2 is the value of RX100. Iac = Light intensity at λ1 (660 nm) or λ2 (940 nm), where only the ac level is present. The output generated by the photodetector is a current that represents the light absorption. This current typically gets converted into a voltage for filtering and then measurement. There’s not much to the typical pulse oximeter circuit described in most literature. It runs via an MCU that does the calculations and generates the PWM signal to drive the LEDs. And that’s what Veridian does in its pulse oximeter. The heart of the device is a Silicon Labs C8051F007 mixed-signal SoC MCU with a 12-bit multi-channel ADC. Among its features are a programmable-gain pre-amp, two 12-bit DACs, two voltage comparators, a voltage reference, and an 8051-compatible MCU core with 32 kbytes of Flash memory. There are also four general-purpose 16-bit timers and four byte-wide general-purpose digital port I/O. The chip has 2,304 bytes of RAM and executes at up to 25 MIPS. The only other chips on the PCB are three CMOS op amp devices from Shengbang Microelectronics, probably used for filtering the light detector signals. And that’s pretty much it for the simple pulse oximeter, which also measures heart rate.

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PRODUCT DEVELOPMENT

What’s in a name? Quite a bit, when it comes to medical devices. A brandnaming professional shares her insights into medtech naming do’s and don’ts.

ll naming has its challenges, but medical device naming especially so. Not only is the medical field a crowded one when it comes to trademarks, but marks must accomplish multiple things in a somewhat restricted playing field. To assist marketers and others confronted with this task, here are some basic tips. Consider sound and sense Healthcare — from surgical equipment to pharmaceutical products — is rife with invented names that mash together Greek and Latinate morphemes — Adcetris, Sylatron, Duexis, to mention a few. The medical device sector is no different. And while these morphemic marriages more easily vault the high hurdles of trademark clearance, they can also sound unnatural. The best invented names are pleasing to the ear. Sense (what the name means) is important, but sound no less so. Altrua (a pacemaker manufactured by Boston Scientific) is bookended with vowels, and, as such, sounds calm and

Margaret Wolfson | River + Wolf |

Medical Design & Outsourcing

7 • 2020

welcoming. On the other hand, the eponymous Vitatron pacemaker sounds more mechanical. There is nothing wrong with a mechanical tonality per se but be sure it’s appropriate for the device’s target market. Physicians, healthcare systems, patients: who’s the audience? The short answer is both. If it isn’t possible to appeal to everyone, at the very least avoid a name that appeals to one group but turns others off. For example, a name that appeals to the high-performance needs of surgeons may be less inviting to patients or administrators. That said, it’s crucial to consider the broad audience of medical professionals because there is often an entire care team involved in the selection and use of medical devices. A physician may prescribe the use of a device, but a nurse may administer it, or even choose it from amongst similar options. Though it’s rare for a name to appeal to all audiences, it can happen. Take Intuitive Surgical’s da Vinci robot-assisted system. It appeals to surgeons because it implies artistry and mastery. For healthcare systems,

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iStock photo, courtesy of River+Wolf

How to name a medical device

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it bestows an element of class to their hospitals. For patients, the name invokes genius. And who wouldn’t want a genius for a surgeon? All that said, think twice before travelling this naming route. Patent and trademark databases are cluttered with artistically and musically inspired medical device names; to ﬁnd one with tolerable risk levels is like ﬁnding a needle in a haystack. Anchor abstractions in reality A name like Airis, Hitachi’s open MRI scanner, is a superior lexical blend because it is grounded in two meaningful words: air and iris. The name suggests a non-claustrophobic or “airy” experience plus vision, as the iris is the thin, annular structure of the eye that regulates the amount of light passing through. So, if you do decide to use an abstract or fanciful naming construction, try to use recognizable words or word parts as road signs. A name with meaning can lead to a better story than an abstract collection of sounds.

Medical Design & Outsourcing

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Don’t overlook the FDA The agency regulates device names, so medtech companies must be careful when developing names not to suggest a beneﬁt claim that is untrue or hovers on the border of untruth. A device can be rejected if its name leads to false impressions or overstates its effectiveness. And as with every naming project, an IP attorney must carefully vet the name to be sure it doesn’t sound too similar to existing trademarks. Don’t be scary, or at least be scary in a relevant way When considering device naming, especially for patient-facing names, it’s crucial to avoid scary or unappealing imagery even if it is brilliantly suggestive. Kraken, a fearsome mythological creature with twisting tentacles, may be a marvelous name for an alcoholic beverage, but it’s too threatening for a surgical device. This doesn’t mean you should avoid unusual names. A good example of this is the Octopus, Medtronic’s whimsically named tissue stabilizing device.

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At the same time, don’t let personal fears guide your naming. For example, you may not like references to sharp needle points. But, to a diabetic, a sharp point is a positive as it allows the needle to pierce the skin more easily. This is why Everpoint, a cardiovascular needle manufactured by Ethicon, is a ﬁne name. Another approach is to take a word part that is functional and cold and transform it into an aspirational name. The Harmonic Scalpel, also manufactured by Ethicon, uses ultrasonic energy to cut, dissect and seal in surgery. The name Harmonic includes the “onic” of ultrasonic but has more pleasing associations. In closing, standing out from the pack is important. But don’t attempt to do so with a name that is painful to say, doesn’t consider everyone who will be exposed to the device, from health administrators and medical professionals to patients and their families, or overly promises or falsely positions the offering. Equally important, be sure your name doesn’t compound the fears people already have around surgery.

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PRODUCT LIABILITY

Medical device litigation and COVID-19: What you need to know

Chris Newmarker | Executive Editor |

The COVID-19 pandemic is creating a new set of medical device litigation challenges — but also a chance for an industry reset. One of Greenberg Traurig’s top medtech litigation lawyers shares her insights.

ara Thompson doesn’t take any guff when she tells people that she defends medical device and pharmaceutical companies from lawsuits. “I say, ‘I sleep great at night because the companies I represent make things that can save and sustain life,’” said Thompson, who is vice chair of the Pharmaceutical, Medical Device & Health Care Litigation Practice at Greenberg Traurig. Thompson thinks the case in defense of medtech is even stronger now that Americans and people around the world desperately need medical devices, drugs and vaccines to overcome the COVID-19 pandemic. “Both drug and device companies

Sara Thompson | G r e e n b e r g Tr a u r i g |

Medical Design & Outsourcing

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want to help. A lot of our clients are developing ventilators, or they’re making their ventilators open-source. They’re contributing parts, and they’re contributing manufacturing space,” Thompson recently told Medical Design & Outsourcing. Thompson summed it up: “I think it’s changing public perceptions in a way that once we get to trials will also be interesting. There’s going to be a lot of reverberations of this for a long time, I would say.” Most commentators agree that COVID-19 is creating a new normal, and medtech litigation is no exception. Improved public perception is but one of a number of changes taking place. Here are ﬁve other ways Thompson sees the space evolving:

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1. Companies are reevaluating litigation For now, many medical device companies have taken a sales hit as health providers scale back on elective procedures and people even hold off on potentially necessary procedures amid the pandemic. CEOs of major companies have said in recent earnings calls that they expect revenue to recover later this year, but Thompson also sees them reevaluating the situation when it comes to lawsuits. “We’re seeing our clients say, ‘Is this something we should reconsider in our strategy? Do we want to just resolve this case now? Should we reconsider a previous settlement?” Thompson said.

It’s all about adapting a litigation strategy to meet the medtech industry’s changing realities, according to Thompson. “Some companies may be thinking, ‘We may not have the budget to go to trial anytime soon.’ So those worries could impact our assumptions and plan.” 2. More leeway to defer cases Tighter budgets make medical device company ofﬁcials less eager to go to trial right now, but Thompson also sees the pandemic giving them stronger arguments to get cases deferred down the road. Judges care about the context when a lawyer is making a case. It may be

necessary, for example, to reschedule a corporate employee’s deposition for a later date because the employee is focused on an essential program related to COVID-19. “That really moves the needle for judges in a way that just saying that discovery would cause a business disruption often does not,” Thompson said. 3. Lawsuit immunity isn’t a given amid pandemic The FDA has granted a host of emergency use authorizations during the pandemic to boost the availability of needed medical devices, virus and antibody tests, pharmaceuticals and more. Thompson suspects courts will be ﬂeshing out for some time how much lawsuit immunity the FDA granted with its EUAs. “Whenever there’s an intention that an immunity or a preemption (will) be broad, you always have very creative plaintiffs’ attorneys who try to ﬁnd the cracks or the contours of that,” Thompson said.

