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Hospitals Want Help from Medtechs On...Everything

Hospitals Want Help from Medtechs On...Everything

It's no secret that hospitals are under tremendous pressure as a new healthcare paradigm emerges.

And a new report suggests that they are seeking help in achieving their goals and priorities from medtech companies that in the past have been happy to simply sell their devices. Now medtechs are realizing that their fortunes will rise and fall with those of their customers. 

The 2015 Strategic Hospital Priorities Study from L.E.K. Consulting shows that hospitals are more eager to work with outsiders to solve their problems now than ever before.

In 2015, 32.7% of respondents said that they are working with outsiders to address the most pressing needs compared with a meager 17.9%, according to the report. 

But more importantly, they want the help of medtech company's help in services across the board.

“The providers are interested in a broader range of services from MedTechs now — not just education/training and equipment services, but clinical IT, analytics and operations management now too,” said L.E.K. Managing Director Lucas Pain, in a news release Thursday.

Here is a graphic from the report that shows where hospitals are seeking help from medtech. Click the image for a larger version.

Hospitals' perception of the ability of medtech companies to assist them has increased across every single category - from clinical analytics and IT to operational management and efficiency improvement. 

This creates new opportunities for the industry to prove their value well beyond products. But it remains to be seen how many companies have not only the wherewithal, but the focus to take advantage of this growing trend. 

"In some ways it is a challenging situation for small and mid-sized companies," says Monish Rajpal, managing director and partner, L.E.K. Consulting, in a phone interview Friday.

He added that smaller companies have a few different options to navigate this environment - develop a focus to perform deeper clinical innovation that differentiates them from the competition, develop some service solutions related to those differentiated products as well as look to collaborate and make alliances with other companies so they can "participate in broader solutions" that are outside their wheelhouse.

While he acknowledged a tougher environment, Rajpal doesn't believe that hospitals' needs beyond the product means a death knell for smaller companies that do not necessarily have a broad solutions capability.

"I think there is opportunity for the narrower solutions for the continued clinical innovation and often times smaller companies might be selling at a scale that is below the radar of hospitals, so they may not get targeted for reductions," he says. "There's definitely going to be challenges but I don't think we're sitting here saying that the game's up."

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

[Photo Courtesy of iStockphoto.com user Mazirama]

NuVasive to Pay $14 Million to Settle Fraud Allegations

The company has settled charges associated with a 2013 subpoena.

Qmed Staff

Less than a month after NuVasive's CEO resigned, the company announced that it had reached a settlement with the U.S. Department of Justice.

Health & Human Services Department's Office of Inspector General (OIG) had subpoenaed the company in 2013 for Medicare and Medicaid fraud. Following that news, the company's stock price dipped 13% in a single day.

The OIG maintained that the company's senior executives knew of a scheme to falsely bill Medicare and Medicaid yet failed to put an end to it.

In a statement, the company explained that it had "cooperated fully" with the government's inquiry, adding that settling the matter avoids the time and expense of litigation.

NuVasive will pay $13.8 million, including fees, to the government as part of the deal.

Even though the company has released details of the settlement, the official deal is yet to be inked. The company anticipates that drafting the final written document could take a number of months.

In other news, the company's executive vice president Russell Powers sold 3888 shares of the company's stock on April 24, which at that time was worth $44.07 per share, making the transaction worth $171,344.16. Powers still owns 82,953 shares, which is roughly worth $3,655,738.71.

Analyst firm Canaccord Genuity recently the firm to hold. In a note to investors, Cannaccord analyst William Plovanic put a $49.00 price target on the stock--an 11.19% upside to the last closing price.

In late April, the stock has been in the $45 range.

Refresh your medical device industry knowledge at BIOMEDevice Boston, May 6-7, 2015.

What Up-and-Coming Technologies are Docs Excited About?

What Up-and-Coming Technologies are Docs Excited About?

Artists have their paintbrushes, poets have their pens, and physicians have their medical devices. And when it comes to the tools of their trade, the latter have strong opinions, in case you haven't noticed. 

