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Articles from 2015 In May


Dealing with Electronic Component Obsolescence in Medical Devices

While many consumer devices have lifecycles of 18 months, medical device developers often must deal with lifecycles in excess of a decade.

Larry Bell

Imagine this nightmare scenario: you have placed a purchase order for your electronic medical device from your contract manufacturer (CM), and you get a phone call from that company's customer service representative who explains: "Several parts for your device are no longer available, so we will not be able to fill your last order placed with us. What would you like us to do?"

For many medical device developers, this is no hypothetical situation, but a very real occurrence in which few good options exist. Most people, when faced with this situation, likely faced with a stock-out condition for your product.

Because electronic components obsolescence is an unfortunate reality of our business, Enercon has developed a multifaceted approach to respond to this eventuality.

A Recipe for Obsolescence

Many electronic components have life cycles that are shorter than the life cycle of the end product itself. This is especially true for medical devices. While most consumer electronics have lifecycles of 18 months, many medical devices have a product life in excess of ten years.

Medical devices are typically not fitted with technology upgrades because of the high costs or long development times associated with the new product development cycle. There are often significant challenges to modify, upgrade, and maintain their systems over the life of the device.

Many medical devices are "safety critical", and therefore require time-consuming and costly qualification and certification cycles, even for seemingly minor design changes. As a result, medical device OEMs are more focused on sustaining (manufacturing as well as servicing) their products for long periods of time (often 5-10 years or longer) rather than upgrading them.

Obsolescence issues occur when the 'slow-to-change' medical device industry relies on a supply chain that was originally and primarily developed to support a rapidly changing industry (such as consumer electronics). To compound the problem, the medical device industry typically has less control over their electronic part supply chain because they have relatively low production volumes compared to consumer electronics.

Verification and Validation Requirements

To compound the component obsolescence problem, any change to a medical device design requires an evaluation related to product risk and performance. The change of a critical component would require notification and re-certification with the FDA, and a revisit to the existing 510(k) submission or PMA. Even a relatively straightforward change to replace something such as a touchscreen user interface would dictate new software, and therefore require third-party testing (from groups such as EMI or EMC), potential packaging changes, as well as subsequent verification and validation tests.

In summary, the need to replace a critical component that goes obsolete can be extremely expensive from a resource and time perspective, as well as the cost ramifications of potentially gapping out supply of the product in the marketplace while a solution is secured.

With the obsolescence of a component, a suitable 'drop-in' replacement may be possible. But much of the time, the mechanical packaging of that electronic component has changed, dictating a new printed circuit board layout, and therefore resubmission for EMI and EMC third party tests.

The Risks of Purchasing Obsolete Parts from Brokers

To avoid design changes, there is always the temptation to purchase obsolete components from part brokers. This brings with it the high potential for counterfeit parts to enter the supply chain. The components may look and appear to be the same, but the performance may be substandard or fail altogether in the field. At first, it could appear to be functioning properly, but in actuality may not be providing the validated performance of the original OEM component. If absolutely required, broker parts should be sampled for physical equivalence to validated components. This may not be necessary for consumer electronics, but medical devices are often safety critical, so additional verification testing (cost) must prove that the brokered parts come from the original OEM, and meet original parametric measurements. Medical device companies know well that a significant cost of doing business includes research of potential replacements, sampling, verification, and validation.

A Multi-Faceted Strategy

For new product developments, Enercon has adopted the strategy of identifying components that should be available for a long time. Using an integrated approach--combining available databases along with our internal processes, we identify the precursors to 'End-Of-Life' (EOL) scenarios for components, such as a reduction in the number of sources, available inventory, or price increases. In addition, we avoid single source solutions where possible. If alternates exist, we work to validate these alternatives up front, and note the alternates on specifications.

For current production, we proactively run databases monthly using an automated process. Program managers share any feedback to their customers at the earliest signs of obsolescence.