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There’s an exception for willful or wanton conduct, for example. “How’s that going to work? What are examples going to be?” A company, for example, may have had a product on the market for another use, and then it received an EUA for a COVID-specific use. “Let’s say plaintiffs were raising design issues prior to all of that happening. Does the immunity apply to those claims? If the EUA is later revoked, does the immunity still apply? Those are real open questions for us to figure out,” Thompson said. “There are a lot of really interesting and novel legal issues that we’re going to be litigating for the next few years.” 4. Less litigation tourism It should also be easier for medical device and pharmaceutical companies to defend themselves from lawsuits. That’s because “litigation tourism” appears to be on its way out after the U.S. Supreme Court’s ruling in Bristol-Myers Squibb v. Superior Court of California, San Francisco County. The 2017 decision makes it much harder for lawyers to shop for plaintiff-friendly courts in which to file their lawsuits, Thompson said. “It’s not impossible if you have a plaintiff who lives there or has experienced an injury there, or if you have a defendant who’s either incorporated in or has their principal place of business there. But you’re not going to have a company located in Minnesota, being named in a case in a West Virginia state court when there’s no connection to the venue.” 5. Sales rep training is more important than ever More than a decade has gone by since the Supreme Court’s Riegel v. Medtronic decision, which found that federal medical device regulation laws provide lawsuit protections for devices with FDA premarket approval. Since then, plaintiff lawyers have focused less on a device’s design, warnings or performance and more on a company’s conduct, especially when it comes to sales representatives, according to Thompson. “Plaintiffs may allege the sales representative trained a doctor, and if so, did they train the doctor how to use a device in a way that led to or allegedly led to the injury? Or did the doctor have a sales representative directly interacting with a patient in some impermissible way?” Courts are scrutinizing adverse event reporting, too. As medical device companies rethink how they market products to health providers during the pandemic and beyond, it’s more important than ever that they make sure their sales reps know what conduct is appropriate and err on the side of caution when deciding whether to report problems, Thompson said.

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TUBING TALKS

How catheters are becoming increasingly complex and efficient As the neurovascular intervention marketplace accelerates toward miniaturization, innovations such as 2.5:1 peelable heat-shrink tubing (PHST), cut-to-length PHST and multi-ﬁlar active catheter solutions will come into their own.

Multi-ﬁlar cable like this is enabling the production of a new generation of small, ﬂexible and intelligent catheters. Image courtesy of Junkosha

Joe Rowan | Junkosha |

atheters are becoming increasingly complex in terms of the procedures they can be used for, making the peelable heat-shrink tubing (PHST) market an extremely exciting area to be involved in. Not only is it helping to address healthcare customers’ unmet needs, but it also paves the way for progressively smaller catheter-based procedures — an ongoing requirement for medical device manufacturers. The benefit of PHST is that it avoids peeling the outer fluorinated ethylene propylene (FEP) lamination layer, which can damage the catheter within. PHST also enables the final product to be produced more rapidly with improved yields and lower inspection levels while being increasingly ergonomically safe. Newer innovations are adding to PHST’s capabilities. For example, the unique 2.5:1 PHST solution has been designed to equip catheter manufacturers with the highest shrink ratio currently possible in peelable FEP. This solution enables them to save time and money through a reduced number of shrink processes. Additionally, thanks to its “take-up,” PHST allows the use of cost-effective, lower-tolerance, baseline materials in the manufacturing process and enables the ability to reflow these easily into a single smooth construct quickly and efficiently. This results in a reduced total cost of ownership for the catheter manufacturer. There is a wide range of applications for this innovation, including neurovascular catheters that have tapered diameters for the floppy distal segments and proximal sections with larger diameters for pushable support. Because these catheters are mainly being braid-reinforced proximally and coil reinforced distally, they need a PHST solution that can accommodate in a single step the compression required to provide significant bond strength of the materials. Miniaturization Aside from 2.5:1 PHST, a greater requirement across the tubing sector is the move toward smaller procedures. Innovations in this area include ultra-small PHST — a tubing suited for laminated jacket coating of tiny guide wires (down to 0.011 in and 0.014 in),

Medical Design & Outsourcing

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TUBING TALKS

leveraging the fact that PHST has a recovered ID down to 0.009 in. These miniature guide wires are perfect for applications including the navigation of vessels to reach a lesion or vessel segment within, for example, the brain or the heart. Indeed, the trend toward procedures using smaller and smaller catheters is driving the market toward miniaturization. This is accelerating as medtech manufacturers demand catheter solutions that can readily penetrate harder-to-reach places. The applications that will result from the catheter miniaturization include neurovascular delivery of devices such as coils and stents for stroke or aneurysm therapies, and even signals/energy to help support treatments such as neuromodulation or neurostimulation in the case of research for the treatment of Parkinson’s disease. Added to this is the requirement for increasingly sophisticated catheters that can send diagnostic signals into

The trend toward procedures using smaller and smaller catheters is driving the market toward miniaturization. This is accelerating as medtech manufacturers demand catheter solutions that can readily penetrate harder-to-reach places. the body or provide therapy — in other words, “active” catheters. Such technology is being enabled by innovations including multi-filar, a new fine wire and cable solution designed using precision-engineered PTFE lamination technology. The solution provides multiple signals through an ultra-small shaft, enabling a new generation of small, flexible and intelligent catheters to push the boundaries of current medical procedures.

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Single-strand configurations are joined into a multi-filar assembly that can be used in electrophysiology catheters for applying pacing and recording protocols from inside the heart, in ablation and balloon ablation catheters for atrial fibrillation, and in cardiac mapping. The multifilar technique also allows for easier assembly of the signal or power wires into the final medical device, making the manufacturing process simpler and more cost-effective.

Cut-to-length Today’s catheter delivery systems rely on increasingly complex shapes, constructions and polymers to deliver their intended treatment. Increasing complexity in catheter bonding and welding applications can only be consistently achieved through advanced technology and proper application of sound engineering principles. Neurovascular catheters are used to deliver various devices to the brain and feature in numerous cranial procedures. Innovation in the treatment of ischemic stroke with new technology such as stent retrievers and ﬂow-diverting stents will drive an increase in the number and type of catheters required. This brings with it the need for shorter-length PHST solutions as the length of the catheter that requires the reﬂow of materials might be shorter. Just like longer forms of PHST, cut-to-length and slit solution enables the catheter manufacturer to use a shortened length

to not only reflow the materials, but also to bond, tip and weld complex shapes, sections and segments needed in today’s procedures. Cut-to-length PHST is also in demand due to the increased availability of custom-engineered diagnostic interventional catheters, which are designed for tougher procedures inside the body. Cut-to-length PHST is perfectly suited for this as it can be cut to a specific size for a given requirement. The cutto-length and slit option incorporates a peeling slit that allows for faster throughput during manufacture, thus improving cost savings. Looking ahead With the push for smaller procedures increasing every year, it is a critical requirement for tubing manufacturers to enable catheters to complete these tasks efficiently and cost-effectively. This challenge can only be overcome through one thing — innovation.

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Medical Design & Outsourcing

TOM SALEMI DEVI CETALKS EDI TORI AL DI RECTOR SEAN WHOOLEY ASSI STAN T EDI TOR

medical device startups you need to know The medtech industry isn't immune to COVID-19 troubles, but exciting innovation continues. These 20 medical device startups grabbed our attention.

number of medical device startups continue to make waves across the space, with new technologies and mouthwatering fundraising rounds highlighting some exciting prospects. From treating children with congenital heart disease to therapy that alleviates the effects of traumatic nightmares — with plenty more innovations between — there is no shortage of intriguing medical devices and therapies coming up through the ranks.

Medical Design & Outsourcing

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“Even in the face of the COVID-19 pandemic, we continue to see tremendous energy in the medtech innovation ecosystem,” said Paul Grand, CEO of MedTech Innovator. “We are noticing a strong trend of minimally invasive medical devices that improve patient outcomes and require less time spent in the hospital.” Here’s a roundup of 20 medical device startups catching the eye of Medical Design & Outsourcing and MassDevice editors this year.

