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Articles from 2014 In July


6 Ways Laser Processing Can Overcome Braided Polymer Shaft Challenges

By Matt Johnson, Resonetics

Medical device engineers thrive on challenges, especially when they can arm themselves with highly-advanced technology to solve them.  One of the toughest challenges is to machine braided polymer shafts, designed to have the flexibility to navigate through tortuous, often lengthy vasculature and the radial strength to avoid kinking or collapse. Laser micromachining offers the precision and capability to machine braided polymer shafts of a variety of different configurations and material types.

Braided polymer shafts consist of a woven material, typically stainless steel, which is thermally bonded to the surface of a polymer catheter. Often, there is an innermost polymer layer inside the metal braid. Each braided shaft design has a number of composition characteristics including type of material, number of layers, outside diameter, wall thickness, number of lumens, pic count and durometer. Any laser processing of the shafts has to take into account all of these characteristics.

Laser micromachining is a proven method for machining braided polymer shafts, offering the following advantages:

  • Intelligent--The process discriminates between soft polymer layers and hard metal braids, unlike most other processes;
  • Clean--Because it is a non-contact process, it minimizes damage or contamination compared to traditional methods such as grinding or mechanical drilling;
  • Economical--It's a cost-effective manufacturing process because it uses a large area beam or multi-beam process to reduce processing time;
  • Quality--It's also a high precision tool offering excellent repeatability, consistency and yield (even if the raw material has variation);
  • Precise--It possesses high resolution and tolerances that can be as small as 1 micron.

Due to the varied material type of the braided shafts and the order in which they are layered, different laser sources are needed for different shaft configurations. Selecting the right laser source (nanosecond, picosecond or femtosecond) is the first step, followed by the selection of the proper wavelength (UV, visible, infrared), machining method (mask projection, direct write) and process paramete

One of the interesting aspects of braided catheters is the unique composition of polymers and metals, which have very distinct chemical and physical characteristics. Although metals can be formulated to behave like polymers, and conversely, polymers can be formulated to have similar traits to metals, no one will deny that polymers and metals are vastly different. This dis-similarity presents challenges to many manufacturing methods that laser micromachining--in many cases--has overcome.

Here are six applications that incorporate laser micromachining to successfully process braided polymer shafts:


Resonetics Selective Laser Ablation of Outer Polymer Layer
Selective laser ablation of polymer material. Image courtesy of Resonetics

1. Selective Laser Ablation of Outer Polymer Layer 

Selective ablation of a specific location of a polymer-coated shaft is achieved by shaping the laser beam into a specific spot size (such as a 75mm long rectangular line) and ablating just that area. Patented homogenization technology greatly expands the laser beam size on target and guarantees +/- 5% energy uniformity, making laser micromachining a compelling and cost-effective manufacturing method.
 
Camera and machine vision systems help direct the laser to the right location, referenced from the edge of the shaft or the transition zone (unstripped to stripped region).
 

2.  Controlled Depth Ablation

Controlled depth ablationcan be achieved by using a closed-loop end-point-detection method that detects material removal and discretely controls the laser dosage. This patented technique permits the partial ablation of a polymer layer to expose the top crests of the underlying braided shaft. This method can also be used for ablating 100% of a polymer coating from a thermally-sensitive metal braid that cannot withstand over-pulsing. Closed-loop manufacturing processes guarantee process repeatability and maximize yield, even if there is lot-to-lot material variability. Widening a process window reduces manufacturing cost and increases overall quality.

Using machine vision and multiple lighting schemes, the laser can drill in-between the checkerboard pattern of a polymer-coated metal braid without touching the edges of the braid. Despite the variations in the size of the braid opening and spacing, intelligent machine vision provides real-time data to the laser controller to place the laser beam in the right location.

3. 100% Ablation to Expose Underlying Metal Braid 


Resonetics Laser ablation removing all polymer material
Laser ablation removing all polymer material. Image courtesy of Resonetics.

Some of the most challenging cases are when the laser must selectively machine a polymer without affecting the underlying metal, or when it's necessary to machine metal without disturbing the underlying polymer. This requires precise process control, much like a surgeon's fine touch to use a scalpel to expose the tissue layer-by-layer. As an example, a laser can remove polyimide from a braided shaft while leaving the metal completely untouched and 100% void of debris.  The laser is able to accomplish this because the two materials have dissimilar characteristics. The ablation threshold to etch a polymer is an order of magnitude less than to ablate metal. Once the laser has etched through the polymer laser, the beam can hit the metal layer for additional pulses (+10%) without any damage.  Precautions are also taken to minimize discoloration and to eliminate any heat affected zone (HAZ) that may occur from beam scatter off the metal braiding.

