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Medtronic Buys Clot Removal Company Lazarus Effect for $100M

Medtronic Buys Clot Removal Company Lazarus Effect for $100M

Medtronic announced Monday that it has bought Lazarus Effect, a Campbell, California company that has developed products to treat ischemic strokes for $100 million in cash.

Lazarus Effect has a  "mesh cover" technology that helps in the capture and removal of clots. The product is a nitinol "mesh cover" that folds over a stent retriever device during clot retrieval and essentially traps the stent with the clot inside similar to the way candy is contained in a candy wrapper. The product is complementary to Medtronic's Solitaire stent retrieval platform.

New guidelines from the American Heart Association and American Stroke Association encourages the use of endovascular treatment for acute ischemic strokes in selected patient for the clinical benefit they offer.

The Lazarus mesh cover is intended to be more effecting in capturing and removing clots than a bare stent retriever.

The standard method of treating acute ischemic strokes is to quickly administer a clot busting drug intravenously. Now clinical studies are showing that adding a device component such as a stent retriever device provides more benefits than medical therapy alone. The Lazarus device is meant to be used as a covering for the stent retriever device to make its use even more effective.

"Medtronic has been a significant supporter of the recent clinical work showing improved outcomes of ischemic stroke patients treated with endovascular therapy," said Martin Dieck, Co-Founder, President & CEO, Lazarus Effect, in a Medtronic news release. "Their support of data driven clinical evidence and the success with their SolitaireTM stent retriever device make them the clear market leader for treating ischemic stroke. Lazarus Effect is pleased to bring our innovative technologies together with Medtronic's market leading therapies." 

The Lazarus Cover device receieved CE Mark in Europe in November 2014. It is not cleared for sale in the U.S. Medtronic will integrate the acquisition into its Neurovascular business under the umbrella of the Restorative Therapies Group.

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

To learn more about medical devices and trends in the marketplace, attend the two-day MD&M Minneapolis conference, Nov. 4 and 5 at the Minneapolis Convention Center. 

Smoothing the Flow of Valve Selection

Smoothing the Flow of Valve Selection

Frank Vinluan

Qosina supplies check valves, which may be normally closed but open when fluid in the line reaches a certain pressure.

When the movement of gas or fluid must be regulated by a medical device, that control is typically managed by a valve. But there are many kinds of valves that find use in a wide array of medical device applications. Selecting a valve requires consideration about the application of the device and the requirements for the valve.

Check valves are a commonly used valve that permit the flow of gases or fluids in only one direction. In an intravenous bag, for example, check valves normally function open, explains Scott Herskovitz, vice president of sales and marketing for Ronkonkoma, NY-based Qosina. But these valves close in response to back pressure if fluid starts moving in the opposite direction. In procedures that call for inserting a catheter, a hemostasis valve can be used to prevent the backflow of fluid. Valves can also have a role in improving safety for medical professionals. In a needleless access site, a valve can be used to transfer the contents of a syringe to an intravenous fluid line without worrying about the possibility of a needle stick injury, Herskovitz says.

When it comes to choosing valves, medical device makers have the option of choosing stock solutions or custom-made components. Off-the-shelf components offer a shorter lead time and are the more economical option. Qosina provides customers with volume discounts and can also configure orders to arrive monthly as needed; customers are only charged for what is shipped, Herskovitz says. The custom-made valves requested of Qosina typically involve orders for valves of a particular size, material, color, or style.

B. Braun, the German medical device manufacturer with U.S. headquarters in Bethlehem, Pa., also supplies both stock and custom valves. Like Qosina, B. Braun encounters custom valve requests involving requirements such as size, color, and crack pressure—the pressure at which the check valve starts to open. “Often times, we can make a small adjustment to a stock valve to reduce the time and expense of starting from scratch,” says Joel Bartholomew, innovation manager for B. Braun’s OEM division.

Valve selection should step beyond specifications and include an assessment of manufacturing needs and user requirements. Only then can the best valve be selected out of the dozens of configurations on the market.

Other factors that affect valve selection include the type of fluid being moved through the valve and the compatibility of the valve material with that fluid. Material compatibility is an important, but sometimes overlooked, consideration for valve selection, Herskovitz says. In some instances, the valve material may interact with the fluid passing through the valve. Lipids, chemotherapy agents, and other caustic substances that move through a device can have a corrosive effect on a valve, Bartholomew explains. Suppliers also aim to avoid potential issues with materials such as natural latex.

