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Articles from 2012 In December


Using Design Software to Develop an Emergency Preparedness Device—A Case Study

Livengood’s Mobile Patient Care Environment (MPCE) provides hospitals and mobile response units the ability to deploy a complete ICU environment rapidly, in any location. The MPCE consolidates all of the equipment typically found in two ICU rooms onto a single platform no larger than a single current IV pole. Classified as a piece of medical equipment itself, it is tested to the IEC 60601-1 standard, which provides requirements for safety applicable to medical electrical equipment that is patient-connected or within the patient vicinity. Far more stringent than similar consumer standards, compliance ensures that hospital safety standards are preserved even when deployed to emergency sites such as a gymnasium or tent.

The Goal

Have Livengood’s MPCE become the standard of patient care in emergency preparedness.

The Challenges

  • Multiple medical products and customer-specific configurations require rapid design of modules to match.
  • Use of different design engineers over time with variable historical knowledge of the product.
  • Limited funding for prototype qualification beyond CAD design.
  • Highly-regulated, heritage market that is resistant to change in established systems.
  • Product use for multiple patient types in varied environments.


The Situation

Livengood’s progression from start-up to production was a long road with multiple product variations along the way. The company needed to to rapidly create new designs to match specific customer needs and demonstrate the modularity of the system. For the Livengood MPCE to become the standard in emergency preparedness, its designers needed the ability to react quickly to meet customer requirements, a critical component for new product introductions. “If we couldn’t make last minute changes, we couldn’t exist. Our new product is first to market, but that market is comprised of many different hospitals and facilities – and each of them have a specific set of requirements,” said Joe Livengood, MD, chief executive officer, Livengood. “Our ability to quickly modify the products is essential to meeting our customers’ needs.”

Barry Phillips who is R&D director for Livengood describes the design environment at his company as fast-paced and high pressure. He generally has little time to train a new engineer on design software, and often needs to pull in contract designers to help deal with overflow work. It’s a stop-and-go development environment complicated by continuous change. Designers don’t have time to look backward and revisit a complex history tree or feature manager in order to make development progress. “If an engineer has an hour in his day available to design, we need the full hour for design—not 30 minutes of set-up and review with only 30 minutes of design,” says Phillips.

For example, Phillips typically spends less than a day instructing new users the basics of PTC Creo. This simplicity allows non-engineers to have more connection with the design. For instance, an illustrator can create third-party equipment models and a product manager is able to create customer specific renderings so they can be included with sales quotes, marketing material and as a tool for customer validation. “Other team members have also used Creo to create conceptual models based on their ideas before passing it off to the R&D lead engineers for consideration and implementation if feasible. It’s a fantastic way to get contributions from the entire company, and ultimately saves the engineering staff a considerable amount of time when they don't have to ask leading questions on someone’s design intent,” said Phillips.

By providing a direct modeling design approach, PTC Creo enabled the firm to respond to changing requirements rapidly and frequently throughout product development—even late into production cycles. Creo has allowed Livengood engineers to make unlimited changes to models on the fly. “Creo’s direct modeling approach allows me to leave a design for another task, come back later, and without review immediately jump into creating or changing a design,” says Phillips. The PTC Creo direct modeling approach is forward facing, working directly off of geometry to accelerate changes to features and models. “PTC Creo fits our development environment, allowing us to be three times faster than if we used other approaches,” Phillips says.

Most significant is what management notices about the design process. PTC Creo enhances the design process by allowing for rapid action on new ideas. Recently, a product went from concept to full prototype featured at a tradeshow, including marketing materials, in less than three weeks. A true testament to the flexibility of the software and ability to collaborate between team members, renderings were created along the way to share information and were eventually included in the marketing material which needed to be created prior to product build the day before it was shipped to the show.

The Results

  • Using the PTC Creo and the direct modeling approach to 3-D product development led to near real-time response to new customer requirements throughout product development—even into production cycles.
  • Livengood was able to developing new products and modules 3 x faster than competitors.
  • Rapid prototyping in early phases of new designs enabled quick changes.
  • The rendering package was of high enough quality to be used in marketing material, as opposed to traditional CAD drawings.

The Bottom Line

For Livengood to achieve its ultimate goal of being a Mobile Patient Care Environment in austere situations, they needed a 3D CAD system and design approach that would enable rapid prototyping and design changes in order to deliver the right products for their prospects customers, and investors. For a company with a vision to introduce an entirely new concept to market, unpredictable change is the only thing that can be predicted. To meet that type of challenge, Livengood chose PTC Creo.

—Brian Thompson is vice president product management, PTC.
 

Transitioning from Rapid Prototyping to Rapid Manufacturing

Last year, a new technology was unveiled that could potentially enable clinicians to detect real-time chemical changes in the body. A proof-of-concept sensor array incorporating three types of sensors would enable the device to measure pH, glucose, and lactate. Such a device could be used to monitor glucose levels in diabetics or the microneedles could be incorporated into sensor arrays that could enable painless patient monitoring of a variety of parameters.

Microneedle
A hollow microneedle can be integrated with sensors to detect glucose, lactate, and pH levels. Image from North Carolina State University. 

