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

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

Sitemap


Articles from 2010 In January


Metamaterials-Based Antenna Packs High Effiency into Tiny Package

A miniature antenna retains efficiency at a fraction of the size of standard antennas.

A miniature antenna retains efficiency at a fraction of the size of standard antennas.

A collaborative research team with members hailing from the National Institute of Standards and Technology (NIST; Gaithersburg, MD), the University of Arizona (Tucson), and Boeing Research & Technology (Seattle) has produced an antenna that demonstrates efficiency and has properties comparable to those of standard antennas in a significantly smaller package. Such an antenna could be useful for microsensors and miniature devices requiring wireless connectivity. In order to operate efficiently, conventional antennas must measure at least half the size of the signal wavelength, according to NIST. Measuring 1/50th of a wavelength and capable of radiating as much as 95% of an input radio signal, the NIST antennas could be a game changer. This dramatic size reduction while maintaining efficiency is attributed to the inclusion of metamaterials, according to the researchers. Metamaterials are specially engineered materials that exhibit unusual properties typically not found in nature. In addition, the researchers speculate that the metamaterials could enable the antenna to communicate at any frequency. "The purpose of an antenna is to launch energy into free space," says NIST engineer Christopher Holloway. "But the problem with antennas that are very small compared to the wavelength is that most of the signal just gets reflected back to the source. The metamaterial makes the antenna behave as if it were much larger than it really is, because the antenna structure stores energy and reradiates it." In the most-recent iteration of the antenna, the researchers employed a z-shaped strip of copper with an inductor in the center as the integral metamaterial. It was mounted to the back of a copper square on which a metal wire antenna was printed. Antenna innovations are cropping up lately, as researchers address industry needs for more-efficient, smaller devices capable of sending and receiving data or information. Read about a novel flexible antenna from the most-recent issue of MPMN.

SHS Invests in TNI Medical AG

Products by the company aim to increase patient comfort while simplifying application and promoting cost-efficiency.

When Is Sustainable Manufacturing Sustainable?

Manufacturing practices themselves are being modified to lower the volume of wastes to all environmental media (i.e., air, water, and land). Although many companies have some kind of waste reduction in place, the judicious use of resource productivity is of increasing importance.