In some instances, valve makers are finding that device companies are now calling on them to provide valves for more specific applications, such as connecting a syringe to a line for drawing the contents of a line back into the syringe, Herskovitz says. In such cases, a valve prevents accidental injection of the syringe contents back into the fluid line. There are also new developments in devices that employ microfluidics, which measure fluids in nano liters or even smaller quantities. But Herskovitz cautions that valves need to be of a certain size for best results.

“Reducing the size of a fluid connector may make the component unusable in a medical device application if the path is not large enough for the required flow rate,” he says. “At some point, capillary action changes how fluids flow through small diameter tubes.”

Outside of the valves themselves, B. Braun is often asked to provide more detailed documentation and validation of the company’s quality systems and processes. Bartholomew says that customers want assurances that their supplier is taking every measure necessary to meet FDA requirements and minimize the chance of a reportable event.

Bartholomew advises medical device companies that a valve’s functionality needs to be viewed over the entire lifespan of the device—from assembly through disposal. For example, customers must consider the combination of all potential mechanical stresses, as well as chemical stresses on the valve. Under low mechanical stress, such as applications involving low pressure, a certain level of chemical stress could be acceptable, Bartholomew says. But a high mechanical stress combined with multiple chemical stresses on the valve could result in malfunction. These stresses can occur during the manufacturing process, as well as during its application in the field. Device makers need to consider whether the valve will withstand the manufacturing process, he says.

Other considerations include the compatibility of the valve material with the adjacent components and the solvent used to bond them, Bartholomew says. Medical device companies need to be aware of the potential for plasticizers to leach from the plastics used in the medical device. New developments in valve design at B. Braun include its work with different materials to address potential interactions with fluids.

The shape, design, and material of the valve can all vary. Medical device companies must remember that some valves are suitable only for fluids, while others are appropriate only for gases, Herskovitz says. Valve suppliers also want to know how the medical device will be sterilized when finished. That’s because some plastics may be incompatible with certain sterilization methods, Herskovitz explains. Qosina recommends that device makers engage with valve suppliers early in the early stages of a project, as early as its design.

“It is an easier choice if there are multiple options to work with for all components of a device being designed, instead of finalizing it one piece at a time,” he says.

Want to catch up on the latest in medical device innovation? Register for the MD&M Minneapolis conference , November 4–5, 2015.

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

 [Images courtesy of Qosina and B. Braun] 

AdvaMed CEO Leaving to Lead PhRMA

AdvaMed has started a nationwide search to replace Stephen Ubl, who has been the medical device industry group's CEO for 10 years.

Chris Newmarker

Stephen Ubl AdvaMed PhRMA
Stephen Ubl

Stephen Ubl is stepping down as AdvaMed's president and CEO, effective October 15, as he prepares to become president and CEO of the Pharmaceutical Research and Manufacturers of America (PhRMA).

"During Steve's time at AdvaMed, the association experienced significant growth in membership, policy development capabilities as well as advocacy impact," AdvaMed's chairman, BD CEO Vincent Forlenza, said in a Friday news release.

Ubl, who started out in Washington working for U.S. Sen. Chuck Grassley, R-IA, joined AdvaMed in 1998 as executive vice president of federal government relations. He left to become a consultant in 2004, but rejoined AdvaMed as CEO in 2015.

Forlenza ticked off some of Ubl's accomplishments over the years:

  • Creating AdvaMedDx and AdvaMed Accel, which are divisions dedicated to the diagnostics industry and emerging growth companies respectively;
  • Bolstering AdvaMed's legal department and engaging with member company attorneys to create an enhanced AdvaMed Code of Ethics;
  • The recent opening of a China office and expanding the group's emerging market capabilities.

A nationwide search is already underway to find a replacement for Ubl, with the group continuing lobbying to repeal the U.S. medical device tax and achieve regulatory reform.

Meanwhile, Ubl is expressing enthusiasm about his upcoming job.

"This is an exciting time to be joining the biopharmaceutical industry as new medicines are coming to the market that are completely transforming care for patients fighting cancer, heart disease, hepatitis c and other debilitating diseases," Ubl said in a PhRMA news release.

"I look forward to working with PhRMA member companies and the broader health care advocacy community to advance public policies that will improve patients' access to medicines and foster the continued development of new treatments and cures for patients," Ubl said.

