Medical Design & Outsourcing — MAY 2021

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HOW 5G COULD AFFECT MEDTECH HOW BIG MEDTECH FARED DURING A YEAR OF COVID-19

THE 10 LARGEST ORTHOPEDIC DEVICE COMPANIES IN THE WORLD

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HERE’S WHAT WE SEE

Medtech moves beyond the pandemic

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he COVID-19 pandemic is still very much with us, and medtech companies continue churning out devices to meet coronavirus patient needs.

Device companies, however, are already looking to the future, including a return to some form of normal life. One scenario that orthopedic companies are counting on is that people who want surgery to correct painful conditions will seek it out rather than avoid it.

The pandemic-induced drop in elective surgeries hit these companies hard, as executive editor Chris Newmarker explains in the feature article, “The 10 largest orthopedic companies in the world.”

Newmarker documents how these firms plan to recover and thrive.

In another feature, senior editor Danielle Kirsh illustrates how some of the industry’s other big players fared during the pandemic.

(Hint: It wasn’t that bad.) And in the Women in Medtech column, Kirsh describes how a biomedical engineer and a vascular surgeon developed a device that enables physicians — and potentially first responders — to help patients survive hemorrhages by blocking blood flow to the extremities.

This edition of Medical Design & Outsourcing also includes: • • • •

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Some experts’ theories on how 5G will affect medtech, courtesy of associate editor Sean Whooley.

Whooley’s drug-delivery column, which pinpoints advances in diabetes care, otolaryngology and in respiratory care, with connected inhalers.

Pharma editor Brian Buntz’s description of a fascinating technology that uses tiny, screw-like robots for precision drug dosing, including for brain tumors.

Hologic CEO Steve MacMillan’s thoughts on how the company plans to create an information index to yield new data on women’s health, from DeviceTalks editorial director Tom Salemi.

A ton of helpful intellectual property protection information in this month’s IP column, gleaned from the expertise of attorneys from Finnegan, Henderson, Farabow, Garrett & Dunner.

Nancy Crotti Managing Editor Medical Design & Outsourcing n c ro tti @ wtwh m e di a .c o m

Spurred on by the pandemic, companies in other industries continue to adapt their R&D and manufacturing expertise for healthcare. In this edition’s cover story, I describe how 3M and a pair of safety equipment companies recently redesigned reusable industrialstyle masks for use in healthcare settings. They each figured out ways to redirect and filter the healthcare workers’ exhalations to protect patients and others from catching COVID from them.

The likelihood of their adoption looks promising. Federal officials want hospitals nationwide to test them and come up with best practices for their use. The FDA has also advised healthcare providers to move away from decontaminating and reusing disposable masks and toward sturdier, longer-lasting and more protective devices such as these.

The sorrows and victories of the COVID-19 pandemic will remain burned in our memories forever. They will also surely inform the decisions that medtech industry leaders make as they plan to meet the next public health challenge. If there’s one thing we learned from the past year, it’s that medtech is up to the task.

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CONTRIBUTORS

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BILL BETTEN is director of medtech solutions at S3 Connected Health, helping U.S. medical device companies transition into digital health. He has served in development and executive management roles at several medical device and Fortune 100 companies.

BILL STEARNS is a senior engineer on Intertek’s medical device team, serving as team lead for evaluating medical products for safety and performance. He has more than 30 years of electrical engineering experience, with more than a decade focused on regulatory and compliance needs.

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SHANE VANDEKERKHOF is the director of consulting and training at RJG. He is experienced in process improvement across multiple segments of injection molding, including medical.

TIMOTHY WEBER is senior metallurgical engineer for Buehler. He focuses on metallographic materials preparation, image analysis and materials characterization. Before joining Buehler, Weber researched the fabrication and characterization of thin films and coatings at Argonne National Laboratory.

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CONTENTS

medicaldesignandoutsourcing.com ∞ May 2021 ∞ Vol7 No3

COLUMNS 4

HERE’S WHAT WE SEE:

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CONTRIBUTORS

• • • • • THE HOT TOPICS ISSUE

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ON THE COVER

Medtech moves beyond the pandemic

3M, OTHERS MAY HAVE UNMASKED A SOLUTION TO FUTURE N95 SHORTAGES

A handful of companies including 3M and MSA Safety are working to ensure that a scramble for disposable masks never happens again.

12 CONNECTED HEALTH:

Why medtech needs a new connected health mindset

16 DRUG DELIVERY:

8 drug delivery innovations you need to know

22 IP ISSUES:

5 IP tips to help medical device entrepreneurs

26 MOLDING:

FEATURES

How to prevent and troubleshoot short shots

28 PHARMA:

Bionaut Labs aims to tackle brain tumors with microrobots

30 QUALITY CONTROL:

Quality assurance can tackle the intricacies of flexible circuits

32 ROBOTICS:

The basics you need to know to make medical robotics

36 TUBING TALKS:

4 innovative devices delivered through catheters

42 WOMEN IN MEDTECH:

This device stops aorta blood flow to save lives

62 DEVICETALKS:

Hologic CEO sees women’s health data making a global impact

64 AD INDEX 8

Medical Design & Outsourcing

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48 HOW BIG MEDTECH FARED DURING A YEAR OF COVID-19

An analysis of financials showed the medtech industry to be fairly recession-proof in 2020.

52 HOW WILL 5G AFFECT MEDTECH?

When will companies take advantage of the superspeedy connectivity that 5G offers?

56 THE 10 LARGEST ORTHOPEDIC DEVICE COMPANIES IN THE WORLD The return to elective procedures will be a wind at their backs following a brutal 2020.

www.medicaldesignandoutsourcing.com

CONNECTED HEALTH

Connectivity offers a holistic view of patient health, meaning better care for patients, richer insights for doctors and more value paths for vendors.

Image courtesy of S3 Connected Health

Why medtech needs a new connected health mindset

C Bill Betten | S3 Connected Health |

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Medical Design & Outsourcing

An outdated focus on device-only operations is preventing the industry from reaching its full potential.

onnected health is on the rise, with the industry set to reach a value of $6.6 billion by 2027, according to a study by Acumen Research and Consulting.

The COVID-19 pandemic has further underlined the importance of connected health for clinicians and patients, and many medtech developers have pivoted to take advantage of the new circumstances. To secure a truly connected future for healthcare, however, more change is required. The medtech industry needs a total mindset shift from “device-only” operations to broader “device-based” services.

We’re starting to see signs of change on that front, too. This expansion in focus could open up a new path of value for the industry. But some roadblocks remain.

5 • 2021

Why device manufacturers should expand their focus The most significant roadblock is the traditional focus on immediate wins and short-term ROI. When looking through this lens, individual devices are perhaps the most lucrative option.

The shift to value-based care, the need to prove new devices’ effectiveness and the demands of an older, tech-savvy population make predictive and preventative medicine more important, and this kind of approach requires services beyond just devices.

The benefits for medical device companies Device-based services offer a far more holistic view of patient health, meaning better care for patients, richer data insights for doctors and vendors and new paths to value in the longer term.

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CONNECTED HEALTH

They also offer huge efficiencies, providing a broader look at an entire healthcare challenge rather than a single therapy in isolation, and economies of scale make it easier to drive down the cost of care without compromising quality. Giving clinicians a complete view of service delivery makes it easier to assess and understand the patient journey, and the data that can be collected may inform new approaches.

Moreover, connectivity allows manufacturers to keep tabs on their device, ensure it’s working, sufficiently supplied, and conduct repairs and make improvements as necessary. Data from the device can also clarify if a patient is using a device properly and regularly enough, allowing clinicians to intervene swiftly to improve care, leading to better long-term outcomes.

Finally, device-based services ensure more sustainable revenue streams for manufacturers. By providing the

infrastructure and services that devices need, as well as the devices themselves, businesses are no longer forced to rely on income from single devices.

2.

Work out the most appropriate business model. Offer the device with connectivity that enables analytics solely within the area of your specialty or create a device with connectivity that covers all the different modalities that bridge your area of expertise.

The further you go up this scale, the more value you will need to offer, infrastructure you will need to create and data you will need to delve into.

This has implications both in terms of cost and personnel, but greater investment may yield greater results.

3.

Consider reimbursement. Your device and any connected systems or approaches must fit into current reimbursement models, showing it works and does what it’s supposed to do. The more your device promises, the greater the burden of proof and the more hoops you’ll have to jump through, so it’s worth considering upfront how much you’re willing to take on.

You may also need to take action to extend reimbursement policies to cover your connected device.

The reimbursement process is in something of a state of flux, with payors viewing some in-person and remote care as interchangeable.

This may work in the short term, but it doesn’t take into account the long-term benefits of device-based systems. As we move more toward a system of reimbursement based on outcomes, you need to consider how best to communicate the long-term value of your solution, rather than simply confirming the device works and has a short-term impact.

Steps to realizing fully connected healthcare With those benefits in mind, what steps do device manufacturers need to take to realize fully connected healthcare?

1.

Consider the long-term gains. Connected healthcare doesn’t offer the same immediate ROI as device-only, partly due to the extra initial outlay required to create truly connected healthcare systems. This may require new partners, new internal hires, new infrastructure, or a combination of all three.

Building connectivity into a device could benefit every additional device or service that could plug into your device or system in the future, with little to no extra cost.

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DRUG DELIVERY

8 drug delivery innovations you need to know Updates to existing devices and entirely new technologies have moved the drugdelivery space closer to managing chronic diseases and treating acute ones.

T

Sean Whooley | Associate Editor |

Tandem Diabetes develops the t:slim X2 insulin pump and ControlIQ advanced hybrid closed-loop technology to control Type 1 diabetes Image courtesy of Tandem Diabetes

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Medical Design & Outsourcing

he drug delivery space has seen plenty of innovation over the years, and there are no signs of that slowing down any time soon.

Some have delivered improvements upon established technologies like insulin delivery devices and inhalers, while others have unlocked new ways of delivering drugs through various means.

Some of the best innovations in the space are from heavy-hitting companies like Medtronic and Tandem Diabetes Care. But some up-and-comers are beginning to make waves, too, while research continues to uncover new ways to deliver therapeutics.

Here are eight types of drug delivery innovations you should know:

levels, or in Tandem’s case, pair with CGMs that track the levels, and automatically administer or withhold insulin depending upon the readings.

Some describe automated insulin delivery as an artificial pancreas.

While the technology has been on the market for a few years, closedloop systems have room to grow in the automated insulin delivery space.

Honorable mention: Medtronic in November 2020 launched its InPen “smart” insulin pen integrated with real-time Guardian Connect CGM data.

It touts the device as the first and only FDA-cleared smart insulin pen on the market for people on multiple daily insulin injections.

Closed-loop insulin delivery Closed-loop insulin delivery isn’t entirely new, but it continues to penetrate the diabetes care market.