If we do identify EOL for components along the way, we develop a response strategy with the customer, which typically includes some or all of the following:

  • Purchase additional inventory (life-time buy, last-time buy).
  • Locate alternative components.
  • Prototype and validate alternatives.
  • Redesign with more contemporary components.

If redesign is necessary, we recommend including design-for-manufacturability (DFM) activities and other cost improvement activities to help justify revalidation expenses

With careful planning and coordination, this product life cycle challenge can be successfully managed. By automating many of the processes to identify EOL, potential problems can be identified leaving enough time to identify the best course of action.

Larry Bell is vice president of sales and marketing at Enercon Technologies (Portland, ME).

Why 3-D Printed Skin Makes Sense

The beauty company L'Oreal is tapping the expertise of 3-D printed human tissue pioneer Organovo. We asked an additive manufacturing expert about the potential behind 3-D printing skin.

Chris Newmarker

Derek Mathers
Derek Mathers, business development manager at Worrell Design, thinks the prospect of 3-D printed skin could potentially have vast implications for healthcare.

It is probably one of the most interesting 3-D printing stories so far this year: L'Oreal USA struck a partnership between its U.S.-based global technology incubator and tissue 3-D printing pioneer Organovo (San Diego). The idea is to leverage Organovo's proprietary NovoGen bioprinting platform and L'Oreal's expertise in skin engineering to develop 3-D printed skin tissue for potential products, as well as advanced research.

Organovo already has a track record in the space. With its NovoGen MMX bioprinting platform, Organovo has been focused on creating tissue samples that can be used by pharmaceutical companies in toxicology tests of new drug candidates. Organovo has successfully bioprinted lung, liver, skeletal muscle, cardiac, oncology (breast), blood vessel, bone, and nerve tissue. Its liver model is the furthest along, while its kidney model is next in line.

Qmed recently turned to Derek Mathers, business development manager at Worrell Design (Minneapolis), for some insights about the L'Oreal-Organovo partnership's potential.

Worrell itself has been annovator in the 3-D printing space, working with 3-D printing firm Stratasys to create a 3-D injection molding process that is meant to combine the benefits of the two manufacturing processes.

Here is what Mathers had to say about 3-D printed skin:
 

Qmed: What is 3-D printed skin, and what would it be good for?

Mathers3-D printing human skin tissue is currently administered in two forms: generic human "prototype" skin tissue that doesn't contain specific DNA information, and secondly in patient specific "end-use" skin tissue form that is printed directly onto a burn or skin wound. 

The widespread adoption of generic 3-D-printed human skin tissue (as I call it "prototype tissue") will enable pharmaceutical, cosmetic, and medical companies to rapidly test the impact of their new devices and formulations with real human cells earlier in the development cycle, without the use of controversial human or animal testing. As the cost of printing human tissues goes down and the speed of this process increases, Organovo could be a critical player in accelerating and improving the development of drugs, lotions, and anything topical.

In order to maximize the benefits of 3-D printing--free complexity and customization, the ability to create architecture that isn't possible with other methods, and the ability to manufacture complete assemblies in one print--in any application is to produce end-use, functional parts. This is the driving force behind the industry tripling in five years to $4.1 billion (according to Wohlers 2015) in 2014. 

This is why I am most excited about using 3-D printing to print patient-specific skin tissue back onto wounds, drastically improving the speed of recovery and quality of life of civilians and soldiers alike.
 

Qmed: I'd be interested to hear your thoughts on 3-D printed skin in general, and curious to know what the next step might be.

MathersFrom an immediate market-size perspective, L'Oreal spent $831 million in R&D in 2014. L'Oreal is a perfect example of a customer for the skin sample as-a-service offering.

Comparing this directly to a current customer of Organovo's liver sample service, biopharmaceutical firm Merck, for example, spent $6.5 billion in R&D in 2014 (nearly eight times as much), it appears that the liver service would have a more immediate return (depending on the frequency and amount of each print-as-a-service purchase). This would change drastically, however, if direct 3-D printing of patient-specific skin were to become a quick reality.