4.  Laser Cutting Polymer Coating and Metal Braid

Laser micromachining a composition of polymer and metal is a significant technical challenge. In order to drill through the polymer-coated metal braid, the laser must operate at high fluence (energy density) to cut through the metal, but this intensity will undoubtedly melt the polymer. If the laser intensity is reduced, then the laser drills through the polymer without melting, but the laser may not have enough intensity to cut through the metal. Proprietary laser micromachining techniques solve this issue using novel laser sources and closed-loop processes. As an example, early detection of the next material type could tell the controller to slow down the laser repetition rate or decrease the intensity or conversely, the opposite command could be given. Cryogenic cooling methods could assist in minimizing thermal damage when laser ablating polymers while still having the intensity to cut through the next metal layer.

5.  Laser Cutting Polymer Coated Metal Braid, Not Innermost Polymer Layer 


Resonetics Rotational laser-cut polyimide and stainless steel braid leaving PTFE untouched
Rotational laser-cut polyimide and stainless steel braid leaving PTFE untouched. Image courtesy of Resonetics.

An even more challenging application is to laser-cut through a polymer-coated braid but not touch the innermost polymer layer, such as PTFE. The PTFE liner creates a very smooth non-reactive inside diameter surface and helps maintain the flexibility of the braided shaft. The laser must not melt the outer polymer coating, yet it must be intense enough to cut through the metal braid and not harm the supporting polymer material below. Contending with three dissimilar boundary conditions of varying material and optical properties--with varying energy levels at which the molecular bonds will break--requires careful selection of the right laser wavelength, pulse duration and process parameters. 

6. Laser Drilling all Layers

In addition to all the choices for laser cutting, you can also laser-drill through the outermost polymer layer, the metal braid and the innermost polymer layer. In this process, lasers can drill through a tri-layer of polymer/metal/polymer with minimal melting of polymer and debris (slag) along the edges of the metal braid. This process is similar to drilling a bi-layer of polymer and metal.

Take precautions, however, to minimize the debris coming out the backside, as this is not acceptable for many applications. Gas assist, debris extraction and flushing are a few examples of methods that can help contain or eliminate debris.

Refresh your medical device industry knowledge at MEDevice San Diego, September 10-11, 2014.

In Summary...

The complexity of braided polymer shafts poses a manufacturing challenge for the medical device community. The distinct properties of polymers and metals, increasingly arranged in composite, layered configurations requires a manufacturing technology that must discriminate between them while precisely controlling the depth and location despite variation in coating thickness, pic rate, braid opening size and inside diameter. Laser micromachining is a compelling, cost-effective, repeatable and consistent process to solve product development challenges and to scale up for volume manufacturing.

Matt Johnson is an application engineer at Nashua, NH-based Resonetics.

Hospital Supply Chain Managers to Device Vendors: Don’t Just Sell Us More

Hospital Supply Chain Managers to Device Vendors: Don’t Just Sell Us More

In a recent conversation with a device industry professional, it became clear how the reality on the ground for device vendors has shifted in the last few years.

The gentleman enlightened me that the nonprofit Fairview Health Services, a large health system in Minnesota, had dramatically reduced the number of orthopedic vendors.

“I would love to know why they did that,” said Shaye Mandle, President & CEO of Lifescience Alley, in a recent interview.

Mandle knows the answer of course - every hospital and health system in the country is scrutinizing costs, and in many cases either pressuring vendors to lower their cost or share in some operational risk.

Nonetheless, it’s still an interesting exercise to know how hospitals are making these decisions.

Fairview is one of the the three largest health systems in Minnesota, along with Allina Health and the Mayo Clinic, according to Allan Baumgarten, a health market consultant based in Minneapolis. In 2012, Fairview had revenue of $2.1 billion, excluding revenue from physician clinics, and profits of $169 million, according to an analysis by Baumgarten.

In December 2012, Fairview Health Services started a new contract whereby at two hospitals the health system cut its orthopedic trauma vendors, which excludes makers of joint replacement products, from four to two said Sue Walters, Supply Chain Integration Project Manager. [Turns out that Mandle had different info - he said Fairview reduced 13 vendors down to 2, which he found shocking.]

Starting in January 2013, the health system also cut stent vendors from three to two,  Walters said. She declined to name who the winning device vendors were for ortho trauma and stent contracts, but added that the process followed for each category was quite different.

In general, there are two contracting models that Fairview follows. One is the so-called all-play model where all vendors’ products are used at different hospital sites allowing for a certain amount of physician preference, Walters said. Where possible, the hospital also makes an effort to review outcomes data of different devices to make sure that there are no major variations between them.

The other contracting model is the primary-source or dual-source method of contracting where the goal is to reduce treatment variation, ironically also in products that show no major variation.

