MD+DI Online is part of the Informa Markets Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

Siemens Has Big Plans for This New MR Tech

The German multinational is working with Case Western Reserve University to bring magnetic resonance "fingerprinting" to market--potentially taking the technology to a whole new level.

Nancy Crotti

Siemens Case Western MR Fingerprinting
MR fingerprinting seeks to identify individual tissues and diseases, similar to how a fingerprint identifies an individual person. (Image courtesy of Siemens) 

Researchers at Case Western Reserve University have introduced an advanced type of imaging called magnetic resonance fingerprinting (MRF) in 2013. Now they've teamed up with Siemens' healthcare business to bring the technology to market.

MRF provides not only images of tissues but also accurate measurement of the physical properties of those tissues, according to the researchers. They have performed initial tests with brain and prostate tumor patients as well as with breast cancer patients who have liver metastases. MRF has also been used in cardiac examinations and with patients with multiple sclerosis, according to a joint statement from Case Western and Siemens.

Here's how the researchers described it in an email:

"In this new method we use the MR machine to generate a unique pattern of signals from each volume of tissue that's like a fingerprint.  We compare that pattern to a library of known patterns that tell us about the specific physical properties of the tissue.

"This would be like hav(ing) a fingerprint to find a person in the computer database and then know where they live, how tall they are and their hair color.  The discovered measurements of the tissues from MR Fingerprinting can then be used to define the specific components of normal tissue and disease such as tumor, in (a) new more reproducible manner.  This may well allow earlier detection of disease and better ways to monitor how well treatments are helping."

Most information gleaned from MRIs is qualitative, based on observed differences between tissues, the statement says. Existing quantitative MRIs can measure diffusion, fat/iron deposits, perfusion or relaxation times, but they are time-consuming, and the results may vary, depending on the scanner and the user, according to the researchers. MRF promises to be faster and more accurate.

"The goal of MR fingerprinting is to specifically identify and characterize individual tissues and diseases," said radiology professor Mark Griswold, PhD. "But to try to get there, we've had to rethink a lot of what we do in MRI."

The team is working to expand this method for a range of different tissue properties. At the same time, the university is working toward expanding the technology to cover additional fields of application, according to the statement.

For Siemens, the focus of this collaboration is to improve reproducibility and possibly extend the procedure to different MR scanners and field strengths.The collaboration launched a work-in-progress imaging package for certain Siemens scanners used in research. The packages have been tested since January 2016 at the University Hospital Essen in Germany, and the Medical University of Vienna in Austria.

The Case Western Reserve researchers first published an article about MRF in the journal Nature in 2013. The Ohio university and the German medtech company have collaborated for more than 30 years on MRI technology, according to Griswold.

The MRF technique could redefine MRI, according to Professor Siegfried Trattnig of the Center of Excellence for High Field Magnetic Resonance at the Medical University of Vienna, referring to the initial research studies involving patients with malignant brain tumors and low-grade gliomas.

"MRF could help us, as radiologists, to make the paradigm shift from qualitative to quantitative imaging and to incorporate quantitative data into our daily routine. This has the potential to reduce scan times and in turn, bring considerable cost savings in the future," Trattnig said in the statement.

Learn more about cutting-edge medical devices at MD&M East, June 14-15, 2016 in New York City.

Nancy Crotti is a contributor to Qmed.

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

This New Laser Tool Enables Coatings at the Nano Level

The new method was designed to enable coating processes to be controlled in real time--providing short laser pulses that can coat electronic medical devices and pharmaceutical products with layers in the nanometer range.

Kristopher Sturgis

Modulationvpolarization laser beam nano coatings Vienna Tech
The polarization and intensity of the laser pulses can then be finely tuned depending on the thickness of the layer being applied. (Image courtesy of Vienna University of Technology)

When it comes to designing electronic devices with layers at the nanometer scale, precision becomes the most crucial component of the manufacturing process. Thanks to a new technique developed by researchers at the Vienna University of Technology in Austria, manufacturers will have a new tool that uses laser pulses to provide unprecedented precision and quality control during the coating process in real time.