All of a sudden, Organovo's market could include the 486,000 U.S. citizens who require medical treatment for burn wounds annually (according to the American Burn Association). In addition, a military contract could be a very lucrative avenue for Organovo since nearly 20-30% of battlefield injuries are from burn wounds.

I spoke with the CEO of Organovo, Keith Murphy, last fall about the incredible things that Wake Forest School of Regenerative Medicine and the U.S. Army are doing with 3-D printing to repair burn wounds incurred by our soldiers--and what he said surprised me. Organovo is already there! They are working with Wake Forest to supply the printing platform for their model of:

  1. Scanning a wound to determine the size and depth.
  2. Taking a small sample of that patients stem cells.
  3. Rapidly growing them throughout the day in a lab. 
  4. Printing-back multiple layers of skin shortly thereafter within a 10 x 10 cm swath of skin. This drastically reduces the amount of time it takes to recover from these wounds, removes the need for traditional skin grafts, and actually improves the scarring or permanent physical effects of the injury.
Hand under a 3-D printer
The Wake Forest School of Regenerative Medicine is exploring the use of 3-D printing to treat burns.

In conclusion, even though the immediate profits from liver samples are important to pharmaceutical development, the likelihood of printing end-use functional livers seems further off than printing patient-specific skin onto wounds for rapid recovery. This is due to the difficulty of printing vascular structures into organs to supply those cells with nutrients.

So, if a consistent and effective method of 3-D printing of human skin onto wounds can be mastered and approved for our military, it will be more quickly be able to revolutionize care for civilians than printing everyone new livers. Although, humans will demand both in just a couple of years 

Refresh your medical device industry knowledge at MD&M East in New York City, June 9-11, 2015.

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

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China Medical Device Official Could Be in Trouble

The Chinese government has mounted an investigation of an official who had served as the director of the China FDA.

Qmed Staff

Tong Min, who had served as the director of the China Food and Drug Administration's department of medical device supervision, had allegedly committed "serious discipline violations," according to the Communist Party's Central Commission for Discipline Inspection on its website Friday.

The move is part of a broader push by the Chinese government to confront corruption. Last year, the Chinese government finedJohnson & Johnson, Bausch & Lomb, and GlaxoSmithKline over price fixing and bribery.

Tong was recruited as the head of China FDA's department of medical device supervision in 2013, after a decade-long stint working in the nation's food safety unit.

China is also attempting to prosecute Wang Yu, the former director of the nation's Health and Family Planning Commission's bureau of medical administration, who helped draft policy and oversaw medical device and drug trials. Yu, who retired last year, had been accused of fostering healthcare-related bribery.

Prosecutions such as those cited above are a part of President Xi Jinping's anti-corruption campaign, which is one of the most aggressive in modern China history, as observed by Bloomberg. The culture of widespread bribery he had inherited had served to put brakes on the nation's growth.

In related news, China has sharply increased the fees needed to register medical devices and drugs, as the country struggles to confront a growing number of applications.

Refresh your medical device industry knowledge at MD&M East in New York City, June 9-11, 2015.

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

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Is There a $500 Million Medtech Deal in the Works?

Becton, Dickinson & Co. appears to be seeking a buyer for its V. Mueller surgical instruments business, according to Reuters.

Qmed Staff

One of the next major medtech deals could involve Becton, Dickinson & Co.

The Franklin Lake, NJ-based medtech company has retained JPMorgan Chase & Co. to assist in the potential sale of BD's V. Mueller surgical instruments business, sources familiar with the matter tell Reuters. (The sources declined to have their names used because the matter is private.)

A BD spokesperson only said that BD is strategically reviewing all its business.

The company could be seeking to sell of non-core businesses after its $12 billion merger with San Diego-based CareFusion, which closed in March.