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Image courtesy of Adobe Stock

MEDICAL DEVICE STARTUPS

Image courtesy of Aidar Health

7D Surgical North York, Ontario Founded: 2009 Rapid, streamlined process to reduce overall image-guided surgery setup time 7D Surgical's MvIGS system uses camera-based technology and machine vision algorithms to increase the precision of imaging technology in brain and spinal surgery. The Toronto-area company received 510(k) clearance in 2018 for its cranial biopsy kit, giving neurosurgeons the ability to target brain lesions during needle biopsy procedures. 7D has sold roughly three dozen systems since going commercial. –TS

Image courtesy of Aerin Medical

Investors include: Ontario Centres of Excellence, Tivona Capital, Toronto Innovation Acceleration, Government of Canada, Federal Economic Agency

Aerin Medical Austin, Texas Founded: 2011 Minimally invasive procedures for chronic nasal airway conditions

Founded by medtech serial entrepreneur Scott Wolf, Aerin Medical provides ENT physicians with tissue-sparing solutions for the treatment of nasal airway conditions to improve quality of life in patients. A physician can use the company’s proprietary technology to apply temperaturecontrolled energy to a specific area of tissue inside the nose in order to resolve a person’s nasal problem without surgery. “Otolaryngologists use Aerin’s platform technology to treat their patients suffering from nasal airway obstruction and chronic rhinitis — massive and debilitating conditions that affect tens of millions in the U.S. annually," Aerin CEO Matt Brokaw told MDO. "We’re gratified to be working with the physician specialty to advance the future of officebased options for patients, and to be supporting near-term interest in procedures that minimize aerosolized virus risk for clinical teams.” The company in December 2019 received FDA clearance for its second product, the RhinAer Stylus for nonsurgical treatment of chronic rhinitis. –TS Investors include: Barshop Ventures, David Shen Ventures, Horizon Technology Finance, KCK Group, Targeted Technology 32

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Aidar Health Baltimore Founded: 2015 Non-invasive medical 'tricorder' for chronic disease management and decentralized clinical trials Aidar Health developed MouthLab, a non-invasive, hand-held, “rapid health assessment” device for home use. The device can be used as a digital thermometer, and can also measure more than 10 vital health parameters in under 30 seconds. The company’s cloud-based data analytics solution reads the data. The software uses AI, including machine-learning algorithms, to identify, analyze and predict health status and disease progression. Data from the “tricorder-style” device can be accessed through a physician triage or surveillance dashboard, which allows for timely intervention and treatment modiﬁcation for patients with conﬁrmed or suspected COVID-19 infection. With secure APIs, the data and insights can be integrated into other telemedicine platforms to send and receive real-time data, interact with at-home patients and enhance the delivery of care. Sathya Elumalai and Gene Fridman developed the device and founded the company. CEO Elumalai told MDO that "Mouthlab is like a 'check engine' light for humans." –TS

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Delivering bradycardia pacing therapy without placing an implant within or on the heart AtaCor Medical is developing novel cardiac pacing therapies that do not require the placement of any hardware inside or onto a person’s heart. The technology has already completed early clinical evaluation and will offer an important alternative treatment option for patients requiring bradycardia pacing support, according to the company. The company announced in April that it had closed a $25 million Series B funding round. –TS Investors include: Catalyst Health Ventures, Hatteras Venture Partners, aMoon Fund, Broadview Ventures, Lymo Ventures

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Augmedics Arlington Heights, Ill. Founded: 2014 Using augmented reality for surgery

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Augmedics has developed what it says is the ﬁrst augmented reality guidance system for surgery, allowing surgeons to see the patient's anatomy through skin and tissue as if the surgeons have "X-ray vision." Founded by Nissan Elimelech and Dr. Raphael Lotan, the company announced in December 2019 that it secured FDA 510(k) clearance for its Xvision Spine augmented reality system. –TS

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London Founded: 2016

Device for deactivating sweat glands

Contactless monitoring system for COVID-19 and respiratory disease Circadia Health’s mission is to enable early detection of respiratory failure, a major cause of death. The company’s C100 System uses radar — no wires — to sense respiratory failure in patients up to 4 feet away. It's meant to be an improvement over the manual method of measuring respiratory rate in which nursing staff visually count breaths per minute. The FDA issued expedited clearance for Circadia’s contactless respiration rate (CResp) due to the demands created by COVID-19, the company announced in July. “Our C100 uses radar to wirelessly look at your breathing pattern from up to 4 feet away,” Fares Siddiqui, co-founder and CEO of Circadia, told our DeviceTalks Weekly podcast. “From that we can pick up your respiratory rate and patterns and then apply machine learning in order to predict and prevent respiratory complications.” For example, Siddiqui said, breathlessness is one of the early signs of distress in COVID-19 patients. “We can pick that up and enable timely interventions effectively.” –TS

Investors include: Village Global, SOSV, and Particular Ventures

CloudCath San Francisco Founded: 2017 Monitoring for catheter-based treatments

Image courtesy of Candesant Biomedical

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Image courtesy of CloudCath

Candesant is a privately held company dedicated to developing novel solutions for excessive sweating and hyperhidrosis. Candesant's initial product, CDX-01, is meant to be a simple device that offers signiﬁcant sweat reduction without the pain and tradeoffs of existing therapies. Founded by Niquette Hunt and Dr. Jacob Waugh, the company most recently posted safety and efﬁcacy data for CDX101, a non-invasive energy device. “We are inspired to be able to help the millions of individuals who sweat too much by developing a novel medical device to alleviate their suffering with no downtime,” Hunt, who also serves as CEO, said in a statement to MDO. “Our team of scientists has created an elegantly simple technology that results in an immediate effect, inactivating the most active ducts and sweat glands in the area treated. We are moving through the development process and look forward to bringing this groundbreaking technology to market in late 2021.” –TS

San Francisco Founded: 2016

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CloudCath develops technology designed to remove patient monitoring complications for patients undergoing catheter-based treatments. The remote monitoring system analyzes drainage fluid and uses proprietary algorithms to detect fluid property deviations, transmitting notifications to healthcare providers automatically. The company closed a $12 million financing round in January, earmarking the funds for its at-home dialysis monitoring treatment platform, plus the development of additional applications. –SW Investors include: Capital Integral, Coconut Tree Investments, FundRx, Hanawa Group, r42 Group www.medicaldesignandoutsourcing.com

7 • 2020

Medical Design & Outsourcing

MEDICAL DEVICE STARTUPS

Image courtesy of GT Medical

Forest Devices Pittsburgh Founded: 2015 A system for triaging stroke patients to the right hospital The recipient of the $350,000 grand prize as the 2019 MedTech Innovator global competition winner, Forest Devices is developing the Alphastroke system for stroke and large vessel occlusion detection. First responders can use the system to triage patients so that they go to the right hospital. After the company won last year’s startup competition, MedTech Innovator CEO Paul Grand called its technology a “holy grail opportunity in healthcare.” Forest Devices announced on June 30 that it has formed a partnership with Alberta Health Services to improve healthcare delivery for stroke patients in Alberta. –SW Investors include: Goose Capital, Lawala Capital, Dorm Room Fund, Innovation Works, Pittsburgh Life Sciences Greenhouse

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GT Medical Tempe, Ariz. Founded: 2017 Implantable tiles to improve cancer care GT Medical’s GammaTile therapy is an FDA-cleared, surgically targeted radiation therapy (STaRT) for operable brain tumors. The implantable tiles ensure that radiation therapy begins immediately at the time of brain tumor removal. The company collected $10 million in ﬁnancing in January 2019. It garnered expanded FDA indication for patients with newly diagnosed malignant brain tumors in January of this year. –SW Investors include: Bluestone Venture Partners, Arizona Tech Angels, Desert Angels, Medical Technology Venture Partners

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Hyalex develops implant systems for osteoarthritis and other cartilage injury and disease, made with its polymer system designed to mimic cartilage. The company raised a $33 million Series A funding round in April 2019. –SW

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MEDICAL DEVICE STARTUPS

Image courtesy of Imperative Care

Imperative Care

Inflammatix

Campbell, Calif. Founded: 2015

Burlingame, Calif. Founded: 2016

Technology for stroke treatment

Rapid diagnostic tests that read the immune system

Imperative Care's TracStar LDP, touted as the ﬁrst LDP on the market, is a 0.088 in. large bore access catheter designed to get closer to the treatment site for stroke procedures, while its Zoom aspiration portfolio, designed to work with LDP, delivers trackable aspiration catheters that are optimized for fast, effective clot removal, treating occlusions from ICA to M2. The company closed an $85 million Series C ﬁnancing round in December 2019. –SW Investors include: 3H Health Investment, Ally Bridge, Bain Capital, Incept, Rock Springs Capital

Inﬂammatix has developed a molecular diagnostic designed to read the patient’s immune system to deliver rapid results, with an initial focus on acute infection and sepsis. Its HostDx tests combine proprietary biomarkers and advanced machine learning. The company closed a $32 million Series C funding round in January and secured a long-term cost-sharing contract worth up to $72 million from BARDA in November 2019. –SW Investors include: Khosla Ventures, Northpond Ventures, Think.Health Ventures, Grey Sky Venture Partners, Stanford-StartX Fund

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MEDICAL DEVICE STARTUPS

LimFlow

NightWare

Paris Founded: 2012

Minneapolis Founded: 2017

Tech for diverting blood around diseased arteries

Smartwatch therapeutic for nightmare disorders

LimFlow’s minimally invasive technology diverts blood around diseased arteries in the leg, bringing it into one of the tibial veins so that it can deliver blood and oxygen to starved tissue of the foot. The company raised $33.5 million in a Series C funding round in 2018 and is conducting the Promise II trial on patients at risk of lower limb amputation. –SW