The new device, known as an inline ellipsometer, requires no moving parts and is relatively cost effective compared to other similar technologies. The device could have significant potential in a variety of fields, particularly when it comes to the manufacturing of photovoltaics. Solar cells are often made up of multiple layers that must be carefully crafted at varying degrees of thickness. The device could also be used to improve the manufacturing of battery and display technology, medical devices, and other electronic components. 

"Our new technique images the object of interest with these different polarizations," says Ferdinand Bammer from the Institute for Production Engineering and Laser Technology at the Vienna university. "From the differences in these images, we deduce information about coating thickness. Other methods obtain thickness information only in a certain spot, or need much more time to get a mapping of the object, or are simply much more expensive. Our device is robust, small, contains no moving parts, and is very cost-effective."

The functionality of the device is actually quite simple. The inline ellipsometer produces laser pulses that are fired in quick succession, which are polarized using a crystal that oscillates thousands of times per second. The polarization and intensity of the laser pulses can then be finely tuned depending on the thickness of the layer being applied, and the coating can consist of essentially any material, provided that the material is somewhat transparent.

"Many devices in all disciplines are based on thin layers with a well defined thickness," Bammer says. "The latter is often crucial for the devices functionality. In medicine, for example, we mention protective or antiseptic coatings for devices. Inline thickness here is essential to check the functionality of the coating during production to adjust real time parameters. This will help manufacturers stay in the desired processing window and avoid waste."

For now, the group has developed a working prototype that can be attached to existing coating systems. The prototype has been tested on various coating systems already and has shown it can be used on various materials, providing all with the ability to customize the layer of thickness down to the nanometer. The next step is to begin rolling the device out to manufacturers for testing in real world environments.

"The technology is currently in an early stage, but we've been confronted with applications from all disciplines of science and technology," Bammer says. "It could even be an important tool for cheaper and reliable production of lab-on-a-chip devices, but it may turn out to be revolutionary for protective and antiseptic coating processes. The first installations are planned for this year, and depending on this, we estimate they could be in use in 6-10 months."

Learn more about cutting-edge medical devices at MD&M East, June 14-15, 2016 in New York City.

Kristopher Sturgis is a contributor to Qmed.

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

Who Would You Trust With Your Wearable Tech Data?

Trust could be a major hurdle to overcome, according to a new PricewaterhouseCooper study.

Arundhati Parmar

There's an explosive growth in the use of wearables--from 21% in 2014 to 49% today, according to results of a new study that shows the proportion of people that own one wearable.

Interestingly enough, the study--PricewaterhouseCooper's The Wearable Life--proves that health is the No. 1 factor driving consumer to buy a wearable. The firm surveyed 1000 respondents aged 18-64, equally split between men and women, in an online quantitative survey in March 2016.

Yet while health and fitness is what excites consumers, there is a rift between the excitement that they feel in getting a wearable from a certain source and the trust they view that source with. Here's how that breaks down:

PricewaterhouseCooper The Wearable Life

It's perhaps not surprising that consumers trust their doctors more than they trust their health insurance company when it comes to feeling at ease that these entities are capturing data through the wearable. But it's revealing that they trust their bank almost as much as they trust their health insurance company to be entrusted with the information gathered through the device.

Meanwhile, 25% of respondents declared they would not trust any company with their personal information associated with wearable technology. The report said that the issue of trust is improving over time and companies can win over consumers by demonstrating that their data is secure and by creating wearable products that are easy to use and improve their quality of life.

Learn more about cutting-edge medical devices at MD&M East, June 14-15, 2016 in New York City.

Arundhati Parmar is a senior editor at UBM.

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

Why Telemedicine Is Gathering Steam in the U.S.

More health providers are recognizing that virtual care can increase patient volumes, assist in care coordination, and more, according to a new survey from KPMG. But there are still significant hurdles. 

Arundhati Parmar

KPMG State of Telemedicine
(Infographic courtesy of KPMG)

A new survey shows that a quarter of U.S. providers believe that their virtual care programs can be sustained financially, but more importantly they are improving efficiency, patient volumes and loyalty.

The survey was conducted by tax, audit and advisory firm KPMG and involved responses from 120 participants on a telemedicine webinar that the company hosted last month. Participants were from healthcare provider organizations.