The CareFusion buy turned BD into one of the 10 largest medical device companies in the world, combining complementary product lineups in the process.

BD makes medical supplies, devices, laboratory equipment, and diagnostic products. Its product lineup includes disposable needles, syringes and intravenous catheters.

With the CareFusion acquisition, BD now also makes include patient identification systems, the Pyxis automated dispensing device, the Alaris IV device, ventilators, skin prep products, infection surveillance systems, and surgical instruments.

Medical device companies have been on a mergers and acquisitions binge of late, partly fueled to meet U.S. health providers' demands for more efficiency and better patient management under Obamacare. Medtech companies with larger product portfolios of devices can better meet such needs. (Think of BD being able to more efficiently supply a hospital operating room now that it has CareFusion's products in the mix.)

Other major medtech M&A deals include including Medtronic's $48 billion purchase of Covidien and Zimmer Holdings' upcoming $13.35 billion acquisition of Biomet.

Refresh your medical device industry knowledge at MD&M East in New York City, June 9-11, 2015.

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

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New Technology Aims to Make Insulin Pumps More Reliable

New Technology Aims to Make Insulin Pumps More Reliable

Insulin pumps have seen innovation in recent years with Tandem Diabetes coming out with the first touchscreen insulin pump - the tslim.

However, on the infusion set side - the accessories that actually deliver the insulin to the body from the pump - there hasn't been that much new in the last 15 odd years or so, says Brian Roper, global market segment leader for infusion sets at Becton Dickinson.

"The features that have changed are really around convenience," Roper says in a recent interview pointing to different colors that are now available as well as the fact that they now come with a disposable inserter which eliminates the need to manually push the catheters in.

But insofar as improving insulin delivery or making diabetes management easier and more reliable, no major change has occurred. Becton Dickinson is hoping to alter that landscape with the official launch of its FlowSmart infusion set technology.

The product was cleared by the FDA in mid May. 

Roper explains that insulin flow is sometimes interrupted because of current design of infusion sets and patients ends up with unexplained hyperglycemia.

"What our research had shown is that there will be periods where the pressure is rising in the pump," but because it doesn't reach thresholds set by the pump, no alert is triggered.

In other words a "silent occlusion" is occurring and patients checking their blood glucose levels will see their blood glucose rise but they won't know why.

"They go through the mental checklist- 'I didn’t eat anything unusual. I think I counted my carbs right. I think I did my exercise right. I don’t feel sick today,' " but despite all that the levels are high.

These problems are caused by design of the infusion sets, Roper says.

"It could be the position that they are sitting or laying at night - Is the catheter being pushed in a direction or is it pushing up against muscle or tissue?" Roper explains. "There’s a lot that occurs in the catheter that is unknown to the patient."

Becton Dickinson in collaboration with the Juvenile Diabetes Research Foundation and the Helmsley Charitable Trust developed the FlowSmart technology that has a novel side-ported catheter design. It also has a smaller insertion needle aimed to minimizing pain and trauma during insertion.

"What we have done is we’ve side ported that catheter so we now have a different way for the insulin to come out so it doesn’t rely on one port out of the distal tip," Roper explains.

"Experiencing hyperglycemia for even a short period of time can lead to disastrous consequences such as ketoacidosis, and over long periods of time, concerns of serious complications are a major part of living with type 1 diabetes for many people," says Derek Rapp, JDRF President & CEO, in a BD news release. "Having the assurance of this new technology in the arsenal of tools to help relieve the daily burden of type 1 diabetes is very encouraging. While the product has won FDA clearance, it won't launch immediately. Roper said that is slated for the company's 2016 fiscal year that begins in October. Preclinical and human trials have shown that the technology reduces these silent occlusion events, he said. 
 
