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Articles from 2015 In July


New Robotics Redefine Minimally Invasive Surgery

Find out about a Vanderbilt researcher's robot that can perform surgeries at tiny scales.

Kristopher Sturgis

Only a handful of researchers worldwide have been capable of performing needlescopic surgery, which uses tiny surgical instruments with the diameter roughly the size of a sewing needle.

A new surgical robot developed at Vanderbilt University holds promise that such procedures could become much more commonplace someday. That is good news, because minimally invasive needlescopic surgeries are so small they can be sealed with surgical tape, often healing without scarring.

The robot, developed at Vanderbilt University's Medical Engineering and Discovery Lab, is a surgical robot equipped with wrists on the end of steerable needles.

It holds promise for a field that has been largely limited to removing diseased tissue with tiny lasers or heated wires, given the limited capability of precision. Not only could this technology open the door for more surgeon operators to perform different needlescopic surgeries, but it could also lead to the use of needles in places that have been beyond the reach of surgeons for years, like the throat, nose, ears, and brain. Each of these areas could now be accessible through the steerable needles that are flexible enough to provide surgeons with dexterity, something that is often compromised when tools shrink to smaller sizes.  

The group hopes to test their robot on a transnasal procedure to remove tumors at the base of the skull and the pituitary gland. Such a procedure normally involves opening up the patient's face, however routing the surgery through the nasal cavity may not only be more efficient, but could significantly reduce the recovery period and limit visible scarring.

For now the group is looking to partner with someone who can eventually help provide funding for clinical trials to help it win FDA clearance. They remain confident that the software that controls the device, as well as the interface that allows surgeons to operate the robot will be completed in the coming months.

Refresh your medical device industry knowledge at MEDevice San Diego, September 1-2, 2015.

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Good News in Europe? There Is for Medtech

Medical device companies including Siemens, Philips, Fresenius, and Smith & Nephew are reporting some good news for a change.

Qmed Staff

Major medical device companies in Europe are proving to be a bright spot on a continent still gloomy about the future of the eurozone.

The homepage of Qmed/MPMN's sister UBM Canon media outlet European Medical Device Technology has been looking unusually cheery lately, with good news from a host of companies including Siemens, Philips, Fresenius, and Smith & Nephew.

Here are the highlights:

Refresh your medical device industry knowledge at MEDevice San Diego, September 1-2, 2015.

Chris Newmarker is senior editor of Qmed and MPMN. Follow him on Twitter at @newmarker.

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FDA: Stop Using Infusion Pump Vulnerable to Hacking

The regulatory agency is strongly encouraging health providers to discontinue use of the Hospira Symbiq infusion system.

Chris Newmarker

Updated August 3, 2015

FDA has issued yet another safety communication over a Hospira infusion system vulnerable to hacking--this time going as far as to advise health providers to stop using the device altogether.

Both Hospira and independent researcher Billy Rios confirmed that the Hospira Symbiq infusion system could be accessed remotely through a hospital's network, allowing unauthorized user to potentially change drug dosages for patients, according to the communication, released Friday.

FDA and Hospira are presently not aware of any unauthorized access of a Symbiq infusion system, or of patients harmed or killed as a result. But FDA is saying: "We strongly encourage that health care facilities transition to alternative infusion systems, and discontinue use of these pumps."

Language from FDA was less strong in May, when the agency warned about hacking concerns around Hospira's LifeCare PCA3 and PCA5 infusion pump systems. At that time, FDA advised health providers to follow recommendations from the U.S. Department of Homeland Security's Industrial Control Systems Cyber Emergency Response Team, which included performing a risk assessment to identify potential effects of the identified vulnerabilities.

A Hospira spokesperson declined to say how many Symbiq system are out there. Hospira had previously said it was providing additional cybersecurity protections at the "limited number of sites where Symbiq remains in use."

Hospira last May reported 55,000 LifeCare PCA3 and PCA5 infusion pumps in use around the world. It has more than 400,000 drug pumps installed in hospitals worldwide, according to Wired.

Hospira has stopped making and distributing the Symbiq infusion system, due to unrelated issues that FDA first brought up in 2013. FDA, though, warned that there are still third parties not related to Hospira that are selling the systems. The safety communication "strongly discourages" third-party purchases of the device.