Telemedicine, which employs technology to deliver care to patients not physically present at the clinic, has been widely considered one of the ways that healthcare costs can be lowered while improving patient satisfaction.

"Telehealth is rapidly evolving beyond urgent care and is increasingly used for follow up visits and helping chronically ill patients connect with their doctor online," Richard Bakalar, MD, managing director at KPMG and a member of the firm's Global Healthcare Center of Excellence, said in a statement.

"Health plans and government payers are seeing the value from the technology and enhancing reimbursement for virtual care," Bakalar said.

The survey found that there are several factors that are expediting the adoption of telemedicine. Survey responders pointed to the following reasons for choosing virtual care programs:

  • Increase patient volumes and loyalty (29%)
  • Care coordination of high risk patients (17%)
  • Reduce costs for access to medical specialists (17%)
  • Meaningful use and payer incentives for adoption (13%)
  • Patient requests/consumer demand (13%).

Yet there is still a significant proportion of U.S. providers lagging behind in terms of adoption. The small survey found that nearly 35% of respondents have not yet started a virtual care program, while another 40% are in early stages. 

So what's keeping them from a full embrace of telemedicine? The survey respondents pointed to the following:

  • Too many other technological priorities (19%)
  • Maintaining a sustainable business model (18%)
  • Organizational readiness to implement new services/technology (18%)
  • Regulatory compliance and risk concerns (15%). 

The above challenges notwithstanding, providers need to adopt telemedicine especially as a younger generation of consumers demand healthcare when and where they need it. According to the Pew Research Center, millennials, mostly in their 20s and early 30s, now number more (75.4 million) than Baby Boomers (74.9 million). And this population will account for 41% of overall healthcare spending by 2025, according to another KPMG report on telemedicine. 

Learn more about cutting-edge medical devices at MD&M East, June 14-15, 2016 in New York City.

Arundhati Parmar is a senior editor at UBM.

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

Why Laser Welding Matters for Neurovascular Catheters

Interventional neurology surgery is a major frontier when it comes to medical device miniaturization, and laser welding has an important role to play.

Kevin Hartke, Resonetics

Resonetics and micro laser welding
Engineer holding a 75 micron diameter nitinol wire assembly (left), high magnification view of the laser weld (right). (Images courtesy of Resonetics)

For over 20 years, laser welding has been acknowledged as an important joining method in the medical device industry, using the native materials only without the use of any additive materials. There have been many critical applications of the technology ranging from cardiac pacemakers and implants to spinal implants, to name a few.

The rapid adoption rate is linked to the availability of laser micro-welding systems with stable output power as well as process know how. These system and process advancements have opened the door for smaller and smaller parts to be joined together in a robust process. 

At the forefront of the miniaturization trend is the emergence of applications for interventional neurology surgery.  Minimally-invasive delivery neurovascular catheters deliver very small implants to the brain, requiring component part sizes with outer diameters from 25 to 250 microns. Laser micro welding has proven to be a reliable and robust joining process for this critical and precise application.

Why Does Small Make Such a BIG Difference?

When the physical dimensions of life science components approach the human hair, there are many process considerations when laser welding these tiny components, including:

  • Geometry control: Part geometry cannot vary more than 10% of the smallest part feature, dictating single micron tolerances on all parts.
  • Part fixtures: Fixture design and fabrication requires specialized laser micro-manufacturing capabilities
  • Laser stability: Laser systems must be industrial, robust and stable, requiring the precise measurement, monitoring, and control of the laser power. Low cost jewelry welding lasers lack the power stability to guarantee a stable process. 
  • Part handling: Part manipulation requires skilled technicians who use micro-manipulators with the aid of optical microscopes.

Laser Welding: Art vs. Science

Welding has evolved.  For the interventional neurology industry, the image of a traditional welder donning a protective mask shield to protect against flying orange and white sparks is an antiquated notion; instead micron-scale laser welding is the new norm.

Picture an operator inside a clean room, using an optical microscope to load parts into a precision fixture, which is in turn loaded into a completely automated machine.  Laser welding for the neurointerventional industry uses validated machines and processes that are capable of producing thousands of parts per week with process capability values well above a Cpk of 1.33. 