However, while the product may be clinically necessary, it's not clear how Type I diabetes patients who predominantly use insulin pumps as opposed to Type II patients, would access the new technology. The infusion sets work many different insulin pumps including those made by Medtronic, Johnson & Johnson and Tandem Diabetes, but no partnerships have been announced such that these pump makers can sell the infusion sets with their pumps in the future.
 
Without going directly to manufacturers, who typically sell pumps and the infusion sets together, Becton Dickinson's product would likely not gain the broad adoption it is seeking to have.
 
"There are patients who get their supplies after they get their pump using alternate models," Roper says. "In the U.S. there are the durable medical equipment distributors who sell these types of products."
 
While executives have not firmed up the commercialization strategy, Roper is only too aware of the market potential. He says that roughly 750,000 people globally use infusion with the majority of them concentrated in the U.S. and Western Europe. The infusion set is changed every 3 days and a patient uses 120 sets a year. Typical reimbursement for an infusion set is $9-$10.
 
"The way that math shakes out is that it is an $800 million category," he says.
 
Some companies that manufacture infusion sets are Unomedical, Smiths Medical, Medtronic and Accu-chek.
 
UPDATE: On June 8, Medtronic announced that it is collaborating with BD to commercialize the new technology to improve insuin pump therapy. 

Arundhati Parmar is senior editor at MD+DI. Reach her at 
arundhati.parmar@ubm.com and on Twitter @aparmarbb 
 
[Photo Credit: iStockphoto.com user Click_and_Photo]  
Stay abreast of industry trends at MD&M East Conference in New York, June 9-11 at the Jacob J. Javitz Convention Center

FBI Investigating Morcellators

FBI Investigating Morcellators

Marie Thibault

Laparoscopic power morcellators continue to be in the spotlight—and that scrutinizing light may be getting harsher. The Wall Street Journal reported this week that the FBI is examining morcellators, which have been known to spread or upstage gynecological cancers in women.

The device is used to chop up uterine tissue, facilitating removal a patient's uterus through a minimally invasive laparoscopic hysterectomy. Patient advocates say that these small pieces of tissue can be spewed around, and if they contain undetected malignant tissue, can upstage and spread cancer. There has been debate over how commonly this happens, with some disputing FDA's finding that 1 in 350 women undergoing hysterectomies or myomectomies for fibroids has an undetected uterine sarcoma. Some surgeons continued to use morcellators after the issue came to light because they think the benefits of a minimally invasive procedure outweigh the risks. The controversy has been covered heavily by the media since late 2013.

In 2014, FDA published safety communications about power morcellation and maker Johnson & Johnson issued a voluntary recall of its power morcellators. Several health insurers, including Highmark and United Healthcare, have said they will not cover use of morcellators during hysterectomies. A number of health systems and hospitals have stopped performing hysterectomies with morcellation.

According to WSJ, in addition to asking questions about morcellators, the FBI is also reportedly trying to learn what knowledge Johnson & Johnson, a major maker of the devices before a voluntary recall last summer, had about the risks of the device. The WSJ article noted that the FBI's Newark, NJ office declined comment and the a Johnson & Johnson spokesperson said the company did not know about the agency's review.

WSJ's knowledge of the investigation seems to have come from interviews with doctors and patients close to the morcellator debate who say they have been asked by the FBI for details about the issue.

One person who has been contacted by the FBI, according to WSJ, is Dr. Amy Reed. Reed and her husband, Dr. Hooman Noorchashm, have actively advocated for banning power morcellators since Reed had a hysterectomy with the device in late 2013 and soon after, was diagnosed with advanced stage uterine sarcoma. The couple is now also advocating for reform of CDRH and recently penned a column for MD+DI on the topic.

Sarah Salem-Robinson is another patient that has been contacted by FBI, according to WSJ. Salem-Robinson filed a citizen petition with FDA earlier this year asking the agency to ban the devices. 