Tandem Diabetes Care is at the forefront of the space, with its t:slim X2 insulin pump and Control-IQ advanced hybrid closed-loop technology to control Type 1 diabetes. The system, which is compatible with Dexcom’s G6 continuous glucose monitor (CGM) and Abbott’s FreeStyle Libre CGM, was approved by the FDA in December 2019.

Medtronic also has a closed-loop insulin delivery system: the MiniMed, which was the first system of its kind to win clearance globally in 2016.

Medtronic and Tandem last summer inked a nonexclusive patent cross-license agreement related to their diabetes treatment tech as they both develop competing products.

The closed-loop automated insulin delivery systems can track glucose

Dyve Biosciences’ transdermal gout treatment Dyve Biosciences CEO Ryan Beal told Drug Delivery Business News in a 2019 interview that there haven’t been enough innovations in treatment for acute gout pain.

Patients often deal with pain for days, but the Thousand Oaks, Calif.-based company’s DYV-700 transdermal treatment seeks to turn that into mere minutes.

The company develops its therapeutic in the form of a topical cream with a moisturizer or lotion consistency. The patient is supposed to apply it to the limb of the affected joint three times per day. The drug’s creators designed it to penetrate the skin, get into the joint space and change the pH environment in the joint, dissolving the crystals that cause pain.

A pilot study revealed a nearly 50% reduction in gout attack duration as meaningful. Researchers observed significant pain reduction in minutes, not days.

More R&D will see what other conditions are a good fit for Dyve’s transdermal therapeutic, but for now, the company is focused on gout and melasma, which is hormone-induced hyper-pigmentation during pregnancy.

5 • 2021

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DRUG DELIVERY

Enable Injections’ drug delivery patch Enable Injections is developing a subcutaneous drug delivery platform with the enFuse, which works as an on-body patch.

EnFuse enables patient-administered subcutaneous delivery of high-volume therapeutics outside of the hospital. The platform has a self-contained drug transfer system compatible with standard syringes and vial container formats.

Enable Injections designed enFuse for controlled subcutaneous administration of large volumes that range from 5ml to 50ml. The company says the device can give patients and caregivers a different delivery method for subcutaneous administration of parenteral therapies outside of the doctor’s office.

Cincinnati-based Enable partnered with Sanofi in 2019 to develop longterm manufacturing and supply arrangements using multiple molecule development programs provided by the pharmaceutical giant. The company also last fall completed a credit Enable Injections' facility worth $25 million from Oxford enFuse device Finance LLC, earmarking the funds to delivers high-volume support the scaling of high-volume therapeutics outside manufacturing and the achievement of of the hospital. significant inflection points as it moves Image courtesy of toward commercialization.

Enable Injections Evox Therapeutics’ exosomes With the backing of major pharmaceutical companies Eli Lilly and Takeda, Evox Therapeutics is breaking into the drug delivery space in an impressive fashion.

Oxford, England–based Evox works to harness and engineer the delivery capabilities of extracellular vesicles, known as exosomes, to develop new therapeutics. The proprietary DeliverEX technology modifies exosomes using molecular engineering, drug loading and targeting strategies to enable targeted drug delivery to organs of interest, including the brain and the central nervous system.

The company recently raised $95.4 million (£69.2 million) in a Series C financing round. Eli Lilly converted a

Image courtesy of Evox Therapeutics

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$10 million convertible note, formed as part of a 2020 collaboration between the two companies, into equity to contribute to the round. CEO Dr. Antonin de Fougerolles also said the company has a strategic partnership with Takeda.

Evox’s novel exosome-based therapeutics could improve the treatment of certain severe diseases that now have limited treatment options. DeliverEX could provide the exosome-based drugs that can address limitations of protein, antibody and nucleic acid-based therapies by enabling delivery to cells and tissues currently out of reach using other drug delivery technologies.

Inovio’s smart vaccine delivery Inovio Pharmaceuticals last summer picked up a contract from the U.S. government to develop a potential gamechanger amid the COVID-19 pandemic.

The U.S. Department of Defense awarded Inovio $71 million to support large-scale manufacturing for the Cellectra 3PSP smart device and the procurement of Cellectra 2000 devices, used to deliver Inovio’s INO-4800 COVID-19 vaccine candidate directly into the skin.

While the late-stage trial for the vaccine candidate is slated later this year after the FDA put a temporary hold on it in the fall, the delivery method is still one to watch.

The small, portable, hand-held device runs on AA batteries and is designed to deliver the INO-4800 vaccine, meant to prompt the body’s immune system to drive an immune response.

Cellectra uses a brief electrical pulse to reversibly open small pores in the cell and allow plasmids to enter, which Inovio says is a limitation of other DNA and other nucleic acid approaches, such as mRNA. Once the DNA plasmids are inside

The Cellectra 3PSP smart device’s creators designed it to deliver vaccines, including Inovio's COVID-19 vaccine candidate.

Image courtesy of Inovio

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DRUG DELIVERY

the cell, they enable the cell to produce the targeted antigen, which is processed naturally to trigger the desired T-cell and antibody-mediated immune responses.

Inovio designed its delivery system to ensure that DNA medicine is efficiently delivered into the body’s cells to drive an immune response, while the medicines do not interfere with or change an individual’s own DNA in any way.

Johns Hopkins researchers tout their shapechanging microdevices that mimic the way the parasitic hookworm affixes itself to an organism's intestines.

Image courtesy of Johns Hopkins

Johns Hopkins microdevices Last fall, Johns Hopkins University researchers touted microdevices that can latch onto intestinal mucosa and release drugs into the body.

The team of researchers and biomedical engineers designed and tested shape-changing microdevices that they say can mimic the way the parasitic hookworm affixes itself to an organism’s intestines.

Each “theragripper,” or dust-specksized microdevice made of metal and thin, shape-changing film and coated in heatsensitive paraffin wax, can potentially carry any drug and release it gradually into the body. Thousands of theragrippers can be deployed in the GI tract, the researchers say.

When the paraffin wax coating reaches the temperature inside the body, the devices close autonomously and clamp onto the colonic wall, which then causes the six-pointed microdevices to dig into the mucosa and remain attached to the colon. The microdevices stay and release medicine gradually into the body before they lose grip on the

Lyra Therapeutics develops the XTreo platform, which is a biocompatible mesh scaffold designed to deliver its LYR-210 drug for chronic rhinosinusitis.

Image courtesy of Lyra Therapeutics

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www.medicaldesignandoutsourcing.com

tissue and are cleared through normal gastrointestinal muscular function.

Results of an animal study in Science Advances found that the animals into which theragrippers were administered had higher concentrates of the pain reliever in their bloodstreams than the control group did. The National Institute of Biomedical Imaging and Bioengineering at the National Institutes of Health and the National Science Foundation provided funding for the study.

While this technology is still very much in its infancy, it’s one to keep an eye on.

Lyra Therapeutics’ bioresorbable treatments Watertown, Mass.–based Lyra Therapeutics is looking to make waves in the ear, nose and throat (otolaryngology) disease treatment space. Their technology involves drugs administered through a bioresorbable polymeric matrix.

LYR-210, the company’s therapeutic, is meant to deliver up to six months of continuous anti-inflammatory drug therapy to the sinonasal passages. The goal is treating chronic rhinosinusitis (CRS) in those who have not undergone surgery for the disease.

The therapeutic is under development for CRS patients. At the same time, Lyra’s XTreo platform is being developed to address other disease areas through precise, consistent and local delivery combined in a single administration.

Comprising XTreo is a biocompatible mesh scaffold to maximize surface area for drug release while maintaining underlying tissue function. It includes an engineered elastomeric matrix to dynamically adapt to target anatomy and a versatile polymer-

drug complex to enable tunable drug elution for long-term dosing.

In December 2020, Lyra announced positive topline results for its Lantern Phase 2 study of LYR-210 for the treatment of CRS, including statistically significant improvement in a composite score of the four cardinal symptoms of CRS compared to control.

Teva digital inhaler The inhaler is nothing new in the world of drug delivery, but Teva Respiratory is taking the device a step further.

Last September, the U.S. affiliate of Teva Pharmaceutical Industries launched its AirDuo Digihaler and ArmonAir Digihaler digital inhalers in the U.S., bringing new forms of treatment for symptoms of asthma.

The AirDuo Digihaler is a prescription inhalation powder for controlling symptoms of asthma and prevention, including wheezing, in those 12 years old and up. The ArmonAir Digihaler is a prescription medicine designed for the

long-term treatment of asthma in patients 12 years of age or older.

Both products include builtin Bluetooth technology, allowing for the connection to a companion mobile app to compile data on inhaler use, which is recorded as an event when the cap is opened or a patient inhales. The digihalers automatically detect, record and store data. They can remind the patient how often devices have been used and determine if they need to improve their inhalation technique.

Neither of the Digihalers is used to relieve sudden breathing problems from asthma, and they will not replace the need for a rescue inhaler.

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Image courtesy of Teva Pharmaceuticals

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IP ISSUES

5 IP tips to help medical device entrepreneurs Taking certain steps — including the easily overlooked — can better protect your intellectual property.

A 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 |

re you thinking of designing a medical device or launching a company? In recent episodes of the DeviceTalks Weekly podcast, two IP lawyers shared several tips that medical device company executives and entrepreneurs should consider as we move into a post-pandemic world.

Below are five pieces of advice from Finnegan, Henderson, Farabow, Garrett & Dunner partners Arpita Bhattacharyya and Jacob A. Schroeder.

1. `FTO’ tips Bhattacharyya advised entrepreneurs to consider four things when conducting “freedom-to-operate” (FTO) patent searches.

•

• •

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Do it early in product development.

Bhattacharyya said it’s easier to design around a problematic patent, negotiate a license or challenge an existing patent before doing too much work on a device.

Be sure to conduct an FTO search in every country you’d like to operate in.

Remember to check pending patent applications.

•

If you’re on a limited budget, start your search with key competitors. If you don’t find conflicts, then slowly expand the circle.

2. Consider a design patent Medical device companies have traditionally focused on obtaining utility patents, which protect how a device’s use and workings, Bhattacharyya said. Design patents protect the way an article looks; people often overlook them.

“But design patents can really help to strengthen your patent portfolio and give you a competitive edge, particularly against similar-looking or knockoff competitor products,” she explained.

In addition to protecting your medical device’s non-functional, ornamental features, a design patent can protect the look of the graphical user interface or the design of replacement parts.

3. Don’t forget method claims In addition to a design patent, a method claim can cover the process of performing a procedure.

Method claims can potentially provide broader protection than device

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IP ISSUES

claims because they do not require a detailed structural recitation, which tends to narrow the scope of the claim.

No one wants to sue the hospital or doctor for infringing on method claims, but a competitor’s device can indirectly infringe your method claims. When it comes to enforcing your patent against a competitor’s device, a broad, well-drafted method claim can really come in handy, Bhattacharyya said.

Design patents can really help to strengthen your patent portfolio and give you a competitive edge, particularly against similarlooking or knockoff competitor products.

Arpita Bhattacharyya | Finnegan |

4. Quality over quantity While patent protection is essential, Schroeder reminds company executives that quality is better than quantity.