Learn more about cutting-edge medical devices at MD&M Philadelphia, October 7-8.

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

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10 Medical Devices That Pushed Design Boundaries

10 Medical Devices That Pushed Design BoundariesSeptember 28, 2015A handful of medical device designers are helping the industry rethink what is possible when it comes to the design of medical technology. This year even marked the first time that a medical product was awarded the London Design Museum's Design of the Year Award.Continue >> Learn more about cutting-edge medical devices at MD&M Philadelphia, October 7–8. Brian Buntz is the editor-in-chief of MPMN and Qmed. Follow him on Twitter at @brian_buntz.Like what you're reading? Subscribe to our daily e-newsletter.

10 Medical Devices That Pushed Design Boundaries

September 28, 2015

A handful of medical device designers are helping the industry rethink what is possible when it comes to the design of medical technology. This year even marked the first time that a medical product was awarded the London Design Museum's Design of the Year Award.

Continue >>

Learn more about cutting-edge medical devices at MD&M Philadelphia, October 7–8.

Brian Buntz is the editor-in-chief of MPMN and Qmed. Follow him on Twitter at @brian_buntz.

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FTC Fails to Block $2B Steris-Synergy Merger

A U.S. federal judge's opinion suggests that x-ray sterilization might not be the next big thing for medical device sterilization--at least not for a while.

XRay-Sterilization-Synergy
Synergy Health's industrial x-ray sterilization facility in Daniken, Switzerland, is able to process up to 80,000 pallets annually. (Image courtesy of Synergy)

Chris Newmarker

A U.S. District Court judge in Cleveland has denied the Federal Trade Commission's request for a preliminary injunction to halt Steris' nearly $2 billion acquisition of medical device sterilization rival Synergy.

Judge Dan Polster's ruling on Thursday cleared the way for Steris and Synergy shareholder votes on October 2 to approve the inversion deal, which would move Steris' official headquarters from Ohio to Synergy's home in the United Kingdom. (The FTC could still appeal.)

"We will work to expeditiously close the acquisition of Synergy Health," Steris' president and CEO Walt Rosebrough said in a news release.

Besides dealing the FTC a rare setback in the courts, Polster's opinion also casts doubt on whether x-ray sterilization is truly ready for prime time in the U.S. medical device market.

The major thrust of the FTC's argument was that the merger, announced in October 2014, provided a way for Steris to prevent Synergy from bringing x-ray sterilization of medical devices to the United States--challenging the status quo in the process.

Sterigenics International, Steris, and Synergy are the first-, second-, and third-largest sterilization companies in the world, according to Polster. But Sterigenics and Steris provide all the gamma radiation sterilization services for finished medical devices inside the United States, accounting for 85% of all U.S. contract sterilization services.

Synergy provides e-beam sterilization services inside the U.S., though it operates many gamma facilities elsewhere. The British company was looking for a way to expand in the U.S. Operating the only commercial-scale x-ray sterilization facility in the world--in Daniken, Switzerland--Synergy officials thought they could gain an edge by bringing x-ray sterilization to the U.S.

Synergy officials listed a number of x-ray sterilization advantages in an article they wrote for Qmed's sister publication MD+Di in early 2014: better penetration than gamma or e-beam; less effects on materials, especially polymers; shorter processing times; and environmental advantages.

But Syergy's x-ray strategy was easier said than done, according to Polster. Officials at medical device makers including J&J, Community Tissue, BD, Stryker, and Bayer signed letters of interest in x-ray sterilization, but their interest remained "academic"--with no one actually committing to use it. At the same time, the manufacturer of the x-ray sterilization equipment--IBA--decided it would need to design and build a new model of sterilization machine for Synergy, which would cost considerably more than previously estimated.

The economics worked against x-ray because sterilization only makes up 3% of a medical device's cost, Polster explains.

"This means that even if Synergy could promise a customer a 30% price savings over gamma sterilization for a product, the conversion would only reduce the product's cost by 1%," Polster says. "On the other side of the ledger was the significant cost of conversion, estimated to be $250,000 to $500,000 per product. The product would need to be tested, then the conversion would need to be approved by the FDA and the foreign counterpart in any foreign country where the product would be sold, then the site would have to be qualified; and then product would have to be put through the facility for validation."

Polster came to the conclusion that Synergy officials decided to discontinue the U.S. x-ray project in February 2015 not because of the proposed merger with Steris, but because the "business model failed every one of the metrics Synergy uses to rank capital investments." 