NightWare developed a smartwatch device that delivers digital therapy to alleviate the effects of traumatic nightmares associated with post-traumatic stress disorder (PTSD). The machine-learning application offers treatment without pharmaceuticals and runs on the Apple Watch. The company’s app can collect highresolution biometric data, analyze sleep patterns, pinpoint the onset of a nightmare and provide vibrotactile feedback to arouse the patient without completely waking them to enable more restful sleep, according to the company. Nightware has obtained FDA breakthrough device designation and submitted for clearance in May 2020. –SW

Investors include: Soﬁnnova Partners, Bpifrance, Balestier

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Moray Medical

Neurescue

Mountain View, Calif. Founded: 2017

Copenhagen Founded: 2014

Robotic system for moving cardiac catheters

Computer-controlled aortic occlusion catheter

Moray Medical is developing a robotic system designed to move a cardiac catheter inside the beating heart of a patient. The company describes the system as having an “eel-like dexterity” that fundamentally improves the way structural heart and other therapies are delivered. –SW

Neurescue touts its aortic occlusion catheter as the first of its type with computer-aided, intelligent safety feedback and pressure-limited filling. The balloon catheter is inserted into a blood vessel in the femoral artery to redistribute the blood flow generated by chest compression to the central circulation. –SW

Investors include: Roseman Institute 38

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Investors include: TMC Innovation, Horizon 2020, Danish Tech Challenge, Green Ocean Capital www.medicaldesignandoutsourcing.com

Image courtesy of NightWare

Image courtesy of Neurescue

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MEDICAL DEVICE STARTUPS

PolyVascular Houston Founded: 2014 Treatments for children with congenital heart diseases PolyVascular is developing polymeric transcatheter valves to combat congenital heart disease, a birth defect that is a common cause of infant mortality. The company says on its website that its PTVs are easy to manufacture in pediatric and adult sizes, with the capability to expand and accommodate growth of children, reducing the need for repeat open-heart surgeries. –SW

PhotoniCare Champaign, Ill. Founded: 2013

Investors include: TMC Innovation, Pediatric Device Innovation Symposium, U.S. Dept. of Health & Human Services

Diagnostic tools for ear infections

Images courtesy of PhotoniCare

PhotoniCare is developing the TOMi scope with advanced, light-based technology for seeing through the eardrum, providing a high-resolution depth image to observe the middle ear. The non-invasive, FDA-cleared TOMi scope is meant to eliminate guesswork and offers objective data in place of subjective diagnosis, according to the company. –SW Investors include: MedTech Innovator, First Leaf Capital, Fox Ventures, Innovation in Motion, Julz

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MEDICAL DEVICE STARTUPS

Zeto Santa Clara, Calif. Founded: 2014 Providing fast, convenient, medical-grade EEGs Zeto has developed a wireless EEG headset with dry electrodes that, when coupled with cloud software, can provide medical-grade EEGs instantly uploaded to the cloud or any laptop, tablet or smartphone. The technology was FDA-cleared in 2018 and is available in the U.S. (healthcare and nonhealthcare). The company closed a $7.3 million Series A funding round in March 2020, bringing total funding raised to $11 million. –SW Investors include: Aphelion Capital, Seraph Group, ShangBay Capital, Sunstone Management, SV Tech Ventures Executive editor Chris Newmarker contributed to this article.

Image courtesy of Zeto

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MEDICAL DEVICE STARTUPS

H E R E A R E 5 A D D I T I O N A L S TA R T U P S T H AT G O T O U R AT T E N T I O N

Iterative Scopes

Oncodisc

Provisio Medical

Boston Founded: 2017

Walnut Creek, Calif. Founded: 2018

San Diego Founded: 2014

Machine learning to detect signs of colon cancer

Pharmaceutical therapy and patient monitoring for the detection of early illness

Providing intravascular ultrasound to measure ﬂow lumen

Iterative Scopes is developing technology using computer vision and machine learning to provide real-time, computer-aided detection of lesions and other signs of colon cancer. In January, the company announced that it closed a $5.2 million seed round of ﬁnancing, bringing its total funds raised to over $7 million at the time. –SW Investors include: P5 Health Ventures, TAU Ventures, TMC Innovation, Wavemaker Partners

Oncodisc is developing an implantable vascular access device embedded with an advanced sensor and communication technology. In addition to facilitating the delivery of pharmaceutical therapy, the device monitors physiology for early detection of illness or treatmentrelated complications, according to the company. Oncodisc’s initial application centers around reducing the risks of cancer treatment. –SW

Provisio is developing sonic lumen tomography through intravascular ultrasound technology, providing realtime ﬂow lumen dimensions in a platform that may be integrated into many currently used endovascular devices. The company pulled down a $4 million funding round in January 2018 and followed that up with an additional $2 million raised in an August 2019 ﬁnancing round. –SW

Sherlock BioSciences Cambridge, Mass. Founded: 2019 Developing fast, accurate and affordable diagnostic tests

Puzzle Medical Devices Montreal, Quebec Founded: 2018 Minimizing blood trauma for chronic heart failure patients Puzzle Medical Devices is a Canadian company specializing in the development of a minimally invasive long-term hemodynamic transcatheter pump. Puzzle Medical enables mechanical hemodynamic support to be more efﬁcacious, safer, and more economical, resulting in increased accessibility, improved patient quality of life and reduction of the global economic burden related to the disease. To date, Puzzle Medical has successfully completed acute in vivo preclinical implantations, according to the company. "This technology clearly answers

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an unmet need in the management of chronic heart failure patients," Morristown Medical Center (N.J.) interventional cardiologist Dr. Philippe Généreux said in a statement. "I have been extremely impressed by the success achieved during the initial preclinical work and remain excited and confident about its future application in patients." On June 15, the company announced that it closed its first convertible debenture financing round for an undisclosed amount. –SW Investors include: Pascal Labrecque

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Sherlock BioSciences is developing applications of Sherlock, a CRISPR-based method for detecting and quantifying genetic sequences, and Inspectr, a synthetic biology-based, instrument-free molecular diagnostic platform. In May, the company earned FDA emergency use authorization for a SARS-CoV-2 diagnostic and has since garnered $7.5 million in grant money to accelerate the development of an at-home COVID-19 diagnostic. The company announced in June that it will collaborate with Integrated DNA Technologies (IDT) to enable largescale manufacturing of the Sherlock CRISPR SARS-CoV-2 kit. ––SW Investors include: Baidu Ventures, Northpond Ventures, Open Philanthropy Project

These medical device industry supplier

innovations are making a difference

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

nnovative medical devices from original equipment manufacturers (OEMs) get a lot of press. But many of those devices wouldn’t exist if it weren’t for innovative contract manufacturers and suppliers. Working with materials as pliable as polyester and as strong as stainless steel, these companies are always innovating to create new or improved components that their customers want — or don’t yet know they need. Here are some of the latest innovations from medtech industry suppliers, selected by the editors at Medical Design & Outsourcing and designed to assist physicians in performing procedures and to help patients heal.

When it comes to creating finished medical devices that work, medtech suppliers have an important role to play. Stratasys’ 3D digital anatomy interface French-American anatomical modeling company Biomodex and 3-D printer manufacturer Stratasys have teamed up to produce “anatomical twins” that allow physicians to rehearse procedures on enhanced 3D models that mimic the structure and texture of an individual patient’s anatomy and surrounding tissue. Designed to replace the traditional training and rehearsal methods of practicing on cadavers or silicone tubing, these replicas are built based on each patient’s unique medical scans using Biomodex’s algorithm and specialized modeling software, Stratasys J750 digital anatomy printers and advanced materials. Biomodex’s anatomical models incorporate the company’s software and imaging capabilities, because physicians perform most of the applicable procedures while looking at a screen.

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Biomodex used a Stratasys J750 digital anatomy printer to produce this anatomical model of a left atrial appendage. Image from Biomodex

Medical Design & Outsourcing

SUPPLIER INNOVATIONS

Current applications include anatomical twins of neurovascular aneurysms and left atrial appendages for left atrial appendage closure systems for the heart. The neurovascular models measure about 5 in. by 3 in., and the cardiac models are about the size of a grapefruit. Biomodex is also working on anatomical twins for endovascular aneurysms as well as for orthopedic and surgical uses. “These models allow physicians to rehearse the procedure on a precise replica of a patient’s anatomy before they perform it on the actual patient,” said Biomodex CEO Ziad Rouag. “It’s a bit like using a flight simulator. You don’t get to fly a 747 as a pilot just sitting in the cockpit and taking off with it.” Biomechanical accuracy is the whole premise behind providing this solution to the market, according to Scott Drikakis, healthcare segment leader at Eden Prairie, Minn.–based Stratasys. The J750 printer launched in 2016, and the digital anatomy interface debuted in the fourth quarter of 2019, he added. The challenges to 3-D printing lifelike anatomical models include having the right materials to replicate vascular, structural heart or orthopedic conditions, and the proper software, Drikakis said. “They all have different biomechanical properties,” he explained. “The software takes the materials and digitally blends them to replicate the anatomy that they’re ultimately trying to 3D print. The biomechanical properties of the solution that Biomodex is offering allows them to do procedures on synthetic digital twins in real clinical environments before they are actually in with the patient.” Five-year-old Biomodex has two Stratasys J750 printers in its Paris facility and one in the Quincy, Mass., operation it opened in 2019. Each printer can produce dozens of anatomical model cartridges per day, which the company sells to major medtech manufacturers including Boston Scientific and Stryker to validate their new product lines, conduct clinical studies and train physicians, Rouag said. Biomodex hasn’t moved beyond B-to-B sales yet, but is planning on reaching out to teaching hospital fellowship programs, he added. As sales take off, Biomodex is looking at buying more Stratasys printers. 44