“Of the over 10 million patents issued in the history of the United States, only a small percentage of these have ever been subject of a lawsuit, and fewer still have made it all the way to a jury verdict,” Schroeder said. “That’s why measuring the value of your company simply by the number of patents it has obtained makes about as much sense as measuring the value of your company

Jacob A. Schroeder | Finnegan |

based on the number of people it has employed over the company’s history.

Both metrics show that a lot of money had been spent, but … as a patent trial lawyer, I’d take one well-drafted patent over a thousand weak patents any day.”

5. Does remote work weaken trade secrets?

The pandemic has forced many companies — including medtech startups — to allow employees to work from their homes using laptops and services like Zoom to keep teams connected and projects moving forward. But has this workplace shuffle endangered your startup’s ability to defend trade secrets?

Using Zoom and other online meeting services may mean many of a company’s most confidential secrets, source code schematics and competitive intelligence gathering could be accessible from anywhere, according to Schroeder.

“With virtual meetings, many of your company’s meetings are now potentially open for unseen eavesdroppers, whether by sophisticated hackers, inadequate restrictions being placed on the meeting or its recording, or simply to family members at your employees’ houses,” he said.

Now that medtech companies have a handle on remote work and, perhaps, an eye toward returning to the office in some capacity, companies may want to consult with attorneys and IT professionals to ensure their trade secrets remain in full force.

“A complete plan should involve not only an assessment of your company’s trade secrets but also your IT infrastructure,” Schroeder said. Companies with employees who will remain at home should consider employee education about protecting trade secrets.

DEVICETALKS WEEKLY PODCAST SERIES Each week, the DeviceTalks Weekly podcast delivers essential insights, analysis and interviews for medical device professionals. Recent guests include Lisa Earnhardt (Abbott), Ashley McEvoy (Johnson & Johnson), Steve MacMillan (Hologic), Geoff Martha (Medtronic), Shacey Petrovic (Insulet) and many others. You can find the podcast on devicetalks.com or subscribe on Apple Podcasts, Google Podcast, Amazon, Spotify, and other podcast channels. If you’d like to appear on the podcast, email co-host Tom Salemi at tsalemi@wtwhmedia.com or on Twitter @medtechtom.

www.devicetalks.com/category/podcasts/ 24

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MOLDING

How to prevent and troubleshoot short shots

Image courtesy of RJG

Deliberate processes to identify and remediate the problem can yield high-quality products and keep patients safe.

S

S h a n e Va n d e k e r k h o f | RJG |

hort shots are among the most common and visually obvious quality issues most molders face, but they are especially hazardous in the medical industry. A short shot could mean life or death.

Imagine if a luer lock connector was short. You run the risk of introducing air into a vein, which could be fatal. Even if the medical staff caught it before harming someone, how can health providers be confident that all the parts they have in inventory are not the same way? Do they stop the procedure to check each part? What if it was an emergency that could be fatal if the procedure is paused for product evaluation?

The risk is too great, so it’s vital to ensure a good, robust process is in place to prevent short shots. So how do we do that? And how do you troubleshoot them when they do occur? Let’s start with what causes them in the first place.

What causes short shots?

A short shot occurs when a plastic injectionmolded part does not completely fill out — a portion of it is missing. A few issues can cause short shots, and the fix is not always straightforward. Issues may include: • • • • •

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Poor venting.

Material variations.

Improper machine settings.

Blocked gates.

Mechanical failures.

It’s often hard to pin down which issue you’re battling, and there are just as many fixes, depending on the root cause of the problem. But the best-case scenario is avoiding them altogether.

Prevention is key There are many ways to prevent short shots that range from equipment to processes to material. Here are five of the most common fixes: • •

•

•

Proper venting — If vents are crushed or non-existent, air can’t escape, causing short shots.

Proper fill volume — Always ensure that 1st stage (or fill) is similar to the setup sheet. If there is not enough fill volume, then the pack pressure can’t complete the fill and pack out the part.

Hold time — Producing a part with the hold time off, even with the hold pressure on, may produce a part with sink marks and possibly short shots.

An Injection Integral PSI alarm set on a process control system can catch this problem.

Pack-and-hold pressure — As the material’s viscosity increases, indicating a thicker plastic, it gets harder to push and harder to transfer the plastic pressure to the end of the cavity during the pack-and-hold phase. You need enough pressure to complete the fill and pack out the part.

www.medicaldesignandoutsourcing.com

•

Pressure-limited process — If your process does not have enough injection pressure, or the injection pressure limit is set too low, the machine may not be able to inject the plastic at a constant velocity when the viscosity increases too much. It is good practice to have your pressure lowered from maximum to act as a safety net, but you must still have sufficient injection pressure during a good production cycle.

How do you troubleshoot short shots?

First, turn off second-stage pressure and time and make what is referred to as a fill-only part. This will give you an idea of the flow pattern of the material inside the cavity and help with the troubleshooting process.

The goal is for this part to appear to be 99% full, with no second stage applied. If the part is significantly smaller than that, start the root cause analysis of the problem: 1. Verify the machine settings are correct by comparing them to the process setup document.

2. Make sure that there are no mechanical problems.

3. Check for foreign material that could be blocking the gates and impeding flow into the cavity.

4. While the machine is down, wipe the mold surface and give vents a good wipe down to remove clogs.

5. If everything seems to be in good working order, the problem could simply be material variation. Add material to the cavity.

6. Adjust shot size to achieve 99% full.

7. Put back the second-stage pressure settings and compare the parts to the target part weight.

8. If the short is still present, or the part is underweight, increase the secondstage pressure to drive more material into the cavity. This move should make the short disappear and bring the part weight up.

Following a systematic troubleshooting procedure allows everyone to work through the process in the same manner for the same reason to fix the problem.

This will help you save costs on waste and save lives by producing high-quality medical devices.

5 • 2021

Medical Design & Outsourcing 27

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PHARMACEUTICALS

A "bionaut" is shown next to a penny for scale.

Image courtesy of Bionaut Labs

How Bionaut Labs aims to tackle brain tumors with microrobots Tiny robots could ferry drugs to the brain to treat conditions ranging from Parkinson’s to cancer.

Brian Buntz | Pharma Editor |

T

he roboticist Michael Shpigelmacher was one of the founders of PrimeSense, a robotic 3-D vision technology company Apple acquired in 2013.

PrimeSense created technology empowering the Microsoft Xbox Kinect and the iPhone’s Face ID feature, allowing users to use facial recognition to unlock their phones.

Now Shpigelmacher has set his sights on drug delivery with Bionaut Labs, a startup aiming to use tiny robots for precision drug dosing. Bionaut recently won $20 million in venture capital funding.

There was the aha moment.

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Microrobots for the central nervous system Bionaut Labs traces its history back to an observation Shpigelmacher made while working for a large consulting firm after the sale of

PrimeSense. It seemed strange that many drugs focused on a small region of the body, but the drug delivery mechanism relied on systemic dosing. “There was the aha moment,” he recalled. He mulled whether he could “build something for precise anatomical targeting.”

Shpigelmacher reached out to a business partner, Aviad Maizels, with the idea to explore the intersection between miniature robotics and medicine.

They ended up discovering and licensing research from the Max Planck Institute that uses microrobots for drug delivery. The concept harkens back to the 1966 film Fantastic Voyage, in which a miniaturized submarine travels in the body of an injured scientist to repair brain damage. “So I think for us, the analogy is almost perfect,” Shpigelmacher said.

But instead of a miniaturized submarine, Bionaut Labs’ devices, which they term “bionauts,” look something like tiny screws.

The smaller microrobots are hundreds of nanometers in size while the largest measure in the millimeter range. “It’s a tiny object

www.medicaldesignandoutsourcing.com

This Bionaut robot has a screw-like shape.

Photo courtesy of Jon McKee Photography

We know that a single Bionaut can carry a dosage that is relevant for the treatment of a clinically representative glioma tumor.

that is rigid and has a magnetic component, so an externally applied magnetic field generates forces and torques on the device, thereby moving it,” Shpigelmacher said.

The bionauts travel through the central nervous system with the help of fluoroscopy. “We steer it to the target in the body and have a remotecontrolled magnetic trigger to release the payload,” Shpigelmacher said. The screw-like shape is helpful when traveling through dense tissue.

Dosing questions “We know that a single bionaut can carry a dosage that is relevant for the treatment of a clinically representative glioma tumor,” Shpigelmacher added. “By steering the bionaut to a specific site in the body, you don’t get systemic waste,” he said. “You can get therapeutic effects with volumes in the single microliter range.”

Once the tiny craft has delivered a drug to a targeted site in the body, it can be retracted using a magnet — similar to picking up a screw with a magnetic screwdriver.

As for the types of drugs that a bionaut can deploy, there are several possibilities, but the dosing for experimental therapies including biologics, oncolytic viruses and cell therapy agents is not well-validated.

“The science is open as to what the right dosage will be. We believe that we can play a big role in that exploration,” Shpigelmacher said.

The company is now in discussions with several pharma companies to discuss the potential of bionauts compared with systemic or intrathecal injection.

A bionaut shown in the cerebrospinal fluid of the spine.

Image courtesy of Bionaut Labs

www.medicaldesignandoutsourcing.com

Regulatory strategy relies on a platform approach In terms of the regulatory strategy, the company plans to get FDA approval for the robotic platform, which can then extend to different therapeutic areas. “It is going to be a drugdevice combination with the robotic component as an enabler for the drug,” Shpigelmacher said.

With its technology already tested in animals, Bionaut Labs plans to have human clinical trials by 2023.

The company is first aiming to win approval for generic chemotherapy for the treatment of brainstem glioma.

Getting approval for a single drug-device combination project should simplify regulatory matters in the long run. “It’s not going to be a 510(k) initially because there are no predicate devices for remote-controlled microrobots. But later on, there will be 510(k)s from our own device,” Shpigelmacher said.

Bionaut Labs also acknowledges that it will need to win over the medical community. “I’m acutely aware of the fact that many people view our technology as very unusual. Some people use the phrase ‘science fiction’ to describe our technology,” Shpigelmacher said.

But the unmet needs in neurology could increase palatability for nextgeneration technology. “The standard of care for many CNS diseases is poor with some exceptions,” Shpigelmacher said. “We wanted to build one tool that solves many problems rather than necessarily building separate solutions for individual problems.”

When asked why the company sought VC funding to accelerate research from the Max Planck Institute, Shpigelmacher said that the VC cash could enable the technology to be commercialized 10 years sooner than if it followed a purely academic path.

“And it’s not just a return-on-investment question — it’s actually the lives of patients,” he concluded.

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29

QUALITY CONTROL

Quality assurance can tackle the intricacies of flexible circuits Here’s how advances in testing can improve feature inspection.

F

Timothy Weber | Buehler |

lexible circuits may seem to be a recent development, but they date back to German inventor Albert Hanson in 1898.

