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This Is How You 3-D Print Complex Metal Parts

Harvard University researchers created a novel method for 3-D printing complex metallic architectures using a programmed laser to solidify ink composed of silver nanoparticles. The method could enable more medical device advances.

Kristopher Sturgis

Laser assist 3-D printing Harvard Jennifer Lewis
These 3-D printed wire butterflies were produced using new printing technique. (Image courtesy of Lewis Lab/Wyss Institute at Harvard University)

When it comes to wearable technologies, many advancements are held back by the complications of creating structures from rigid, inflexible materials. The increase in demand for innovative wearable technologies was what inspired researchers from Harvard University to devise a unique 3-D printing method that can produce flexible metal electrodes and complex structures in real time.

Jennifer Lewis, professor of biologically inspired engineering at the Harvard School of Engineering and Applied Sciences and leader of the study, says that this new method is much more suited for the production of electronic sensors and coils than traditional printing methods.

"The traditional method of 3-D printing metal is a process known as selective laser sintering, where a bed of metal powder is melted by a scanning laser in a layer-by-layer process," she says. "While this process is useful for producing large, bulky components like a wrench or engine part, it is not well suited to producing delicate wire structures for electronics, such as sensors, antennae, or coils. Instead, with laser-assisted direct ink writing, we can write these delicate structures in a single step, within seconds, without relying on a step-by-step, layer-by-layer process."

Lewis and her team devised a method that uses ink made from silver nanoparticles. The ink is sent through a printing nozzle before a laser precisely applies the right amount of energy to anneal the ink and solidify it. The nozzle is programmed to move along x, y, and z axes to provide the ability of freeform curvature. The result is a 3-D printing technique that can create metallic hemispherical shapes, spiral architectures, and other freeform designs--all of which can be crafted with accuracy down to the width of a hair in a matter of seconds.

"Normally, we can't produce curvy structures in mid-air since the material is too soft to hold its shape," Lewis said. "Here, we have devised a silver nanoparticle ink that has a toothpaste-like consistency that can be squeezed out through a nozzle to generate microscopic, conductive silver wires. We co-align an infrared laser to rapidly heat the silver ink as it exits the nozzle, effectively solidifying it in place. This is how we can draw complex structures in three dimensions without support material."

The market for 3-D printing technologies is one that continues to expand with each passing year. Just last week Johnson & Johnson announced a partnership with HP that will see the two industry giants collaborate on developing medical products from 3-D printing technologies. The two companies plan to focus on the personalization of instrumentation and software related to medical devices, signaling a bright future for 3-D printing technologies in the realm of medtech.

Stryker is meanwhile spending $400 million to build a 3-D printing plant in Ireland, and Smith & Nephew recently turned to 3-D printingto promote in-growth for one of its newest titanium hip implant cups.

It's this kind of demand that drives research and innovation--much like the work that Lewis and her team have invested in. The team's new technique could serve as the basis for more programmable 3-D printed devices in an industry where precision is paramount. Lewis even noted that as they move forward with their research, this process could eventually be turned into a simple-to-use technique for anyone. 

"We believe that this technology has great potential," she says. "Many implantable and wearable electronic devices require complex, customized, flexible, patient-specific geometries. Laser-assisted direct ink writing allows for programmable conductive architectures that can be written directly onto and above flexible plastic substrates, which we believe will be of interest to the medical devices industry. With further engineering and industrial development, such as incorporating automated alignment procedures, we believe that this process can be turned into a more user friendly, off-the-shelf system as well." 

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.

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How Toyota Is Bringing Back the Amazing iBOT

Shelved amid lack of reimbursement from Medicare, DEKA's stair-climbing, all-terrain wheelchair is set for a comeback amid a new partnership with Toyota. 

Qmed Staff

DEKA Research and Development (Manchester, NH) has inked a deal with Toyota that will enable the development and launch of a next-generation iBOT motorized wheelchair, the two companies recently announced. 

Under the deal, Toyota will license balancing technologies held by DEKA and its affiliate. The technologies are for medical rehabilitative therapy, but could potentially be used for other purposes. The two companies are in discussions for Toyota to provide further assistance. 

The iBOT was originally created in partnership with Johnson & Johnson and FDA approved. But it was discontinued in 2009 amid poor sales. Medicare would only cover about a fourth of the wheelchair's roughly $22,000 price tag.