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

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

[Image courtesy of SIMON HOWDEN/FREEDIGITALPHOTOS.NET]

Why Total Cost of Ownership is Now the Name of the Game for Imaging Vendors

Why Total Cost of Ownership is Now the Name of the Game for Imaging Vendors

In the post-ACA landscape, vendors of medical imaging systems must focus on lowering the total cost of ownership of their products.

Tim Bosch

New healthcare economics have begun altering the radiology industry in profound ways. Shifting reimbursement models and accountable care initiatives are forcing radiology equipment manufacturers—and radiologists themselves—to redefine their role in the patient care continuum.

Against this dynamic backdrop, one of the prevailing questions we heard at RSNA in November 2014 was, “How can we produce solutions that deliver greater value at a lower price point?”

Image quality alone can no longer be seen as the universal key to success. To succeed in the Affordable Care Act era, vendors must deliver solutions that provide reliable results within a holistic workflow system while reducing the total cost of ownership over the lifecycle of their products. There are four dimensions to this challenge: accelerating time to market, reducing life cycle cost, adding value, and addressing the commoditization challenge.

Accelerating Time to Market

Whether developing new systems or integrating new features into existing systems, time to market is a key factor that directly impacts the cost of development. The longer it takes to design and verify a new product or feature, the greater the sunk cost.

Yet, the landscape into which these new systems are deployed is changing rapidly. There are many potential new points of connection as the use of image data proliferates across care protocols. Additionally, the business models of device manufacturers are evolving to include a wide variety of new long-term arrangements with hospitals.

Keeping pace with these changes requires critical skills that are often outside the core competency of in-house engineering teams. This includes rigorous systems-level analysis of today’s complex user environment and the ability to rapidly adopt and transform the many new technologies essential for next-generation imaging products. Recruiting new talent with the requisite expertise is time consuming and costly. Too often, this translates into a product arriving to market late, missing key competitive capabilities, and with a higher price tag than the competition.

Recognizing this, manufacturers are increasingly teaming up with partners who have the needed expertise. Leveraging these external partnerships intelligently can deliver a time-to-market advantage while controlling development costs and long-term product support costs. A well-managed partnership also enables vendors to keep up with the accelerating pace of change—giving them the flexibility to “plug in” whatever specific technical expertise is required for a particular project quickly and cost-effectively. Indeed, this agility will prove to be a critical competitive advantage as the healthcare landscape continues its rapid evolution.

Reducing Life Cycle Cost

Perhaps even more important than the costs of development and manufacturing is the ongoing cost of managing and maintaining systems. To justify the investment in any new system, radiology practices are taking a hard look at the costs of operating and maintaining devices over their life cycle. Forward-looking device manufacturers are focusing on strategies aimed at making their systems easier and cheaper to operate, service, and maintain. Reducing warranty and support costs also enables device manufacturers to free up resources to reinvest in new technologies and R&D.

Examples of capabilities designed to reduce operating costs include remote monitoring, equipment diagnosis, and predictive failure analysis technologies that can improve system uptime while eliminating costly and time-consuming unplanned downtime and service calls. Remote system calibration technologies enable vendors to know when a system is moving out of proper calibration and proactively recalibrate the system. In addition to reducing expense and downtime, these remote technologies improve service and clinician/patient satisfaction—competitive metrics that are crucial in this era of patient-centric care.

Reducing costs is just one side of the total cost of ownership equation. Competitive device manufacturers also need to find innovative ways to add value.

Adding Value with Analytics

Integrating the right connectivity and analytics into imaging systems opens the door to a host of value-added capabilities. Next-generation products provide information on system uptime, use of consumables with automated inventory control and management, and even operator metrics with the ability to indicate which users are in need of additional training or recertification. The key is investing precious development time and resources in the analytics that customers actually want—not analytics for the sake of analytics.

Another aspect of total cost of ownership is compliance. Standards and processes are changing continually. Remediating systems to address these changes draws engineering resources away from new system and feature development. Strategic partnerships can help here, too—updating component design or new processes to extend service life, while reducing total cost of ownership and keeping in-house teams focused on high-value engineering tasks.