When it comes to infusion pumps, Hospira has been in the process of retiring old pump models and replacing them with new ones. The company has said its next-generation infusion systems have more cybersecurity protections than the older models.

Pfizer is seeking to close a $17 billion acquisition of Hospira by the end of the year.

Refresh your medical device industry knowledge at MEDevice San Diego, September 1-2, 2015.

Chris Newmarker is senior editor of Qmed and MPMN. Follow him on Twitter at @newmarker.

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Full Speed Ahead: FDA’s Expedited Access Pathway

Full Speed Ahead: FDA’s Expedited Access Pathway

Marie Thibault

FDA has long combated stereotypes that its regulatory process is too slow, too cumbersome, and discourages medical innovation in the United States. While Congress has been focused on legislating away regulatory hurdles for devices and drugs with bills like the 21st Century Cures Act, the agency itself has taken a different tack.

Enter the Expedited Access Pathway (EAP), which CDRH director Jeffrey Shuren described in an FDA Voice blog post as a way “to speed qualifying devices to patients with life-threatening or irreversibly debilitating conditions without compromising FDA’s high standards for safety and effectiveness.”

More broadly, the program is an attempt by the agency to get innovative devices on the market faster.

“I see the EAP program as part of a continuum of several different programs that are aimed at moving important technologies toward the clinical environment as early and as quickly as possible where we think that there’s real promise,” says Owen Faris, PhD, acting clinical trials director at FDA.

The Details

The EAP program, which launched April 15, 2015, is available only to devices that tackle the toughest conditions and would file a PMA application or de novo request. For a device to be eligible, there must not be other good therapeutic or diagnostic options available or, if there are, the device must be a “breakthrough technology,” have important advantages over the alternatives, or be "in the best interest of patients," according to FDA’s description.

The EAP is supposed to speed up the regulatory process for these most-needed devices. Not only will the devices receive priority review, but FDA regulators will work closely with the device sponsor and consider using postmarket data whenever possible.

“Under the EAP, FDA may accept a greater degree of uncertainty if it is sufficiently balanced by other factors, including the probable benefits to having earlier access to the device," Shuren wrote. "If, after careful analysis, FDA determines that some data can be collected after the device is on the market, then patients in need will benefit sooner.”

That could be good news for companies with eligible technologies.

“In general, for companies with the right type of device, I think this could be an attractive program," says Yarmela Pavlovic, partner at Hogan Lovells. "How popular it will be remains to be seen.”

Importantly, the device sponsor needs to craft a Data Development Plan draft and submit it to FDA as part of a presubmission requesting EAP designation. The Data Development Plan is a thorough description of all studies that will be conducted, all premarket and postmarket data that will be gathered, intended labeling, and timelines. The presubmission should also include a cover letter, table of contents, description of the device, intended indications for use, and an explanation of the device’s EAP eligibility.

FDA plans to respond to an EAP presubmission within 30 days. If the agency requests more information, sponsors are expected to send in a supplement to the presubmission and will be notified of FDA's decision within 30 days of the additional info request. If the agency still needs more information, it will reject the EAP request.

FDA’s Faris wouldn’t divulge how many applications have been submitted so far but says the program has seen “substantial interest.”

What Came Before

The EAP program was proposed in April 2014 and formally launched in April 2015. The EAP program builds on the Innovation Pathway initiative, which began in 2011 and was updated in 2012 as “Innovation Pathway 2.0.” The Innovation Challenge was a pilot initiative of the Innovation Pathway 2.0 program with a focus on end-stage renal disease. Three device sponsors were selected as participants and worked together with regulators to create a data collection plan—a concept that is being carried forward with the EAP’s Data Development Plan.

CreatiVasc Medical Inc., maker of the Hemoaccess Valve System, was one of the Innovation Challenge participants, and Steven Johnson, CEO of CreatiVasc and president and chief operating officer of parent company Brookhaven Medical, speaks highly of the initiative.

“We felt as if we had a team of up to as many as 10–12 people involved with what we were doing . . . from biomechanical engineers to a clinical trial design specialist to labeling experts to a veterinarian. It was every major discipline within the agency . . .” Johnson says.