Now Toyota is helping to bring back a new and improved iBOT.

"Toyota and DEKA share the same vision of making mobility available to people of every kind of ability," said DEKA founder Dean Kamen. "We are excited about this new relationship and excited about what it means for making that dream a reality."

Check out this video of Kamen showing off the iBOT:

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

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

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5 Tips On How To Compete in Bundled Care Environment

5 Tips On How To Compete in Bundled Care Environment

Bundled payment in orthopedics represent an opportunity for smart medical device firms that are not afraid to change how they do business.

Michael Abrams and Gordon Phillips

On the morning of April 1, hospital and medical device company executives woke up to yet another new chapter in bundled pricing -- CMS' Comprehensive Care for Joint Replacement (CJR) initiative. Unlike the Bundled Payments for Care Improvement (BPCI) programs that preceded it, there is no opt-out clause for the 800 hospitals designated as participants across the U.S. 

The implementation of CJR signals CMS's intent to ramp up pressure for progress toward value-based reimbursement. Making hospitals accountable for cost and quality for complete care episodes represents a stepping stone toward broader accountability.

By paying hospitals a fixed target price for a hip or knee replacement episode that extends for 90 days post-discharge, CMS expects to realize savings in excess of $340 million over the five year span of the initiative. In 2014 alone, 400,000 hip and knee replacement procedures were performed, costing more than $7 billion just for hospitalization. 

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.

Beyond the sheer total costs, a key driver behind the focus on these procedures was the broad variation seen in cost and quality. Average Medicare expenditures for surgery, hospitalization and recovery for hip and knee procedures ranged from $16,500 to $33,000 across geographic areas. Complication rates associated with factors such as infections or implant failures after surgery were more than three times higher at some facilities than others.

With CJR and other bundled payment programs, not only are hospitals challenged with getting their own house in order, but they must also pay greater attention to managing cost and quality across the entire 90 day post-discharge period. They will need to better understand their cost structures, establish evidence-based care paths and manage non-value-added variation. 

Although, many hospitals will focus on the post-acute care to drive out the biggest expenses, there are other cost drivers -- specifically, the implants and associated instruments that are used in the procedure. Current efforts to drive these costs down through vendor consolidation and price renegotiation could intensify.

Further, hospitals will need to more closely analyze cost and quality variability, both in acute and post-acute care. This will require better access and analytics of clinical and financial data to identify the procedural elements behind those differences. And that will call for new models of collaboration as providers across the continuum develop new care paths and interact to ensure that patients consistently are receiving the right care, at the right time, in the right care setting. These factors are driving new and increasingly urgent conversations about value - between hospital administration and surgeons, between hospitals and their care continuum partners, and between medical device companies and their hospital customers.

Here are five moves that medical device companies should take to successfully compete in an increasingly complex and value-conscious market.

Challenge and re-conceptualize your commercialization model
Fundamental changes are occurring at the provider level, and this demands reassessment of assumptions and practices that may no longer be adaptive.  Take for example the configuration of the sales and product delivery process to include mentoring and relationship management through reps. Given the growing pressure on provider margins and the lack of differentiation that characterizes some product classes like implants, can your product continue to be price-competitive with the cost of rep-mentoring factored in?

At least one major manufacturer is experimenting with a "rep-less" model for those provider organizations determined to cut underlying costs as far as possible. It's time to challenge basic assumptions like this.

Likewise, given the consolidation across the provider sector and the ongoing centralization of decision making for purchasing that is happening in tandem, does it make sense to continue business development structured around surgeons alone? Although the shift is far from uniform, purchasing decisions increasingly reflect institutional and administrative concerns. Clinical input, while still important, is no longer the single biggest factor. Remaining competitive in this new, more value-sensitive and institutionally oriented purchasing process calls for new skills, capabilities and support processes. 

This will require stronger C-suite relationships and the accompanying upgrade in executive level relationship skills and business acumen on the part of account teams. Device companies will also need to segment their target markets in order to more precisely match their commercialization approach to the decision-making process and relationship receptivity of each segment.