Facing the Challenge of Commoditization

Radiology is a specialty that has thrived on innovation and technology advancement from its birth more than a century ago. Now, it faces a new challenge: the very real threat of commoditization as cost becomes the key market driver. It’s no longer a race solely to deliver the highest resolution or the greatest number of advanced features that most radiologists will never use. Instead, it’s about delivering the capabilities radiologists truly need to deliver patient-centric care—solutions that are “good enough”—at the lowest feasible total cost of ownership.

Complacency is Not an Option

It is increasingly obvious that the strategies that worked in the past won’t work today. Imaging system vendors must rethink their entire business model—from system development through service and support—to meet the needs of radiologists in the new value-driven healthcare economy. Working with external partners who understand these challenges and have already solved them successfully can be an important step toward achieving this transformation.

Radiology will continue to play a critical role in the diagnosis and treatment of patients. The imaging systems purchased to support this effort will be designed and built to do more with less for longer. Imaging system manufacturers that develop the most effective total cost of ownership solution will have a tremendous advantage in this new world. Those that delay are in real danger of being left behind. And the clock to develop and deliver these systems is ticking.

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


Tim Bosch is vice president and chief architect at Foliage Inc. Reach him at tbosch@foliage.com.

 [image courtesy of COOLDESIGN/FREEDIGITALPHOTOS.NET]

A Biodegradable Microchip Made of Wood

A research team from the University of Wisconsin-Madison has developed a microchip that could be theoretically be placed in a forest and be degraded by fungus, rendering it as safe as fertilizer.

Kristopher Sturgis

A cellulose nanofibril (CNF) computer chip on a leaf. Image from Yei Hwan Jung, Wisconsin Nano Engineering Device Laboratory
A cellulose nanofibril (CNF) computer chip on a leaf. Image from Yei Hwan Jung, Wisconsin Nano Engineering Device Laboratory.

Developed in collaboration with Shaoqin "Sarah" Gong, a UW-Madison professor of biomedical engineering, and the Madison-based U.S. Department of Agriculture Forest Products Laboratory, the team devised a method that involves replacing the substrate of a computer chip with cellulose nanofibril (CNF), a flexible and biodegradable material made from wood, according to a news release.

The group was inspired by how paper is made by felling a tree and extracting individual fibers from it. They decided to take this a step further and break it down to the nanoscale, in an effort to make the material into strong and transparent CNF paper. Once the group decided to try to use materials derived from wood, they needed to address the two most glaring issues: surface smoothness and thermal expansion.

Project leader for the engineering composite science research group at FPL, Zhiyong Cai, has been developing sustainable nanomaterials since 2009. He noted that wood is a natural hydroscopic material that can attract moisture from the air and expand. The group addressed this issue by using an epoxy coating on the surface of the CNF, solving the issue of surface smoothness, while also protecting it from moisture expansion.

The team believes that the advantage of the CNF over other polymers is that it is a bio-based material, while most other polymers are petroleum-based, making them non-biodegradable and possibly harmful to the environment. Bio-based materials have the benefit of being sustainable, biocompatible, and biodegradable. Not to mention that the CNF has a relatively low thermal expansion coefficient when compared to other polymers, making it quite unique when compared to what's already being used in most electronics today.

Most importantly, the group believes their biodegradable chip is comparable to existing chips in terms of performance and functionality.

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

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The Moral of This Story? Use Test Method Validation

The Moral of This Story? Use Test Method Validation

An expert illustrates why test method validation is important in the real world.

José Ignacio Mora

Tom was ready to send the multi-cavity fixtures. I asked him to perform a Gage Repeatability and Reproducibility (R&R)—one more time—before they were to be sent to Europe where they would serve as online inspection fixtures for the new multi-cavity mold. It passed with flying colors!