Learn more about cutting-edge medical devices at MD&M Philadelphia, October 7-8.

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

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AdvaMed Makes it Official CEO is Leaving

AdvaMed Makes it Official CEO is Leaving

Stephen Ubl, who has led the medical device industry's largest and most influential lobby group, is jumping ship to lead a pharma trade association.


Arundhati Parmar

After initially declining to comment on rumors of its CEO leaving, AdvaMed, the medical industry's influential lobby group, confirmed on Friday that Stephen J. Ubl is resiging.

“AdvaMed’s Board of Directors has accepted Steve’s resignation as president and CEO of AdvaMed, effective Oct. 15," read a statement from Vincent Forlenza, chairman of AdvaMed and CEO of Becton Dickinson. "The Board wishes to express its deep appreciation for Steve’s leadership over his sixteen year involvement with the association, including the last 10 years as president and CEO."

Ubl has been instrumental in raising the profile of device industry at the nation's capital and vociferously opposed the 2.3% of the medical device tax. He led the organization at a time of great turmoil wrought by changing market demands stemming from healthcare reform and the move to value-based care.

It was under him that AdvaMed also opened its doors in China intending to serve its members in a region widely considered to hold the greatest opportunity for growth as the industry matures and slows in the United States and Europe.

While the AdvaMed statement lauded Ubl's contributions and stated its intention to undertake a search to replace him, it didn't acknowledge where Ubl was headed after Oct. 15

A separate announcement from the Pharmaceutical Research and Manufacturers of America confirmed that, as originally reported by Politico, Ubl would be taking over as CEO of that trade group at the end of the year. Earlier this year, that group's CEO, John Castellani, indicated his plans to retire come January.

In moving to the pharma industry, Ubl will be leading an organization with roughly 10 times the spending power based on current lobbying expenditures. Pharmaceutical Research and Manufacturers of America has spent about $10.3 million so far in 2015, according to the Center for Responsive Politics, while AdvaMed has spent $1.44 million over the same time period.
 

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

 [Image Courtesy of AdvaMed]

Audit of Major Breast Implant Maker Leads to International Scare

The United Kingdom, EU member states, and other countries have suspended sales of products made by the Brazilian firm Silimed amidst an investigation into the safety of its products.  

Qmed Staff

Silimed

A recent audit of the Brazilian company Silimed has triggered the biggest breast implant scare since the 2010 Poly Implant Prothèse (PIP) debacle, which ultimately led to the jailing of that company's CEO, the shuttering of PIP, and stricter regulatory requirements in the European Union.

In the Silimed case, however, it is still uncertain what the fallout might be. An audit of the company's manufacturing facility by a German notified body detected that some of the products were contaminated with an unknown substance. This in turn has led to the United Kingdom halting sales of Silimed-made product, which include breast implants, breast tissue expanders, and an array of other devices. The company makes 5000 types of implants used for everything from general surgery to bariatric surgery. Other countries such as Switzerland, Ireland and other EU member states, Australia, and New Zealand have also suspended sales of the products made by Silimed.

Santa Barbara, CA-based Sientra, who uses Silimed as a contract manufacturer, has seen its stock take a nosedive during the fallout tied to the alarming audit. On September 24, its stock fell more than 50%.

Silimed, which is the biggest maker of silicone implants in South America and claims to be the third largest implant manufacturer internationally, insists on its website that its products are safe. It adds, however, that it has voluntarily halted sales of its products until "on the European market until local health authorities have received the official technical report [regarding the recent audit]." The company's announcement goes on to say that the levels of unidentified particles was "extremely low" and claims that its products comply with regulatory requirements throughout the world.

The company had been the first South American firm to claim that its silicone breast implants had been approved by FDA.

It is theoretically possible that FDA may rescind its approval of Silimed products following the news, but there is little precedent of FDA following this course of action. It is also possible that the suspension of the CE Mark be overturned in a number of months. "We were able to identify at least one product where the CE mark was suspended and then lifted 3-6 months later; however, we do not believe the product was simultaneously sold in the U.S.," said Stifel analyst Jonathan Block on Streetinsider.

Learn more about cutting-edge medical devices at MD&M Philadelphia, October 7-8.