Shift away from a traditional product development strategy focused on incremental improvements
The days of "last version plus 7%" are over.  Given the intense pressure to reduce high cost supplies like implants, hospitals are much less willing to pay more for incremental improvements. New products or enhancements without a compelling economic and clinical value rationale will increasingly be treated as orphans, hard-pressed to recoup even nominal development costs. The implication is deeper analysis of market needs on which new product ideas are based, and a more demanding bar for product development choices.

Align product portfolio offerings and supporting value arguments with more targeted market segments.
As greater emphasis is placed on the economic and clinical value of products, device companies must more precisely identify target beneficiaries and craft supporting value arguments that resonate with hospitals and payers alike. The days when the most advanced design is the only one offered in a "one size fits all" scenario are rapidly fading. 

Going forward, providers will look to manufacturers to rightsize the therapeutic value of a product for a particular population. In short, the 62-year old grandfather doesn't need the same implant as the 37-year old marathon runner, especially at the same price. This pressure actually creates opportunities to extend the life cycle of older product lines, as long as the functionality of the older model is sufficient for targeted patient segments.

Some companies have begun to offer a line of more basic implant systems for hospitals who want to lower the cost of care by more closely matching implant functionality to the needs of their patients.

Develop products and service wraps that reduce "total episode costs" while improving outcomes
Hospitals, as the party responsible for the cost of a CJR episode, are struggling with the challenges of coordinating care across multiple settings. Medical device companies can offer differentiated value by offering products and services that help hospitals reduce the overall cost.

These offerings can range from assistance with the development of standardized care pathways to Internet-delivered patient videos for pre-operative and post-operative education and compliance. Manufacturers who hope to enhance their competitive position by adding products or services outside their core capability set may need to consider partnerships and acquisitions as the path to that end.

Consider risk-sharing agreements with providers
As providers are increasingly pushed to bear financial risk for the cost and quality of their services, they will turn to their suppliers to do the same. Prudent manufacturers should begin preparing now for the time when their customers insist that they back up their marketing claims with their checkbooks. 

Contracts are already beginning to reflect the risk of product defects. For example, St. Jude Medical covers 45% of the net price for cardiac resynchronization therapy if a lead revision is required within a year of implantation. Manufacturers with a compelling value story need to back up their claims with action.

This is both an exciting and challenging time for hospitals and device manufacturers alike. CMS' introduction of the CJR program raises the bar for hospitals already under pressure to reduce costs, increase transparency, and demonstrate greater value to patients, payers and employers. It also suggests the shape of things to come - not just for the 800 participating CJR hospitals, but for the entire industry. 

As is often the case, market fear and uncertainty breed opportunity. This is the case for device manufacturers who can get out in front by making the necessary changes to their product development and commercialization models and capabilities. The better medical device companies understand the impact of CJR and other bundled payment models on their customer base, the better prepared they will be to develop and communicate differentiated value propositions in the years ahead.

[Photo Credit: iStockphoto.com user knape]


Michael Abrams is Managing Partner and Gordon Phillips is a Consultant at Numerof & Associates, Inc. They can be reached at info@nai-consulting.com.


Reprocessed Medical Device Market Size to Triple by 2022

Reprocessed Medical Device Market Size to Triple by 2022

The opportunity for cost savings as well as efforts to reduce medical waste are driving rapid growth in the reprocessed medical device market.

The worldwide reprocessed medical device market is set to triple to $5 billion by 2022 as healthcare facilities look to cut costs and reduce medical waste. This forecast, from a study by Grand View Research, Inc., anticipates significant growth from the Asia Pacific region. 

The global market is expected to grow at an over 20% compound annual growth rate (CAGR). Almost half (47%) of the $1.141 billion reprocessed medical device market consisted of North American business in 2014, but the report authors expect Asia Pacific to exhibit the highest growth as emerging markets in the region devote more attention to healthcare.

Growth will also be spurred by the increase in FDA-approved critical and non-critical cardiovascular reprocessed devices. Cardiovascular devices made up more than half of market revenue (55%) in 2014, and diagnostic electrophysiology catheters were almost a quarter of the reprocessed. cardiovascular devices. Positioning devices are expected to have the highest growth rate going forward, according to a release about the report. Laparoscopy devices, used in minimally-invasive surgical procedures, make up the next largest segment of reprocessed device market share.