The stent contracts followed this latter model.
“We saw that there were significant variation in price of products but they were comparable in terms of clinical outcomes," said LeAnn Born, Vice President of Supply Chain at Fairview. "For cardiac stents there are a limited number of vendors and there is clinical research and some comparative effectiveness to suggest that there is lot of similarities in the product that the limited number of vendors offer. So it makes sense to reduce the number and know what price points are and know that the prices are comparable."

So, the health system worked with physicians to review the products and tapped into its group purchasing organization to access clinical research data and comparative effectiveness information.

In the end, it wasn't that one device vendor's stents did not measure up and that was the one that lost contract, Walters said.

"The other two vendors were a little more aggressive in their pricing," she said. Fairview purchases about 1,900 stents a year.

The top stent makers worldwide are Abbott, Boston Scientific and Medtronic.

For the orthopedics trauma contracts, a different process was followed. That's mainly because orthopedic trauma products are not standardized in the same way as stents are.

"It seems like in today’s world, there’s still a little bit more physician preference around that trauma piece as compared to the there being more standardization that’s been done industrywide on the stent side," Born said. "One hip implant isn’t exactly identical to the next one because of how you got into that situation."

Therefor, Fairview worked with eight physicians who heard presentations from several orthopedics vendors both about product and service capabilities. They also took into consideration pricing of products, Walters said. 

"The physicians made the decision based on the breadth of the product line that these two vendors had. Service was very important to that." she noted. 

Last year, Fairview saw significant cost savings from this new contract = In 2013, savings from reduced number of orthopedics trauma vendors exceeded $350,000.

"I would say almost on any project that we work on, we try and save between 5% and 15%," Born explained, noting that physicians' readiness to work with health systems to tackle costs and treatment variation were key in providing good quality care to patients while managing costs.

Ultimately what they want from device vendors is not for them to push product and sell more but to take a partnership approach. She pointed to a partnership model involving Covidien, the medtech company that sells higher risk surgical products as well as commodity items such as electrodes, underpads, bandages and the like. This partnership included the latter group of commodity products.

"We have identified a variety of products that we purchase from Covidien and we’re trying to move from a relationship where they try to sell us more to a relationship where they help us more appropriately utilize their products," Born explained. "Covidien is going at risk with us. So there’s an amount that we’ll pay for an appropriate amount of product. if we use too much, then they lose out. If we use too little but deliver the same patient outcomes, then we both won. It puts an incentive on them helping us appropriately utilzing their products rather than them having an incentive to sell more."

[istockphoto.com user nui7711]  

-- By Arundhati Parmar, Senior Editor, MD+DI
arundhati.parmar@ubm.com

The Secrets to Assembling the Right Molding Team

When it comes to molding a medical device component, thorough preparation is of the utmost importance. This requires that the medical device firm has the best-possible team in place--both internally and in terms of the suppliers they do business with, says Phil Katen, the president of Plastikos (Erie, PA), an injection molder offering tight-tolerance parts for the medical and electronics industries that works hand in hand with sister company Micro Mold, a mold-maker. 


Phil Katen
Phil Katen, president of Plastikos

MPMN: What strategies work best to ensure that the proper material is being selected for a molded medical device component?

Katen: The medical device OEMs strive to find a fairly common, readily available (off-the-shelf) grade. If at all possible, steer away from custom grades. Price is one reason for this. More custom blends can drive the material's price up and the availability could be a question depending on how much of that grade the raw material supplier sells.

Here's a specific example: One of our customers is a global medical device company. They had a transfer project with a spec'ed out niche grade material. We reached out to material supplier to get that custom grade as there was only one source that produces and sells it. It came to light that only two companies were using that specific grade of custom grade raw material. The other customer that used this material, their demand dropped. And the price of the material went up approximately by 50% as a result of that.

The other part was that the company offering this material had jacked up the minimum order quantity for it. The minimum you could order was a rail car, which have lasted us 500 years or even longer. That was beyond crazy.

Our customer found themselves in between a rock and a hard place. They had written agreements that precluded them from switching material. They were in a near impossible position. We were able to work with the raw material supplier and get one gaylord of material from that other user of material--I believe in Europe--that would last for about two years of production.

Our customer looked at their clients that used those components and worked to requalify the device using an alternate grade of material. It was a slightly different grade that was much more common. No one knew why the exoctic grade was spec'ed initially. The material performed well and met all of the performance and testing requirements, but it was a very time consuming and stressful process to find enough for manufacturing. This was driven by the fact that once something is qualified in production, it is very difficult to change it down the road.

This goes back to getting the experience of a cross disciplinary team to select that material to meet the requirements and to make sure that it is readily available now and in the future and that it can be processed very well by the molder. When OEMs do that, they set themselves up for the greatest chance of success.

molding
Plastikos and Micro Mold have longstanding relationships with medical device OEMs. Image courtesy of Plastikos.