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Heart Monitoring Goes Mobile

Heart Monitoring Goes Mobile

Frank Vinluan

St. Jude Medical's CardioMEMS HF System uses a miniaturized wireless monitoring sensor implanted in the pulmonary artery (above) along with a portable electronic unit and pillow contaning an antenna to measure and transmit data about patients' pulmonary artery pressure.

For decades, the standard in mobile heart monitoring was a bulky device with wires and electrodes that connected to the patient. Patients wore these Holter monitors for one day, perhaps two, in order to record arrhythmias. Though Holter monitors did not replace 12-lead electrocardiograms, they gave doctors a way of capturing a record of a patient’s heartbeat outside of a clinical setting. But Holters are not without problems. Bulky and cumbersome, many patients dislike them, and clinicians see diagnostic limitations in these devices, as well. Holters record heartbeat data for only up to 48 hours—if patients manage to keep the devices on that long.

AliveCor's AliveECG app features an FDA-cleared algorithm to provide real-time atrial fibrillation detection when paired with the company's smartphone heart monitor.

The future of heart monitors is smaller, mobile, and in some cases traces a path to the cloud. A newer line of heart monitors is gaining market traction, representing a confluence of technological developments. Wearable and wireless, these new devices allow patients to shower, sleep, and carry on their lives in ways that Holter monitors do not. These new devices are showing themselves to be as adept as the Holter, and perhaps better, at detecting arrhythmias, such as atrial fibrillation.

That’s significant because arrhythmias are prevalent among Americans and expensive for the healthcare system.
Atrial fibrillation affects between 2.7 million and 6.1 million Americans and costs an estimated $6 billion per year, according to the CDC. Meanwhile, heart failure affects approximately 5.1 million Americans and kills half of those who are diagnosed within five years. The condition leads to an estimated $32 billion in annual healthcare costs, according to the CDC. The global cardiac monitoring and cardiac rhythm management devices market is expected to top $26 billion by 2020, up from more than $21 million in 2015, according to MarketsandMarkets. The research firm does not break out figures for mobile heart monitors specifically, but among the factors it cites for the growing market is the rise in cardiovascular diseases and the launch of new technologies to monitor for them.

The most commercially accessible of these new mobile heart monitors might be AliveCor’s Mobile ECG, which attaches to smartphones and is available over the counter. By pressing the device to the chest or placing two or more fingers onto the electrodes, a user can get an ECG reading. In clinical studies, the single-lead AliveCor device was comparable to a single lead of a standard ECG machine. AliveCor’s device is FDA cleared for detecting atrial fibrillation, although only a medical professional can diagnose it. A downloadable app sends the heart reading to the company’s secure cloud, where a patient’s cardiologist can review the ECG. AliveCor CEO Euan Thomson concedes that his company’s device won’t replace the 12-lead ECG. But the device captures heart data in the context of a patient’s daily life, which he believes offers an advantage for detecting atrial fibrillation—a condition that often eludes detection.

The Zio XT Patch, from iRhythm Technologies, can be worn for up to 14 days to provide continuous cardiac monitoring.

The Zio patch from iRhythm Technologies was developed to do everything the Holter monitor does and more. Unlike AliveCor’s device, the Zio patch captures continuous heartbeat data, and it does so over a longer period of time. In a National Institutes of Health-funded clinical trial, Zio detected more arrhythmias than a Holter monitor. Patients wear the water-resistant patch continuously for up to 14 days, which improves the chances of recording arrhythmias, explains iRhythm CEO Kevin King. Patients then send the patch back to iRhythm. Ordinarily, two weeks of heartbeat data produces the equivalent of 30,000 pages of information. The company uploads the heart reading from a patch into its secure cloud, where proprietary algorithms crunch the data to find heart beat anomalies. Relevant information is condensed into a 12–14 page report, which can be integrated into an electronic medical record or provided to the patient’s cardiologist. IRhythm counts 400,000 patients who have used Zio so far. “Our whole business is that the Holter monitor, while inexpensive, is ineffective,” King says. “We’re replacing that as a first-line test.”

For longer monitoring, doctors can turn to the wearable Seeq Mobile Cardiac Telemetry System. The Medtronic device provides continuous monitoring for up to 30 days, but it’s a second-line device—behind the Holter monitor. The device is cleared to diagnose patients whose symptoms suggest an irregular heartbeat but who could not be diagnosed with a Holter monitor. The Seeq connects via Bluetooth and cellular connections to a Medtronic Monitoring Center, which sends reports to patients’ physicans.