The microneedle sensors hints at the medical applications to come in the burgeoning field of 3D printing. The technology is poised to play an important role in healthcare in future decades, provided the numbers of materials it can be used with continues to expand and the costs of the 3D printing equipment continues to fall. The manufacturing-related applications are beginning to receive increasing attention in the broader tech industry. Seven companies are expected to exhibit 3D printers at CES 2013.  

Roger Narayan, MD, PhD, one of the researchers who helped develop the aforementioned microneedles, specializes in 3D printing technology that is appropriate for creating small-scale devices. While his group previously focused on using microneedles for drug delivery, more recently, the researchers have explored using two-photon polymerization and other 3D printing techniques in order to create microneedles for in situ sensing. "Over the past year, we have spent a lot of time looking at how to integrate sensors for glucose, lactate, and other biologically relevant molecules as well as pH to microneedles so you can essentially put these small-scale painless devices on the skin and try to obtain some kind of real time monitoring of what is going on in the body," Narayan explains. For the microneedles, the researches are using rugged acrylate-based polymers. "Fracture of these devices within the skin is not a concern," Narayan says.

3D printing also can be used not only to create scaffolds for tissue engineering applications ultimately destined for implantation, but also could also be used to create structures used for testing new drugs and investigating treatment modalities on a petri dish. "Our students right now in the lab are working on making various sorts of reproducible structures that could be used for those sorts of petri dish based studies," Narayan says.

Roger Narayan speaking about 3D printing at BIOMEDevice in San Jose. Narayan will be speaking on the topic again in February 2013 at MD&M West in Anaheim. His talk is titled "Innovations in additive manufacturing: Transitioning from rapid prototyping to rapid manufacturing." Image by Rick Merritt of EE Times

Two-photon polymerization relies on the use of infrared lasers for selective polymerization and hardening of material. One drawback to the technique is that the number of materials types that can be used with it is a number of photosensitive polymers. Other techniques such as selective laser sintering and selective laser melting can be used with metals but "they have limitations in terms of their minimum feature size, which are in the micrometer range," Narayan explains. "You can get some pretty small-scale features in a part that you want to design but you aren't able to go to submicron features."

For medical device companies evaluating 3D printing technologies, a big part of the decision depends on whether your firm wants to use it in-house, Narayan says. Companies willing to outsource 3D printing generally have more options in terms of the types of techniques and the types of input materials that are appropriate. For companies interested in in-house prototyping applications, fused deposition modeling might be an option, he says. It is a popular technology for creating prototypes although the parts that can be produced with the technique have limited mechanical properties and microscale geometries, which makes them difficult to use in functional parts.

Narayan became interested in the field of 3D printing after doing research in laser processing of thin films. "Prior to 2004, most of my interest was using a laser for ablation of materials," he says. "There are thin-film processing techniques out there that rely on ablation of a material in order to create a vapor plume and then deposit on the surface." As it turns out, some of the lasers Narayan used in that research were also applicable for 3D printing. 

Brian Buntz is the editor-at-large at UBM Canon's medical group. Follow him on Twitter at @brian_buntz

Editor's Note: Narayan will be speaking on 3D printing (in the Design & Prototype track) at the upcoming MD&M West trade show and conference.
 

CEO of Tandem Diabetes Care to Deliver Keynote at MD&M West

With the debut of the iPhone in 2007, Steve Jobs proclaimed that Apple had reinvented the phone. That proved to be no idle boast, despite predictions that the smartphone would flop. Now, five years later, it is hard to argue that Apple succeeded in making smartphone technology substantially "smarter" and easier to use than the then current generation smartphones. One of the most striking features of the iPhone then, as well as now, is its design and the prominence of the touchscreen. Rival phone makers went on to follow a similar pattern in product lines from that point on.

The influence of the iPhone can be felt, too, in the medical device sector. One of the best examples is the t:slim Insulin Delivery System whose design has been called 'Apple-esque.' Developed by Tandem Diabetes Care (San Diego), the device was cleared by the FDA late last year, making it the first insulin pump to have a color touch screen. When it debuted, the device, which has the footprint of a credit card, was 25% smaller than competing products. 

One of the most remarkable things about the t:slim's design is that Tandem Diabetes Care gathered insights from more than 4000 patients, caregivers, and healthcare professionals when developing the product. Contrast that approach with Apple's. According to the company's senior VP of worldwide marketing, Philip Schiller, proclaimed that Apple "[doesn't] use any customer surveys, focus groups, or typical things of that nature. That plays no role in the creation of the products." 

Kim Blickenstaff
Kim Blickenstaff

Following the device's FDA clerance, Tandem Diabetes Care's CEO Kim Blickenstaff said in a press release that the "clear message" the company heard from their focus group research was to 'make [the insulin pump] cool and make it uncomplicated to use. Give us access to the most advanced features without extra effort.'  

Blickenstaff will discuss his company's approach to product design at MD&M West in Anaheim, CA on February 12, 2013. It should be interesting to hear how the company is inspired by the tech sector, which is known for rapid iteration, while addressing regulatory and reimbursement matters.  

Those are topics well known to Blickenstaff. Before taking the head position at Tandem Diabetes Care in 2007, he served as chairman, CEO of Biosite Inc., a diagnostic firm he cofounded. In June 2007, the company was acquired by Inverness Medical Innovations for $1.8 billion. He has also served on the board of directors for healthcare companies such as SenoRx and MediVation Inc. 