MPMN: How can medical device companies ensure that their components conform to Advanced Scientific Molding principles?

Katen: Any medtech company definitely needs to perform their due diligence up front and seek out the best suppliers. Throughout the process, they should periodically reevaluate those suppliers to make sure their standards are being met. It comes down largely to selecting the right suppliers up front. The OEM or any company should seek out the very best suppliers available and treat them as a strategic asset. Actions speak louder than words.

One of our global medtech partners not only talks the talks but walks the walks. They tell us that they view us as a strategic asset and don't want their customers to know we are doing business with them. They don't want their competitors to gain the advantage.

In the relationship between the device OEM and its strategic partners, a positive mindset is key--I would argue essential. The supplier should be viewed very much as part of the team. Some companies view their suppliers as a necessary evil or a line item with the goal to continuously reduce that cost. You can tell pretty quickly whether engineering and quality really drives the company or if it is finance and accounting driven. You can tell who has the decision-making authority.

Here at Plastikos, I will be the first to state that it is our goal to retain and recruit the best people from entry people to managers. Both at Micromold and Plastikos, we stack our team with all stars throughout the organization. ... It makes it rewarding to work with winners. This is the same as with our suppliers. The companies that help us maintain our facility are the very best. We put the best team on the field.

That same vision can and should be applied by medical device OEMs when they are doing their due diligence and looking for suppliers. In the medical industry, open honest communication is key to success.

True partnership is key to collaboration. In reality, we work together towards common goals. The most successful projects were viewed as though they were employees of the OEM company. Of course, we are not, but that mindset is really key.

On the flipside, there are other companies that talk the talk but may not walk the walk. They may cut corners on tooling or push us to got to low-cost tooling sources. ... The wrong perspective is that we should cut costs. It is ultimately putting the team on shaky ground at best if not a near impossible position. ...

Another case that doesn't lead to a good collaboration is when an OEM comes to an injection molder in a competitive quoting process and asks the molder to reduce the cost of the project. That doesn't strike the right tone. It is different if the engineers at the company has an idea of using alternate materials or eliminating features that would reduce the overall cost of a project.

It goes back to that perspective of treating everyone as if they are on the same team. Treat the supplier's team as as your employees.

It is also important to watch out for mixed messages--both verbal or written.

Once we had a meeting with a supplier manager who gave us all-around positive accolades for the past three years we had been running production of the mold. He said good things about the team and visibility throughout the production. Then, 5 minutes later we move onto the next project, he leads it off with a suggestion to work with low-cost tooling suppliers. This was 180 degrees different than what we just talked about. How can we do a good job when we have C- or D-quality players in the mix?

The further you venture from home to get low cost, the frequency of problems tends to increase. Even domestically, there are poor companies that don't have the engineering or technical capabilities to deliver for their customers.

Ensuring that you are working with a company that has a solid grasp on Advanced Scientific Molding principles goes back to that due diligence. Don't just take their word for what they say. If they are implementing cutting-edge technology, they should be able to show you examples of that. They should be able back it up with proof. Every one of our partners does a manufacturing / engineering audit. In some cases, there are concrete proven examples that back up the claims we make and demonstrate that we live the principles we strive for every day.

Refresh your medical device industry knowledge at MEDevice San Diego, September 10-11, 2014.

MPMN: About two years ago, you wrote a column reflecting on the intersection of the electronics and medical device industries. If anything, those two industries are cross-pollinating now more than they were then. What advice would you have for medical device companies designing consumer-inspired products?

Katen: I think ... you touched on a great topic. You see more devices weave in high tech electronics. You are seeing devices pushed into the home and outside of the home--into the sphere of life. Performance is critical for these products.

The other element is the elegant design that we are seeing more devices take on. Devices are being pushed out into the world at large. Life pushes a lot onto people every day. Devices have to be rugged and durable and as error-proof as possible in their end use. On the flip side, they should be easy to use.

The other element is that elegant simple design. If it has electronic components, it has to feel right. I am a big fan of Apple. The iPod through the iPhone and iPad are groundbreaking products. When you get an Apple device, even the box was thought out and well designed. Attention to detail was put in by the designers. The look and fit was just right. Apple notoriously is known for simple, easy to use, largely intuitive devices. ...

That is really where electronic devices and medical devices--and the intersection--is continuing to go. At Apple, from one generation to the next, the original versions that were so innovative, compared with 2 or 3 more innovations, they look big and clunky. Even since then, you continue to see that design evolution that makes them more seamless and elegant.