From the beginning, laser welding processes are designed with manufacturability and repeatability in mind, accelerating the product time-to-market by allowing contract manufacturers to deliver quick-turn prototypes, followed by scalable volume manufacturing. Moving seamlessly from development to production requires expert laser knowledge of the process parameters, material weldability, geometry control, fixture design/manufacturing, and part handling. Collectively these factors are critical for a successful implementation of micron-level laser welding for high valued applications such as neurovascular and neuromodulation.

Learn more about cutting-edge medical devices at MD&M East, June 14-15, 2016 in New York City.

Kevin Hartke is chief technology officer at Resonetics (Nashua, NH). 

TransEnterix Learns it's Not Easy to Battle Goliath

TransEnterix Learns it's Not Easy to Battle Goliath

All of us love a good David vs. Goliath story, but in business it's not easy to see them happening with much regularity.

Arundhati Parmar

Take the example of Research Triangle, N.C.-based TransEnterix. The public company was riding high expecting FDA to greenlight its SurgiBot robotic system. CEO Todd Pope was fuly expecting that SurgiBot's clearance would increase the small footprint of surgical robots in the U.S. created by Intuitive Surgical's pioneering but expensive Da Vinci robots. On April 20, the company was dumbstruck when FDA decided that SurgiBot was not substantially equivalent to a predicate device. A new 510(k) application would be needed. Shares nosedived 54% on that news.

TransEnterix has now shifted its focus to a second robotic system - ALF-X - that it acquired in Europe and which already has the CE Mark. Analysts believe that this might be a system that could be a better competitor to Intuitive Surgical.

Stay on top of medtech trends and attend the MD&M East conference at the Jacob Javits Convention Center in New York, June 14-16.

But in Europe, where commercialization is ongoing, ALF-X is facing some competition even on price from Intuitive Surgical. In an interview with MD+DI in March an analyst had described the pricing structure of the competing robots like this:

"Da Vinci costs are about $1.5 million, plus $150,000 per year in system maintenance expense, and cost per procedure is approximately $1,600, but this depends on procedure type," Gregory Chodaczek, an analyst with Sterne Agee CRT, explained via e-mail. "SurgiBot will be approximately $800,000, with procedure cost about $1,600. ALF-X costs about $1.8 million, with procedure costs approximately $1,200." He added that while the average selling price of a da Vinci system is about $1.5 million, a full-featured Xi with a dual surgeon console runs up to $2.5 million.

In other words, ALF-X is slightly cheaper upfront and saves dollars when viewed through the prism of cost per procedure. So purely from a price perspective, it should have an edge over Da Vinci.

Except that Intuitive, smelling blood in the water, is playing hardball in Europe. Here's how Pope described the Sunnyvale, CA company's tactics in TransEnterix's May 10 earnings call.

The old norm of deciding whether to buy a robot or not, is being replaced with the new normal that adds, which robot is the best fit for my needs. In these situations, when our ALF-X is compared with the competitor's newest technology, our features, benefits, and low per procedure cost model, positions us extremely well.

We have, however been somewhat surprised by the competitive response, which has included withdrawing their high-end platform and substituting refurbished older technology at highly discounted price and attempted to win the deal. Over time, we remained convinced that our ability to offer the most advanced robotic technology with materially lower per procedure cost will resonate with hospitals and allow us to be successful in the market.

In other words, TransEnterix is finding it hard to compete even on price, and Sean Lavin, an analyst with BTIG, believes that revenue ramp will be slower as Intuitive puts up roadblocks.

Despite the big stumble -- TransEnterix has laid off people after the FDA rejection even though it hired a handfull to ramp up sales of ALF-X in Europe -- some believe that the company's ALF-X system is valuable.

Rick Wise, an analyst with Stifel, remains optimistic on the future of the company partly because ALF-X's "truly differentiated system functionality and favorable economic profile" will "offer distinct advantages over existing systems to surgeons and hospital administration," according to a research note published May 10 after the TransEnterix earnings call.

Pope expects the first ALF-X unit to be sold soon and is aiming to file a 510(k) with FDA by the end of the year to bring the device to the U.S. market in 2017. 