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“We have a very good relationship with Stratasys,” Rouag said. “We want to continue collaborating with them. We want to see their new software and new systems.” TE Connectivity doubles connectors in cath lab platform TE Connectivity has developed Versio, a catheter connector platform designed to be compatible with a variety of medical devices used in cardiac catheterization and other minimally invasive procedures. Versio offers highdensity signal and power connectivity in a low-profile platform to improve access to and sensing within the most complex areas of the body — without changing surgical best practice or clinical workflow, according to the Schaffhausen, Switzerland-based company. With a diameter of about 1 in., Versio was designed by TE’s Portland, Ore., team to have 208 contacts — about 2-½ times as many as the competition, according to Tom Medina, an engineering fellow in the company’s medical business unit. “The key innovation is being able to present to the clinical world this kind of high-density connectivity in the imaging space and the electrophysiology space,” Medina said. Customers for these types of applications want higher resolution to produce better images and shorten procedure times, he added. This requires more connections, but the handle can’t be too large or heavy. The main challenge to company engineers in Kawasaki, Japan, was fitting 208 contacts in a 1-in. diameter. They solved this using printed circuits and multiple rows of contacts. They also had to use thin walls able to withstand the force of mating with the catheter and maintain the signal in up to 1,000 uses. “I’m challenging these guys with requirements where the components need to be very small to fit into the overall volume,” Medina explained. “We www.medicaldesignandoutsourcing.com

Image from TE Connectivity

SUPPLIER INNOVATIONS

have in aggregate a very high amount of contact force that we need to manage, but structurally it’s a real challenge to get that kind of robustness in the overall structure when the diameter is so small. And then I’m asking them to design it so that it works consistently for over 1,000 mate cycles.” The printed circuit board also had to offer enough separation between contacts to control impedance and thus, image quality. “The design is very simple, but manufacturing is very difﬁcult,” said Makiya Kimura, a product development engineering manager at TE’s Japan headquarters in Kawasaki. Customers also wanted the company to incorporate human factors engineering into their design from the beginning. TE engineers had to make sure the device would feel comfortable in the hand and be easy to use. Multiple cardiologists also told the company that they want to be able

to feel the connection being made when they insert the catheter into the connector, because their view is often blocked by a sheath to maintain the sterile ﬁeld. Versio can also be designed with different electrical requirements for custom applications, Medina said. The company’s plan is to make a platform variant that can be used in up to 10,000 cycles. The ﬁrst version of Versio is scheduled for release in August. Accu-Tube produces less costly tubing for ortho drills Accu-Tube CEO Kevin McGrath saw a need in the market for less expensive stainless steel thick-wall tubing that could lower the cost of orthopedic drills and reamers and other cutting instruments. Thick-wall tubing is usually manufactured in a process called gun drilling, which entails using a drill to create a hole through solid stock and produce

a cannulated rod. It’s a relatively slow, and therefore expensive, manufacturing process with long lead times, according to Accu-Tube sales director Todd Oehlerking. Orthopedic drills and reamers that are on the market now are reusable, but the industry would like to ﬁnd a disposable option, and Oehlerking said Accu-Tube wanted to make its orthopedic thick-wall tubing disposable. An acquisition gave the Englewood, Colo.based company the extra talent and technology it needed. In February, Accu-Tube bought nearby Mercury Tube Products, which makes thick-wall tubing for the industrial and aerospace markets. The combined companies now had the ability and expertise to develop welded-and-drawn tubing with wall thicknesses as high as .100 in. and an inner diameter as small as .049 in. (Welded-and-drawn tubing is made by folding a ﬂat strip of stainless

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

www.medbioinc.com www.medicaldesignandoutsourcing.com

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Medical Design & Outsourcing

SUPPLIER INNOVATIONS

Image from Accu-Tube

steel into a circular tube and welding the edges together. Drawing is the process of passing a large tube through a smaller die to resize it.) Accu-Tube regularly uses a special stainless-steel alloy known as 17-7, which Oehlerking said is much stronger than the most popular stainless steel used in tubing, the 304 alloy. The stronger tubing would also have a sharper edge than what’s on the market, according to McGrath. Experts from Accu-Tube and Mercury worked through several iterations and produced some catastrophic failures, according to Oehlerking. “We literally had some tubes that would come apart because the forces we were putting on the tubes were too high in the drawing process,” he said. Achieving medical-grade cleanliness with a high-quality surface finish was another challenge they had to overcome. The company is continuing to refine the process of making its 10-to-12-ft tubing straight enough for machine shops to put in their CNC tools for drill and reamer manufacturing. “We’ve completed the initial runs of manufacturing the tubing,” Oehlerking said. “We’ve provided samples to some of our contract manufacturing partners who are presenting finished components to their customers, the medical device OEMS. We have secured very strong interest on two or three programs to start off with.” Accu-Tube’s next step is to do more testing and provide the tubing to partners for them to fabricate drills and test them. Once that’s finished, the company can begin manufacturing in earnest. “It’s conceivable that we could have product that is production-ready and finished device-ready by Q1 of 2021,” Oehlerking said. 46

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Cortland Biomedical engineers design double-duty medical textiles The medical textile industry is moving toward fully electronic knitting machines with software that allows for inﬁnite patterns and repetitions. This technology replaces older machines that were unable to produce density variations within one fabric unless gears were changed manually. Armed with these machines and their advanced software, engineers at Cortland Biomedical (Cortland, N.Y.) have begun developing fabric patterns with areas that vary in density to alternately prevent leakage and promote tissue regeneration. This type of fabric is designed to work well with mitral valve replacements, hernia mesh and tissue scaffolds for shoulder repair. Knit patterning software enables the engineers to create custom patterns with dimensions, permeability and axial stretch to suit the application and native anatomy of the implantation site. Variations in knit density can also give surgeons clear clues for suture and attachment zones. “What’s really, really innovative about this fabric is that you can change density so rapidly,” said Shanzeh Farooqui, development engineering lead at Cortland Biomedical. “It really changes the game as far as surgical applications.” Programming the machines for the right density initially proved challenging to Farooqui and development engineer Michelle Lishner. So did ﬁguring out how to geometrically reinforce the www.medicaldesignandoutsourcing.com

structure of fabric to make it very strong while using very small yarn for minimally invasive procedures. To solve both problems, Farooqui and Lishner had to manipulate parameters such as courses per inch (CPI) and wales per inch (WPI) to influence porosity, thickness, flexibility and stability. Changing those parameters allows the fabric to stretch in one direction and be more rigid in the other, Farooqui explained. “Every fabric that we create is completely custom,” Lishner added. “With software that’s so advanced, our pattern options really are infinite.”

Engineers at Cortland Biomedical are developing fabric patterns to alternately prevent leakage and promote tissue regeneration. Image from Cortland Biomedical

SUPPLIER INNOVATIONS

Spectrum Plastics’ disruptive balloon technology allows for reduced balloon tail dimensions relative to balloon body diameter, enabling larger balloons to be developed for smaller guidewire platforms and devices. Image from Spectrum Plastics Group

This technology where you have a really large-diameter balloon with really small tails is really unique.

Spectrum Plastics develops megaballoon with tiny tails Earlier this year, a customer asked Spectrum Plastics (Alpharetta, Ga.) to develop a large, soft balloon that could be delivered by a tiny guidewire through narrow coronary vasculature. The request was unusual, according to Steve Maxson, VP of sales for vascular technologies. The guidewire platform is 4 to 5 Fr, calling for similarly sized balloon tails, but the balloon itself had to be able to inflate to 30 mm. “This technology where you have a really large-diameter balloon with really small tails is really unique,” Maxson said. “It’s very difficult to do that. It allows you to reach difficult-to-access anatomy but with a very large-diameter, highly compliant balloon.” The new balloon required compliant, highly elastic polymers such as polyurethane and low-durometer PEBA. Engineers at Spectrum Plastics’ Earnan balloon technology facility in Wexford, Ireland, did the work. It took a few weeks, according to Maxson. “We knew it would be a challenge,” he said. “It’s always under the guise of a ‘best effort,’ meaning we can’t guarantee it, but we can give it a shot. Then we developed the appropriate polymer technology and extrusion technology that allowed us to do it.” There are certain parameters within the extrusion process that enabled the physical properties required to make it happen, according to Maxson, who declined to elaborate, citing customer confidentiality. “It was an iterative process,” he said. “It’s not like we got it the first time.”