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

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How Medical Device Tubing Is Processed

Check out the following video highlighting a high-speed medical device tubing line. Shot by extrusion-equipment provider Milacron LLC (Cincinnati), the video shows a PAK350 medical extruder running at 500 ft/min. Among the company's offerings are extruders and extrusion lines for manufacturing a range of tubing, including small catheters, single-lumen tubes, draw-down tubing for vascular applications, multilumen tubing, and dialysis and drug-delivery tubing.

Bob Michaels is senior technical editor at UBM Canon.

bob.michaels@ubm.com

A Robotic Electrode System That Interfaces with the Brain

Have you heard someone say their brain is like cheese? Actually, it's more like Jell-O, and hyper-vigilant Jell-O at that.

The brain moves continuously in response to bodily movements and breathing patterns, making it exceedingly difficult to track electrical signals that pass from one cell to another. In addition, brain cells attack intruders--even the thinnest of probes - and barricade them from the electrical signals that researchers are trying to understand.

Brain Sensor
Sandia scientist Murat Okandan demonstrates one of the microscale actuators used in the research.

Lack of communication between brain cells can cause slurred speech, unresponsive muscles and memory loss, which affect millions of people. Experimenters have found that even a thin wire probe made of sharpened metal is too big and cumbersome to reliably retrieve strong signals from neutrons.

A pair of researchers at Arizona State University in Tempe, AZ, and Sandia National Laboratories in Albuquerque, NM, has been working with microscale thermal actuators and microelectrodes built at Sandia Labs to interact with brain cells while animals are awake, with minimal damage to surrounding tissue.

The microelectrodes are made of highly conductive polysilicon, almost metal-like in its conductivity, but durable enough for millions of cycles, the researchers found. It provides a signal-to-noise ratio much greater than previous wire probes and provides high-quality measurement signals, according to a press release from Sandia, a wholly owned subsidiary of Lockheed Martin Corp. that works for the U.S. Department of Energy's National Nuclear Security Administration.

Their research may lead to better understanding of how neurons and brains work, leading to new prevention, diagnostic and treatment techniques for humans. Researchers at MIT have also been working on brain cell communication research.

"We are working to develop chronic, reliable, intelligent neural interfaces that will communicate with single neurons in a variety of applications, some of which are emerging and others that are closer to market," said researcher Jit Muthuswamy, an associate professor of biomedical engineering at Arizona State University. "Applications like brain prostheses are critically dependent on us being able to interface and communicate with single neurons reliably over the course of a patient's life."

Muthuswamy has been working with Sandia engineer Murat Okandan since 2000.

"The process flow we use to make these isn't available anywhere else in the world, so the level of complexity and mechanical design space we had to design and fabricate these was immensely larger than what other researchers might have," Okandan said.

He and Muthuswamy are working on producing richer data with resolution in the submicron range so they can take measurements inside cells. They also are working on stacking the existing neural probe chips and decreasing the spaces between probes.

"By building a three-dimensional array, we would have access to significantly more information, rather than just a slice," Okandan said. "We're very encouraged by the progress we have made, and are looking forward to building on that progress."

A separate group of researchers, funded by the military, is working on developing brain-restoring brain implants.

Refresh your medical device industry knowledge at MEDevice San Diego, September 10-11, 2014.

Nancy Crotti is a contributor to Qmed and MPMN.

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The 10 Top Medtech Stories of 2014

Medical Device Recalls and FailuresContent related to the topics of recalls and failures have proven to be of considerable interest to our audience.In 2014, there have already been several medical devices that have been subject to multiple serious recalls. A post titled "5 Most Recall-Prone Medical Devices" rounds up the most notable of these.A related piece titled "7 Recent Medical Device Failures Catching FDA's Eye" lists inadequate instructions, component issues, and assembly errors as some of the problems behind several notable Class I recalls.Related Content:7 Recent Medical Device Failures Catching FDA's Eye5 MedTech Firms with the Most Recalls9 Ways Medical Devices Fail>>Next

The 10 Top Medtech Stories of 2014

Medical device failure, the money, the history, the important medtech locations—Qmed readers have responded to grand themes so far in 2014. And why not? A great theme is an important part of a great story.

Read on to find out what Qmed stories have been read the most so far in 2014.

Refresh your medical device industry knowledge at MEDevice San Diego, September 10–11, 2014.

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

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Image courtesy of Flickr user Antonio Casas

Top Medtech Breakthroughs of July

Top Medtech Breakthroughs of JulyFrom using Google Glass as a neural interface to utilizing heat-seeking missile technology for malaria detection to fly-inspired hearing aid technology, there were plenty of amazing medical technology breakthroughs to report on in July.Read on to find out more: Using Google Glass as a Neural InterfaceRefresh your medical device industry knowledge at MEDevice San Diego, September 10–11, 2014.Related ArticleTop Medtech Breakthroughs of 2014 (So Far)Chris Newmarker is senior editor of MPMN and Qmed. Follow him on Twitter at @newmarker.Like what you’re reading? Subscribe to our daily e-newsletter.