Sponsors and regulators kept in near constant contact. Johnson says there were monthly meetings as well as weekly interactions, and FDA regularly responded to questions within 24–48 hours. Many features from the Innovation Challenge, including close collaboration and input from a case manager and senior leadership, have been carried forward to the EAP program.

Victor Gura, MD, who participated in the Innovation Challenge with the Wearable Artificial Kidney he invented, reports a similar experience. Gura says he learned of IDE approval on a Friday night after receiving an e-mail from FDA at midnight Eastern Time—“that means the guy that sent the e-mail with the approval on Friday night was there working,” he says.

Both Johnson and Gura say they saw major benefits from their involvement in the Innovation Challenge. Gura says FDA “really shepherded” the process of getting the first IDE approved.

CreatiVasc’s Hemoaccess Valve System didn’t have a predicate device and might have otherwise been considered a Class III PMA device, Johnson explains. But FDA decided to reclassify it from a Class III PMA device to a 510(k) device because it could be considered an accessory to the approved arteriovenous graft.

“When [FDA] said they wanted to think outside the box, they really did," Johnson says. "They really did think of ways for simplifying the review and approval process."

Is EAP Right for Your Company?

Despite the positive experiences reported by the Innovation Challenge participants, companies may still be skeptical of the EAP program. Pavlovic notes that with new programs there is always some nervousness, as no company wants to be the first to “work out all the kinks.”

Another reason for trepidation may be the lack of actual rulemaking around the EAP program. The EAP program is not backed by a final rule from FDA but is instead supported by two guidances—“Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions” and “Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval.”

Beverly Lorell, MD, senior medical and policy advisor with King & Spalding’s FDA & Life Sciences Practice Group, says that on the drug side, there is both rulemaking and precedent to make companies more comfortable with the Accelerated Approval program, which is similar to the EAP program for devices.

“. . . [T]he rules of the road for the Accelerated Approval have really been in place and well trod for over two decades . . . " Lorell says. "It’s based on rulemaking . . . with roughly between three and four new drugs a year being approved on that pathway . . .[There’s] a lot of experience as to what FDA is going to expect . . . For a device company, there’s not yet that experience on interacting with CDRH.”

Lorell’s colleague, David Farber, a partner at King & Spalding, points out that since one requirement for EAP eligibility is a draft Data Development Plan, there may be some concern that FDA could agree to a sponsor’s plan, then backtrack on it later. Still, he admits this is probably unlikely. “[FDA] has an interest in making the EAP program successful. . . it’ll stick to its commitment, is my prognosis,” Farber says.

FDA’s Faris adds that as much as possible, the agency will stick to its word. “When you look at our presubmission guidance, we have specific language in there that talks about how we want to document a commitment to any advice we provide," he says. "However, there are certain things that could make that advice no longer applicable . . . we’re giving you our best advice, and we’re not going to change that advice unless there are very strong reasons that have to do with protecting the public. . .”

Innovation Challenge participants spoke highly of FDA’s close involvement with the companies, which, of course, required financial and personnel resources. Will the agency also do what it takes to support this new effort?

“I think we do have the resources to make a real meaningful difference in the space under the EAP program,” Faris says.

But he adds that the agency did learn one important lesson from the Innovation Pathway: “Because of the resource intensiveness of this program, we really do want to see companies coming to us as prepared as possible, so that we’re not really starting at absolute ground zero.”

Thinking of Diving In?

So what should prospective EAP designees do to get started?

“I think the biggest point of guidance is to come talk to us early," Faris says. "The earlier we engage with the sponsors, the more flexibility and opportunity there is to think about how to do things differently and to engage at a very high level and speed things up.”

When asked how best to interact with FDA, Johnson recommends a collaborative approach. “My advice would be, don’t go in there with two lawyers and two consultants," he says. "Go in with your team.”

He makes an apt analogy: “FDA is much like a swimming pool. If you want to do a bellyflop and fight your way into the water, then it’s going to hurt . . . But if you ease into the water and take it a step at the time, work with them, you’re all of a sudden in the middle of the pool without even knowing it.”

The impact of the EAP program is yet to be seen, but perhaps the best indication that FDA’s programs are having their intended effect comes from Gura, who says if he hadn’t taken part in the Innovation Challenge, “I’d probably be working outside the U.S."