In the case of heart failure, medicine has lacked any device to diagnose the condition. Before St. Jude Medical’s CardioMEMS HF System last year became the first FDA-approved implantable wireless device to monitor for heart failure, doctors diagnosed heart failure by examining patients, explains David Shavelle, a cardiologist and professor at the University of Southern California’s Keck School of Medicine. CardioMEMS was approved for class III heart failure patients who have been hospitalized within the last three months. The implantable sensor, about the size of a dime, provides a reading of the fluid buildup indicative of heart failure. To get a daily reading, the patient lies down with their head resting on a pillow containing an electronics system. That system receives the signal from the sensor and relays it a secure Web site accessible by the patient’s doctor. Based on that reading, the doctor can then direct the patient to tweak the medication for stabilizing pulmonary artery pressure. “We look for trends or changes in the pressures,” Shavelle says. “If the pressures are going up, we adjust the medication.”

Medtronic's Seeq Mobile Cardiac Telemetry System consists of a wearable sensor and wireless transmitter that sends patients' cardiac data to a monitoring center.

These new heart monitoring technologies are finding their way to doctors’ prescription pads. Shavelle prescribes CardioMEMS to qualified heart failure patients, though he adds that the device is not suitable for all heart failure patients. Those who are uncomfortable adjusting their own medications might not fare as well with the device, he says. In the case of the AliveCor Mobile ECG, the device’s availability as an over-the-counter product is intentional; Thomson says the company wants ECGs to be accessible to all. Despite the availability of both prescription and over-the-counter heart monitoring options, insurance does not yet cover all of these devices.

Mobile heart monitoring is still an emerging technology area with a developing reimbursement landscape, says Michael Sanchez, founder of the Minnesota consultancy Pivotal Reimbursement. Aetna, for example, covers iRhythm’s Zio patch as medically necessary but considers St. Jude’s CardioMEMS and AliveCor’s Mobile ECG as experimental. Humana covers neither of those devices, nor does it cover the Seeq or CardioMEMS. But spokesman Jeff Blunt says Humana reviews medical literature and may make assessments as new data is reported. In particular, the company is closely watching CardioMEMS’s impact on patients with congestive heart failure, he says.

Payers are looking for clinical evidence—data from well-designed, randomized clinical trials, Sanchez says. The problem is that many devices reach the market in the United States through FDA’s 510(k) regulatory pathway, which does not require those studies. In this regard, CardioMEMS stands as an exception to other mobile heart monitoring technologies. Like other implantable devices, CardioMEMS was evaluated in clinical trials required of the PMA pathway. Data from those trials helped payers make their reimbursement decisions. Reimbursement is a tougher case to make for devices that work with smartphones and tablets, such as AliveCor’s product. Sanchez says the third-party payer models are not yet established, and he has seen some payer policies that explicitly do not cover such technologies.

Companies are trying to demonstrate to payers and providers that their devices can reduce healthcare costs. By better monitoring for heart failure, St. Jude’s CardioMEMS is intended to reduce hospitalizations, which in turn saves money. USC’s Shavelle, who was also one of the investigators for the CardioMEMS clinical trials, says the device reduced heart failure hospitalizations by 40% in those studies. He now sees similar results in his own practice. IRhythm notes that as a single-use device, Zio saves a return trip to the doctor to return a Holter monitor and spares medical staff the time and expense of cleaning, recharging, and maintaining that older device. AliverCor’s Thomson believes his company’s device saves healthcare dollars by decreasing the frequency of emergency room visits. The company is still gathering data to make that case to payers. “If we want them to part with money, we have to ultimately show them that we can save them money,” he says.

In the meantime, companies are pressing forward on research that could expand use of their technologies. With a cloud holding 3.5 million ECGs, AliveCor is researching how big data analysis at the population level can be used to gain insight in diagnosing and treating patients. IRhythm is now studying its device as a way to diagnose arrhythmias in patients who don’t show atrial fibrillation symptoms but are at high risk for the condition. Atrial fibrillation can cause a stroke, and King is betting that payers would value a device that could identify such risks early.

“It will take a little while to prove that out, but it could be very helpful to the community,” he says.

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

[images courtesy of ST. JUDE MEDICAL, ALIVECOR, IRHYTHM TECHNOLOGIES, MEDTRONIC]

Getting IDE Approval Is Now Quicker than Ever

Getting IDE Approval Is Now Quicker than Ever

Marie Thibault

CDRH is getting faster on metrics that matter to medical device manufacturers, like shorter device review times. Now, the center has become even speedier on another measure—the time it takes to get an Investigational Device Exemption (IDE) approved.