Top Medtech Breakthroughs of July

From using Google Glass as a neural interface to utilizing heat-seeking missile technology for malaria detection to fly-inspired hearing aid technology, there were plenty of amazing medical technology breakthroughs to report on in July.

Read on to find out more: Using Google Glass as a Neural Interface

Refresh your medical device industry knowledge at MEDevice San Diego, September 10–11, 2014.

Related Article

Top Medtech Breakthroughs of 2014 (So Far)

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

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Smith & Nephew Wary of 'Mega-Merger'

London-based Smith & Nephew plc, frequently brought up as an acquisition target, is going its own way, according to a report in the Telegraph.

Since his arrival at the company in 2011, CEO Olivier Bohuon has been redirecting the company's emphasis on hip and knee replacements toward innovations in one of its oldest businesses--wound care. It's not sexy, but it should be big business as Baby Boomers age, particularly those with diabetes.

Smith & Nephew's dressings have chips that alert the physician when the patient should have them changed, according to the Telegraph article. It also produces a line of gauzes that can cut in half the time it takes a serious wound to heal by applying suction to the surface of the dressing to encourage blood vessel growth beneath the wound. It branched into using living cells to accelerate healing following the 2012 acquisition of Texas-based Healthpoint Biotherapeutics.

To increase market share, Bohuon began targeting emerging markets for the company's products, centralizing R&D and manufacturing facilities and eliminating hands-on company technicians who come with its high-end products. Smith & Nephew recently began targeting existing markets--including U.S. hospitals--for such no-frills service, the Telegraph story said.

This latter strategy contrasts with Medtronic's (Minneapolis, MN) emphasis on providing complementary services as it transitions from being merely a medical device maker to what it calls a chronic disease management company. In August 2013, Medtronic purchased Cardiocom for $200 million in cash to expand into chronic disease management. Last year, Medtronic also announced that it had a formed a business unit to help hospital cardiology departments more efficiently.

Medtronic, along with Stryker, was rumored to be interested in acquiring Smith & Newphew. Despite initial reports, Stryker downplayed its interest, saying in May it had decided against making a bid. Medtronic, on the other hand, will likely shy aware from new M&A activity as it is busy working to see that its proposed acquisition of Covidien actually goes through as the United States cracks down on U.S. companies relocating their headquarters abroad to save on taxes.

That's probably just fine with Bohuon, who also told the Telegraph he's not interested in a mega-merger. Bohuon criticized such tax-driven deals as "defensive."

Refresh your medical device industry knowledge at MEDevice San Diego, September 10-11, 2014.

Nancy Crotti a contributor to MPMN and Qmed.

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The Medical Device Is Safe, But Would I Use It?

The Medical Device Is Safe, But Would I Use It?

By Martin Bontoft

Thinking carefully about how physicians and patients view medical devices can yield useful design insights.

Most companies understand why they need to invest in ensuring that a medical device is as safe and effective as possible. Regulatory-focused human factors work is mandated, after all. The processes to ensure safety and effectiveness are systematic, mature, and relatively well integrated into medical device development.

But the human factors activities that deliver safety and effectiveness do not necessarily deliver a good user experience or, ultimately, a good product. In fact, some industry experts have observed unintended consequences of regulating human factors and design: Regulated activities can crowd out unregulated efforts to improve device design, and consequent increases in safety and effectiveness may be at the expense of user experience.1 In other words: The device is safe, but would anyone actually want to use it?

The activities that do deliver a good user experience are not as mature—at least, within this industry—or as well integrated into marketing and product development. Nor is their financial case well understood. Because the cost of developing a medical device is high and likely to rise further, the allocation of development money is likely to be placed where the return on investment is greatest.

As such, human factors professionals have a job to do: help the industry understand why a good experience matters. We need to establish a body of evidence that justifies expenditure on those activities and devices that fall outside the sphere of regulation in order to improve user experience and market acceptance.

Case Study: Exubera Inhaled Insulin

Among the most prominent examples of an FDA-approved product that failed to gain adequate market acceptance is Pfizer’s Exubera inhaled insulin delivery system. Launched in 2006, the novel concept was the result of more than 10 years of development. Exubera was touted as a game changer and predicted to be a $2-billion-per-year product by 2010. In its first year, however, the product made only $12 million and was withdrawn from the market soon after, leaving a $2.8-billion hole in Pfizer’s balance sheet.2

On the surface, Exubera looked like a winner. The device safely and effectively delivered insulin, and it did so rapidly and with minimal risk. Moreover, insulin delivery via an inhaler provided a seemingly attractive alternative to injectable insulin by eliminating the pain and inconvenience of needles.