Phillips-Medisize makes pill-dispensing easier to swallow Large pills can be hard for kids, the elderly and cancer patients to swallow, and tiny pills can be difficult for some patients and caregivers to count accurately. Phillips-Medisize (Hudson, Wis.) aims to solve both problems with a mini-tablet dispenser cap that fits on a standard prescription bottle. The company acquired the patent for the dispenser in a pharmaceutical company acquisition in 2019. The dispenser uses mechanical features to pre-set and count the minitablets dispensed into the proper dose. It mounts directly onto a standard 38 mm-diameter prescription bottle or can be customized for other bottle formats. It dispenses one to 20 mini-tablets of approximately 2 to 2.5 mm in diameter at once, according to Bjørn Knud Andersen, director of front-end innovation and head of technology accelerators and intellectual property rights for Phillips-Medisize. The user can confirm the measured tablet count through the transparent lid of the metering chamber before dispensing the medication. The dispenser is also designed to minimize the potential for damage or crushing of mini-tablets during dispensing, Andersen said. The mini-tablet dispenser is a Class I medical device which needs no FDA clearance, and holds the CE Mark in Europe. It is ready for clinical trials or co-packaging for commercial launch, according to Andersen. PhillipsMedisize is marketing it to an array of pharmaceutical companies. “We see the largest market potential for highly regulated healthcare areas where medication dosing is critical to patients’ well-being,” Andersen said. “These include pediatrics, geriatrics and oncology patients who may desire custom, highly flexible dosing and often find it easier to take small, easy-toswallow tablets versus large pills or liquid medication.”

Mini-pill dispenser

Image from Phillips-Medisize

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Medical Design & Outsourcing

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CO VI D19

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H ow

he COVID-19 pandemic continues to ravage the world, leaving the medical device industry no choice but to continue churning out devices that have been in short supply, such as ventilators and infusion pumps. Those devices cannot operate without tubing, and tubing and extrusion companies have seen a spike in orders that industry-watchers have noticed. Analysts recently estimated that the coronavirus pandemic would grow the medical tubing market by over 13% by next year. Markets and Markets projected that silicone tubing would lead that growth because of its use in drug-delivery applications such as infusion pumps. Before the pandemic, analysts estimated that the medical tubing market would grow at a revenue-based consumer annual growth rate of 9.2% over the next 5 years. Freudenberg Medical’s operation in Germany has seen a sharp increase in silicone tubing requirements for ventilators and oxygenators, Rudi Gall, general manager of Freudenberg Medical Europe, told Medical Tubing + Extrusion. The 48

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company’s silicone operation in California reported a similar increase in extruded tubing orders for pharmaceutical and medical device customers. “Demand for silicone raw material exceeded the supply side in 2019, which had a negative impact on price and availability,” Gall said. “This has somewhat changed in recent months and we are seeing the market trending to a more equal demand and supply-side pattern. "In the last business quarter, we have seen a weakening of product requirements for components going into elective procedures, as those have been postponed on a large scale," Gall added. "However, this shortfall in demand was more than offset by an increase in demand for medical tubing and pharmagrade tubing requirements used in ventilators, oxygenators and drug and vaccine manufacturing." Ventilators are essential to combating the coronavirus but are in short supply around the world. The device helps patients breathe and takes over the breathing process when the SARSCoV-2 virus causes the lungs to fail.

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TUBING COMPANIES

The anatomy of an invasive ventilator is standard. A ventilator unit controls air pressure and sends air through a tube to a humidiﬁer that matches the air to the patient’s body temperature and adds moisture. The tube is inserted into a patient’s airway and into the lungs to give them oxygen, according to Hamilton Medical. Medtech trade group AdvaMed said on April 1 that respiratory device companies that belong to its organization had boosted ventilator production to 2,000–3,000 per week — and expected to soon reach 5,000–7,000 ventilators per week. Those same companies were making 700 per week domestically last year. Tubing companies are helping on the front lines by modifying their manufacturing processes. “We are asking customers requiring components related to COVID-19 support and treatment to reach out to us as soon as possible,” Laura Wilson, marketing manager at Fluortek, said in an email. “Our team is making sure components related to COVID-19 support and treatment are prioritized while keeping other customer projects on schedule. Our employees have stepped up to the challenge and are doing what it takes.” “We are working closely with several world-leading medical device companies to ramp up production of certain devices that may help ﬁght the COVID-19 pandemic,” added Kaitlin Sullivan, marketing manager at Putnam Plastics. Some major car manufacturers in April started to shift manufacturing practices to support ventilator

production. General Motors, Ford and Tesla started producing ventilators with partners Ventec, GE Healthcare and Medtronic, respectively. Ford and GE Healthcare announced on March 31 that Ford would start producing 50,000 ventilators in 100

As manufacturers of respiratory equipment worldwide struggle to meet current demand, we are honored to support them with expedited deliveries of the tubing and sealing components necessary to make their life-saving products work. days at its Michigan plant and would continue to produce 30,000 a month as needed. Medtronic on March 30 reported making 250 ventilators a day with the help of Tesla, and many other companies like Minnetronix, Foxconn, Nortech and Xerox have ramped up production of ventilators, too.

Putnam Plastics cleanroom facilities Image from Putnam Plastics

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“As manufacturers of respiratory equipment worldwide struggle to meet current demand, we are honored to support them with expedited deliveries of the tubing and sealing components

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necessary to make their life-saving products work,” Amy Swab, marketing communications manager of Trelleborg Sealing Solutions, told MT+E. “For these healthcare companies and other industrial, oil and gas, and aerospace manufacturers who are doing their part to deliver vital equipment and services

TUBING COMPANIES

during this time of need, we are forever grateful. We are here for them. We will help however we can to provide the sealing products they need.” Flexan’s Chicago plant makes a part that goes into a miniature pneumatic that a customer provides for about 50% of all ventilators sold in the U.S., according to Mike Huiras, the tubing company’s VP of sales and marketing. “They use their miniature pneumatics in all ventilators and other respiratory devices that are in high demand,” Huiras said. “We’re seeing a pretty large increase in those segments. In addition to offering support to our current customers, we have extensively reached out to a number of ventilator manufacturers and every other company that’s announced they are focusing their manufacturing on ventilator parts and components. So where there is a need for medical-grade tubing, seals, connectors, things of that nature, we have actively reached out to over 50 companies and (are) in contact with a number of them.” Many tubing and extrusion companies have also noted that their employees’ safety is a top priority during the pandemic. “Fluortek is implementing strategies to protect our workforce from COVID-19 while ensuring continuity of operations,” Wilson said. “The integrity of our manufacturing facilities is our number one priority. Fluortek manufactures products in controlled environments and are certiﬁed ISO 13485:2016. We have implemented restrictions on manufacturing plant attendance and visitors.” “Our number one priority is making sure we operate in a safe and healthy environment for our employees who are deemed essential for manufacturing and ensuring their safety,” added Huiras. The coronavirus has affected more than 10.2 million people globally, with the U.S. experiencing the most COVID-19 cases at nearly 2.6 million cases so far, according to Johns Hopkins University’s Center for Systems and Science Engineering. Nearly 503,000 people have died around the world since the pandemic started, including more than 125,000 in the U.S. “Nobody in this space right now is looking to capitalize on the situation, but only to ﬁgure out how we can help and focus our efforts there,” Huiras said. 7 • 2020

Medical Design & Outsourcing

Geotrans extrusion Image from Trelleborg

v 52

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What is a

medical

ventilator and how does it work?

The ventilator has come to the fore as a vital piece of equipment during the COVID-19 pandemic. SEAN WHOOLEY ASSI STAN T EDI TOR

Workers test a VOCSN multi-function ventilator subassembly during production. Image courtesy of Ventec Life Systems

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ut simply, ventilators exist to help patients who can’t breathe, breathe. The novel coronavirus’ attack on the respiratory system brought ventilators into the spotlight, forcing the U.S. to turn to its strategic national stockpile as manufacturers scrambled to scale-up production in short order. While some of the major manufacturers pump out machines and fulfill recently awarded government contracts, researchers at universities and laboratories have entered the ring with alternative ventilators falling under FDA emergency use authorization (EUA) guidelines. However, while useful in a time of need, the alternative machines that cover mechanical ventilation struggle to scratch the surface of capabilities attributable to the indemand ICU ventilators. University of Minnesota Earl Bakken Medical Center lab supervisor Aaron Tucker helped develop the Coventor, the first such alternative ventilator to receive an EUA. In developing the device, which is now being manufactured by Boston Scientific (NYSE:BSX), Tucker and the Coventor team consulted clinicians who have used ICU ventilators to understand how the machines function. “There are many different ways you can control and force air in and out of a patient’s lungs,” Tucker told Medical Design & Outsourcing. “What the ICU ventilators offer is lots of sensors, data and various alarms for when a patient could be experiencing shock, over-ventilation, something like that. They also have more adjustments. … These are some of the things that make these ICU ventilators very useful and very sought-after.”