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

Hospitals are the major consumers of reprocessed devices, at 46% of end users in 2014, according to the report. Using reprocessed devices can help their bottom line, as the release cites a statistic from the Association of Medical Device Reprocessors (AMDR) that hospitals can save up to 50% on every reprocessed device purchased. Reprocessing also has kept 8000 pounds of medical waste out of landfills annually, the report noted.

There are a number of companies in the reprocessed medical device industry, including well-known names like Stryker Sustainability Solutions, Philips Healthcare, GE Healthcare, Siemens Healthcare, and many more. 

In the past, there was some skepticism of reprocessed single-use devices, but those concerns seem to have faded, as third-party reprocessing is now common among hospitals. The AMDR recently announced that its members work with 13 of the top 15 hospitals on U.S. News & World Report's Honor Roll and that reprocessing is a "best clinical practice." A study of more than 3000 devices published in the Journal of Medical Devices in December found that defect rates were actually much higher in new bipolar and ultrasound diathermy devices than in reprocessed devices.

[Image courtesy of COOLDESIGN/FREEDIGITALPHOTOS.NET.]

Rounding Out the List of Most Compensated Medtech CEOs

    Arrow  backCash
 

No. 8: Boston Scientific CEO Michael Mahoney

Total Compensation: $11,594,128

Total Salary: $967,740

Previous Fiscal Year Compensation: $10,527,884

Percent Difference: +10%

No. 9: Zimmer Biomet CEO David Dvorak

Total Compensation: $11,392,178

Total Salary: $1,056,258

Previous Fiscal Year Compensation: $9,521,874

Percent Difference: +20%

No. 10: Hologic CEO Stephen MacMillan

Total Compensation: $11,333,859

Total Salary: $1,000,000

Previous Fiscal Year Compensation: $24,458,289

Percent Difference: -54%

 

Download the full spreadsheet >>

Or find out the best-performing medtech companies of early 2016>>

Image courtesy of worradmu at Freedigitalphotos.net

This Polymer Could Matter for Heart Valves

A new study from Rice University uses a natural polymer to serve as a template for the middle layer of synthetic heart valves--providing a potential novel solution in a field with limited options.

Kristopher Sturgis

Allen Puperi Rice University
Rice University bioengineering professor Grande Allen and her graduate student Dan Puperi test a sample in her lab at Rice's BioScience Research Collaborative. (Photo courtesy of Rice University)

When it comes to heart health, the functionality of heart valves can't be overvalued. The American Heart Association estimates that nearly 100,000 patients are hospitalized each year in need of heart valve repair or replacement. So far, replacement options have been limited to metal-based valve replacements--which require patients to be placed on anticoagulants--or biological valves made from pigs, which wear out over time.

Neither of these solutions are ideal for children in need of replacement valves, as they can't grow with the patient's heart over time. Which is why Jane Grande-Allen, a professor in bioengineering at Rice university, and her colleagues decided to design replacement heart valves made from natural materials. Her team set out to use a natural polymer called hyaluronan, one of the central components of skin and connective tissue, to serve as the template for spongiosa tissue--the middle tissue layer in valve leaflets.

"A tissue engineered heart valve, containing living cells, would be transformative for children, as well as adults who are not well suited to the options currently available," Grande-Allen says. "Hyaluronan is naturally present in heart valves and many other parts of the body, so it won't be rejected. Cells also have a number of receptors that can bind to hyaluronan, and it's also available in a range of molecular weights, so we can really tailor the characteristics of the hydrogel by working with different concentrations."

In a study that's nearly three years in the making, the group examined a variety of hydrogels based on hyaluronan, as the molecule attracts water and can serve as both a shock absorber and lubricant in heart valves. Through their study, the group found that naturally produced hyaluronan was just as effective as a synthetic hydrogel when used as a template for growing new spongiosa tissue. 

"The sponginess layer has been challenging to study because it is so soft," Grande-Allen said. "But it is essential to the proper mechanical behavior of heart valves, since it allows the stronger and stiffer outer layers to slide past each other as the valve opens and closes. Showing that valve cells will grow and behave normally in these soft spongiosa-mimicking scaffolds is a step towards incorporating these layers into more complicated scaffold structures for the tissue engineering of heart valves."