 
The term sustainable manufacturing means different things to different people. Many of these differences come from the discipline and bias of the manufacturing professional. People often get needlessly sidetracked by definitional disputes. Suffice it to say, achieving sustainable manufacturing in any business is considered to be a journey, not a destination or static state.
Sustainable manufacturing is a key component of operating a sustainable business while creating value for the environment, the stakeholders, and the communities where the company conducts its business. There is a lot of interest in sustainable manufacturing within the device manufacturing industry sector. After the humble beginnings in the late 1980's, we are currently experiencing a major shift in philosophy, acceptance and emphasis on sustainable manufacturing.
Becoming sustainable often starts when a company adopts a formal program to drive resource productivity. Many companies use ISO 9001:2008 as the foundation for this program. They integrate elements of ISO 14001, risk management (ISO 31000), social responsibility (draft ISO 26000) and a business excellence framework (Baldrige Performance Excellence Program). This integrated management system helps make sustainable manufacturing practices part of the way the business is operated day-in and day-out. Products made to these specifications can be certified to sustainable product standards currently being issued by the American National Standards Institute (ANSI) and other similar standard setting bodies.
Next, the manufacturing process needs to be operated in an ecoefficient manner. Companies pay attention to the direct and indirect use of all resources (i.e., energy, water, and materials) and the loss of these resources from each activity in the manufacturing process. The indirect use and loss of resources comes from supporting processes and facility infrastructure processes (e.g., air compressors, air and water pollution control equipment, boilers, chillers and heating ventilation, and air conditioning). Process mapping and resource accounting are used to ensure the use of what ISO 9000: 20000 calls a process focus and a systems approach to management.1
An interest in sustainable manufacturing does not automatically translate into a commitment to make the necessary changes in a product process. Many businesses worry about the cost and benefit of moving down this path. Many manufacturing executives view this as a choice between being more environmentally responsible and allowing employees to keep their jobs. This view of sustainable manufacturing is slowly being converted to a realization of the business opportunities that gain positive feedback from environmentally conscious customers and the increase in sales resulting from this acceptance.
Reducing energy and water use are the most common and simplest places to start when it comes to turning a process into a sustainable manufacturing process. Eliminating all wastes from all business practices is an important mid-term goal. In the longer term, the manufacturing business can develop sustainable manufacturing technology and products that take the business to a higher level of sustainability. Environmental and social responsibility in manufacturing not only includes contributing to sustainability in an individual company, but also being able to manufacture those supplies that will facilitate the ability of other sectors in becoming sustainable. This involves the notion of life cycle management that is based on the fact that everything is connected to everything else.
Having a successful journey to sustainable manufacturing requires a company to align the manufacturing program with the company's vision, mission, and core values.2 Only by fully integrating the sustainable manufacturing effort with the core business will it have the management support necessary for enabling the business to complete the journey. The employees and stakeholders need to be involved in the planning as well as the implementation of this program. Employees are a key source of knowledge for the sustainability transformation. It is important to have mutually beneficial relationships with the suppliers, customers, and key stakeholders.
The most common ingredients of success are the integrated use of performance frameworks, management systems, and process improvement. Sustainable manufacturing uses these proven methods to meet customer and market needs with ecoefficient processes and their corresponding benefits to the environment, key stakeholders, and the community. The sustainability comes from the value to the business' top line branding and the bottom line as it contributes effectively to creating a robust local economy. This may be the best argument for senior management to support sustainable manufacturing processes in an operation.
Green versus Sustainable Manufacturing
The term green is usually restricted to manufacturing that has substantially lowered its energy use or where it has used materials with high recycled content or has lowered its waste production. Sustainable manufacturing seeks to move beyond what people call green. Three types of outcomes need to be examined—environmental, social, and economic—if the practices are truly considered to be sustainable. This is controversial because many manufacturers limit their so called sustainability efforts to what is essentially environmental sustainability. Other manufacturing companies refer to their work as green manufacturing or lean-to-green manufacturing. If there are three responsibilities or outcomes involved in sustainability, then green efforts and lean-to-green efforts do not fit the definition.
Stakeholder Engagement
A major differentiator of sustainable manufacturing practices when compared to business as usual is the use of something called stakeholder engagement. It is very important to listen to the stakeholders and learn more about their interests in the sustainable manufacturing practices. Many companies think that if stakeholders are engaged at all, they must also be appeased. This is not true, but it is important to listen to what stakeholders have to say. Many sustainable manufacturing companies are showing a wide variety of stakeholders detailed information on their core processes responsible for their activities, products and services. Knowing more about what the company does, takes away some of the fear. Stakeholders appreciate transparency and accountability. And they often have good comments that could lead to further innovation. Stakeholder engagement starts with an intensive effort to increase employee involvement in the process. Next, the company should be asking the suppliers about how they make their products and how others are using them in their processes. Suppliers are usually only asked about delivery time and price. They have so much more information that could be of help to an OEM. There are other stakeholders in the neighborhood and community that could be approached to determine their interest in the manufacturing process. Some good stakeholder engagement tools are available on the Internet.3 The use of these tools becomes apparent over a longer time as the company gets familiar with them and sees the value of using them to add sustainability to the manufacturing processes.
Management Systems
Many manufacturing managers feel that management standards are needed only to meet a customer requirement. This requirement by a key customer—to be certified to a particular ISO standard (e.g., ISO 14001, environmental management system standard)—is treated by managers as “the need to put a certificate on the wall.” Such thinking leads to the implementation of minimally responsive programs, so naturally, the company realizes little benefit from the management system. A management system is defined as making quality, environment, sustainability or social responsibility (depending on which management system is used) part of the way the organization is operated. Many medical device manufacturers adopt ISO 9001 to help them meet good manufacturing practice requirements of FDA. However, it is unlikely that these manufacturers are using the management system to make quality part of every employee's job every day. ISO 9001 provides an excellent foundation for the company to implement ISO 14001 and OHSAS 18001 (i.e., health and safety management system). There are management system standards for sustainability and social responsibility (e.g., ISO 26000, BS 8900 and AS 8303) that can also be integrated with these other management system standards to provide a foundation for a sustainability management system. The key to success is to ensure that the employees are involved in the program and that the program is designed and operated as an active means for promoting sustainability within the company.
Operating in Silos
Many manufacturing companies operate their process improvement programs and management initiatives independently of one another. Independent programs are commonly referred to as silos.4 Each of these silos is often run by a champion whose value to the company is determined, to some extent, by the success of the activities associated with the initiative (silo). These people are often reluctant to consider the integration of programs (e.g., management systems, business excellence frameworks, risk management, and process improvement techniques like lean and six sigma). They find such integration threatening. However, if the integration is focused on equipping the employee with a single integrated approach to their work, some of these threats can be mitigated. Employees become confused with the large number of initiatives and the competition between them for their attention. The initiative champions are not able to help the employee do their job better or more effectively. By having all of these programs coordinated by the integrated sustainability management system as described, it will be possible to have one process improvement system in the eyes of the employees. In this way, the silos are not destroyed—they are harmonized in an integrated fashion to help the employee move to sustainable manufacturing processes.
It may be easy to understand the many varied elements that constitute sustainable manufacturing practice, but it takes a lot of focus and dedication to put these elements into place and begin the continual improvement process that will ultimately lead to sustainable manufacturing practice. Companies that have discovered the benefits of an integrated sustainability management system are convinced that it helps them improve the business. However, it seems that many manufacturing companies have precious little time for implementing a sustainability management system. When manufacturing volume is high, they are too busy to work on these projects. When manufacturing volume is low, they cut the resources necessary to plan and implement these processes and programs. Companies that implement the integrated sustainability management system gain a competitive advantage because all activities, products, and services can be coordinated and controlled in a manner that promotes the environmental, social, and economic responsibilities that are inherent in the sustainability program.
Conclusion
After reading this article, you may be reminded of some of the activities that you have initiated that meet the criteria for sustainabilty. That's great! You are officially on your way! The challenge now is to keep these efforts moving forward. Engaging stakeholders, channelling existing standards, and integrating silos are significant steps that can help a medical device company improve resource management and thereby improve productivity and the bottom line.
 