Learn about the latest medical device technologies at the MEDevice San Diego conference and exposition, September 1–2, 2015.

Marie Thibault is the associate editor at MD+DI. Reach her at marie.thibault@ubm.com and on Twitter @medtechmarie

 [Image courtesy of JESADAPHORN/FREEDIGITALPHOTOS.NET] 

HeartWare Sees the Silver Lining in Thoratec Acquisition

HeartWare Sees the Silver Lining in Thoratec Acquisition

HeartWare's CEO strikes an optimistic tone regarding the acquisition of competitor Thoratec by cardiac company St. Jude Medical. 

Marie Thibault

As one of two major players in the left ventricular assist device (LVAD) market, HeartWare has been seen as an acquisition target in the past. In fact, LVAD pioneer and HeartWare competitor Thoratec tried to purchase the company once upon a time. But last week, it was Thoratec, not HeartWare, in the spotlight, when St. Jude Medical announced it plans to buy Thoratec for $3.4 billion, net of cash acquired. 

All the more credit to HeartWare's executives for taking the high road when discussing the proposed acquisition. In a July 30 earnings call with analysts, according to a Seeking Alpha transcript, HeartWare CEO and president Doug Godshall said, "First, we couldn't agree more with St. Jude's choice of a market to jump into . . . We do believe the long-term implications are encouraging for LVAD referrals and market growth, given St. Jude's reach into the cardiology community."

St. Jude's proposed purchase of Thoratec immediately raises two big questions for HeartWare. What does this mean for HeartWare's chances of acquisition? And how will HeartWare compete against a relatively large company like St. Jude Medical?

Godshall was asked to reflect on both questions by analysts, and he had an upbeat outlook on St. Jude's potential impact on the LVAD market. He pointed out that St. Jude, which is known primarily as a maker of ICDs and pacemakers, has a direct line to electrophysiologists (EPs). Up to this point, cardiologists and cardiac surgeons have been the main targets for LVAD makers, so EPs represent a new entry point to reach new patients. HeartWare should see some benefit from this, Godshall said, because EPs will not be referring patients for a specific brand of LVAD.

HeartWare and Thoratec are the only LVAD companies that have FDA approval for their products, though Thoratec has a more extensive approval for the destination therapy population. Destination therapy patients remain on LVAD therapy instead of using the LVAD as a bridge to a heart transplant.

According to the Seeking Alpha transcript, Godshall said,

"One of the larger untapped populations that we have been targeting as we expand our market development efforts is the CRT [cardiac rhythm technology] refractory population that tends to get to the electrophysiologist, not necessarily to the heart failure cardiologist and the EPs don't necessarily have a bridge to VADs, per se. And obviously, St. Jude has a better network in the EP labs than we do. And so if they can just siphon off a small proportion of that 30%, 40% of the patients who are refractory to CRT and get them to VADs, then we really like our chance to capitalize on a meaningful percentage of those patients, since the electrophysiologists won't be referring to a specific brand of VAD. They will just be getting referred to the heart team to be evaluated for transplant or VAD."

In response to whether HeartWare needs to consider being acquired by a larger company in order to remain on a level playing field with St. Jude/Thoratec, Godshall emphasized his team's commitment to building a strong standalone business—but not without a little added humor. According to the transcript, he said, "And I think, as I've joked for a long time, everyone who doesn't buy a VAD company is missing the boat. But at the same time, we love building this business and have a team that is firmly committed.  . . We want to build a great company that saves more lives than anyone else. And that's what we plan to do." 

Learn about the latest medical device technologies at the MEDevice San Diego conference and exposition, September 1–2, 2015.
Marie Thibault is the associate editor at MD+DI. Reach her at marie.thibault@ubm.com and on Twitter @medtechmarie

 [Image courtesy of GREENLEAF DESIGNS/FREEDIGITALPHOTOS.NET] 

Connectors Conform to Medical Device Design

Connectors Conform to Medical Device Design

Frank Vinluan

Nano-sized connectors can be made in a rectangular shape to match the leads on a printed circuit board.