He described the production of flat conductors on a paraffin-coated sheet to improve telephone exchange boards.

What flexibility the waxed paper provided, it lacked in durability. Flexible circuit creators today sandwich them between a polymer cover layer and base film of either polyimide or polyester.

Designers favor polyimide where soldering of the assembly is required, and it is the material of choice for nearly all chip-scale packages and flex ball grid arrays.

The wider application of flexible circuits took the recent development of new materials and manufacturing techniques, enabling the design to recently become one of the fastestgrowing segments of the global printed circuit industry. New applications, usually

involving smaller, more mobile devices, have pushed this expanded use along, particularly in the medical field.

Circuitry in medical devices — a tight squeeze Medical device product specifications can limit space available for circuitry. A multilayer flexible circuit board can handle all the control functions of a complex medical device and provide greater functionality.

Evolving design can pose manufacturing and testing challenges.

PCB manufacturers are finding that thinner material leads to smaller vias, a reduced aspect ratio of vias, smaller lines and spaces, less copper plating and better fill grades, but it can also increase handling complexity.

Flexible circuits’ quality assurance needs differ from rigid PCBs’. In response, testing systems manufacturers are developing new products and techniques to inspect features such as vias and through-holes. These approaches meet the unique needs of increasingly smaller and lighter flexible circuits demanded by the medical market.

Metallography plays an integral role in analyzing and understanding the effects of these improvements on the PCB internal structure. Quality control benefits from evaluating the product at various stages of a new production process. Crosssectioning samples can reveal vital details, including cracks, voids, conducting layers and interconnections.

Flexible medical circuit Images courtesy of Buehler

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Isolating problems and finding improvements In other cases, a more targeted approach involves crosssectioning the center-line of through-holes or progressively thinning the specimen and examining each layer. The more information gathered during an analysis, the higher the probability of improvement.

Labs cut these boards using a precision saw to minimize the potential for damage to the board. Cutting and handling these boards inappropriately can cause defects such as delamination — sometimes incorrectly attributed to the manufacturing process.

Testing equipment manufacturers offer precision saws with table attachments. These saws enable the testing lab to quickly cut flex and hybrid boards without damaging the area of interest while providing a higher degree of safety for operators than band saws or hand tools.

Flex circuits and the hybrid rigid-flex circuits in medical devices present a more significant challenge in targeting regions of interest. The same properties that make these board materials (often PEEK or polyamide) useful also introduce the potential for inaccuracies.

Bi-directional flex circuit, a multilayer flex circuit cross-section as polished at 100x

Dealing with small feature size Note that these features are, in many cases, quite small, ~100 microns or even less. It’s necessary to avoid pin placement variability (when pinning boards for processing) or positioning of board coupons in the accessory when mounting.

These boards are often very light compared with rigid PCBs. Care is needed to prevent coupons from “floating” in media during mounting, leading to inaccuracy in targeting.

Reduced feature size has been the trend, along with the miniaturization of medical devices. Smaller feature size enables flexible boards to have multiple rows of features, often at varying dimensions within the same board. These boards have targeted features of varying sizes and features placed at different distances from a reference within the board.

Testing equipment manufacturers have developed accessory kits for semi-automatic grinder-polisher equipment that can target these smaller features. These latest kits can target such features in relatively high production volume, with up to 18 PCBs processed in less than 30 minutes. These newer accessory kits also have a significantly reduced cost.

They can also handle tighter tolerances that have been specified on small features, use polycrystalline diamond stops that resist wearing when compared to mono-crystalline or carbide stops, and reduce the span of the reference pins used in the kit, ensuring these features are presented in a plane perpendicular to the view under the microscope. Kit manufacturers can provide technical expertise specifically for users working with small (<= 4 mil) feature sizes and aspects of preparation to pay particular attention, which enhances the capability of success in targeting.

In addition to these developments in PCB production, preparation, and inspection, there has been an increased demand for reliability. Accordingly, addendums to IPC standards have been published not only for medical devices but other industry segments such as aerospace and automotive.

Proper preparation provides the capability to verify reliability standards. Testing equipment manufacturers continue to work with many PCB manufacturers to ensure compliance with IPC specifications. www.medicaldesignandoutsourcing.com

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ROBOTICS

The basics you need to know to make medical robots

Photo courtesy of Adobe Stock

Medical robots and robotic devices bring complex challenges to the table. Manufacturers must be prepared to address them to bring a product to market.

M Bill Stearns | Intertek |

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edical robots are complex, with lots of pieces and components: base stations, robotic arms, sophisticated software, instruments and integrated support equipment. These robotic subsystems are often designed and assembled by multiple teams, including software, hardware, medical professionals, integration and regulatory.

These teams can be siloed within a company or spread out geographically.

Medical robot makers also frequently subcontract subsystems or parts to other manufacturers.

Medtech manufacturers need to pay greater attention and emphasize coordination to ensure they produce a successful complex device and avoid

5 • 2021

mistakes. Here are some best practices and ways to prepare for obstacles and overcome them.

Communicate and document Everyone involved in developing a medical robot must communicate well from the beginning, and those communications must include everyone: designers, engineers, medical experts, programmers, robotics teams, R&D and compliance managers.

Miscommunications and missteps can increase costs and waste time. From the start, manufacturers should establish, share and clarify the goal, expectations, responsibilities, timelines and deadlines to ensure the process is as smooth as possible. All teams should have a common quality system for a compliant design and

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ROBOTICS

a smooth regulatory approval process.

Using a common quality system allows each subsystem to integrate properly into the top-level product design file.

Teams should also apply common risk management, software development and usability processes across all subsystems.

Using different processes makes system integration increasingly complex, leaving companies to evaluate different processes during the regulatory review.

This requirement can add unnecessary cost and increase time to market.

When subcontracting components or subsystems using a different quality system, the manufacturer must review, accept and integrate the subsystem design file into the product design file.

Medtech companies should also use common procedures to document and communicate among the different product teams to ensure all teams follow and use the same processes, forms and worksheets.

Robot basic safety, essential performance, hazards and assessments Like other types of medical equipment, medical robots fall within the scope of IEC 60601-1, which includes requirements for basic safety and essential performance. Some basic safety requirements include preventing shock,

robobusinessdirect.com

Robotics-Assisted Surgery: Critical Challenges and Robotics Opportunities

fire, excessive temperatures, radiation exposure, mechanical hazards and electromagnetic emissions. It’s important to maintain basic safety in normal and single-fault conditions. The standard also requires robots to meet the essential performance requirements defined by a manufacturer risk assessment.

Additional requirements for medical robots are defined in the standards IEC80601-2-77 for robotically assisted surgical equipment and IEC80601-2-78 for medical robots used for rehabilitation, assessment compensation or alleviation. Examples of essential performance include information essential to perform surgery, motion control or force/ torque of movement. Manufacturer risk management must address all aspects that can contribute to the loss of essential performance, including the breakdown of hardware, software, and hazards related to usability, including misuse of the system.

Design review A thorough design review early in the development process can be critical to a product’s success. Companies typically perform a regulatory review after completing product design. Major changes at this stage can be difficult to correct, costly and time-consuming. A proper regulatory design review considers many of the key aspects of a product, including: •

• •

Sponsored by:

•

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www.medicaldesignandoutsourcing.com

The ISO 14971 risk management process, which can be very complex when a product has multiple subsystems. This should include a review of the checklists required by the regulatory review process.

Operator and patient isolation issues, which lead to costly re-designs.

Critical component identification and review for proper ratings and regulatory compliance.

Identification of all applicable and necessary standards and testing. Some robots are used in conjunction with other medical equipment that can affect the robot design. High-frequency surgery and endoscopic equipment are examples that can have a direct impact on the isolation strategy, component selection and testing that will need to be performed.

A review of the electromagnetic radiation and immunity test plan as required by IEC60601-1-2. This test plan is required to consider all the applicable standards, procedures to monitor essential performance during testing, and the different configurations of the product to be tested. The addition of wireless communication makes this plan more complex.

Performing an early design review helps kick off the regulatory review and can establish important relationships among the design teams and the test lab. The work performed during the design review can often be used during the final regulatory review. In addition, the reviewer will be more familiar with the product and design team, which can lead to a smooth, timely and less expensive regulatory approval process.

Manufacturers can expect the requirements and expectations around medical robotics to change. They must stay informed on new standards, new technology, industry demands and trends to adapt existing products, change products in development and create new technologies. Working with trusted vendors and paving the way for communication within your company will help guide devices from concept to production to market, helping ensure product success.

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TUBING TALKS

4 innovative devices delivered through catheters There are new devices designed for conditions such as renal denervation and heart failure — and more.

Medtronic’s Harmony nonsurgical pulmonary heart valve.

Image courtesy of Medtronic

P

Danielle Kirsh | Senior Editor |

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hysicians use catheters to deploy numerous life-saving devices across the healthcare realm, from cardiovascular to neurovascular.

They typically insert the thin, flexible tubes in a process called catheterization to deploy devices such as left ventricular assist devices (LVADs), transcatheter aortic valve replacements (TAVRs) and occluders to stop bleeding. The catheter industry is regularly innovating to keep up with the medtech industry’s growing demand for smaller devices for larger patient populations.

Throughout 2020, we saw several FDA clearances and approvals for catheter-based technologies, including ones designed for conditions such as renal denervation and heart failure. Just a few months into 2021, the FDA has approved catheterbased innovations by two major medtech companies. Two others developed for highrisk patients are worth revisiting.

5 • 2021

Medtronic: Harmony transcatheter pulmonary valve Medtronic won FDA approval for its Harmony transcatheter pulmonary valve system on March 26. The device is a non-surgical heart valve that treats severe pulmonary valve regurgitation.

The Harmony transcatheter pulmonary valve system could delay the time before someone with congenital heart disease may need additional openheart surgery, according to the company.

It could also reduce the number of openheart surgeries required over time.

Medtronic’s device is for adult and pediatric patients who have certain types of congenital heart diseases. A doctor implants the device using a thin catheter with a collapsed Harmony valve at the end. The catheter goes through a vein in the groin or next to it, running into the right side of the heart and then into the right ventricular outflow tract.

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TUBING TALKS

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Abbott: Amplatzer Piccolo Abbott won FDA approval for its Amplatzer Piccolo occluder in January 2019. The device goes into babies weighing as little as 2 lb in a minimally invasive procedure to treat patent ductus arteriosus.

Amplatzer Piccolo is a device smaller than a small pea that treats one of the most common congenital heart defects in premature babies. Patent ductus arteriosus (PDA) is a potentially life-threatening opening between two blood vessels leading from the heart.

For most infants, the pathway seals itself shortly after birth, according to Abbott.

However, PDA could occur in some babies who are born prematurely.

Abbott’s Amplatzer Piccolo occluder is a self-expanding, wire mesh device that is inserted through a small incision in the leg and guided through vessels to the heart to seal the opening in the heart. A physician inserts it through the aortic or pulmonary artery where it can be retrieved and redeployed for optimal placement.