 
References

1. R B Pojasek, “Understanding Processes With Hierarchical Process Mapping,” Environmental Quality Management 15, no. 2 (2005): 79–86.

2. R B Pojasek, “A Framework for Business Sustainability,” Environmental Quality Management 17, no. 2 (2007): 81– 88.

3. Stakeholder Engagement and Facilitation, AcountAbility; available from Internet: www.accountability21.net/default.aspx?id=256.

4. R B Pojasek, “Energy and Water Management Systems: Building More Silos?” Environmental Quality Management 18, no. 2 (2008): 79–87.

Robert Pojasek is senior program director at Capaccio Environmental Engineering Inc. (Marlborough, MA). He can be reached at rpojasek@capaccio.com

The MX Q&A: e-Zassi.com’s Peter von Dyck

The Web site is designed to enable the device industry identify opportunities for acquisitions, licensing, and collaboration. It uses 46 specific business interests and member profiles created through a Web-based interface that taps into 5000 attributes. The business interests carry headings such as technology investing, acquiring/licensing technology, manufacturing, seeking strategic partners, and funding. A Q&A interface called Device Network Attributes, or DNA, leverages the 5000 traits to help members find compatible business matches, according to the start-up. An additional FDA Regulatory Calculator shortens product classification searches to minutes rather than months by allowing users to input nonconfidential product attributes and details about their new product or technology. The calculator then provides potential predicate codes and other regulatory information and offers an FDA classification analysis of up to three medical device technologies, according to the company.
 