Brian Buntz is the editor-at-large at UBM Canon's medical group. Follow him on Twitter at @brian_buntz

Unique Device IDs “A Single Source of Truth” says FDA’s Jay Crowley

No one is debating the value of a unique device identification (UDI) system to manage medical devices. As Jim Dickinson notes in his column, most of the comments received by the agency on UDIs showed support for the project.1 FDA is still in the process of collecting and reviewing those comments, although the comment period officially ended November 7 (FDA is still taking feedback).  “There are over 300 comments and about 3000 pages of comments,” says Jay Crowley, senior advisor for patient safety at CDRH.

Crowley, who leads a team of about 15 FDA employees and several contract workers in managing the UDI project at FDA, says that the majority of comments the agency has gone through so far have to do with questions on implementation. “There are a number of issues raised, none of which are new to us—they are problems we’ve been discussing all along.” Device makers, he explained are chiefly concerned with how the system is going to work, and how it will work for individual device types.

The scope of medical devices is very likely the biggest hurdle any UDI system will have to overcome, and Crowley says the comments reflect that difficulty. According to WHO, there are more that 1.5 million types of medical device products on the market.2 The challenge is not lost on Crowley. “I’ve been in this industry a number of years and I still get calls about device products and technologies I’ve never heard of before.”

Another challenge is implementation time—that is, how soon device makers will have to figure out how to tag their products, with understandable tension on all sides. “We’ve laid out this phased in approach and manufacturers would probably like a little more time, while users would like the timeline compressed a bit and to have it happen more quickly,” says Crowley. Trying to satisfy all the stakeholders isn’t easy.

But a few things are predictable. Crowley anticipates that adjustments will come in the preamble or in additional guidance, rather than in the tenets of the document. For example, some comments highlighted a disconnect between how the document described UDIs for kits and their individual components. “These are more about FDA clarifying through guidance on how we expect it to work, rather than a change in policy or regulatory text.”

Another issue highlighted by the comments is how companies should handle the meta data. How companies organize and validate the data generated will be a significant indicator of the success of the system. Crowley advises that firms focus on flexibility and adaptability in the organizational structure—requirements from FDA are almost certain to change. “I’ve tried to emphasize that you shouldn’t think of this as a one-time system.”

What is key is that none of the comments have indicated a need to change the basis of the system. This means that companies do not have to (and in Crowley’s mind) should not wait to start planning for implementation. “I’m sure there are some companies that are waiting to begin implementation when the rule is finalized.” He strongly recommends against waiting. “We’ve got 80% of the issues figured out . . . the basics of the law are not going to change.” The longer companies wait to implement, says Crowley, the more expensive it will be.

But that doesn’t mean medical device firms are on their own. “We are not the first industry to institute barcode printing technology. There are a lot of resources.” Some of those resources come in the form of consultants, but Crowley has been on the circuit for a while, offering his expertise as a resource, as well. “FDA hopes to release draft guidances in February.” Crowley is also speaking at MDM West in February, so it’s a good bet that his topic will be the user’s guide.

Most important is that device makers not loose sight of the significance of a unique device identification system. Crowley believes the system will fundamentally change FDA’s ability to assess medical devices. “It will be a single source of truth.” To ensure that vision, Crowley is working tirelessly to make the UDI system as accurate and clear as possible. He still welcomes your comments.

Register for Jay Crowley’s session at MD&M West to get the latest on FDA’s User Guides on Unique Device Identification.

Heather Thompson is editor-in-chief of MD+DI. 

How Medical Device Companies Can Boost Operating Performance to Improve Shareholder Value

How Medical Device Companies Can Boost Operating Performance to Improve Shareholder Value

Following an era of high growth and profitability in the medical technology industry, total shareholder returns have been declining during the past few years. This decline, combined with slower revenue growth and flatter profits, indicates a transition from a growth stage to a more mature stage of the industry’s life cycle. While many medtech companies are seeking topline growth by reassessing their capabilities, global business models, and marketing strategies, they have focused less on improving operating performance as a strategy for driving shareholder value. Yet, this may be an approach they cannot afford to overlook.

Slower growth has come amid intense pricing pressure and new mandates, such as the Affordable Care Act’s medical device excise tax, which went into effect this month. At the same time, global emphasis on controlling healthcare costs is raising questions about overuse of medical technology and driving down prices of devices, supplies, and diagnostics. This greater demand to demonstrate clinical and cost effectiveness raises the bar on medical innovation, even as talk of more stringent regulatory requirements increases uncertainty about the risk of developing new products. Boosting shareholder value in the medtech industry has never been more difficult.

Operational Excellence Drives Shareholder Value

Although not the only driver of shareholder value, operational excellence is critical for maturing industries. PwC created an operating performance index (OPI) to better understand industry trends and identify operational levers that medtech companies can pull to improve shareholder returns.a The OPI and publicly reported data obtained from S&P Capital IQ were used to analyze the operating performance of 56 global medtech companies, collectively representing nearly $200 billion in medtech revenues, during a 7-year period (2005–2011). Table I shows elements of the OPI and the annual medtech industry trend for each.