Edwards Lifesciences: Sapien 3 Ultra Edwards Lifesciences won FDA approval for its Sapien 3 Ultra transcatheter aortic valve replacement (TAVR) device in for use in severe, symptomatic aortic stenosis patients for whom openheart surgery is considered a low-risk, intermediate or greater risk, according to the company.

Sapien 3 Ultra comes in 20 mm, 23 mm and 26 mm sizes and has an improved valve, delivery system and sheath. It includes a heightened outer skirt designed to eliminate paravalvular leaking. The delivery system has a low-profile 14 Fr Axela expandable sheath and an “on-balloon” design to eliminate the need for valve alignment mid-procedure.

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WOMEN IN MEDTECH

This device stops aorta blood flow to save lives Stopping internal bleeding from torso trauma has its technological challenges.

Asha Parekh, co-founder and CEO of Front Line Medical Technologies, has developed a small, quick and easy-to-use device that could solve the problem.

F

ront Line Medical Technologies (London, Ontario) is an early-stage medical device company developing a way to stop internal bleeding with its flagship device, the COBRA-OS (control of bleeding, resuscitation, arterial occlusion system).

Asha Parekh, who holds a PhD in biomedical engineering, collaborated on it with vascular surgeon Adam Power, who realized the potential for a device to stop internal bleeding more quickly to save more lives. They created COBRAOS for physicians and potentially first responders to help patients survive non-compressional torso hemorrhage.

“This was a huge opportunity. The technology that’s out there isn’t the easiest to use,” Parekh Outsourcing. “We’re told Medical Design and Outsourcing not reaching a lot of the patients that could be surviving these types of situations.”

According to Parekh, 90% of patients who suffer from internal bleeding outside of the hospital can’t make it to a hospital.

She described COBRA-OS as a temporary medical device that “bridges the gap of time” and allows patients to get definitive care.

COBRA-OS’ has Health Canada approval for arterial occlusion.

Its most prominent use is for a procedure called resuscitative endovascular balloon occlusion of the aorta (REBOA). Doctors perform REBOA procedures on hospital patients suffering trauma, postpartum hemorrhage and gastrointestinal hemorrhage.

The physician inserts the device through the femoral artery in the groin and uses a guidewire to push it up to the aorta, deploying the device to block blood flow. Cutting the blood supply to the lower extremities limits the circulation temporarily to the brain and the heart to prevent stroke Asha Parekh or heart attack.

Danielle Kirsh | Senior Editor |

This was a huge opportunity.

The technology that's out there isn't the easiest to use.

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The COBRA-OS (control of bleeding, resuscitation, arterial occlusion system) Image courtesy of Front Line Medical Technologies

“You’re essentially turning off the tap to the lower limbs but making sure that the two vital organs that keep you in good standing — the brain and the heart — continue to receive blood,” Parekh told MDO. With the COBRA-OS inside the aorta, the physician pumps liquid into the device to create the occlusion. Once the aorta is blocked, the patient can receive definitive care. Device deflation and removal take place once the bleeding subsides.

One of the biggest challenges for Parekh and the team was creating a device that was so small that it could be used quickly and efficiently while pushing fluid through a small channel. It also had to safely enter and move through the vasculature into a larger artery — the aorta — which it needs to occlude. Creating a device almost as small as the diameter of a pinhead risked losing the rigidity of the device as it gets smaller, Parekh said.

“When developing something so small, the assumption might be that you’re trading off the rigidity because it’s smaller and maybe not as sturdy,” she said. “We have not forsaken any of that stiffness. It’s comparable.”

The COBRA-OS has a 4 Fr diameter sheath and eight components: an

“The small factor is the most important point because it allows it to be faster and leads to it being safer,” Parekh said. “There’s a law of physics there that you need to abide by. It can only go so fast, depending on the size of the channel. There’s a trade-off, practically speaking.”

Front Line Medical plans to study the device more to show additional benefits and features. Parekh said the company is also looking at ways to broaden the device’s application to situations beyond trauma.

Others are investigating REBOA procedures for non-traumatic cardiac arrest and other non-bleeding applications. In non-traumatic cardiac arrest, the aorta is blocked, and if CPR can be performed at the same time, the benefits of the device increase, Parekh said. There’s potential to revive patients and restore their circulation.

“There are studies going on right now that are showing you can actually revive patients and get return circulation in way more patients than you could without it,” she said.

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You're essentially turning off the tap to the lower limbs but making sure that the two vital organs that keep you in good standing — the brain and the heart — continue to receive blood. atraumatic flexible J-tip, RO balloon marker, reusable J-tip straightener, compliant offset balloon, safety shoulder reservoir, suture tabs, zone 1 & 3 markers and a 10 cc sword-handled syringe.

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Medical Design & Outsourcing 43

3M, others may have

unmasked

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www.medicaldesignandoutsourcing.com

N A N C Y C R OT T I M A N A G I N G E DITO R

a solution

to future N95 shortages

A handful of companies including 3M are working to ensure that a scramble for disposable masks never happens again.

3M EVF with 3M 6000 series half facepiece respirator Image courtesy of 3M

T

he face of the next pandemic could be very different than that of COVID-19, thanks to a handful of companies that have redesigned reusable industrial face masks to better protect healthcare workers and help prevent mask shortages.

The makers of reusable elastomeric half-mask respirators designed them for industrial use with two inhalation valves flanking an exhalation valve. The exhalation valve enables wearers to breathe out comfortably and keeps the rubber masks from becoming too hot.

Some healthcare workers had been using them during the pandemic, but the FDA became concerned last year about the possibility of spreading the virus through the exhalation valves.

Three companies — 3M, MSA Safety and Dentec Safety Specialists — recently gained NIOSH approval for elastomeric respirators they redesigned by either removing the exhalation valve or fitting it with a new filter and valve to trap the virus inside. HHS plans to buy some of the redesigned masks.

The proposed fixes may sound easy, but the companies had to figure out where and how to safely and comfortably channel wearers’ outbreaths without leaving them uncomfortably warm, according to NIOSH.

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How 3M did it Maplewood, Minn.–based 3M developed a new exhalation filter and valve to fit its 6000 series of elastomeric halfmask respirators, which had been used occasionally in healthcare before the pandemic, according to Nikki Vars McCullough, director of application engineering and regulatory affairs in the company’s personal safety division.

In addition to selling new respirators, the company wanted to offer the new exhalation filter and valve to those who already owned them.

“That was really important to us because anytime you buy a new facepiece or a new design, the healthcare workers have to go through what’s called a fit test,” McCullough said. “We didn’t want people who already had these respirators to have to go through another fit test. We didn’t want them to have to go through new training.”

With the 3M elastomeric half-mask respirators, it’s possible to remove the inhalation and exhalation valve filters and wipe them off, as well as separately submerging the facepiece in water for cleaning. “Once the (virus) particles are captured by air filter media, they stick to those fibers. They don’t come back off. They’re really, really stuck,” McCullough said.

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N95 SHORTAGES

Determining the best filter media to capture virus particles and still be comfortable for breathing was another challenge for 3M. Company engineers had to make sure the new exhalation valve filter would seal properly and that it would not impede the wearer’s line of sight. Plus, the company had to develop new machines to manufacture the new exhalation valve filter and scale that manufacturing capability to meet demand.

NIOSH approved the product in January 2021, and 3M has begun selling it to healthcare providers.

“NIOSH hadn’t really approved an accessory like this before. These were not ever needed before,” McCullough said.

“This was a solution that we came up with in a short period of time. I’m very proud of it.”

Smaller companies take up the challenge MSA Safety, based near Pittsburgh in Cranberry, Pa., developed a half-mask respirator with no exhalation valve for use in healthcare settings. MSA also worked with Allegheny Health Network, a 12-hospital system based in Pittsburgh, to test the masks.

MSA engineers had to figure out how to redirect exhaled breath through the inhalation filters at the same high filtration level while ensuring the breathing resistance was still low, according to Zane Frund, executive director of product research and development for the company.

TOP: Dentec white elastomeric respirator for healthcare use.

BOTTOM: Dentec black elastomeric respirator for healthcare or industrial use Images courtesy of Dentec

To test its reusability, MSA staff also immersed their respirator in several types of disinfecting solutions for up to two weeks, then reassessed it for fit and function, Frund said.

NIOSH approval, which typically takes a few months, took just weeks for MSA’s healthcare-appropriate respirator, MSA Advantage 290. The company has since sold it to more than 20 hospitals and hospital networks in the U.S. and Canada and is working with a medical consultant on European medical approvals, Frund said.

Meanwhile, Allegheny Health has switched its entire staff to MSA’s elastomeric half-mask respirators.

It is working with NIOSH (as is the University of Maryland) to develop best practice guidelines for other healthcare organizations to use them.

Making masks personal A third company, Dentec Safety Specialists (Newmarket, Ontario), has been making elastomeric half-mask respirators for industrial use for 40 years in its Lenexa, Kan., factory, according to president Claudio Dente.

Dentec designed its new ComfortAirNx series with two-way filtration through the same filters rather than having a separate exhalation filter.

To test it out, company employees wore the new mask and measured the temperature inside it at 45-second, one-, two-, five- and 10-minute intervals to see how quickly it heated up.

They concluded it was more comfortable to wear than a disposable respirator.

The mask wearer then walked at a brisk pace for 500 steps, simulating a healthcare worker’s movement, then breathed hard for 20 breaths and did temperature

readings inside the mask five and 10 minutes later. Repeated tests showed the ComfortAir Nx MD elastomeric mask produced a temperature slightly below that of a disposable N95 mask without an exhalation valve, according to the company.

“It’s all about how hard it is to breathe,” Dente said. “We wanted to measure the heat buildup inside the mask versus an N95 disposable versus a 3-ply disposable surgical mask.”

The new mask’s material is also different. When the virus first hit New York City and the country shut down, people frantically called and emailed Dentec, begging for respirators.

Dente watched the TV coverage of overwhelmed hospitals and PPE-encased workers hovering unrecognizably over sick and dying patients and vowed to do something — manufacture new respirators out of white elastomeric rubber instead of the usual black.

MSA Safety Advantage 290 elastomeric respirator for healthcare Image courtesy of MSA Safety

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N95 SHORTAGES

Our hope is, by offering these elastomerics and the powered air-purifying respirators ... there's some relief provided to the inventory of respirators to the healthcare organization.

LEFT: Woman wearing MSA Safety Advantage 290 elastomeric respirator for healthcare RIGHT: Man wearing MSA Safety Advantage 290 elastomeric respirator for healthcare Image from MSA Safety

www.medicaldesignandoutsourcing.com

“I made it in white on purpose so you can write a message,” Dente explained.

“You can say, ‘I care for you.’ It was about having to have some type of humanity.”

Uncle Sam is buying In mid-February 2021, the U.S. Department of Health and Human Services posted a request for bids to supply the Strategic National Stockpile with 375,000 elastomeric half-mask respirators that meet the new NIOSH requirements. 3M, MSA Safety and Dentec Safety Specialists all submitted bids by the March 17 deadline. HHS has yet to award the contract(s).