Electronic connectors are ubiquitous in medical devices, connecting one device to another in order to carry data, signal, and power. The most commonly found medical device connector is a front panel connector that plugs into machines moved around the hospital on carts. While these large, standard connectors aren’t going away any time soon, medical device manufacturers continue to develop products in smaller and more portable form factors. The progressively smaller footprint of medical devices is challenging suppliers to make connectors smaller without sacrificing functionality.

“Combining the electrical and the cable performance in the connector is a challenge we’re facing as we’re going into smaller [form factors] and higher speeds,” explains Bob Stanton, director of technology at Minneapolis-based Omnetics Connector Corp. “It’s not just the shape and the mechanics. It’s the performance.”

As medical devices become smaller, the electronics within them change accordingly. Computer chips can do more than ever, but they also draw less power. In a connector, the pins need to be a certain distance apart in order to carry voltage, Stanton explains. Smaller devices require less voltage, which means that the pin distance in the connector can also shrink, allowing for a smaller connector. Smaller devices call for microconnectors, or the even smaller nanoconnectors.

When it comes to choosing electronic connectors, medical device designers should consider both size and shape, as well as the application of the device. For example, a designer would choose a circular connector over a rectangular one in order to match the round cable and keep the device small, Stanton says. When a device is designed to enter the body, designers need a connector no bigger in diameter than the device. As an example, Stanton points to transurethral microwave therapy (TUMT), used to treat an enlarged prostate. TUMT destroys excess prostate tissue with a small microwave antenna inserted through the urethra.

“You don’t want [the connector] any bigger in diameter than the wire has to be,” Stanton says. “A nanocircular [connector] lets you fit in very small places and be the same shape of the sensor, or the camera, or whatever it is.”

Micro-size connectors with a hybrid pin configuration can carry power, plus a mix of smaller signal wires.

But rectangular connectors have their place, too. A design engineer might want a rectangular connector because all of the leads on the printed circuit board are rectangular, Stanton explains. A direct neural interface, which connects to the spinal nerves or the brain, has a circuit board about the size and shape of a postage stamp. A rectangular connector fits the shape of the board.

Designers can choose from a number of different types of connectors depending on need and turnaround time. Off-the-shelf, also called standard connectors, are products routinely kept in stock because they are the connectors used and ordered most often, says Randy Jew, applications engineer for Rohnert Park, CA-based Lemo USA. These connectors can be found at the best prices and ordered with the shortest lead times.

“Generally, when an OEM is designing a device that will have low annual quantities of about 500 or less, they choose a standard model connector,” Jew explains. “If they have quantities greater than 2000 a year, they can begin to consider customs or hybrids.”

A hybrid connector contains two sizes of pins in the same connector: one size to carry power and the other to transmit signal. Hybrid connectors allow designers to develop a product that does not require two separate wires and two separate connectors for power and signal. Robotics, prosthetics, and medical devices that call for moving or articulating something would typically use hybrid connectors, Stanton says. Hybrid connectors are also found in the laser devices used to remove skin wrinkles. These devices handle multiple signals for the laser, the sensors that detect temperature, and sensors for the cooling system accompanying the unit.

As medical devices become more sophisticated, designers may opt for a custom connector. A custom connector is made to fit exactly what the designer is looking for and will perform to specifications, Jew says. But custom connectors are also more expensive and will have longer lead times, at least at first. Custom connectors require additional time to design, prototype, and then bring into production. In certain circumstances, a custom connector might also be chosen in order to meet a required level of medical cleanliness.

Increasingly, designers are looking for the connector to have a particular fit with the size or appearance of the device, giving it a sleek look, Stanton says. Cochlear implants, for example, employ custom connectors that are small, flat, and thin.

Not all connectors are made for the long haul. Devices that come in contact with the skin or blood may have single-use attachments that employ disposable connectors. Neonatal monitors, for example, now routinely use sterile, single-use attachments with disposable connectors. When the device needs to be used again, a sterile connector can be plugged into the instrument for the next patient.

Designers can make mistakes in choosing connectors, such as making connector contacts that are too small for the current contact or choosing the wrong material for the application, Jew says. Designers can also choose the wrong cable materials for the application. Stanton says he sees problems arise when designers aim for the lowest cost option. Materials vary in quality and durability, and designers can make the appropriate choice by considering the number of cycles a connector is certified for, as well as the longevity of the device. Designers can also avoid problems by leaving sufficient lead time to work with the connector company, Stanton says.