A few weeks later, the bad news came from John in the United Kingdom. They repeated the same Gage R&R study, on the same fixtures, and they failed.

How could that be? Everything had been done to the letter. Design controls, studies, etc.

The easy answer was that “someone didn’t do the test right” or “the samples were not properly prepared.”

As the supplier, Tom agreed to honor the guarantee of his work, and accepted the gages back from the United Kingdom. When they arrived at his lab in the United States, he repeated the Gage R&R. Again, it passed with flying colors!

The more difficult answer was that everyone, in fact, did everything right. Yet the test failed in the United Kingdom—and passed again in the United States!

Needless to say, both parties began to distrust each other’s work. Solving a problem, especially when two different parties are involved, can be stressful.

So, what else could explain the discrepancy? As it turns out, there were three factors involved:

  1. The gage that measured the molded part for each cavity;
  2. The parts themselves;
  3. The test itself—who performed it, and how

But it is even more difficult to step back and see the bigger picture.

What were we trying to do? What were these fixtures for?

They were intended to measure part-to-part shot-to-shot variation—for parts coming out of the same mold. In other words, the same parts!

What happened here is that we asked the gage to do what it wasn’t designed to do—to measure parts that were the output of a mold before and then after a tooling modification.

In other words, this was no longer simple part-to-part shot-to-shot variation. When the mold cavity itself was dimensionally modified, this resulted in a different part as far as the gage was concerned. The very nest of the part had been compromised.

John used parts coming from his modified mold. Tom used parts from a prior mold version.

In other words, same gages, same test method, but parts from different origins.

Test method validation isn’t just about performing Gage R&Rs. It is about knowing the requirements, applying design controls, verifying the requirements, and validating that the test method actually performs as intended.

And it isn’t just about following regulations. One must truly understand the process, the nature and origin of the materials, the environment, and also the design itself.

And that is why we validate.

This was a true story. In fact, it will be one of the case studies I plan to present during the MD&M East conference.

Want to learn more? Mora will lead a session called “Scrutinizing Your Test Method Validation to Verify the Performance of a Medical Device” during the MD&M East Conference, June 9–11, 2015, in New York City.

José Ignacio Mora is an instructor in Lean Quality System, Process Validation, and Lean Manufacturing at Atzari Enterprises, LLC.

How War Drove Medical Advances: Examples Throughout Modern History

How War Drove Medical Advances: Examples Throughout HistoryMany would like to prove wrong the American philosopher George Santayana, who wrote in the 1920s: “Only the dead have seen the end of war.”The sad truth, though, is that some of humanity’s greatest technological advances have occurred amid the crisis of war, and that is true of medical devices as well. Whether it was the U.S. Civil War 150 years ago or World War I 100 years ago or World War II 75 years ago, innovation accelerated.The situation makes one wonder whether the medtech needs something like the original space race in the 1960s, which President John F. Kennedy envisioned as a way to create technological advances through means other than war. The medical device industry needs its own path to such moonshot thinking.Here’s a look at some of the major medical advances developed in order to patch up human bodies mangled by the brutality of war:Continue >>Learn more about cutting-edge medical devices at MD&M East, June 14–15, 2016 in New York City.

How War Drove Medical Advances: Examples Throughout History

Many would like to prove wrong the American philosopher George Santayana, who wrote in the 1920s: “Only the dead have seen the end of war.”

The sad truth, though, is that some of humanity’s greatest technological advances have occurred amid the crisis of war, and that is true of medical devices as well. Whether it was the U.S. Civil War 150 years ago or World War I 100 years ago or World War II 75 years ago, innovation accelerated.

The situation makes one wonder whether the medtech needs something like the original space race in the 1960s, which President John F. Kennedy envisioned as a way to create technological advances through means other than war. The medical device industry needs its own path to such moonshot thinking.

Here’s a look at some of the major medical advances developed in order to patch up human bodies mangled by the brutality of war:

Continue >>

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