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Medical Design & Outsourcing

MEDICAL VENTILATORS

Medtronic (NYSE:MDT), one of several medtech companies boosting ventilator production, notes on its website that its acute-care ventilator requires more than 1,500 parts from more than 100 suppliers in 14 countries and includes more than a million lines of software code. Even its portable model has more than 700 components. Ventec Life Systems developed the VOCSN multi-function ventilator, which Chris Brooks, the company’s chief strategy officer, told Medical Design & Outsourcing is the only machine on the market capable of providing ventilation, oxygen, cough therapy, suction and nebulizer therapy, all in one system. The company partnered with General Motors to scale production and has since received orders from the strategic national stockpile for 30,000 critical-care ventilators by the end of August, a number Brooks said Ventec is on track to meet. A major factor in partnering with GM centered around the car maker’s manufacturing capabilities and supply chain. Much like the Medtronic models, Ventec’s VOCSN machines are complex and require many components. According to Brooks, there are about a dozen criticalcare ventilator manufacturers in the world that make, on average, no more than 100,000 devices a year. Suddenly having to increase production has created the potential snag of being unable to procure the necessary parts and components. “You can only build ventilators if you have the parts to build them,” Brooks said. “The key item, for us, was [obtaining] parts. Then, it was manufacturing at scale, which meant a larger space with more lines and more people. Then, it was understanding and finding efficiencies in manufacturing in that process as well.”

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Critical-care ventilators and the parts that comprise them are increasingly valuable. A market analysis by ECRI revealed that Medtronic charged an average price of $35,383 for a particular ventilator model last year — before the pandemic even started. Prices rose early this year as states, federal governments and other entities essentially competed against one another for the machines, according to a recent Kaiser Health News report. Medtronic told Kaiser that it responded by moving to ﬂat rates with prices lower than before the pandemic. Part of medical ventilators’ value lies in the services provided by the critical care machines. As Tucker noted, they offer far more in-depth treatment than the mechanical ventilation performed by alternatives. There is an international standard for safety and accuracy around a ventilator, according to Brooks. “It’s very easy to create a pump that moves air in and out, which is fundamentally what a ventilator is doing. To do that in a precise manner and to adjust with the patient is both an art and a science, and there’s a reason why there are only a few companies doing this and doing it well.” Moving air in and out is not as simple as it may seem and even has the potential to cause problems, highlighting why ventilators are not just “plug-and-play” machines. The power of a ventilator’s blower component needs to be controlled. www.medicaldesignandoutsourcing.com

MEDICAL VENTILATORS

“If you over-inflate the lungs or under-inflate the lungs, you can cause patient harm or death,” Brooks explained. “Just having a device that’s moving air in and out could end up doing more harm than good.” Each machine relies on what is normally proprietary software that controls the blower’s airflow, patient monitoring, and alarms that alert clinicians when patients are receiving an improper amount of air, when there is a blockage, when there is a leak, and more. Brooks said that those features help to reduce user error, while the onus is on manufacturers to create a manageable user interface for clinicians. He noted that little has changed in the respiratory care space over time, meaning clinicians are relatively familiar with the technologies they are using. “The power and precision, the alarms and patient monitors and then the modes and settings, those three buckets are kind of the three elements that create a critical-care ventilator,” Brooks said. “Ultimately, you want to get a ventilator patient off the ventilator. Unless you have those three components, it’s very difficult to do. That’s what sets VOCSN and a handful of other devices apart from other devices.”

TOP: The VOCSN multi-function ventilator MIDDLE: A worker inspects a VOCSN multi-function ventilator during routine maintenance. BOTTOM: VOCSN multi-function ventilator assembly. Image courtesy of Ventec Life Systems.

The Original Push-Pull Connector

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Medical Design & Outsourcing

On April 24, 2020, millions of 3M N95 respirators were delivered to Baltimore/Washington International Thurgood Marshall Airport in a shipment coordinated with the Federal Emergency Management Agency. Image courtesy of 3M

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

Medical Design & Outsourcing

COVID-1 T

he COVID-19 pandemic put medtech contract manufacturers, OEMs, distributors and healthcare providers in situations for which they were unprepared, particularly with their supply chains. What they learned will undoubtedly help them all going forward, especially if the world faces a second wave or another novel virus. Here are some supply chain lessons learned by Nonin Medical, a small manufacturer of a critical device for COVID-19 patients; 3M, a major manufacturer of respirators for frontline workers; CentraCare, a central Minnesota health system; and logistics company King Solutions, which recently entered the medical supply business. They participated in a webinar hosted June 17 by Minnesota’s Medical Alley Association trade group. “Every element of an organization’s operations was impacted by COVID-19, and the value of partnerships and relationships, more than anything, helped essential organizations to find a way to meet demands that spiked beyond what could have been planned for,” said Medical Alley CEO Shaye Mandle after the webinar. “There are silver linings, there are lessons learned — every company is re-evaluating its supply chain and relationships to improve capabilities to serve customers. There is an opportunity for companies to engage each other, with increased visibility, to solve challenges more collectively.”

7 • 2020

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lessons learned:

2 manufacturers, a healthcare system and a logistics company share their wisdom The whole world learned about the importance of supply chains when the novel coronavirus began circling the globe earlier this year.

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LESSONS LEARNED

Nonin Medical Plymouth, Minnesota Nonin Medical manufactures pulse oximeters — critical devices for COVID-19 patients. Image courtesy of Nonin Medical

Small manufacturer: Nonin Medical (Plymouth, Minn.) Nonin is the inventor of finger pulse oximetry, making devices that measure the amount of oxygen in a patient’s blood. Low blood-oxygen has proven a strong indicator of COVID-19 infection and its severity. The demand for pulse oximeters soared during the first few months of 2020 as the pandemic spread around the globe. “At the beginning of March, we started getting the noise of increased demand,” said chief operating officer Christine Meidinger. “Unfortunately, we had no idea what that meant.”

systems should have been automated, which would have helped the company internally, she said. Automating highlevel communications with the supply base, such as production forecasts with suppliers would have helped, too. The company also quickly — and safely — had to add staff when the state was under a stay-at-home order and social distancing was new.

Every one of our components and materials is custom or unique so there isn't an inventory or a stockpile out in the market that we can leverage. The company had to scramble to ﬁgure out what it would need and how to react. By April, Nonin had a better handle on what the pandemic would mean for the company, its product and some of its larger customers, who were under federal Defense Production Act orders to increase output. Like many medtech manufacturers, Nonin learned pretty quickly what it needed to work on, including weaknesses in business processes that would have helped it work faster, better and with greater productivity, according to Meidinger. Internal planning 58

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Nonin also faced challenges with component supply because it didn’t have the leverage of a local supply base in India or China. Medical Alley helped with that, she said. Like many other manufacturers and customers during the height of the pandemic, Nonin also had to wait for critical supplies. “Every one of our components and materials is custom or unique, so there isn’t an inventory or a stockpile out in the market that we can leverage,” Meidinger said. “A majority of our supply base is domestic, but you only www.medicaldesignandoutsourcing.com

have to be short one component and you can’t build a unit.” Meidinger said she learned to ask about the types of agreements foreign suppliers have with their governments, such as their status as a preferential medical supplier that could boost production quickly in an emergency. Nonin executives also realized they needed to think about sourcing more from lower-cost geographies in North and South America and Asia. A lot of what the company learned stemmed from the need for inventory planning, Meidinger added. Nonin learned to ask suppliers how much inventory they’re willing to hold beyond standard safety stock, and to plan to account for risks due to geography and political issues within supplier agreements and inventory planning. What it all came down to in the end was the relationships the company had in place going into the pandemic, according to Meidinger. “We have some suppliers who have worked with the company since its foundation,” she said. “Those guys were willing to do anything. We had suppliers immediately go invest in new capital equipment and in material … without going through a bunch of bureaucratic normal steps. And that was based completely on relationships.”