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

[Photo Credit: iStockphoto.com user im25150]

Does Medtech Have an Appetite for M&A?—BD

Does Medtech Have an Appetite for M&A?—BD

BD's Commentary on M&A

"As many of you already know, in March, we celebrated the one-year anniversary of the closing of CareFusion, and we are extremely proud of our achievements over the past year. We have been acutely focused on the integration and a significant amount of work driven by the integration teams across the businesses . . .

In the short run, we still have the flexibility to do plug-in acquisitions."

Vincent Forlenza, BD chairman, president, and CEO, according to a Seeking Alpha transcript of the company's fiscal second quarter earnings call

             

Get inspired to innovate in medtech at the MD&M East Conference, June 14-16, in New York City. 

[Image courtesy of BLUEBAY/FREEDIGITALPHOTOS.NET]  

Does Medtech Have an Appetite for M&A?—Boston Scientific

Does Medtech Have an Appetite for M&A?—Boston Scientific

Boston Scientific's Commentary on M&A

"Near term, our capital allocation priorities are to prepay debt, manage our contingencies, and pursue tuck-in M&A."

Daniel Brennan, Boston Scientific CFO, according to a Seeking Alpha transcript of the company's first quarter earnings call

             

Get inspired to innovate in medtech at the MD&M East Conference, June 14-16, in New York City. 

[Image courtesy of STUART MILES/FREEDIGITALPHOTOS.NET]  

Does Medtech Have an Appetite for M&A?—Hologic

Does Medtech Have an Appetite for M&A?—Hologic

"Yes we are ready and willing to spend there on M&A and actually we did make an acquisition of our own stock in the quarter. That was actually a pretty good acquisition that we made and we are feeling pretty good about that.

The teams are definitely looking and where Bob and Eric and I are now reviewing on a more regular basis ideas . . . Ultimately I look forward to the day that we have no converts left on the balance sheet, but I would suspect we will be doing some acquisitions along the way while we continue to clean those up.

So, still in the way at this point in time still focusing the division on what we call bite size, things that supplement the existing businesses and we are very willing and ready to go, but . . . nothing imminent wouldn't even necessarily expect any, anything much in this fiscal year necessarily. So we thought mop up some share as well that the market gave us a nice opportunity."

Steve MacMillan, Hologic chairman, president, and CEO, according to a Seeking Alpha transcript of the company's fiscal second quarter earnings call.

             

Get inspired to innovate in medtech at the MD&M East Conference, June 14-16, in New York City. 

[Image courtesy of STUART MILES/FREEDIGITALPHOTOS.NET]  

Does Medtech Have an Appetite for M&A?—Smith & Nephew

Does Medtech Have an Appetite for M&A?—Smith & Nephew

Smith & Nephew's Commentary on M&A

"Our entry into the fast-growing area of orthopedic robotic-assisted surgery with the acquisition of Blue Belt is off to a good start. The integration has been smooth. And we're excited about the prospects and our pipeline . . .

So the mid-tier was really one of a number of interests that we have in M&A. As you know M&A remains one of our five key strategic pillars. There's no change really in the level of interest. Clearly, there are a number of areas that we're focused on in terms of high growth areas in established markets. But we're also interested in continuing to build out our presence, our legal entity presence in emerging markets. So no actual change.

And the key thing is that you mentioned about prices, are they more attractive? Clearly, we have seen a softening of prices in the M&A space. But our financial criteria remains very clear and very strict in the sense of we look for return on capital employed greater than by year three. And we look for long-term investments in terms of the NPV [net present value] and the IRR [internal rate of return] of the deal.

So I think that the good news is we've developed a very strong track record now in M&A. I think the Healthpoint acquisition we've delivered returns greater than that that we expected in terms of what we modeled. And similarly with ArthroCare we've turned a very low single digit growth business into double digits. So great success I think on the M&A front. And just a general continued interest in looking for M&A targets."

Julie Brown, Smith & Nephew CFO, according to a Seeking Alpha transcript of the company's first quarter earnings call

             

Get inspired to innovate in medtech at the MD&M East Conference, June 14-16, in New York City. 

[Image courtesy of DIGITALART/FREEDIGITALPHOTOS.NET]