The industry certainly isn't short on investors, as companies seek innovative solutions for patients in need of heart valve repair and valve replacement surgeries.

This kind of demand next-gen valve technologies is why Grande-Allen and her colleagues have turned to hyaluronan as a potential solution that addresses the need for natural heart valve replacements that can regulate cell behavior. Grande-Allen says that these hydrogel components are the future of synthetic valve technologies, and could offer doctors the ability to customize valves for individual patients.

"Many scientists and bioengineers are already working with hyaluronan for various tissue engineering applications," she says. "These hydrogel models may be studied for the purpose of replacing diseased valves, or for studying aspects of valve disease in vitro by creating a simple valve model. I believe that the future of synthetic valve technology will include a hydrogel component--whether this is hyaluronan based or derived from another polymer -- because these materials offer so much potential in their ability to regulate cell behavior, as well as their ability to be extensively customized." 

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.

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Why You Need to Embrace Medtech Outsourcing

Outsourcing greatly improves return on investment in medical device commercial operations--but is being underutilized in the industry, according to a new survey.

Varun Saxena

There is apparently a surprising difference between medical device companies that achieve a strong return on their investments in commercial operations, and the 81% of them that do not, according to a new survey of 60 medtech executives leading companies with with revenues ranging from $50 million to $2 billion.

It comes down to one word: "outsourcing." It's an area in which medtech companies lag behind their pharmaceutical industry counterparts.

"Approximately 85% of respondents say they rely on 'personal experience' to stay on top of commercial operations best practices, yet key commercial operations functions such as advanced analytics, incentive compensation, and information management are highly sophisticated and require deep technical knowledge (as are the technologies associated with them)," Evanston, Ill.-based sales and marketing consultancy ZS Associates said in a report.

The firm found that companies that reported a strong return on their investments leverage partners a precise 2.6 times more than those that reported weak or no return on their investment.

ZS also said that companies who reported strong returns on their investment made investments in analytics of all sorts in order to give their salespeople better leads, including pricing analytics and social analytics. Among companies that reported a return on investment of more than 10%, 84% invested in big data analytics, compared to 5% of those who achieved no return.

An integrated approach to the investments is preferable. "Companies that have seen bottom-line results from commercial operations investments have not only invested in technology, but also in building the right processes and teams to support their commercial teams," the report says. Examples of wise business process investments include territory design tools and territory management systems, according to the report.

The respondents included a majority of the top 25 companies in the industry across a range of categories. Commercial operations capabilities studied by ZS include business intelligence, advanced analytics, and contract price management.

"Our study shows that while major hurdles do exist to achieving meaningful return on commercial operations investments, some forward-looking companies are already doing it well and offer valuable lessons," ZS manager Bhargav Mantha said in a statement. "The commercial operations organization at these companies is closely aligned with the business and has become an important profit driver by providing actionable business insights and enabling better productivity among the commercial teams."

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

Varun Saxena is a contributor to Qmed.

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BD CEO Vincent Forlenza Sees 7% Rise in Compensation

    Arrow  backBD CEO Vincent Forlenza

Total Compensation: $11,710,032

Total Salary: $1,045,000

Previous Fiscal Year Compensation: $10,983,518

Percent Difference: +7%

Barrett's salary crossed the $1 million mark in 2015. His compensation was up in almost all the other categories, from stock awards to non-equity incentive plan compensation. 

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Image courtesy of BD

Cardinal Health CEO George Barrett's Compensation Up 7%

    Arrow  backCardinal Health CEO George Barrett

Total Compensation: $13,269,731

Total Salary: $1,320,000

Previous Fiscal Year Compensation: $12,448,618

Percent Difference: +7%

Barrett was among a number of highly paid medtech CEOs enjoying an increase in stock awards and option awards in the most recent fiscal year. 

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Image courtesy of Cardinal Health

Abbott Labs CEO Miles White Enjoys 9% Rise in Compensation

    Arrow  backAbbott Labs CEO Miles White

Total Compensation: $19,401,704

Total Salary: $1,900,000  

Previous Fiscal Year Compensation: $17,732,241

Percent Difference: +9%

White, who has been Abbott Labs' CEO since 1999, saw stock awards and option awards each go up by nearly a third, to more than $6 million apiece. 

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Image courtesy of Abbott Labs