 

OPI Element

Description

Annual Trend Relative
to 2005 Baseline

Primary Metrics
 

Revenue growth rate Annual revenue growth rate –12%
Operating profit Last 12-month EBITDA margin 2%
Invested capital productivity Return on invested capital –2%

Secondary Metrics



 

Asset productivity Revenue/property, plant, and equipment 2%
Labor productivity Revenue/employee 8%
Gross margin (Revenue – cost of goods sold)/revenue 1%
SG&A effectiveness Revenue/selling, gneera, and administrative expense –1%
Inventory management Inventory turns –1%
working capital productivity Return on working capital –1%
Industry-wide trends in operating performance, 2005–2011

On most dimensions, operating performance in the medtech industry held relatively steady from 2005 to 2011. However, some dimensions changed notably. Average annual revenue growth rates declined at a rate of approximately 12% per year, dipping into single digits during the recession and failing to return to prerecession levels by 2011. The analysis also showed that revenue growth rates among industry leaders and laggards are beginning to converge, indicating diminishing differences between them.

The OPI revealed opportunities for improvement in invested capital productivity, inventory management, working capital productivity, and selling, general, and administrative (SG&A) spending effectiveness—all of which remained relatively flat during the study period. Other key findings of the analysis revealed the following:

  • Operating profits grew at an average annual rate of 2%, suggesting that medtech companies worked to manage costs and became more efficient.
  • Although revenue growth rates declined, R&D investment held at a fairly steady level as a percentage of revenue, resulting in a 10%-per-year downward trend in R&D impact.
  • Labor productivity, measured by revenue per employee, improved an average annual rate of 8%.
  • Asset productivity showed more modest gains of 2% per year, reflecting increased focus on efficiency.
  • Gross margins remained essentially flat, indicating that companies reduced cost of goods sold amid pricing pressures.

Strengths and Weaknesses by Segment

Breaking the industry analysis into segments—in vitro diagnostics (IVD), medical consumables, medical equipment, implantable devices, and diversified life sciences—revealed wide variations in operating performance.b As shown in Figure 1, the highest-performing segments were IVD, implantable devices, and diversified life sciences. The implantable devices segment led in 2005 but declined gradually, losing its edge over other segments. IVD, on the other hand, steadily improved to become one of the leading segments. The diversified life sciences segment remained fairly stable throughout the study period. Prior to the recession, medical consumables began to decline but regained lost ground by 2011. Medical equipment achieved stable operating performance prior to the recession, suffered the sharpest drop of any segment during the recession, and rebounded afterward.

Medtech segment OPI scores, 2005–2011.



The implantable devices segment’s decline was likely driven by the maturation of the cardiology and orthopedic implant markets, which were both characterized by low growth, reimbursement challenges, and changes in purchasing dynamics and buyer behavior. The implantable devices segment also had the highest SG&A expenses (stemming from a high-touch sales model) and the fewest inventory turns because of its practice of maintaining large field inventory to support high service levels.

The growing importance of molecular diagnostics and personalized medicine helped the IVD segment become a leader in operating performance after 2006. Rapid operating profit gains and steady improvements in cost management and operational efficiency also boosted sector performance.

Operating performance in medical consumables showed low operating profit and low revenue growth relative to others, reflective of overall and ongoing trends in the push for value over volume.

The analysis found that medical equipment companies were hit hardest by the economic downturn. Although efficient compared with other segments’ performance, the medical equipment segment was hurt by its customers’ difficulties in accessing funds for capital investments. This problem was evident in the sharp drop in growth rates.

Conversely, the diversified life sciences segment, which includes large companies offering a diverse portfolio of medical products, remained relatively stable compared with other segments. The variation in the operating performance of these companies’ medtech units apparently was mitigated by the performance of biopharmaceutical and other business divisions. 

Strategies to Improve Operating Performance

These insights into industry operating performance trends can inform specific companies about strategies for improvement. Once a company conducts its own operating performance review, business leaders can identify challenges and opportunities for improvement and decide which of the following strategies could work best.

Take a broader view of innovation. Value over volume is the mantra for the healthcare system of the future. A changing healthcare ecosystem (characterized by, for example, shifts in pricing power from device manufacturers to healthcare providers, and increasingly sophisticated customers demanding total solutions) means that medtech companies must develop new offerings catering to new ecosystem needs. In the past, innovation in the medtech industry has had a relatively narrow scope, being largely technology driven, product based, and physician focused. In the future, medtech companies will need to take a broader view of innovation. With the growing emphasis on healthcare costs and quality, areas such as clinical effectiveness, improved patient outcomes, and/or improved healthcare efficiency will become just as or more important than product innovation. In other words, Medtech players must address the needs of a broader set of stakeholders including, healthcare providers, payers, and patients, and innovate around new business models and a broader set of offerings including, products, associated services, and data or information management.

For example, some enterprising medical technology companies are securing their innovation efforts around the concept of “owning the disease” with products, services, and solutions across the continuum of care. They are adopting strategies pioneered by leading technology companies, creating innovation models anchored in consumer-centric disease solutions.