“A little more front-end investment will give them a pretty good product at a reasonable price, but it won’t be the cheapest,” he says. “The cost will come down in time.”

Learn about the latest medical device technologies at the MEDevice San Diego conference and exposition, September 1–2, 2015.

Frank Vinluan is a contributor to MD+DI. Contact him at frankvinluan@gmail.com

 [Images courtesy of OMNETICS] 

Could there Be a Wave of M&As in Mitral Valve Replacement Market?

Could there Be a Wave of M&As in Mitral Valve Replacement Market?

In this month alone, Edwards Lifesciences and Abbott have made deals with three mitral valve disease startups underscoring the possibility of a M&A flurry in this market. 

Arundhati Parmar

Now that the efficacy of transcatheter aortic valve replacement has been firmly established, companies are turning their focus on another structural heart procedure: transcatheter mitral valve repair or replacement.

And just as acquisitions consolidated the TAVR space - Edwards Lifesciences bought Percutaneous Valve Technologies, Medtronic bought CoreValve and Boston Scientific bought Sadra Medical - it appears as if the market is poised to see a few acquisitions in the TMVR space too.

Earlier this month Edwards Lifesciences announced it was acquiring CardiAQ Valve Technologies despite the fact that the California heart valve company has its own internal device to tackle mitral valve regurgitation. Edwards Lifesciences is paying $400 million to acquire CardiAQ, the only company to have implanted its TMVR valve using both the transfemoral and transapical approach. Analysts describe the company's mitral valve device as having the "best-in-class design."

Following suit, Abbott announced on Thursday that it is making two transactions in the TMVR space in order to expand treatment options for mitral valve disease. Abbott is buying up the rest of Roseville, Minnesota-based Tendyne that it already did not own for a total price of $250 million, in addition to undisclosed milestone payments.

Separately, it also invested in Cephea Valve Technologies and secured an option to buy the company outright in a future date, but Abbott did not provide terms of this deal. While Tendyne's valve employs a transapical approach, Cephea, based in Santa Cruz, California, uses a transfemoral approach to deliver the device. Joanne Wuensch, an analyst with BMO Capital Markets, pointed out in a research note Thursday that she has heard "good things about the [Tendyne] product" noting that it is "fully repositionable and fully removable."

Abbott already has an approved mitral valve repair product known as the MitraClip, which won approval in October 2013, followed by Medicare providing national coverage for the device in August 2014. That technology was itself the result of an acquisition - in 2009 Abbott bought Evalve for $410 million to treat mitral valve disease in a minimally invasive fashion.

Whereas Edwards with its internal Fortis TMVR device and the CardiAQ valve has "two shots on goal" as described by Glenn Novarro, an analyst with RBC Capital Markets, Abbott now has three.

It's interesting to note how similarly Abbott and Edwards executives view the TMVR market.

"Mitral valve disease is highly complex and requires multiple treatment options in order to tailor the therapy based on each person's anatomy and health situation," said John M. Capek, executive vice president, Ventures, Abbott, in a statement. "The Tendyne acquisition and our agreement with Cephea broaden our foundation as one of the leaders in treatments for mitral valve disease, with the goal of bringing promising, less invasive valve treatment technologies to people who need them."

Edwards' CEO Michael Mussallem has also described the disease as something requiring a multi-pronged approach.

"We think very broadly about structural heart disease and particularly about the mitral valve. And I think we have been pretty open in the past to say that we don't think that there is just going to be one solution for all patients," Mussallem said in an earnings call with analysts on Tuesday.

The interest in TMVR is not misplaced. Novarro of RBC Capital Markets estimates that the global TMVR market opportunity could be five times that of TAVR, which he projects will be $5 billion in 2020.

Which startups are left in TMVR following these transactions. Wuensch says two other companies who have tested their devices on humans are NeoVasc, which has developed the Tiara device and Twelve, which is currently enrolling patients in a pilot study.

Medtronic is also a company with an interest in TMVR and has tested its device in animals, according to Wuensch. If the size of the market is as large as analysts predict, it won't be surprising to see Medtronic jumping into buy another company. 