MD+DI asked several docs what up-and-coming medical devices they're clamoring to get their hands on. Here's what they had to say:

I am excited about new endovascular technology allowing vascular surgeons to treat tibial artery disease. The tibial vascular bed remains a challenging location to treat and contributes to a significant number of lower extremity amputations. San Antonio has one of the largest diabetic populations, at 14%. If a new device allowed the efficacious treatment of tibial peripheral arterial disease, the diabetic amputation rate could be addressed.

—Lyssa Ochoa, MD, vascular surgeon in San Antonio, TX

Electronic anesthesia records. This is something that can provide a complete billing for what we’ve used. The hospital coders can take this and use it for their billing as well. We’re looking at increased revenue for the work that we’ve done by being able to have error tracking and have the software ensure the completeness of our documentation. We should be able to capture additional revenue that we currently are not simply by inadequate documentation in our paper record. It’s showing value to everyone along the way. 

—Maneesh Amancharla, MD, anesthesiologist and partner
at Capitol Anesthesiology Association in Austin, TX

 

Wireless technologies for surgical instruments. Covidien’s wireless harmonic has really facilitated how I operate. Wireless cameras would be good as well. Right now it is too cumbersome in the OR with all the tubes, cables, and cords—suction, gas, cameras, etc.

—Marlon Guerrero, MD, Director of Endocrine Surgery and Assistant Professor of Surgery at the University of Arizona
 

A rapid molecular test that could identify specific pathogens without requiring heat or enzymatic activity would lead to faster, more cost effective diagnostic alternatives and facilitate pathogen-directed therapies. 

—Robert Sambursky, MD, cornea specialist with Manatee Sarasota Eye Clinic and Laser Center in Sarasota, FL

 

There’s a portable extracorporal membrane oxygenation device that Maquet manufactures called Cardiohelp. So this is [an] example of an old technology that’s become portable and so much better. The old technology is the heart-lung bypass machines that were used in the '50s, '60s. But it’s a very clunky, high-risk kind of tool that’s become better over time. Now they make those machines, they are super efficient and super cool. They don’t have as much bleeding risk and [are] much easier to place. They are for patients who need respiratory and circulatory support for a long period of time.

—Sumanth Ambur, MD, emergency medicine physician and critical-care fellow at Hennepin County Medical Center in Minneapolis 

 

Continuous transesophageal echocardiography. The ultrasound probes are smaller [and] can remain in the esophagus for several days. This may solve some of the problems with resuscitation and cardiovascular function in critically ill patients. I think it will be the new Swan-Ganz catheter, only better at measuring actual stroke volume and cardiac output. It’s a very new way to look at an old problem with existing technology.

—Thomas Granchi, MD, director of the Burn Treatment Center and clinical professor of surgery at the University of Iowa 

 

Jamie Hartford is MD+DI's editor-in-chief. Reach her at jamie.hartford@ubm.com or on Twitter @MedTechJamie

[Main image courtesy of STOCK IMAGES/FREEDIGITALPHOTOS.NET]

Medical Device Hacking—Why Are Patients Innovating and Companies Failing to Deliver?

Medical Device Hacking—Why Are Patients Innovating and Companies Failing to Deliver?

Patient-led initiatives are engineering improvements to medical devices and companies looking to catch up will need to apply significant rigor to risk management, hazards identification, and user testing processes.

Mike Dunkley and Samantha Katz

There are two sides to medical device hacking.

On one hand, there is justifiable concern that nefarious objectives could motivate hacking wireless medical devices, which may include gaining unauthorized access to private patient data, or in an extreme example, the potential to assassinate a sitting Vice President (in the case of Dick Cheney’s implantable defibrillator).

On the other hand, the rise of the maker-culture coupled with meaningful pain points is leading to creative medical device hacks where the end goal has a clear user benefit. As an example, flaunting the social media hashtag #wearenotwaiting, NightScout represents a valuable initiative for remote monitoring of continuous glucose readings by hacking currently available medical device technology. A group of concerned parents has figured out a way to connect Dexcom’s continuous glucose monitor (CGM) to the cloud so they can monitor their children’s glucose levels remotely via their smartphones.