NIOSH will send a portion of the respirators it buys under the contract to about 90 healthcare organizations to test the best practice guidelines drawn up by Allegheny Health and the University of Maryland, according to Maryann D’Alessandro, who directs the National Personal Protective Technology Laboratory for NIOSH in Pittsburgh.

NIOSH will then use that information to draw up best practices for healthcare providers nationwide.

“Our hope is, by offering these elastomerics and the powered airpurifying respirators and putting some good best practice guidelines in place for hospitals … there’s some relief provided to the inventory of respirators to the healthcare organization,” D’Alessandro said.

HHS acknowledged that these elastomeric masks cost more than disposables, but also noted that they last much longer. As part of its study, Allegheny Health concluded that the cost of the reusable masks was 10 times less per month than disposable N95s and that the cost-benefit increased the longer they are needed.

“In addition, elastomeric masks can be stored for future surges and should be considered an essential part of all healthcare facilities’ supply of personal protective equipment,” the Allegheny Health researchers reported in an article published in September in the Journal of the American College of Surgeons. “Implementation of the program has eliminated our dependence on disposable N95s to maintain normal operations during the global pandemic.”

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How big medtech fared during a year of COVID-19

Despite numerous challenges, the medtech industry showed itself to be fairly recessionproof in 2020, according to a Medical Design & Outsourcing analysis of financials.

DA N I E L L E K I RSH S E N I O R E D ITOR

A

nnual reports recently released by 20 of the world’s largest medical device companies showed only a slight dip in revenue during 2020 — a year in which medtech held the front lines against the COVID-19 pandemic.

Employment was also up slightly amongst the top earners, while R&D spending held its own.

The 20 companies included in the MDO analysis include 3M Healthcare, Abbott (medical device segment), Alcon, Align Technology, Baxter, Boston Scientific, Danaher (life sciences and diagnostics segment), Dentsply Sirona, Edwards Lifesciences, GE Healthcare, Henry

We had different kinds of companies that were able to benefit on some level from COVID and shutdowns.

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Schein, Intuitive Surgical, Johnson & Johnson (medical device segment), Medline Industries, Owens & Minor, Royal Philips, Smith+Nephew, Stryker, Teleflex and Zimmer Biomet.

Revenue for those companies totaled $208.8 billion in 2020, a –0.3% decrease from the year prior when the same companies brought in $209.5 billion. In comparison, the 20 companies saw a 3.4% increase in revenue from 2018 to 2019 without a global pandemic affecting sales.

Those that topped the list of increased sales included diagnostic and imaging companies, while orthopedic and other elective procedure device makers saw a slight dip in sales in 2020.

MassDevice and MDO‘s MedTech 100 Index, which includes stocks of the world’s 100 largest medical device companies, was up nearly 20% in 2020. In contrast, the S&P 500 was up about 16%.

“We had different kinds of companies that were able to benefit on some level from COVID and shutdowns,” Richard Newitter, senior research analyst at SVB Leerink, told MDO.

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Image courtesy of Adobe Stock

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HOW MEDTECH WEATHERED COVID-19

“Companies that do diagnostic tests saw sales increase throughout COVID. We also had other companies that had products that were well-suited for at-home type of treatment or things that require fewer in-person visits that also unironically saw a tailwind throughout COVID.” Kaila Krum, managing director of Truist Securities, noted that orthopedic and acute cardiac procedures were negatively affected in 2020, while devices used in lifesaving procedures or acute emergency cases saw more of a revenue increase.

“A lot of large-cap medical device companies did see revenue decreases in 2020. It was pretty diverse across our sector. We did see revenue decline in our midsize and small-size companies, too. Despite that, about two-thirds of our stocks within the medtech universe outperformed in 2020,” Krum said. “I think we learned [the medtech industry] isn’t bulletproof, but the stocks held up pretty well, albeit with a little bit of volatility throughout the year. We learned that procedure volumes can swing to pretty big degrees, and we learned that procedures that aren’t traditionally considered elective procedures were still getting pushed out.”

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The Centers for Medicare and Medicaid Services (CMS) recommended postponing elective procedures to preserve personal protective equipment in March of 2020. Analysts expected the move to affect companies specializing in devices for higher-acuity procedures, like cardiovascular devices. CMS relaxed the guidelines in June, stating that hospitals could resume procedures on a case-by-case basis while observing federal and state orders for keeping adequate facilities, workforce and PPE available for COVID patients.

“The biggest factor that really played into whether or not a company was doing well was elective procedure volumes and how the companies adapted to the declines in those procedure volumes,” Krum said.

There were also shifts to the outpatient environment and greater use of patient monitoring. Those types of trends accelerated in 2020 and will continue into 2021. Pent-up demand will also be geared more toward things like orthopedics, according to Newitter.

“I think the pent-up demand, some of it, has already been worked down in the back half of 2020 — the elective, deferred procedures — but not all of it,” Newitter said. “We also have another dip or a retreat in December/January with resurgences, so that probably created a little bit of new pent-up demand, in addition to the pentup demand that was still lingering from our first initial big COVID wave.”

Research and development spending was up slightly in 2020 among 15 of the 20 companies that reported the figure. All companies — excluding Danaher, Medline Industries, 3M Healthcare, Henry Schein and Owens & Minor — reported $12.3 billion in R&D spending in 2020, a 0.9% increase from 2019 when the same companies spent $12.2 billion on R&D efforts.

Align Technology reported the most significant jump in R&D spending — 11.4% more in 2020 than 2019. Zimmer Biomet’s R&D spending took a –17.2% hit between 2019 and 2020 as orthopedic procedure volumes slowed through Q3 last year.

With fewer people wanting to visit doctors during the pandemic, Newitter said that companies like Align saw increased demand during the pandemic because their products reduced the need for in-person appointments. Align, for example, sells clear www.medicaldesignandoutsourcing.com

The biggest factor that really played into whether or not a company was doing well was elective procedure volumes and how the companies adapted to the declines in those procedure volumes. teeth aligners that compete against traditional braces.

“Align and Invisalign allow for people to have fewer office visits to have orthodontist treatments done,” Newitter said.

“You can imagine that that has clear benefits during a time when people don’t want to be going into doctors’ offices.”

Employee counts were up 2.7% in 2020 as well despite the COVID-19 pandemic. Seventeen of the top 20 companies reported their employee counts in 2020. Excluding Abbott, Owens & Minor and J&J, large medtech companies employed a total of 450,298 in 2020, a 2.7% increase from 2019 when the same companies reportedly employed 438,351.

GE Healthcare’s employee count took the biggest hit as it reported 3,000 fewer employees, representing a –6% reduction in its workforce. (GE completed the $20 billion sale of its BioPharma business to Danaher in 2020.)

Align Technology saw the biggest spike in workers, employing 3,540 more people in 2020 for a 24.4% increase year-over-year.

That number, however, is on trend with Align’s hiring numbers.

The company hired 24.6% more people from 2018 to 2019 when there wasn’t a pandemic.

HOW MEDTECH WEATHERED COVID-19

M E D I C A L D E V I C E C O M PA N I E S T H AT B E AT T H E C O V I D - 1 9 PA N D E M I C A N D PROSPERED Danielle Kirsh

|

COMPANIES THAT LOST SALES While diagnostics and imaging companies seemingly benefited the most from the COVID-19 pandemic, other elective procedure device companies took revenue hits.

Senior Editor

Some medical device businesses not only survived the COVID-19 pandemic but actually thrived — with many producing the medtech needed to fight the coronavirus’ spread.

Medical Design & Outsourcing recently analyzed financials for 20 of the largest medical device businesses in the world. Not only was overall revenue slightly down for the 20 during 2020, but it was actually up for eight of them.

For many of the eight companies that saw sales increase, there was a common theme: They pivoted their focus to the diagnostics, imaging and personal protective equipment needed to fight COVID-19.

“We had different kinds of companies that were able to benefit on some level from COVID and shutdowns,” Richard Newitter, senior research analyst at SVB Leerink, told MDO. Overall, medtech sales declined in Q1 and Q2 but then bounced back in a V-shaped recovery for the rest of the year, according to Newitter. “It plateaued and actually started to go the other direction into January. Then into January, February and now March, we in the U.S. have hit a stable to improving mode from that slight retracement in December/January.”

HERE ARE 8 LARGE MEDICAL BUSINESSES THAT SAW REVENUES GROW IN 2020

Teleflex: –2.2% R&D spending up 5.1% Headcount down –2.8% Intuitive Surgical: –2.7% R&D spending up 6.8% Headcount up 10.3%

Danaher (life sciences and diagnostics segments): Revenue +33.1% 2020 revenue: $17,979,000,000

Stryker: –3.6% R&D spending up 1.3% Headcount up 7.5%

Medline Industries: +25.9% 2020 revenue: $17,500,000,000

Abbott (medical device segment): –3.7% R&D spending up 8.3%

3M Healthcare: +12.3% 2020 revenue: $8,345,000,000 No change in headcount

Boston Scientific: –7.7% R&D spending down –2.6% Headcount up 5.6%

Align Technology: +2.7% 2020 revenue: $2,471,900,000 R&D spending up 11.4% Headcount up 24.4%

Owens & Minor: –7.9%

Baxter: +2.4% 2020 revenue: $11,637,000,000 R&D spending down –12.4% No change in headcount Royal Philips: +2.1% 2020 revenue: $22,269,900,000 R&D spending up 3.5% Headcount up 1.4% Henry Schein: +1.3% 2020 revenue: $10,119,141,000 No change in headcount Edwards Lifesciences: +0.9% 2020 revenue: $4,386,300,000 R&D spending up 1.1% Headcount up 6.4%

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GE Healthcare: –9.7% Alcon: –9.9% R&D spending up 2.6% Headcount up 18.3% growth in employees.

Smith+Nephew: –11.2% R&D spending up 5.1% Headcount up 2.9% Johnson & Johnson

–11.6% R&D spending up 7.2% (medical device segment):

Zimmer Biomet: –12% R&D spending down –17.2% Headcount up 0.5% Dentsply Sirona: –17.1% R&D spending down –12.4% Headcount down –1.3%

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SEA N W H O O LEY A SSO C IATE ED I TOR

HOW

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www.medicaldesignandoutsourcing.com

Photo from Steve Halama on Unsplash

Photo courtesy of Adobe Stock

COULD AFFECT

The latest standard of broadband technology continues to make waves in 2021. But what about medtech?

W

ireless tech companies such as Qualcomm predict download speeds as high as 10 gigabits per second as next-generation 5G cellular networks roll out worldwide.

The open question in medtech is how quickly companies will take advantage of the super-speedy connectivity for their products.