It certainly hasn't shied away from dealmaking even after acquiring Covidien for $50 billion. 

Arundhati Parmar is senior editor at MD+DI. Reach her at arundhati.parmar@ubm.com and on Twitter @aparmarbb 

[Photo Credit: iStockphoto.com user draco77]

To learn more about medical devices and trends in the marketplace, attend the two-day MEDevice San Diego conference, September 1-2 

Correction: An earier version of this story wrongly referred to Abbot's mitral valve device. It is called MitraClip. 

Zimmer Biomet Exceeds Expectations Post Merger

The new orthopedic device giant appears off to a good start.

Nancy Crotti

The recently combined orthopedics manufacturer Zimmer Biomet surprised Wall Street by beating analysts' second-quarter earnings projections by 4 cents per share.

The Warsaw, IN-based company ended the quarter with earnings per share of $1.59, excluding one-time merger-related charges. Revenue for the quarter--which included the $14 billion merger closing--totaled $1.17 billion, compared with analysts' estimate of $1.19 billion.

In particular, Zimmer's knees segment saw a 2.3% revenue increase compared with Q2 2014, while sales of hips slipped 1.3% to $307 million.

Figure in the one-time $465 million pre-tax, merger-related charge, and Zimmer Biomet lost $158 million during the quarter. It upped its prediction of full-year earnings to $6.65 to $6.80 per share, compared with its previous prognostication of $6.60 to $6.80

"During the quarter, we completed our landmark combination to create Zimmer Biomet, marking a new era for our company and an unprecedented opportunity to drive our growth and value creation strategies," said David Dvorak, president and CEO of Zimmer Biomet. "With a broad and diversified musculoskeletal portfolio, Zimmer Biomet is well positioned to reach new heights of commercial and operational excellence, and to accelerate the pace of our innovation for the evolving healthcare landscape."

The combined company has operations in more than 25 countries, and markets its orthopedic reconstructive, spinal and trauma devices, biologics, dental implants and related surgical products in more than 100 countries.

Refresh your medical device industry knowledge at MEDevice San Diego, September 1-2, 2015.

Nancy Crotti is a contributor to Qmed and MPMN.

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Why Orthopedic Braces Are a Growing Market

The market for braces and supports is expected to grow by more than a third in coming years, according to a new report.

Chris Newmarker

The global market for orthotics--external orthopedic braces and supports--is expected to expand from $2.56 billion in 2014 to $3.5 billion in 2021, according to a new report from research and consulting firm GlobalData (London).

Growth will be driven by an aging population and the preference of many of those aging people to delay surgery and seek less invasive solutions, says Jennifer Ryan, GlobalData's analyst covering medical devices.

"Braces provide a cheaper and less invasive option to surgery, two attractive qualities in patients' eyes," Ryan says.

Major implantable orthopedic device companies such as Johnson & Johnson, Stryker, Zimmer Biomet, and Medtronic shouldn't worry about the trend, though, according to Ryan.

Ryan says "surgery is generally eventually necessary for these patients."

"Additionally, not every patient is appropriate for bracing; there does exist a patient population in too much pain to delay surgery so they will certainly skip over the bracing option," Ryan says. "Therefore I do not expect the orthopedic joint replacement/surgical markets to be affected by an increase in bracing as even the bracing patients will eventually come around to surgery."

Ryan noted that the market is dominated by knee braces, but upper extremity braces are expected to grow at the fastest clip over the next six years.

"While the global orthotics market is fragmented and composed of many smaller players, major companies that have made a name for themselves do hold large shares in this space courtesy of their known and trusted brands," Ryan said. "These include DJO, Bauerfeind, Breg, Ossur, and Ottobock."

Besides braces and supports, devices that help aid people with movement could also be an option for people seeking to delay surgery. For example, Minneapolis-based RxFunction has its externally worn Walkasins device, which provides gentle, vibratory cues around the lower legs to help people maintain balance.

"I agree that implants of any kind should be avoided whenever possible (although they are certainly important and lifesaving when needed), and I think emerging wearable medical devices that have a meaningful use for patients represent a huge market opportunity over the next five to 10 years. We hope to be a leader in this emerging space with a particular focus on advanced balance technologies," says Lars Oddsson, a University of Minnesota adjunct professor in physical medicine and rehabilitation who is RxFunction's founder and chairman.