But the several large pharmaceutical companies involved in Exubera’s development failed to spot the warning signs and piece together the evidence to suggest that the product may not reach anticipated volumes.

From the perspective of the prescriber, inhalable insulin represented a dramatic step change that deviated far from clinicians’ comfort zones and knowledge base amassed during the era of subcutaneous insulin delivery. Yet, this was not matched by a similar step change in efficacy; the bioavailability of the drug was much lower and much more variable, depending on user technique. It also came with the worrying introduction of new side effects.3 

In the end, the negative aspects of the product outweighed the advantages. It soon became clear that the device, though designed to be safe and effective, was nowhere near as small and discreet as a modern insulin pen. The delivery system was large and cumbersome, and looked troublingly similar to drug paraphernalia.2 Additionally, the dose was delivered via blisters, which were measured in milligrams rather than the “units” that were the basis of patients’ prior knowledge and skill, and delivered a far lower control resolution.

Designers also neglected to realize that many people with diabetes are not particularly concerned about injecting themselves. They do, however, actively dislike the regular finger pricking required for blood glucose testing, which this system did not address. This new mode of delivery didn’t even entirely replace injections; basal insulin—rather than postprandial—still required injection.

The Importance of User-Focused Research

Tactical, device-focused human factors work aimed solely at regulatory success could potentially develop the evidence to inform the type of situation that occurred with Exubera. But, on its own, this type of work may not be enough to change minds or direction for the following reasons:

  • It occurs after the decision to invest in a device type has been made and after considerable costs have been incurred.
  • It typically does not reach the decision-maker audience; it is considered tactical and not strategic.
  • Human factors professionals, like designers, want to improve the design of products; they will move heaven and earth before they admit defeat.

Because of these factors, the best approach is to conduct user-focused research in conjunction with device-focused user research. Design research includes a range of techniques that provide insights about people—not just users—and that do not require, or even presume, a device. This approach yields evidence that is likely to be relevant to device developers, but it is also relevant to a wider range of stakeholders. It will tell you, for example, not only whether people are likely to want your product, but why or why not, input that is essential to good product development.

Techniques inspired and informed by ethnography, such as contextual inquiry and design ethnography, are key to successful user-focused research. Both of these ethnographic field research methodologies seek to understand and explain—and thereby predict—user behavior, even though that behavior may seem inexplicable and even irrational. However, contextual inquiry best describes the research activities focused on people in a specific context of use, such as an operating theater or with a legacy device, such as an injector. Design ethnography, on the other hand, is slightly more open-ended, less focused on an existing context, and more likely to look obliquely at peoples’ existence, perhaps because the device or context of use is so new.

Colloquially known as “deep hanging out,” these observational research techniques are not as easy as they may seem.4 Researchers immerse themselves in the milieu of interest and attempt to understand the way things are through experience and questioning. Critical to this tactic is researchers’ ability to make themselves open to the meanings, categories, and framework that others apply to things, which likely differ from the meanings they and other stakeholders apply.

It is through these meanings that we achieve the true value of user-focused research: We understand why people want our designs. With this knowledge, we can predict—or at least speculate about—incremental design improvements and new products and categories.

For example, on a design research project, I was observing total knee replacement surgery and looking for opportunities to improve the design of the instruments used to install the knee joint. The patient in this case, who had a spinal anaesthetic and was conscious, was asking the surgeon about all aspects of the operation. The surgeon, unaccustomed to this level of interest, warmed to the task and, in an atypical move, showed the patient the knee joint before implanting it. The patient, in response, was clearly moved by the exotic nature of the materials, the meticulous level of finish, the evident science behind its design, and the skill and attention of the surgical team.

For me, the replacement knee was something that fitted to the instruments. For the surgeon, it was something that had to be protected and installed precisely. But for the patient, it embodied something altogether different: care, mobility, and freedom from pain.

This is more than an anecdote; it is an example of how ethnographic field research yielded some important design opportunities at the tactical and strategic levels. Three people shared the same experience and had three completely different perspectives. It is only by valuing and integrating all of them that we fully understand the user-centred perspective on our designs.

We considered, for example, that the rehabilitation of this patient would be affected by the emotional connection he now had to that device. In turn, he would trust that implant and challenge himself to use it to its fullest, engaging in his rehabilitation and, consequently, improving surgical outcomes. Further, if this is true for him, it may be true for others. And all of this is testable.

If these suppositions were true, what could the implications be? Tactically, the packaging had never been designed to support end-user engagement and rehabilitation. A simple design exploration project could be initiated to quickly develop packaging concepts from this new perspective and judge their relative worth.