Focus on productivity. Gross margins, SG&A expense effectiveness, inventory management, and working capital productivity, have remained essentially flat over the past seven years, presenting significant opportunities for improvement. Medtech companies can adopt successful practices from other operationally efficient industries, such as high-tech, consumer electronics, automotive, and industrial technologies. For example, medtech companies can use value engineering and strategic sourcing to improve gross margins. Similar to those in other industries, medtech companies can outsource to tap external partners and capabilities and moderate development and manufacturing costs. To improve working capital and inventory management, medtech companies can more efficiently manage supply chains. They also can improve sales operations and reduce indirect expenses to drive SG&A effectiveness.

Forward-thinking medtech companies are revamping their operations to reduce business complexity and drive efficiencies by streamlining supply chains, product portfolios, supplier networks, and manufacturing and distribution footprints. Some companies are using platforming and product roadmapping approaches, similar to those of automobile manufacturers. They are designing interrelated product lines that offer differentiated products for different market segments (e.g., value, mid-range, and premium versions) and use common design, components, and manufacturing processes. This strategy allows companies to offer sophisticated products to more affluent markets but more basic devices where cost is the primary concern.

Adapt a go-to-market approach. The ongoing transformation in the healthcare ecosystem is changing the way medical devices are purchased. While buyers consolidate and gain more power, the influence of physician preference is eroding. Transparency requirements of the Physician Payment Sunshine Act are placing more scrutiny on personal contact with individual physicians. Meanwhile, healthcare delivery and payment models are evolving from fee-for-service to value-based, creating new decision-makers, different buying criteria, and greater customer diversity.

Savvy medtech companies will find opportunities to help shape new decision processes and even change the basis of competition. They will adjust sales and marketing budgets to target traditional physician customers and critical new stakeholders, including those within healthcare organizations (e.g. hospital administrators, supply chain groups, technology assessment committees), as well as patient advocacy groups, payers, and accountable care organizations. Each stakeholder requires a different value proposition and marketing approach. For example, some are best engaged through social media and mobile technology, whereas others prefer more traditional methods of communication

Explore new avenues for growth. As industry growth in developed regions slows and markets mature, developing economies present new opportunities for serving large and growing populations and accessing talent and manufacturing capabilities, often at significantly lower cost. Several leading medtech companies have established significant footprints in emerging markets. For example, some U.S.-based medtech companies have opened innovation centers in China, where internal R&D teams work with Chinese universities, research institutes, and physicians to create products tailored to local needs.

Companies also are considering a variety of other growth strategies. While traditional mergers and acquisitions are common, other creative approaches include open innovation, corporate venturing and incubation, codevelopment through partnerships, and in- and out-licensing. For example, some leading medtech companies have created corporate venturing groups to identify, fund, and accelerate the development of breakthrough opportunities. Others have established online open innovation portals to invite external product ideas and other engagement platforms to cocreate new products and solutions with external stakeholders.

Where to Begin

As the medtech industry continues to mature, individual companies may want to turn their attention inward to improve their operating performance. An OPI-based review can enable a broad evaluation to help identify significant challenges and pinpoint improvement opportunities.

The OPI can help companies establish a baseline and benchmark performance against their peers. Using the primary OPI metrics of revenue growth, operating profit, and invested capital productivity, companies can measure overall operating performance. They can use secondary OPI metrics to establish benchmarks and identify performance gaps and improvement opportunities in innovation and product development, operations and supply chain management, customer service and sales operations, and asset and labor productivity.

With an understanding of where operating performance stands most in need of improvement, management can begin digging deeper into these areas to determine what, in particular, is inhibiting better performance and where to target initiatives for change.

In an environment likely to remain difficult and uncertain, the difference between winners and losers in the medtech industry increasingly may come down to the basics of operating performance. Improving operating performance over several dimensions presents challenges. However, implementation of tailored strategies, business models, and capabilities will yield improvements that can increase shareholder value over the long term.

Sharad Rastogi is a principal in PwC’s pharmaceutical and life sciences practice. He advises medical devices/equipment, pharmaceutical, and biotechnology companies on operational strategies and execution to drive growth and improve profitability. He can be reached at sharad.rastogi@us.pwc.com.

 

Stratasys: 3-D Printing’s New Giant

The potential for 3-D printing to transform medicine are substantial. To cite but a few examples: the technology can be used to make custom implants, "print" virtually any drug, drug delivery devices, and even living tissue. Earlier this year, medical researchers successfully implanted a 3-D printed jaw into an 83-year old woman.

The implications of 3-D printing on manufacturing could be sizeable as well. The technology could be used for rapid prototyping (one of its most common applications at present) but all manner of replacement parts. In September, Business Week announced that the era of retail 3-D printing had begun.

Still, this is a young industry, and the applications of this technology still mostly relate to manufacturing. Pioneers in the field include 3D Systems, Stratasys, Massachusetts Institute of Technology, and the University of Texas at Austin.

Earlier this month, Stratasys merged with Objet, another large 3-D printing company, making the firm the biggest player in the space. The resulting company, called simply Stratasys, is valued at roughly $3 billion. It is larger than the previous market leader, 3D Systems. After the merger, the company can 3-D print objects from more than 120 materials.

Before the merger, Stratasys had a significant number of products that were used for healthcare-related applications. That was the case for Objet as well, whose product portfolio included technology for healthcare applications such as creating surgical and diagnostic aids, prosthetics and medical products, tissue engineering, as well as prototypes of medical devices.