Refresh your medical device industry knowledge at MEDevice San Diego, September 1-2, 2015.

Chris Newmarker is senior editor of Qmed and MPMN. Follow him on Twitter at @newmarker.

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These Medtech Desks Are Really Interesting

Updated August 7, 2015Medical device industry professionals have responded to our request and sent in photos of their desks. They are truly more than just lessons in neatness versus clutter. The desk photos provide a wonderful window into how people in medtech think and work.“Being in product development, driving new products to the market, I have always wanted to be immersed and surrounded by the physical aspect of what I am working on to keep it in the front of my mind and hands to deliver better products, not stowed away in a cabinet or lab,” says Hugh Hestad, a principal development engineer at Zimmer Biomet’s Spine Division who is based in Edina, MN.Claudine Richon, a medical device consultant based outside of Paris, might have an engineering background, but her medtech works feels strongly connected with nature, so she is big on a workspace that feels naturally connected.Or even check out the photo above, captured from the website of Medtronic founder Earl Bakken. “I’m the young guy in the crew cut hard at work in Medtronic’s world headquarters, circa 1950,” he writes. “‘Casual day’ was still in the future. A flannel shirt and jeans was the uniform of the day, every day, during our formative years.”That pioneering spirit is obviously still alive and well at Medtronic. “In fact, most of my teams’ desk areas are monuments to med device development free-thinking. Device and document avalanches have been reported when ‘critical clutter’ levels have been exceeded,” says Ed Bon, an Irvine, CA–based senior manager in development engineering at Medtronic’s Neurovascular Access Group.Read on to check out the pictures and the descriptions (gently edited for punctuation, style, etc.).Continue>> And we would still love to get more medtech desk pictures with important lessons. Email me at chris.newmarker@ubm.com with a picture of your desk or workspace, your name and title, and a description of what’s there and what it indicates about working in medtech.Refresh your medical device industry knowledge at MEDevice San Diego, September 1–2, 2015.Chris Newmarker is senior editor of Qmed and MPMN. Follow him on Twitter at @newmarker.Like what you’re reading? Subscribe to our daily e-newsletter.

Updated August 7, 2015

Medical device industry professionals have responded to our request and sent in photos of their desks. They are truly more than just lessons in neatness versus clutter. The desk photos provide a wonderful window into how people in medtech think and work.

“Being in product development, driving new products to the market, I have always wanted to be immersed and surrounded by the physical aspect of what I am working on to keep it in the front of my mind and hands to deliver better products, not stowed away in a cabinet or lab,” says Hugh Hestad, a principal development engineer at Zimmer Biomet’s Spine Division who is based in Edina, MN.

Claudine Richon, a medical device consultant based outside of Paris, might have an engineering background, but her medtech works feels strongly connected with nature, so she is big on a workspace that feels naturally connected.

Or even check out the photo above, captured from the website of Medtronic founder Earl Bakken. “I’m the young guy in the crew cut hard at work in Medtronic’s world headquarters, circa 1950,” he writes. “‘Casual day’ was still in the future. A flannel shirt and jeans was the uniform of the day, every day, during our formative years.”

That pioneering spirit is obviously still alive and well at Medtronic. “In fact, most of my teams’ desk areas are monuments to med device development free-thinking. Device and document avalanches have been reported when ‘critical clutter’ levels have been exceeded,” says Ed Bon, an Irvine, CA–based senior manager in development engineering at Medtronic’s Neurovascular Access Group.

Read on to check out the pictures and the descriptions (gently edited for punctuation, style, etc.).

Continue>> 

And we would still love to get more medtech desk pictures with important lessons. Email me at chris.newmarker@ubm.com with a picture of your desk or workspace, your name and title, and a description of what’s there and what it indicates about working in medtech.

Refresh your medical device industry knowledge at MEDevice San Diego, September 1–2, 2015.

Chris Newmarker is senior editor of Qmed and MPMN. Follow him on Twitter at @newmarker.

Like what you’re reading? Subscribe to our daily e-newsletter.