Device makers and trial sponsors for a high-risk medical device need to get IDE approval from FDA for a clinical trial. This used to be a common cause of delays in the device development process. As CDRH director Jeffrey Shuren, and Owen Faris, acting clinical trials director in CDRH's Office of Device Evaluation, wrote in a January FDA Voice blog post, "Just a few years ago, it was therefore not uncommon for a year or more to pass before FDA could grant approval to a medical device developer to begin the trial. This type of delay was one factor that led developers to seek approval in other countries."

Now, it looks like those days are behind CDRH. According to the center's summarized tally of its performance against its strategic priority to "strengthen the clinical trial enterprise," the median number of days it takes to secure full IDE study approval is just 30 days. That's a whopping decrease from the median 442 days in fiscal year 2011 and a dramatic reduction even from the median 101 days in fiscal year 2014. That achievement is exactly in line with CDRH's goal of reaching a 30-day median time by June 30, 2015.

In a September 24 FDA Voice blog post, Shuren and Faris explain that this speed is the result of a few actions, including draft guidances on benefits and risks for IDE decisions and adaptive trial design, as well as real-world training for IDE review staff.

Hand-in-hand with faster review times is how many review cycles it takes for IDE studies to gain approval. It makes sense that CDRH has made strides here too, with 73.5% of IDE studies fully approved within two review cycles in fiscal year 2015, as opposed to 63.0% in fiscal year 2014 and just 14.8% in fiscal year 2011. This is meaningful, Shuren and Faris write, because it "means that important technologies have the potential to reach US patients sooner."

In addition, the center has been working on upping the number of early feasibility and first-in-man IDE studies submitted and approved. Here too, CDRH is hitting its goals. The number of such submissions increased 50% between fiscal year 2013 and the first 9 months of fiscal year 2015 and during this time, the number of early feasibility studies approved doubled.

Want to catch up on the latest in medical device innovation? Register for the MD&M Minneapolis conference , November 4–5, 2015.

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

[Image courtesy of SALVATORE VUONO/FREEDIGITALPHOTOS.NET]

The Best Places to Be a Med Device Engineer?

As our sister publication MD+DI proclaimed, the medtech job market is heating up, and the demand for good engineering talent is outstripping supply. While that is certainly good news, it is less clear where in the United States is the best spot to be a medical device engineer.

Qmed Staff

Results from poll on best places to work in medtech
In our previous poll, the Twin Cities scored better than any of the other medtech hubs in the United States. But is it slipping?

Roughly six months ago, we asked our audience where the best spot in the country for engineers in the biomedical space. The most popular answer now seems to be Minneapolis-St. Paul.

That seems to fly in the face of a recent piece by MD+DI, which states that "recruiters agree that the San Francisco Bay Area--which also leads the nation in medical device venture funding, according to PwC and the NVCA--continues to be the hottest area for medtech hiring." It then goes on to state, unsurprisingly, that Boston and Southern California "remain good bets for industry job seekers" but adds that "the jury is out on Minneapolis." While one recruiter believes that the Twin Cities area "is still a hotbed for medtech hiring," another seems to say that the the Twin Cities' cardiovascular technology market is "lukewarm." Meanwhile, Texan cities like Dallas and Austin are seeing significant growth in medtech recently.

We are still looking for feedback on which hubs are the best for engineers in the field and share below the feedback we have already received from nearly 200 industry professionals:
 

Orange County, CA

"I currently live in Orange county and I enjoy the fact that there are so many medtech companies here. There is always something to do in Orange County and the people are very laid back."

"The variety of start-ups."

"1) Hundreds of companies with particular strength in cardiovascular, ophthalmic and neurovascular devices. 2) Great weather and recreation."

"mix of start-ups and big caps"

"higher wage and the nicer weather means you do not have to sacrifice cold and dirty cities to make the best wages. Its the best work-life balance choice to me."

"Over the national mean salary, south CA top world in science development, Weather, very close to LA, SD & Mexico, Beach, beautiful city, Multicultural & multi ethnic city."

San Diego, CA

"plenty of biotech companies, life style, environment"

"Best place to live and raise family.

"Best place to live"

"Weather!"