"5G is about bringing more capacity and speed to the pipes," said Don Jones, a member of the advisory council at BrightInsight and a veteran of the digital healthcare space. Jones spent more than 11 years building Qualcomm's healthcare group. www.medicaldesignandoutsourcing.com

"What you have to analyze is, 'Can healthcare take advantage of what essentially amounts to these bigger pipes?' Because more data can be shoved through them with more speed," Jones said during a recent interview with Medical Design & Outsourcing.

Put into practice, those increased speeds and "pipe" sizes can bring data together to enable everything from robotic telesurgery to better decision-making on vital therapies such as drug delivery.

An evolution toward 5G For now, 4G technology adequately supports telehealth, according to Philips connected care leader Phil Raymond.

But Raymond expects new medical technologies to develop as 5G lowers latency and download delays, plus high bandwidth and high numbers of connected devices.

"The road to 5G will be an evolutionary process that will follow technology rollout and accompanying new care paradigms that drive innovative disruption in existing care models," Raymond said.

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5G & MEDTECH

Dexcom's G6 Pro with a physician reader. Devices like this could benefit from the capabilities provided by 5G. Image courtesy of Dexcom

Some 5G-based applications have already made their way into medtech as the COVID-19 pandemic sped up the adoption of telehealth and remote monitoring. Wearable biosensor patches and other wireless technologies, along with the 5G-powered Internet of Things (IoT), have benefitted from the scale of cloud storage and computing power already enabled by 5G, Raymond noted.

"Wireless connectivity is pervasive today in healthcare, but with the advanced capabilities and features within 5G, it will be a foundational component of delivering on the promise of the 'quadruple aim' of enhancing the patient experience, improving health outcomes, lowering the cost of care and improving the work life of care providers," he said.

Jones pointed out that ResMed and Philips each have 25 million CPAP machines wirelessly connected through cell phone chips on the market today, indicating that the structure for a higher level of connectivity is already in place.

"The interesting part is beginning to figure out ways that [medtech companies] can use the communications capabilities to add more services," Jones said. "It's a question of how far they want to go with the capabilities."

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Ushering in robotic telesurgery Robotic telesurgery could be one of the most obvious areas that could benefit from 5G. Simply put, there's a lot of data involved when surgeons are controlling a robot from a remote location.

AVRA Medical Robotics CEO Barry Cohen wrote in an end-of-2020 letter that as the company looks to meet modern requirements of robotic-assisted healthcare, 5G may be a game-changer.

"The company is exploring remote operations for its intelligent robotic system for medical procedures using the new 5G mobile network at a time when social distancing, even in the spaces reserved for surgical and medical work, has never been more important," Cohen said. "The effectiveness of 5G has reduced the latency issue encountered in the early days of remote robotic surgery operations, a significant and potentially life-saving improvement."

Corindus, which Siemens Healthineers acquired for $1 billion in 2019, has been a pioneer in the robotic telesurgery space. Former Corindus COO and current innovation advisor Doug Teany sees 5G enabling the movement of large data packages with edge computing between a Siemens imaging system and a Corindus robotic system. www.medicaldesignandoutsourcing.com

Robotic telesurgery system users could pull information for a patient, preprocess that information (with images of the heart or arteries or other areas) and deliver it in a way that offers warnings of potential complications or specifications for a patient's anatomy.

"Technologies and advancements in imageguided robotics that are enabled by 5G will truly change the quality of care you get," Teany said. "Then we move to safer, targeted options that are more prescriptive to the patient themselves, and the risk of remote care will be removed. We're excited about those possibilities."

Teany acknowledged that cybersecurity poses a hurdle. Higher levels of security tend to slow networks down, somewhat negating the impact of 5G. But as advances continue, Teany is optimistic about overcoming security snags.

"The world is evolving to maneuver around these continual threats and these continual considerations for cybersecurity and it's getting better," Teany said. "So, I think we'll all benefit from that. There's only a path forward, not a path backward for the issue of cybersecurity."

Technologies and advancements in image-guided robotics that are enabled by 5G will truly change the quality of care you get. Then we move to safer, targeted options that are more prescriptive to the patient themselves, and the risk of remote care will be removed.

5G & MEDTECH

Enabling more automated insulin delivery Jones recalls how major diabetes technology developer Dexcom brought him in years ago to help move the compmany toward developing connected devices. The networkable continuous glucose monitor (CGM) developed by Dexcom, currently the G6 (with a G7 in development), can connect with several other insulin- or diabetesrelated devices, like a Bluetoothconnected pen from Novo Nordisk or a pump from Tandem Diabetes Care.

Faster communications through 5G could help companies overcome some of the safety challenges involved in what has been a holy grail for the diabetes tech space: automated insulin delivery.

"We're going to have a more complex world of sensors that are intercommunicating, and that's where 5G will start to be of help, for two reasons," Jones said. "First, in a local area, the

5G allows a lot of computing and interconnectivity to not clog the cellular network. Then, when it needs to go to the cloud, it can go much faster."

Other major medtech companies including Medtronic anticipate that 5G will make a big difference and are keeping a close eye on technology developments.

"From our perspective, the increased bandwidth, faster speeds and lower power associated with 5G cellular networks offer interesting possibilities for improved connectivity between pumps, sensors, peripherals, digital health devices and cloud services," said Ali Dianaty, VP of product innovation for Medtronic's diabetes business.

Dianaty told MDO in a statement: "We continue to monitor technologies like 5G for the potential impact they can have on the way we can help make living with diabetes easier while producing better outcomes."

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largest orthopedic device companies in the world

Pent-up demand could make orthopedic devices a hot space in 2021.

T

he COVID-19 pandemic was especially brutal for the orthopedic device industry.

Many of the largest companies in the space saw double-digit percentage declines in revenue in 2020. Health providers delayed or canceled elective procedures to focus on the pandemic, and patients stayed away in droves.

It’s a new year now, though, and vaccines are rolling out. People don’t want to live with a bad knee or hip or back forever. Growth will eventually return for the industry, and orthopedic device companies are positioning themselves to be ready.

SVB Leerink senior research analyst Richard Newitter thinks there may have been more setbacks in January and February, but there is optimism for the rest of the year.

"Orthopedic particularly will get an extra wind at the back from deferred procedures.

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There will be a boost beyond whatever normal looked like,” Newitter recently told Medical Design & Outsourcing.

Rather than hunkering down during the pandemic, many ortho device companies chose to shop for new technologies and major M&A deals. They’re reorganizing and launching new products ranging from surgical robots to smart implants.

"Despite the procedure volatility in the last year, many companies found creative ways to launch new products and continued to invest in innovation. As volumes normalize, we think those companies will come out on the other side stronger, and they will be prepared to support the rebound we expect in the coming quarters," said Truist analyst Kaila Krum.

Read on and discover the latest about the world’s 10 largest orthopedic device companies.

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C H R IS N E W M A R K ER E XE C U T I V E E D ITO R

Medtronic is expanding capabilities for its Mazor robotic spine surgery system.

Image courtesy of Medtronic

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10 LARGEST ORTHOPEDIC COMPANIES

10: SEASPINE

9. CONMED –

2020 revenue: $154.3M (–3.0%) Headquarters: Carlsbad, Calif.

Spine surgery tech company SeaSpine is looking to cover the complete continuum of care through its $110 million acquisition of Toronto-based 7D Surgical and its flagship navigational system. The deal is expected to close soon.

SeaSpine took a hit from the COVID-19 pandemic, but showed signs of recovery later in the year, with nearly 9% year-over-year U.S. revenue growth in the second half of 2020.

SeaSpine reported in April that it expects 2021 revenue of $193 million to $198 million, reflecting growth of 25% to 28% compared to 2020. The 7D Surgical acquisition should boost revenue even higher.

7. NUVASIVE

Despite the COVID-19 pandemic and its revenue effects, NuVasive made investments in infrastructure, talent and innovation to enable the company to thrive over the long term, CEO J. Christopher Barry explained in the minimally invasive spine surgery tech company’s fourthquarter earnings announcement in February. The company increased R&D investment by more than 10% in 2020. In February, NuVasive spent $150 million to acquire Simplify Medical and its Simplify cervical artificial disc for cervical total disc replacement (cTDR) to add to the company’s new C360 cervical portfolio.

The Simplify disc received FDA approval for two-level cTDR in April.

NuVasive points out that it's only one of three approved devices for the procedure. Next, the company is driving toward a summer global launch of Pulse, an integrated technology platform to enable better spine surgery.

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2020 revenue: $374.7M (–19.1%) Headquarters: Largo, Fla. ConMed’s orthopedic surgery business includes sports medicine instrumentation and small bone, large bone and specialty powered surgical instruments. The company also sells imaging systems used with minimally invasive surgical procedures.

Sales of the company’s ortho surgery products fell nearly a fifth in 2020 as hospitals and surgery centers deferred non-urgent surgeries — and reduced capital equipment buys — to better focus on the COVID-19 pandemic, according to ConMed’s most recent annual report.

ConMed officials expect sales to grow this year, though the company’s general surgery business will likely rebound faster than ortho surgery.

8. ORTHOFIX 2020 revenue: $406.6M (–11.6%) Headquarters: Lewisville, Texas The musculoskeletal products and therapies company saw revenues return to near-2019 levels by the fourth quarter of 2020. CEO Jon Serbousek said in February that Orthofix plans to capitalize on new capabilities this year.

“A great example is our recent expanded FDA clearance for the Fitbone system, making it the only pediatric lengthening nail in the U.S., and an important addition to our pediatric portfolio,” Serbousek said.

Orthofix in April announced FDA 510(k) clearances for its Construx Mini Ti cervical spacer system and its 3D-printed Forza Ti TLIF spacer system.

6. COLFAX CORP. –

2020 revenue: $1.051B (–10%) Headquarters: San Diego

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MEDICAL TECHNOLOGY SEGMENT (DJO)

2020 revenue: $1.121B* DJO headquarters: Dallas Colfax had major news in March: The company will split into two publicly traded companies in early 2022 — with businesses including DJO forming a new, stand-alone orthopedic device company. The split will create a to-be-named medical device company headquartered in Wilmington, Del., with a significant presence in Dallas. Current Colfax CEO Matt Trerotola will lead the medtech business.

The company expects the medical technology segment to reach $1.4 billion in revenue this year.

Colfax acquired DJO for $3.15 billion in early 2019. The business further expanded last year when Stryker sold its total ankle replacements and finger joint implants businesses to Colfax/DJO to appease U.S. and U.K. antitrust regulators as part of Stryker’s merger with Wright Medical.

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Orthofix’s 3D-printed Forza Ti TLIF spacer systemw Image courtesy of Orthofix

* An entire year of 2019 revenues was not available.

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10 LARGEST ORTHOPEDIC COMPANIES

5. MEDTRONIC – SPINE DIVISION 2020 revenue: $2.503B (–5.7%)* Medtronic Spine HQ: Memphis, Tenn.

Medtronic CEO Geoff Martha touted a record number of Mazor robotic spine surgery system sales during the company’s Q3 earnings call in February — one of many positive signs for the world’s largest medical device company as it emerges from the pandemic. Medtronic is expanding capabilities for Mazor, which helps drive demand for the company’s spine implants in general.