Katz

User expectations for medical devices are being shaped by their experiences with consumer products and services, and the confluence of these experiences with their unmet needs as patients and care partners is creating clear demand for medical devices that look, feel, and operate like consumer devices. Where companies are failing to innovate fast enough to keep up with consumer technologies, patients and care partners are becoming increasingly impatient and, consequently, are innovating directly or via online communities of like-minded people.

Medical device hacking is perhaps the clearest expression of unmet need. People are asking themselves why they are able to monitor the performance of their favorite stock in real time, but cannot do the same for their child’s glucose reading. The technology pieces are all out there, they wonder, so why aren’t companies putting them together to design and deliver the new products and services their customers are demanding? If companies will not deliver, then patients are becoming increasingly driven to do it themselves.

One of the major reasons holding companies back is the need to address patient safety risk in the design and deployment of such systems. Take Type 1 diabetes, which is the focus for Nightscout. It is clearly valuable to be able to monitor your child’s glucose levels while she is at a sleepover, but what happens if the link goes down? How can you be sure the reading you’re seeing is correct? If not adequately mitigated, these risks have the potential to lead to serious problems, such as incorrect insulin dosing, and companies rightfully have to take such risks very seriously.

FDA has created a regulatory environment that requires companies to design medical devices with demonstrable rigor and with particular emphasis on risk management. In the case of devices that leverage mobile infrastructure, it has also offered guidance to companies as to whether a particular type of device is subject to oversight, whether it will use enforcement discretion, or whether a device presents sufficiently low risk that it is not considered a medical device.

Dunkley

For remote monitoring of Type 1 diabetes, it is clear that FDA will need to be satisfied that a company has been diligent in its risk management activities before it gains market clearance. This includes extensive testing and documentation at the device and system levels.

The key starting point, particularly for systems involving mobile elements and multiple interfaces, is to be clear about how the system functionality is distributed, because it can have significant impact on the regulatory implications. For instance, if a CGM system is configured with a primary display on the patient’s smartphone and a secondary display on the parent’s smartphone, then the risk management activities will be likely impacted by the expectation that both patient and caregiver are involved in monitoring glucose levels. In this scenario, the glucose sensor and patient’s smartphone application would be regulated as Class III medical devices, while the secondary display (on the parent’s smartphone) may be separately regulated as a Class II accessory device.

Alternatively, if the patient’s (and, hence, parent’s) smartphone apps both serve as secondary displays with the company’s proprietary, FDA-approved display device serving as the primary display, the apps would be considered lower risk Class II devices. This was the case with Dexcom’s G4 PLATINUM with Share CGM system. This is because the approved Class III Dexcom display device that is responsible for alerting the user to glucose excursions must be present in order to use the secondary app, and, consequently, the rest of the cloud-based system.

A crucial next step for any risk management activity in the regulated medical realm is to be clear about the intended use and associated marketing claims, even if these might be reasonably inferred by a user rather than explicitly stated by the company. In other words, a parent might reasonably expect that a remote CGM system will reliably alert them if their child’s glucose levels drop to dangerously low levels. They may not anticipate that cellular signals could be interrupted or that their child’s sensor could temporarily lose connectivity if the child is sleeping on it.

Next is a thorough hazards identification process with input from medical professionals that forms the basis for the risk assessment work that follows. Key concerns for remote CGM monitoring will likely include hypoglycemia and hyperglycemia with the former being the most serious and immediately life threatening.

The high-level failure conditions that might enable either of these situations include “no result,” “wrong result,” or, depending on the user’s expectations for timeliness of CGM data, “late result.” Effective risk analysis seeks to identify, quantify, and mitigate potential failures in the system, which have the potential to lead to a hazard. The “art” of risk management is to put yourself in the user’s shoes and understand how they will incorporate the device into their daily life, including all the potential opportunities for misuse, to ensure the optimum balance of safety and usability for a product or system that is commercially viable. Ultimately, in the United States, FDA is the arbiter of whether the overall approach is adequate but companies who apply smart, user-centered, and timely methodologies are more likely to succeed.