"Not only do you have San Diego, but you are also close to Orange County"


Silicon Valley, CA

"Silicon Valley lots of good jobs and innovation. SV is the hub of the US."

"greatest diversity and innovation in the nation"

"Talent pool is deepest"

"Venture Capital, vast infrastructure catering to medical device development, start up culture, networking, many medical device companies from start up to multinational, perfect weather, attractive urban area close to beautiful natural resources, great academic centers to collaborate with."
 

Warsaw, IN

"Orthopedic Capital of the World"

"Wages are very competitive and cost of living is way low...... do your homework"

"Orthopedic capital Zimmer, Biomet, Medtronics, J&J, Greatbatch, and others"

New Orleans, LA

"The diverse culture and community creates a perfect environment for collaboration and development of innovative technologies." "New Orleans is a new emerging city that is allowing for new ideas to emerge. Many VCs are coming into New Orleans to invest in new startups. Not to mention all the good food you can eat and amazing music throughout the city."

"There is a vibrant community of biomedical engineers seeking to make a different in the world through many biotech start-ups which are supported by the many universities and hospitals in the area."


Boston, MA

"There are some many universities to work with in Boston. MIT, Harvard, Boston College and some many great research hospitals. Boston General, and the list goes on and on"

"Education, # of biotech companies"

"versatility, being able to move from one hospital environment to another without even having to travel beyond the next street. Many things to do, places to eat, and great entertainment, good place to bike or take short drives to Salem, Gloucester, etc. Good sports town"

"Best Universities and biomedical firms located in Greater Boston Area"


Detroit, MI

"Great region for growth, low cost real estate, plenty of skilled workers, great manufacturing base."


Minneapolis-St. Paul, MN

"sub-tier suppliers are there allowing design work to happen quickly."

"Best wage in comparison to cost of living. Excellent opportunities across a wide spectrum of biomedical companies."

"Highest salary vs cost of living. Number of jobs. Number of opportunities."

"The 112,000 equals 125K-175K in the other expensive cities to live in SanFran with housing costs 300% higher food costs 25%, higher taxes nearly double those of MN"

"High wages, great quality of life, lower cost homes and ability to enjoy your money to the max"

"It is well known to be medtech hub of US."

"Good wage and the cold drives away the competition."

"A network of knowledge and talent that is unlike any other place on Earth"

"good wages, low cost of living, good health care, 4 seasons, good quality air, great place to raise kids"

"Diverse economy; mid-west values; Economically, socially, and politically stable; Plenty of Bio-med and non-bio med opportunities"

"Cost of living is better than the other cities listed."


Raleigh, Durham, Chapel Hill, NC

"Great schools, weather & job growth!"


Middlesex County, NJ

"concentration of employers, quality elementary & HS education."

"I am a BME, lived there, and had a great career there. Proximity to NYC and lots of companies."


Cleveland, OH

"Large influx of both large and small companies including start-ups field by the strong academic hospitals."

"Good work, cost of living low, great parks, world class music, lots of theaters, great lakes, four seasons"

"I make $93,000 here and the cost of living is cheap."


Philadelphia, PA

"Close to major cities. Not expensive to live. Lots to do nearby. Scenic areas nearby. Moderate climate - no freeze, drought, or disasters. Good sports. City w character unlike western and midwestern cities. I've worked in most of the areas - this one is better overall."


Dallas, TX

"Rapidly growing local economy, reasonable cost of living, and strong growth in the high-tech space"

"There are several medical device manufacturers in the DFW area which are frequently overlooked."


Houston, TX

"The nation's fourth largest city continues to be among the top metros leading the nation in population and job growth; is ranked a top city with greatest number of STEM positions currently open, and boasts the world's largest medical center."

"Texas Medical Center is the kargest medical center in the world and Houston is home of Rice University."
 

San Antonio, TX

"2015 influx of medical device and pharmaceutical manufacturers into San Antonio requires more biomedical talent."
 

Salt Lake City, UT

"Low cost of living and great outdoor activities such as skiing & hiking. Traffic is also not bad with shorter commutes."

"Close to multiple ski resorts"

"It's not a hard town to get around in and you can go out in the country and not have to put up with thousands of people. Nature is real close to you."

"Salary is relatively higher than cost of living. Other areas are either expensive to live in and/or have crappy weather."

Learn more about cutting-edge medical devices at MD&M Philadelphia, October 7-8.

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