The product offerings of the new Stratasys will be broken into three basic areas: fused deposit modeling for making fast and inexpensive prototypes; PolyJet, a photopolymer-jetting technology for detailed prototypes requiring a fine surface finish; and Solidscape Drop-on-Demand 3D wax printers for investment casting.

Brian Buntz is the editor-at-large at UBM Canon's medical group. Follow him on Twitter at @brian_buntz

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New Medical Device Polymer System Is a Jack of All Trades

SEM image shows peptide-functionalized poly-benzyl L-glutamate nanofibers produced using a new polymer initiating system that can work with an array of drugs, biologics, vitamins, and other therapeutics.

Medical device manufacturers have traditionally fabricated drug-delivery and other combination products using different polymeric systems for different therapeutic agents. In addition, they have had to add the agents to the polymer ingredients before producing the polymer structure, causing potential processing issues. Now, researchers in the College of Polymer Science and Polymer Engineering at the University of Akron (Ohio) have simplified the process of producing combination products, developing a single, multifunction polymer system that can incorporate a vast array of drugs, biologics, vitamins, and other therapeutics.

"The innovation in our technology is that we have been able to come up with an initiating system for ring-opening polymerization, a process used for creating all polylactic acids and biodegradable polyesters used in biomaterial applications," remarks Matthew Becker, associated professor of polymer science at the University of Akron. Constructed of a highly strained, triple-bond molecule called dibenzylcyclooctyne, the initiating technology is compatible with a range of biodegradable polymeric systems, including cyclic lactic acids, caprolactones, and amino acid-based benzyl-protected L-glutamic acid, which is often conjugated with paclitaxel to treat cancer.

While it is able to work across polymers, the new initiating system also survives the electrospinning fiber-generation process, a fabrication method that typically uses very small amperage but very high voltage. "A polymer as energetic or strained as ours would not normally survive a fabrication process like this," Becker explains. "But our technology enables us to form such constructs as nanofiber mats and then functionalize them with bioactive species after the polymer construct is made."

Most combination products, according to Becker, are typically the result of a process in which the peptide, carbohydrate, drug, or prodrug is put onto the polymer before it is fabricated into a structure. But because most polymerization processes require heat, solvents, or other processing steps that can damage the therapeutic agent, manufacturers must carefully derivatize, characterize, and control the process. "Here, in contrast, we can fabricate the polymer construct using the electrospinning process, and our strained reactive groups survive this process," Becker comments. "This means that after our construct is fabricated, we can go back and put the peptide, carbohydrate, or DNA molecule on last, which makes our process much more cost effective and much more likely that the bioactive species, which is the most expensive part of the entire construct, is going to be preserved."

In addition to developing its polymer technology to produce such medical devices as wound-care bandages, the Akron team is also in the early stages of using the material to create blood vessels. "While researchers have had real clinical success in using electrospun nanofibers to fabricate tubes in very precise ways as surrogates for blood vessels, incorporating peptides and gross factors to enhance or accelerate blood-vessel formation remains one of the grand challenges facing regenerative medicine," Becker explains. "However, our new polymer system can be combined with bioactive species to accelerate this process."

Because the researchers are working with polymers and functional groups that are already employed in biomedical applications today, incorporating them into existing applications using the new technology should be a relatively seamless process, Becker remarks. "We are still going to have to perform due diligence, but despite the very rigorous review process, we think that our technology is a much more translationally relevant strategy than other strategies that have been brought forward recently."

Overcoming the “Dufus Factor:” Designing Wearable Devices People Actually Want to Wear

Sonny Vu
Sonny Vu, CEO and co-founder of Misfit Wearables. 

People don't generally like to wear electronics, observes Sonny Vu, who is the cofounder of AgaMatrix, a maker of innovative iPhone-interfacing blood-glucose meters that won the Red Dot Design award in 2011 for product design. Since stepping down as the CEO of that company, Vu has set his sights on pushing the boundaries of wearable technology with a firm known as Misfit Wearables. 

"In this whole world of wearable technology, what I have found is that it feels like a big misnomer because many of these products are not that wearable," he says. "People don't wear electronics and technology; people wear things like jeans, t-shirts, belts, and shoes. I think our job as product makers is to make products that are either invisible and unobtrusive like a pair of underwear, socks or an undershirt," he says. 

That's a tall order, he acknowledges. As is the other possibility he advocates: making a technological products that are so beautiful and elegant people would want to wear them even if it didn't sense anything. "This is the direction we need to head in if we are going to actually make wearable products truly wearable."

"We have to go to remove the dufus factor from these products. They don't have to necessarily be cool; they just can't be uncool."

Misfit Wearables is exploring the consumer technology space with the goal of making products people would want to wear all of the time. "What is more useless than a really accurate sensor that you don't wear because it is not comfortable or it makes you feel like a dufus wearing it?" he quips. "We have to go to remove the dufus factor from these products. They don't have to necessarily be cool; they just can't be uncool."

After a device has been developed that people will want to wear, they can start developing devices with expanded functionality.

For now, the company is focusing on motion tracking. "Motion is the simplest thing to go after. It is the easiest sensing thing that you can do. But yet you can derive lots of really useful information from it," he says. "That is why we started with that technology [in the Shine]."