More broadly, how else could the device maker support the surgeon and team in managing the negative, as well as the potential positive, psychological impacts of this surgery? The device is clearly implicated in this, but what else affects the patient’s mind-set and how could these things be influenced?

Further, does the device maker simply want to sell product, or is there a higher value role available here? Would it be interested in becoming the emotional and intellectual partner of the clinician in an effort to improve outcomes? There may be exciting new positioning as a result.

This kind of thinking also makes us more relevant to an increasing number of stakeholders, such as payers. It may provide more opportunities for meaningful conversations, a wider set of relationships, and sell more product.

Conclusion

By observing the use environment and being sensitive to what is happening, design researchers can spot signals and extrapolate them into new opportunities—whether simply useful or transformational. At the same time, we also achieve the tactical, or device-focused, aims. We will see the coping strategies employed by people using the equipment and can extrapolate those into human factors and design opportunities.

Companies that explore this type of work will discover for themselves the potential value in new ideas and perspectives. Human factors professionals have to make it easy for them, though, by making the focus on user experience as accessible as they have made the concept of safety and effectiveness while illustrating the value of doing so.

References

1. Stephen B. Wilcox, “Relying Exclusively on Trial and Error Makes No Sense,” [online] (Santa Monica, CA: Human Factors and Ergonomics Society, 2013 [cited 6 May 2014]); available from Internet: http://www.hfes.org/web/HFESMeetings/HCSPresentations/hcs2013wilcox.pdf.
2. Avery Johnson, “Insulin Flop Costs Pfizer $2.8 Billion,” in The Wall Street Journal [online] (New York, NY: News Corp., 19 October 2007 [cited 6 May 2014]); available from Internet: http://online.wsj.com/news/articles/SB119269071993163273.
3. Lutz Heinemann, “The Failure of Exubera: Are We Beating a Dead Horse?” in Journal of Diabetes Science and Technology, (Foster City, CA: Diabetes Technology Society, May 2008 [cited 6 May 2014]); available from Internet: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2769732/.
4. Clifford Gertz, “Deep Hanging Out,” in The New York Review of Books (New York, NY: The New York Review of Books, 22 October 1998 [cited 6 May 2014]); available from Internet: http://hypergeertz.jku.at/GeertzTexts/Deep_Hanging.htm.

Martin Bontoft is head of design research at Team Consulting Ltd.

FDA Plans to Close 510(k) Loophole

Medtech manufacturers may soon have clearer guidelines on how to get their products through the FDA's 510(k) process--with the changes meant to address the widespread criticism of the regulatory pathway in recent years by Congress, consumer advocates, and others. The FDA's new final draft guidance, issued July 28, was revised to avoid situations in which risky products such as metal-on-metal hip replacement and vaginal mesh are cleared on the assumption they are similar to other products on the market deemed to be safe. Both of those products cleared via the 510(k) pathway and have resulted in widespread injuries and lawsuits. In the document, FDA explains that guidance was created "in order to improve the predictability, consistency, and transparency of the 510(k) premarket review process." The document does so by updating the definition of substantial equivalence, in which devices can be cleared based on similarity to products already for on the market. In the past, under the 510(k) process, a device firm would claim that a new device is substantially equivalent to another device on the market that was technologically similar--on top of another existing device that had the same intended use. Called "split predicates," such arguments were a loophole of sorts to the substantial equivalence definition. But the final draft guidance says: "For a new device to be considered substantially equivalent to a predicate device, the new device must have the same intended use as the predicate device and [FDA's emphasis] the same technological characteristics or different technological characteristics that do not raise different questions of safety and effectiveness than the predicate device. Therefore, the use of a 'split predicate' is inconsistent with the 510(k) regulatory standard." The guidance, however, still allows use of multiple predicates to help demonstrate substantial equivalence in certain circumstances, such as when a device such as a patient monitor combines multiple devices, that are each similar to a separate in-use device that also the same intended use. Manufacturers may also use "reference devices" intended to provide scientific and/or technical information to help address the safety and effectiveness of a new technological characteristic. Reference devices are not predicate devices, and manufacturers may only use them after completing three hurdles in the 510(k) approval process. The FDA originally entrusted the Institute of Medicine (IOM) with making recommendations on how to approve the pathway. In 2011, the IOM concluded that the 510(k) process was so problematic that it should be eliminated. The FDA chose to revise the 510(k) pathway instead, ultimately leading to this final guidance document--which is now under a comment period until October 14. The new guidance also contains new information on special and abbreviated 510(k) programs. FDA promised to finalize those sections later. Manufacturers use the special 510(k) program to modify a previously approved device, and the abbreviated 510(k) program for devices already subject to FDA guidance or standards.

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