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

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

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

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

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

ENGINEERING BETTER DEVICES. BUILDING BETTER COMPANIES. presented by:

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

@DeviceTalks

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

LESSONS LEARNED

3M Maplewood, Minnesota Image courtesy of 3M

Major manufacturer: 3M (Maplewood, Minn.) A giant corporation can be more ﬂexible than a smaller manufacturer, but even 3M wasn’t ready for what the pandemic would bring, according to Scott Munson, global healthcare supply chain lead for the company. “For us, it hit pretty early on with China. We did start to get some large orders from China and Asia in December. And when it moved to EMEA, things started to explode.” As the world began to learn how dangerous the virus is and how easily it can spread, the call went out for millions of 3M’s N95 respirators — normally used in industrial settings — to protect healthcare workers exposed to

COVID-19. The masks are designed to ﬁlter out 95% of airborne particles. 3M started to work with existing and new suppliers to increase the volumes of supplies the company needed. It also had to increase production staff and boost speed and output from its existing equipment while reducing waste in the supply chain, Munson said. 3M was able to scale up distribution fairly quickly, in part by shipping directly from its plants to customers rather than going through a distributor, he added. The company also learned that neither it nor its customers had enough inventory to meet the pandemic-fueled demand, even though Munson had worked with the U.S. Centers for Disease Control in recent

King Solutions Dayton, Minnesota King Solutions warehouse

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Image courtesy of King Solutions

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years on planning for a pandemic. “It’s not an easy calculation,” he said. “I think this is going to change a lot of people’s thinking in regards to what we do need to be prepared.” 3M learned to look at its pandemic response from the standpoints of resilience, risk mitigation and global presence. The company had a great deal of cooperation from throughout the world but learned never to underestimate the need for surge capacity or for good communications. “An absolutely critical piece of this… Make sure that you are very collaborative with all your partners” Munson said. “Go out and see them before these things hit. Have a good relationship before these things happen so when it does happen, we’re in a much better spot.”

LESSONS LEARNED

CentraCare St. Cloud, Minnesota St. Cloud Hospital is part of CentraCare in central Minnesota. Image courtesy of CentraCare

Health system: CentraCare (St. Cloud, Minn.) CentraCare may be a small health system, but it has all the types of patient care that have been hard-hit during the pandemic: 8 hospitals, more than 30 clinics, 11 senior housing facilities and 7 long-term care facilities, all in a 16-county area of central Minnesota. According to COO Craig Broman, the pandemic showed that the system needed more data and greater agility in analyzing that data so it could communicate better with its clinical partners. CentraCare also suffered from a lack of information about the origin of products it needed to care for patients, including manufacturers’ locations and suppliers’ disaster preparedness plans.

The health system started planning for shortages of personal protective equipment (PPE) for its providers when Cardinal Health announced a recall of 9.1 million surgical gowns in January. Although not a Cardinal customer, CentraCare found itself on the receiving end of supply limitations imposed by PPE suppliers who saw sudden spikes in orders. Having a less global supply chain would have helped during the pandemic, as would knowing suppliers’ master plans and their ability to respond to unanticipated events, Broman said. CentraCare ended up competing with other healthcare providers for supplies, paying inflated prices, having no-show shipments, and

deliveries of low-quality supplies. “We’re all just fighting for ourselves making sure that we get ample supply, and it has been pure chaos to try and identify suppliers,” Broman said. “Many have asked for money down from 25% to 100%, and you don’t know if you’re going to be getting counterfeit product or not.“ Now CentraCare leaders know what they must to do to improve and strengthen their supply chain, including having an enterprise planning system in place and having manufacturers ship directly rather than relying on distributors. “It’s been really crazy,” Broman said. “We’ve been fortunate so far, but we’ve got to ﬁnd a solution.”

Logistics company: King Solutions (Dayton, Minn.) King Solutions couldn’t have known a pandemic was on the way when it opened a 100,000-ft2, temperature-controlled warehouse largely dedicated to medical supplies about a year ago. The company gained Good Manufacturing Practices certiﬁcation to boost its attractiveness to medical customers, and aims to provide

comprehensive services to them, from guidance on inventory control to order and shipment tracking and transportation management. The offerings could include logistics services as well, according to CEO Mike Patterson. King Solutions executives learned about the frustration of global sourcing during the pandemic, as well as the importance of the supply chain to medical customers.

“There are all these frustrating points along the supply chain,” Patterson said. “It was interesting to learn about all those pressure points.” The company already has one system in place to help during the next pandemic. It includes a tracking device with each shipment sent within North America. “Every 10 minutes, we know where that product is, domestically,” Patterson said.

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Medical Design & Outsourcing

DEVICETALKS

Josh Strakos works on a Stratasys F370 3D printer Image from Mayo Clinic

Mayo Clinic needed to engineer its way through COVID-19: Here's what they did

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 |

The health system’s medical and engineering staﬀs had to devise their own solutions for lab gear, PPE and operating room air decontamination.

s COVID-19 settles into several regions of the U.S., healthcare systems that once sat on the sidelines likely will ﬁnd themselves in the same situation as their counterparts in the Northeast did earlier this year. While this may serve as little comfort, hospitals in regions getting hit by the new wave of the deadly virus do have the beneﬁt of seeing how hospitals elsewhere managed the pandemic. One of the easiest — or at least most evident — lessons available is the use of additive manufacturing or 3D printing. Mayo Clinic and other hospital systems, including Beth Israel Lahey in Boston, used their 3D printers to produce critical personal protective equipment

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(PPE) such as masks and face shields, as well as swabs used with COVID-19 diagnostic tests. But hospitals looking to secure vital PPE need to be aware that Mayo’s success came as much from an organizational commitment to innovation as from an acquisition of 3D printers. During a DeviceTalks Tuesday presentation in May, a team from Mayo Clinic in Rochester, Minn. — three engineers and a physician — spoke about the institution’s success in overcoming supply shortages during the ﬁrst dark days of the pandemic in March and April. While COVID-19 never hit Minnesota as hard as it did the Northeast, Mayo engineers, physicians and other hospital staff worked in overdrive to ensure Mayo

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healthcare providers had the necessary tools to treat sick patients. Amy Alexander, a senior biomedical engineer who works in the Mayo Clinic anatomical modeling lab with its director, Dr. Jonathan Morris, said 3D-printing technology can give hospitals a backup plan if traditional supply routes dry up. “I’ve been thinking 3D printing was going to disrupt the supply chain for a couple of decades now,” Alexander said. “It will be exciting to see how healthcare institutions take advantage of this option. It’s almost like doomsday preppers. It’s not that extreme, of course, but you can be prepared for that time when maybe you can’t get an order through Amazon in two days. People are looking at additive manufacturing now more than they were before, which is huge.” The potential for 3D printing is considerable, but it must be supported by deep engineering and healthcare expertise. Mark Wehde, chair of Mayo Clinic’s division

TOP: An EOS M290 titanium printer BOTTOM: Robbie Highet in the Mayo Clinic Division of Engineering additive manufacturing facility, working with an EOS M290 titanium printer. Images from Mayo Clinic

of engineering, said Mayo has a “very robust” safety/risk process and a welldefined project management. “We have all the pieces in place that allow us to safely develop devices that can be used in patients,” Wehde said. Organizations that have engineers but don’t have an established process are at a disadvantage, according to Wehde. He recalled an example in which a valve 3D-printed in Italy was being touted as a solution for the ventilator shortage as it would allow two patients to be connected to the same ventilator. “I asked our respiratory therapy staff if they had any interest in that and they said [those valves are] probably part of why the mortality rates are so high,” he said. Mayo passed on the valve. In addition to working with internal experts, Mayo Clinic worked with companies including Stratasys and Medtronic to manufacture more than 10,000 masks and face shields, according

to Morris, who is also a consultant in diagnostic radiology. To do this, the health system had to reassign 10 employees from its quieted radiology department to a conference room where they made an additional 22,000 masks. Mayo also retrained 30 other employees to work in a traditional manufacturing lab to make face shields non-stop over three shifts. Mayo Clinic’s success in generating supplies could create a tempting path for others to follow. But executives note the www.medicaldesignandoutsourcing.com

Claire Eggleston working with a FormLabs Form 3B 3D printer at Mayo Clinic. Image from Mayo Clinic

hospital system came into the pandemic with a long streak of developing devices. Mayo boasts 7,000 ft2 of manufacturing space within its Rochester campus, including a printer capable of manufacturing titanium implants. The units are located near clinicians, so engineers and physicians can collaborate. “I don’t know that everyone should have something like this. Just like every hospital doesn’t have robotic surgery,” Morris said. “You know, there are centers that are equipped to have multidisciplinary teams like this. I mean, Mayo Clinic has a huge infrastructure because of the size and scope of problems we handle. Whereas other hospitals and the health system will never have that because they don’t need to have that.” Sean McEligot, section head of technology and development in Mayo’s engineering division, said hospital systems should be building out their teams now, so clinical and engineering professionals will be in place to collaborate on future projects. Through the pandemic, Mayo has finished over two dozen projects and has an equal amount ongoing. McEligot said he sensed a pattern in the projects as they came in waves. The first wave centered around lab safety and efficacy, requiring safety shields, totes and racks for Mayo labs. The second wave required new respiratory therapies for patients. PPE demand came in the third wave, forcing Mayo to develop its own PPE. The fourth and fifth waves focused on controlling the airborne spread of the disease and creating new ways to clear potentially contaminated air out of operating rooms. “I think if there’s a next pandemic, we have the recipe,” he said. “[The team] is focused and ready to go.” 7 • 2020

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