The device plans on tracking other parameters than motion in the future. "Clearly we need to move beyond just motion sensing," he says. "We haven't made any announcements about what we will be sensing but we will be releasing another product later in 2013 that will measure some really neat stuff and, again, it is going to be something that is very comfortable to wear that won't make you look like a dufus."

To test the assumption that consumers would want an elegant solid-metal fitness tracker, Misfit Wearables turned to crowd-sourcing. "We ran the experiment on Indiegogo to see if people will actually pay for this thing. We have taken some pretty bold design decisions on the display and the halo of lights that tell you how you are tracking to your daily activity goals," he says. "We launched it on Indiegogo to gauge to see how people will buy into it--literally," he adds. "We didn't just ask people: would you buy this? You being nice might say: "yeah, sure, I'll buy it. But that is not an interesting test. A more interesting test is to say: 'OK, great, give me your credit card and $99 is going to come out of your credit card.'"

The company started with a goal of raising $100,000. The resulting money raised would be used to commercialize the device. "It was supposed to be a 30-day campaign and within 9.5 hours, we got 1400 orders. That helped us cross the $100,000 barrier in under 10 hours," he says. "It was amazing. We got orders from 48 different countries, all 50 states, all with no advertising or marketing."

The firm, however, has substantial funding support apart from Indiegogo, having received nearly $8 million from Peter Thiel's Founders Fund Vinod Khosla's Khosla Ventures.

The Challenge of Putting Design First

Vu acknowledges that it was difficult to design of the Shine first and figure out the functionality after that. "We basically said we are going to make a thing out of solid metal. This is what it is going to look like and this is what the user experience has got to be. Now go make it work," he says. "Basically, we had to come up with new stuff to make it work. The engineers thought this was a crazy idea but we have great technical people and I think they figured out how to do it."

Particularly challenging was the fact that the device was made from a solid piece of aircraft grade aluminum. "Because of that, as you'll remember from your physics, there is a Faraday Cage phenomenon," he says.

"Here's to the crazy ones, the misfits, the rebels, the troublemakers, the round pegs in the square holes... the ones who see things differently--they're not fond of rules... You can quote them, disagree with them, glorify or vilify them, but the only thing you can't do is ignore them because they change things... they push the human race forward."
--Steve Jobs

"It was very difficult to transmit data from outside of the device. As a result, we have had to come up with an entirely new way of sending data. We will start shipping the product in March and I am sure that within five minutes of receiving the product, people will say 'oh, that is how they did it.' And it will be a complete non-surprise," he says. "But we did have to break some rules and do some new things to make it work. That was hard. This is the hardest product I've ever made."

The company's focus on design was partly inspired by Apple co-founder Steve Jobs and his penchant for user experience. "We were founded on the day that Steve Jobs died--October 5, 2011. "[AgaMatrix co-founder] Sridhar Iyengar, [former Pepsi and Apple executive] John Sculley, and I were sitting in Menlo Park and then we get text messages and e-mails about Steve dying and we thought: 'Oh my God, I can't believe that happened. That's crazy. And we decided to name the company in honor of him.'"

The Lean Hardware Movement

Vu also draws inspiration from the Lean Startup Movement and talks warmly of the idea of "iterating as fast as you can so that you can learn based on user input." He continues: "Meaning: make some stuff, get some feedback, update it, get more feedback, and if you are moving in the wrong direction, back up and do something else. Do that as rapidly as you can because the lifetime of your startup is not measured in months but the number of times that you can pivot."

The question is: how do you apply that software strategy to developing hardware? "That is not an easy thing to do," he says. It is not easy to build a product and then say, immediately after: 'OK, let's do another one.' Still, a number of companies are becoming trailblazers in this field. "They will 3-D print stuff, lay out a board, try it out, make a bunch of prototypes and have people try them out. If it works, great. Take it production. If it doesn't, re-do the form factor, try something else and try it again."

Misfit Wearables had the unique challenge of dealing with metal, which made it difficult to make quick iterations of product prototypes. Still, he stands by his choice of material. "It is really not until you hold and feel the product in its original material that you get why it is so magical. When you hold the Shine, it doesn't feel like a piece of technology. It looks like an alien piece of technology to be honest," he says. "I don't think most people have seen an electronic device that feels like this. It literally feels like a button. It is smooth like a button. It is a matte gunmetal gray finish. It is beautiful. We have had some challenges trying to figure out how to move quickly but one of the ways was to make a prototype, make a video, and share it with the world, and see what people think." 

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

Top Medical Device Challenges for Healthcare Technology Professionals

Medical devices help a lot of people, but they also present challenges for hospitals. The Association for the Advancement of Medical Instrumentation (AAMI) surveyed healthcare technology management professional about the biggest difficulties they face in dealing with medical devices.

Here are some of the top challenges they identified:
 

  • 72% say managing devices and systems on the IT network.
     
  • 65% say integrating medical device data into EHRs.
     
  • 50% say broken connectors.
     
  • 50% say battery management.
     
  • 49% say alarm management.
     
  • 48% say maintaining infusion pump systems.
     
  • 47% say cybersecurity.
     
  • 44% say developing preventive maintenance strategies.
     
  • 42% say incident reporting and investigations.
     
  • 42% say personal medical devices brought in by patients.
     