Consider the potential failure mode of “no result”—the system is not reporting data to either the patient’s or the parent’s smartphone with the potential harm being that the patient could be at risk from entering a dangerous hypoglycemic state. Risk management needs to consider the likelihood and severity of this event and also balance the potential mitigations with usability implications for different stakeholders. Should the system always alarm the patient in the event of “no result,” even if it is a likely scenario that the patient is asleep and laying on top of the CGM sensor, impeding the wireless connection with the smartphone? Should the system also alarm the parent and should it distinguish between connectivity failures local to the patient and those related to unreliable network connectivity? These potential mitigations need to be mapped to each stakeholder’s expectations and needs for the system and also relate back to the manufacturer’s intended use and related claims. The right approach must find the optimum tradeoff between providing effective warnings without becoming intrusive or overly irritating.

Lastly, when it comes to mobile technologies, it is important to consider how verification and validation activities will be executed, given the speed at which mobile operating systems can change independent of the medical devices in the system. A solution for an identified hazard could elegantly mitigate a safety risk but at the same time generate a lengthy revalidation process, which merely shifts patient risk to business risk if part of the medical device system is inoperable due to the OS change.

There is a clear complexity to a remote CGM system with multiple displays and users, as well as the incorporation of third party hardware and cloud-based infrastructure. Therefore, the analysis required for a CGM system with significant safety hazards requires tremendous rigor and will need to be backed by effective and representative functional and user testing.

Returning to the topic of hacking, in many cases, rather than being something to eschew, designing these workarounds for medical devices can be a clear indicator of unmet patient needs and therefore point to an attractive opportunity space for medical device manufacturers seeking to develop regulated products and applications. Groups like NightScout are innovating to improve the lives of children with diabetes and lessen the burden on their parents because the medical device industry simply cannot move as quickly to get to a regulated, commercially available product. However, for the companies who can successfully catch up, the commercial benefits will be sizable, while the improvements in the lives of the patients and caregivers will be invaluable.

Stay on top of the latest trends in medtech by attending the MD&M East Conference, June 9–11, 2015, in New York City.

Mike Dunkley is senior vice president and Samantha Katz is a senior strategist and digital health lead at Continuum, a global innovation design consultancy.

[Image courtesy of STUART MILES/FREEDIGITALPHOTOS.NET]

Could Pacemakers Use Energy Harvesters? This Professor Thinks So

Amin Karami
Amin Karami

Amin Karami at the University of Buffalo found a materials solution to overcome a design challenge related to energy harvesting from the heart.

Chris Newmarker

The dream of pacemakers that make their own power still seems years if not more than a decade away, but a University of Buffalo professor's work may be bringing it closer to reality.

As a postdoc research fellow at the University of Michigan and now as a professor at Buffalo since 2013, Amin Karami has found more effective ways to utilize the piezoelectric properties of a crystalline, ceramic compound called lead zirconate titanate (PZT).

Karami is in the process of securing a patent and forming a company to commercialize his inventions. (See Karami discuss energy harvesting at MD&M East, June 9-11 in New York City.)

PZT has already proved useful when it comes to converting vibrations to electricity to self-power sensors on bridges or airplanes, according to Karami. But using it to harvest energy off the heart is trickier because heart beat frequency varies a great deal, making it hard to even squeeze out the few microwatts needed for a pacemaker.

"We have a very meaningful amount of motion, which is heart motion. ... It's a very small amount of power, but it's enough to power a pacemaker," Karami says.

The PZT might not be able to always be layered in a flat surface, either, since the latest generation of tiny leadless pacemakers such as Medtronic's Micra and St. Jude Medical's Nanostim require a lot of electronics packed into a tiny horse pill-sized shape. With the Micra, for example, the pacemakers canister is actually it's battery, too.

Karami started out four years ago by testing heart beat vibrations all over the inside of pigs.

He then figured out that two strategically placed magnets on a brass strip covered with PZT created nonlinear behaviors in the PZT that boosted power production a hundredfold, to up to 20 microwatts, and allowed it to take place anywhere from seven to 700 beats per minute. It could utilize heart vibrations that could be found all over a torso.

While an improvement, there was still a major challenge because magnets are not MRI-compatible, which would post challenges for heart disease patients.