Medtronic also further strengthened its orthopedic spine surgery platform offerings last year by purchasing Francebased spinal surgery technology company Medicrea. “Medtronic will become the first company to be able to offer an integrated solution including artificial intelligencedriven surgical planning, personalized spinal implants and robotic-assisted surgical delivery, which will significantly benefit our customers and their patients,” Martha said. *Fiscal year ended April 24, 2020

4. SMITH+NEPHEW –

(ORTHOPAEDICS + SPORTS MEDICINE)

2020 revenue $3.250B (–13.5%) Headquarters: London The COVID-19 pandemic’s impact on elective surgery levels also dogged Smith+Nephew’s ortho business in 2020. But the British medtech giant also saw some bright spots, including what it described as a positive reception after the launch of its next-gen Cori surgical system.

FDA-cleared and available for both total and unicompartmental knee arthroplasty, the handheld Cori robotics platform is meant to be faster than S+N’s previous Navio system. The company also launched its Real Intelligence suite of digital surgery solutions to improve patient engagement, pre-operative planning, digital and robotic surgery, post-operative assessment and outcomes measurement.

Early this year, Smith+Nephew significantly strengthened its extremities business through the $240 million purchase of Integra LifeSciences’s business in the space. The deal brought onboard a focused sales channel and complimentary shoulder replacement and upper and lower extremities portfolios — and a new product pipeline.

Later this year, Smith+Nephew will debut its first cementless knee implant, CEO Roland Diggelmann told investors in February.

Said Diggelmann: “This is probably the one portfolio gap that we’ve needed to address.”

The Canary Health Implantable Reporting Processor (CHIRP) can go inside the tibial extension segment of a commercial knee prosthesis, shown here. It’s key to the smart knee implant that Zimmer Biomet plans to launch.

Image courtesy of Canary Medical

3. ZIMMER BIOMET 2020 revenue: $7.025B (–12.0%) Headquarters: Warsaw, Ind. Zimmer Biomet has engaged in a significant reorganization in recent years. Now it’s slimming down to become even more focused.

In February, the company announced that it plans to spin off its spine and dental businesses into a new, independent, publicly-traded company by mid-2022.

Former Medtronic executive Vafa Jamali will serve as CEO of the new company.

The spine and dental businesses made up nearly 13% of Zimmer Biomet revenues over the past two years.

Zimmer Biomet officials are also getting a better fix on the company’s digital and robotic technologies, which they’re packaging together into the new ZBEdge connected intelligence suite.

“Where I think that we have an edge over the competition is the connectivity piece — and that everything is working in concert with each other already today and built on a solid platform,” said Liane Teplitsky, Zimmer Biomet’s VP and GM of worldwide robotics, during our DeviceTalks Weekly podcast on April 16.

The company’s Rosa robotics platform recently secured its latest clearance for partial knee replacement surgeries.

Next up, Zimmer Biomet is on the cusp of a De Novo 510(k) clearance and launch of the ortho device industry’s first smart knee implant.

The Persona-IQ is a next-gen version of ZB’s successful, personalized Persona Revision knee implants that will incorporate the CHIRP sensor created by startup Canary Medical.

Newitter at SVB Leerink thinks Zimmer Biomet is well-positioned to gain market share, particularly in the knee space.

CAN CORZA BUST UP MEDTECH’S SURGICAL SUPPLY MONOPOLIES? WHY ZIMMER’S SPIN OUT IS ONLY THE BEGINNING Rich Newitter, managing director of SVB Leerink, explains how Zimmer Biomet is grabbing share in the orthopedic space and building an enviable portfolio of digital sensors and systems. www.devicetalks.com/category/podcasts/

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10 LARGEST ORTHOPEDIC COMPANIES

2. JOHNSON & JOHNSON – DEPUY SYNTHES

2020 revenue: $7.763B (–12.2%) DePuy Synthes locations: Raynham, Mass.; West Chester, Pa.; Warsaw, Ind.; Palm Beach Gardens, Fla. J&J’s DePuy Synthes has its own major product launch this year: its Velys tablemounted knee robot, which received FDA clearance in January. J&J acquired the Velys technology from its developer, Orthotaxy, in 2018. The company boasts that Velys is a first-of-its-kind, table-mounted robotic ortho surgery system with an efficient design that can integrate into any operating room — a plus as more procedures move to ambulatory care centers.

Other planned 2021 launches include: • A dual mobility system addition to DePuy Synthes’ Pinnacle acetabular cup system. The Pinnacle dual mobility system is modular and combines the Pinnacle acetabular cup system and the Bi-Mentum dual mobility polyethylene liner. The goal is enhanced stability hip construct.

• A 2.7 mm variable-angle locking compression clavicle plate system to treat lateral, shaft and medial fractures for small-, medium- and large-stature patients.

The Velys table-mounted knee robot Image courtesy of Johnson & Johnson

1. STRYKER 2020 revenue: $14.351B (–3.6%) Headquarters: Kalamazoo, Mich.

The world’s largest orthopedic device company performed better during the COVID-19 pandemic than other top competitors, many of which saw doubledigit percentage drops in revenue in 2020.

Stryker even closed a major M&A deal — its $4.7 billion purchase of Wright Medical, which CEO Kevin Lobo said “helps us toward our goal of achieving category leadership in all areas of our business.”

(Lobo described how he managed Stryker through the pandemic during a DeviceTalks Weekly podcast in December.)

When Stryker announced Q4 earnings in January, it predicted that its 2021 organic net sales growth would be in the range of 8% to 10% from 2019 — a projection that Stryker officials thought the company could meet even if the pandemic stays strong through the second quarter.

“We have enough confidence now with the hospitals being ready to do these procedures as soon as the pandemic starts to subside, as soon as the vaccines start to become more prevalent,” Lobo said at the time.

Stryker saw more COVID headwinds in Q1 2021 as another wave of cases hit the U.S. But even as the company missed the Wall Street consensus for the full quarter, it stuck by the 8–10% sales growth projection and even upped its earnings prediction for 2021. Lobo said business picked up meaningfully in the latter part of the quarter.

It helps that Stryker is arguably the dominant player in the robotic ortho surgery space, with the company passing the 1,000 mark for Mako robotic system installations last year. Mako has proven to be a significant growth engine for Stryker as health providers buy all the tools and accessories around the system.

Stryker is also seeking to catch up with Zimmer Biomet in the smart ortho implants space, announcing in January that it had bought privately held OrthoSensor and its Verasense intraoperative sensor tech that could further enhance Mako robots.

Overall, Stryker is facing increased competition from Zimmer Biomet, but it remains in a good spot, according to Newitter at SVB Leerink. "Stryker is still by far the market leader, and it has the leading robotic system on the market." www.medicaldesignandoutsourcing.com

Stryker in 2020 passed the 1,000 mark for Mako robotic system installations.

Image courtesy of Stryker

STRYKER CEO KEVIN LOBO SHARES SUCCESSFUL STRATEGIES FOR MANAGING MULTIPLE CRISES (AKA LIFE IN 2020) The past year of pandemic, social unrest and a divisive election – provided a crash course in crisis management for CEOs. In this DeviceTalks Weekly Podcast, Kevin Lobo, the CEO of Stryker, explains how he led his company through this difficult year. www.devicetalks.com/category/podcasts/

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DEVICETALKS

Hologic CEO sees women's health data making a global impact The company is working with Gallup on a survey to build a wider snapshot of healthcare delivery to women.

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 |

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ologic emerged two decades ago as a potential leader in women’s health products and fulfilled that promise with timely acquisitions and effective device and diagnostics product releases. But CEO Stephen P. MacMillan believes the company hasn’t made its biggest impact yet.

In an interview with the DeviceTalks Weekly podcast, MacMillan said Hologic’s decision to partner with the global analytics and polling company Gallup to create the Global Women’s Health Index may be the most important contribution the company can make.

“For all the products we’ve made over our company’s lifetime — 3D mammography, the PAP test or HPV test and everything else — the data we get from this [survey] may turn out to have the biggest impact on human health of anything we’ve ever done,” MacMillan said.

5 • 2021

The survey launched last year during the COVID-19 lockdown. MacMillan said Hologic never considered pulling out of the partnership or reducing funding when the pandemic created uncertainty. “This was a commitment we made,” he said. “We wanted to start because we just don’t think there’s enough information about women’s health.”

Gallup delivered its survey questions in over 40 different languages to more than 100,000 women and men living in 116 countries, according to the company. The 232,000 minutes of conversation produced 36 million data points.

The survey doesn’t focus only on areas where Hologic has products but instead tries to build a wider snapshot of the healthcare delivered to women, according to MacMillan. Hologic’s offerings include diagnostics and treatment in breast health,

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Images courtesy of Adobe Stock

CEO MACMILLAN ON HOW COVID-19 STRENGTHENED HOLOGIC Hologic CEO Steve MacMillan says he didn’t appreciate how COVID-19 would change the world forever. But the diagnostics company quickly rose to the challenge, creating one of the surer supplies of diagnostic tools to chart the pandemic’s severity. www.devicetalks.com/category/podcasts/

gynecological surgery and skeletal health, as well as a wide range of tests for cancer and other diseases that affect women. The company has also built a line of diagnostic tests for COVID-19, using its line of Panther PCS testing systems.

“We thought if we can start to shine a brighter light on women’s health and bring data to governments around the world, that alone will start to have a massive impact,” MacMillan said. “For example, many governments want to make sure that 50% of all women are getting screened for cancer every two years. Well, they’re not necessarily measuring that. We’re able to go … country by country and say, `Here are your goals. Here is the data we have found.’ We can shine a bright light on things.”

The results will be ready for release in the fall of this year at the World Economic Forum in Davos, Switzerland. MacMillan said Hologic was approached by the conference organizers, who saw the importance of the data. “They’ve invited us to join them because they’re fascinated by the impact this study can have.

There’s nobody that’s done anything like this.”

For all the products we've made over our company's lifetime, the data we get from this [survey] may turn out to have the biggest impact on human health of anything we've ever done.

The survey will also apply a broader definition of health, assessing the risk of domestic violence and other critical safety concerns.

Hologic has no plans to monetize the survey, according to the CEO. Company officials saw this as an extension of a “deep purpose” to improve women’s health.

“Hopefully, we’ll bring something to society that is going to be of tremendous value,” MacMillan said. “It should be able to have a massive impact on human health, you know, not just women’s health, but by definition, human health.”

The index’s timing coincides with major companies inside and outside of medtech awakening to lend their voices to a push for social change. MacMillan sees the survey results as helping to further discussions and advance causes for improving women’s health.

“There’s no company on the planet that’s done more for breast and cervical cancer then Hologic,” said MacMillan, who joined the company as CEO 10 years ago. “My own mother is a two-time breast cancer survivor. So, it’s been very personal part of the journey as well for me, and just magical [that we’re] in businesses that can make a real difference in the world.” www.medicaldesignandoutsourcing.com

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