Jamie Hartford is MD+DI's managing editor.

Wireless Innovation Takes the Stage at MD&M West 2013

MD&M West, the most anticipated medtech event of the year, will take place February 11–14 in Anaheim, CA. With an exposition featuring world-class suppliers, medtech professionals worldwide will come together, sharing best practices and innovative ways to transform the future of medical devices. This year’s conference program features a brand new slate of sessions curated around each stage of the product development cycle. Industry experts, innovators, and entrepreneurs will address topics in design and prototyping, validation, testing, trials, regulatory submissions and approvals, and postmarket compliance and production. 

This year MD&M West is also expanding its agenda with the addition of a selection of Medtech Innovate Seminars. The seminars consist of eight interactive learning forums, each delivered in a two-hour format, designed to inform attendees of the latest developments and technological innovations shaping the medtech industry. Seminars include “Design of Implantable Devices,” “Bioresorbable Polymers,” “Innovations in Orthopedic Devices,” “Developing Medical Mobile Apps,” “Microelectronics and Sensors,” “Innovations in Cardio Devices,” “Power Source Technologies,” and “Wireless Medical Devices.”
 
Jung-ik Suh
Jung-ik Suh of Agilent Technologies will  chair the February 13 Wireless Medical Devices seminar. Suh is the marketing manager of the Electronics Measurement Group of Agilent, a manufacturer of analytical instrumentation that focuses on testing and measurement. Suh, who began his career at Hewlett Packard in 1997, has more than 15 years of experience working in the realm of wireless technology and has published numerous articles on the subject. The wireless seminars are designed to give attendees an overview of how wireless technology is shaping medical devices today and how it will affect them in the future. Speakers will discuss the process of bringing wireless-enabled medical devices to market, the challenges faced by device manufacturers in doing this, and how these challenges can be overcome. 
 
“Wireless technology has changed a lot of people’s lives and has even saved lives,” Suh says. “Now wireless technology has moved to medical devices. Wireless sensing has allowed us to see more than we could than wired sensors. Wireless sensors on your body can help doctors and hospital staff better monitor patients. Many people who want to be healthy are using wireless technologies to monitor themselves for fitness purposes.” He also cites the cost benefits of wireless medical devices. “You allow for seamless communication from machine to machine or even machine to person. Using wireless technology has [helped] reduce hospital and medical device costs.”
 
For device manufacturers looking to get into this field, Suh sees several challenges that must be addressed. In addition to technical challenges, there are also regulatory hurdles to clear. “We have the FCC and FDA in the U.S., but if you look at the international market, China has its own regulations, Korea has its own regulations, and European countries have their own,” Suh says. “So one of the biggest challenges for the medical device developer is how to meet all these various regulations.” 
 
On the technical side, Suh says radio frequency (RF) interference can present issues in designing wireless medical devices, as can electromagnetic interference (EMI) and electromagnetic compatibility (EMC). “Almost all headphones and smartphones today have an automatic connection to Bluetooth or sometimes wireless LAN, even if the user doesn’t recognize it.” The concern is that someone could bring a device like this into, say, a hospital environment and create interference. That could potentially harm a patient if a medical device starts working incorrectly. Designers must also choose among various types of wireless technologies—from commercialized ones, such as Bluetooth, wireless LAN, and 4G, to lesser known but still effective ones such as near-field communication (NFC). Understanding how these signals relate to and can interfere with each other and which may be best for a particular type of device or system also becomes a challenge. 
 
“There are so many wireless radio technologies that can be applied into the medical device area,” Suh says. “Such a broad selection of technology is something [manufacturers] need to address.” Though wireless LAN and Bluetooth technology are the top wireless technologies used by medical device manufacturers today, there are many other options designers can choose from depending on the needs of their devices, he says. 
When it comes to implantable wireless devices in particular, battery life and battery drain is another important technical issue—one Suh plans to focus on in his opening presentation. “If a battery goes down in an in-body device or in an emergency situation, it can be a critical issue.” 
 
The “Wireless Medical Devices” seminar will also feature Ken Fuchs, senior principal architect for enterprise systems for Chinabased device manufacturer Mindray, who will be speaking on many of these issues in his talk, “Using Risk Management to Successfully Deploy Wireless Medical Devices.” Philips Healthcare chief wireless architect Phil Raymond will cover more technical aspects of wireless technologies in “Medical Device Integration Using Current 802.11 Wireless Infrastructures in the Unlicensed RF Band.” Finally, Stacey Chang, director of the healthcare practice at IDEO, will give a presentation titled “Preparing Your Wireless Medical Device System for Operating in Real-World Acute Care Environments.” In addition, speakers will present two case studies detailing wireless applications—covering design, functionality, testing, security and compliance. 
 
While manufacturers of wireless devices have a lot on their plate to consider, Suh is confident MD&M West attendees will leave his seminar with a strong understanding of how to overcome these challenges in their own devices. 
 
 
(Editor's Note: Jung-ik Suh will be introducing and chairing the seminar on Wireless Medical Devices at the upcoming MD&M West trade show and conference. Join him and other wireless technology experts February 11-14, in Anaheim, CA. Registration for MD&M West is now open
—Chris Wiltz is the Associate Editor of MD+DI 
 
 
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