Karami found a materials solution to create similar nonlinear behavior without the magnets.

"We are achieving the same thing without the magnets by placing the PZTs on a composite structure. Before it was a thin sheet of brass. Now it is a thin sheet of carbon fiber composite manufactured in a way to be unstable, to have these natural properties we want," Karami said.

The composite is made up of two layers of carbon fiber, fused together with an epoxy at high temperatures.

"There will always be internal forces. The composite, the substrate has two shapes. In either shape, one of the two materials will be under internal stress, because one of them would be pulled and the other would be in a comfortable situation. This internal type of structure makes it nonlinear," Karami said.

"The arrangements of the two layers of fibers is very key here."

Karami has also been able to shrink the energy harvester down to a cubic centimeter.

When it comes to incorporating the energy harvester, there will be more regular engineering challenges, such as making sure voltage matches a pacemaker or integrating the PZT harvester into a pacemaker's design. "All of these can be done. I don't see a significant challenge down the road," Karami said.

Researchers elsewhere have been experimenting with using PZT-based energy harvesting for pacemakers and other devices. For example, a team led by flexible electronics pioneer John Rogers, PhD, of the University of Illinois-Champaign, has created a super-thin silicone-encased, bendable energy harvester that can be affixed to a beating heart.

Karami sees an important advantage with his technology: "It doesn't have to be attached to the heart."

Related Article: Find out five things you need to know about energy harvesting.

See Karami discuss energy harvesting at MD&M East, June 9-11 in New York City.

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

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How is Tissue Engineering Progressing in Europe?

How is Tissue Engineering Progressing in Europe?

Henrik John

Tissue engineering has a lot of potential to transform the field of medicine.

Since the first hype in the early 2000s, a lot of money has been burned, but still only very few real tissue engineered products have found their way successfully in the market.

The question is why?

First of all we are talking about a Class III medical product, which has the highest requirements on biocompatibility testing according to ISO standard 10993. Secondly, we are talking about a “living” and/or pharmaceutical product, having an active biochemical interaction with the human body. So the classification of these products is the first hurdle on the way to the market.

And then there are multiple ethical, regulatory and financial difficulties too on the road to commercialization. For the certification of tissue engineering products, say a simple scaffold-based product with autologous cells like bioartificial cartilage or bone, it can take four years and about 4 million euros just for the clinical trials. This high upfront investment in time, resources and money implies that there must be a solid business plan supporting the commercialization of such products.

To be successful, a tissue-engineered product should be able to either offer an alternative to existing solutions or fulfil an unmet need, for instance in serving patients waiting for transplants. But that will be decades in the making as organs have the highest complexity of all tissues.

Nonetheless, here are some concrete examples of how tissue engineering is progressing in Europe.

  • In Portugal, Stemmaters is pursuing the combination of stem cells with biomaterials.
  • In the Netherlands, Dr. Lorenzo Moroni and his team at the MERLN Institute for Technology-Inspired Regenerative Medicine at Maastricht University is looking into functionalized scaffolds.
  • Also in the Netherlands, Clayton Wilson at CellCotec B.V., an orthopaedic medical device company, is dealing with the certification of a tissue-engineered product as a cartilage replacement containing autologous cells.
  • Tissue engineers at the Biomedical Institute of Basel University in Switzerland have replaced nasal cartilage tissue cultivated on collagen fleece.
  • A new biofabrication center is being built at the Utrecht Medical Center (UMC), in Netherlands.
  • Syseng is developing a Bioscaffolder tool for processing all kinds of biomaterials.

Stemmatters works at the intersection of cell biology and biologically inspired materials to solve unmet medical needs in human healthcare. They harness the potential of stem cells and combine them with proprietary biomaterials into advanced cellular based therapies. Their mission is to provide customized manufacturing and novel regenerative medicine products that help people counteracting degenerative and traumatic medical conditions.

The research group of the MERLN Institute for Technology-Inspired Regenerative Medicine at the Maastricht University (UM) will conduct top research in the field of tissue regeneration. The MERLN Institute specialises in bone and cartilage repair, with a particular focus on developing new technologies for regenerative medicine. These include “smart" biomaterials that lead to tissue regeneration through the patient’s own stem cells.

The orthopaedic medical device company CellCotec is one of the few companies that has a tissue-engineered product in the market. The company uses a ground-breaking proprietary Cellular Regeneration Technology (CRT), providing single-surgery solutions for damaged articular cartilage in the knee. As such, CellCoTec has developed and certified, unique technology, which combines cell interaction with the use of a mechanically functional polymer scaffold in a single surgical intervention.

For skin cancer patients who have the tumor on the nose, tissue engineers at Basel University have developed a method to regenerate the missing nasal cartilage tissue after resection of the tumor. They took a healthy tissue sample from the nasal septum, isolated and proliferated the autologous cartilage cells and seeded them on a collagen membrane to achieve a 40 times larger, bioartificial tissue as the sample taken.

The regenerated cartilage transplant was shaped manually according to the defect in the nasal septum and successfully implanted. But regulatory hurdles impede the use of this procedure in patients who want this procedure but for another indication. Tissue engineering is a nascent field where standards are still developing.

At the Utrecht Medical Center in the Netherlands, the Utrecht Biofabrication Facility aims at expediting emerging biofabrication technologies in areas of regenerative medicine, 3D in vitro cell culture models and therapeutic treatments. Closely related to this is the world’s first two-year biofabrication research master’s program beginning September 2015.

The facility is a leading European knowledge center in the area of biofabrication and is equipped with a number of different bioprinting devices for creating three dimensional scaffolds and bioartifical tissues using additive manufacturing and combining biomaterials and cells. Amongst the equipment is also a BioScaffolder System, a technology I co-invented at the company I run, Syseng, in Germany.

The BioScaffolder is based on a computer controlled 3D-dispensing device that allows the creation of three-dimensional scaffolds from multiple materials. The scaffolds incorporate cells with complex internal architecture in a controlled and repeatable way by patented software.

Due to the availability of different types of dispense heads it is possible to process many different biomaterials from thermoplastic polymers to gels and fluids. Also jetting of thermoplastic polymers and processing of two-component materials is possible.

John will deliver a presentation of the future of tissue engineering June 11 as part of the MD&M East Conference and Tradeshow, June 9-11, in New York City.

Henrik John is CEO of Syseng, which has developed the BioScaffolder computer-aided tissue engineering system that can be used in the manufacturing of 3D scaffolds.

[Photo Courtesy of iStockphoto.com user belekekin]
 

2015 MDEA Finalists: Evo Shipper

2015 MDEA Finalists: Evo Shipper

The Evo shipper, manufactured by Savsu Technologies (United States), provides 100-hour temperature stability for sensitive vaccines and biomaterials and relays critical data about the shipment in real time.
          

2015 MDEA Finalists: AccuVax

2015 MDEA Finalists: AccuVax

AccuVax

 

AccuVax, manufactured by TruMed Systems Inc. (United States), is a computerized, self-monitoring, cloud-connected, refrigerator/freezer vending machine for vaccines.

Supply/design credits: DDstudio, Novo Engineering

          

2015 MDEA Finalists: StabiLink MIS Spinal Fixation System

2015 MDEA Finalists: StabiLink MIS Spinal Fixation System

StabiLink MIS Spinal Fixation System

The StabiLink MIS Spinal Fixation System, manufactured by Southern Spine LLC (United States), is a less invasive option to pedicle screws for spinal fusion procedures; benefits include smaller incisions; significant reductions in blood loss, operative and recovery time, and postoperative pain, resulting in a quicker return to normal activities for patients.

Supply/design credit: Enginuity Works Corp.

          

2015 MDEA Finalists: Kiva Vertebral Compression Fracture Treatment System

2015 MDEA Finalists: Kiva Vertebral Compression Fracture Treatment System

Kiva Vertebral Compression Fracture Treatment System

The Kiva Vertebral Compression Fracture Treatment System, manufactured by Benvenue Medical (United States), treats vertebral compression fractures due to osteoporosis and cancer by leveraging minimally invasive access to expand within the vertebra into a cylindrical structure that stabilizes fractures and help prevent new fractures.

Supply/design credit: Flambeau