Von Dyck says the idea for the site grew out of the “real-world frustrations” he experienced while running his Florida-based company, Zassi Medical Evolutions, which manufactures gastrointestinal products for waste management and incontinence control. He says individuals and institutions with innovative ideas and good research “have the science part down but struggle with key business-related areas like regulatory assessments, reimbursement, manufacturing, sales, marketing, and quality control. We knew we could speed connectivity and deal-making between innovators and industry if we created the ability for this data to be generated automatically and without bias.” Particularly in an economy with a weak pulse, von Dyck asserts that the device industry needs “new-economy” methods for finding partners, sharing noncompetitive research, and getting products to market faster than traditional methods allow.
 
Von Dyck founded Zassi Medical Evolutions at the age of 28. The inventor of the e-Zassi Innovation Diagnostic Tool (IAE), he was selected by Ernst & Young as the 2000 Florida Entrepreneur of the Year for healthcare and life sciences. In 2004 Medical Device & Diagnostic Industry named von Dyck one of the 100 Most Notable People making a material difference in the global medical device industry.
 
In this MX interview, von Dyck touches on topics such as the challenges in launching the online venture, the benefits and drawbacks of using social media as a business tool, navigating “the paranoia element” of the device industry, and the familial origins of the company's name.
 
MX: How many members are there in the e-Zassi business network now?
 
Peter von Dyck: We're very pleased. We already have more than 800 individual and corporate subscribers in the short time since we launched and membership grows every day to reflect an impressive diversity of global leaders within the medical device industry. We have an equal distribution of C-suite execs, top researchers, academic institutions, and finance community and service provider leaders. Much of our development work is focusing on the influencer and early adopter segments of our target audiences. Unlike the homogeneity of many other networks, this diversity of decision makers assures the range of counterparts typically needed to move a project forward are accessible by all e-Zassi members.
 
What challenges did you face launching the online business Web site?
 
There were two primary issues.
 
The capabilities of the software were underestimated because it was a new technology solution. It was difficult for potential members to believe that a software platform could facilitate so much collaboration and disclosure without any intellectual property exposure. In essence, InnoVision, our predictive analytical software that digitizes key traits and attributes from medical technologies, does so without using any confidential inputs or generating any confidential outputs from a patent perspective, eliminating the need to fight over confidentiality agreements first.
 
The second challenge was the economy. In 2009 it was clear that, for the first time, even the medical device industry was materially impacted by the recession and most folks were a bit restrained in implementing anything new until the smoke had cleared. Now they see us increasingly as a new-economy tool and one that's a more powerful and less expensive way to connect and collaborate versus the manual and traditional means.
 
Did you adapt anything you may have learned from social networking sites such as LinkedIn or even Facebook when designing your industry-specific site?
 
A few things. While these sites are a bit shallow in comparison to what we have built and customized for a very deep and technology-centric industry, we adopted certain best practices and features, such as the membership alerts systems and integrated e-mail features.
 
Specifically, what real-world frustrations caused Zassi Medical Evolution to launch e-Zassi?
 
The primary frustration we observed was that many individuals and institutions on the research and innovation side of the industry were ill-equipped to calculate and depict, to industry partners, the key opportunities and burdens that are involved with a newer medical technology. They have the science part down but struggle with key business-related areas like regulatory assessments, reimbursement, manufacturing, sales, marketing, and quality control.
 
We knew we could speed connectivity and deal-making between innovators and industry if we created the ability for this data to be generated automatically and without bias and then be available to facilitate deeper initial reviews for diligence that didn't require premature formation of arduous confidentiality agreements. There also was the fact that searching for and building the evolving array of synergistic partners and experts that a technology or company needs took an enormous amount of time and money. Typically, industry members had accomplished this by traveling and attending and exhibiting at conventions, or by placing and reading general trade ads and such. As the world has become more digital, these “old school” means have become less effective and are quickly losing their relevancy.
 
What challenges do device companies face when bringing products from design to market?
 
There are tremendous challenges entailed in the process of maturing a concept from design to market. Many involve the detailed road-mapping and planning around the development burdens of the product. It is critical to have not just an early understanding of these challenges so that clinical plans can be designed properly to satisfy safety and efficacy but for regulatory approvals and competitive analysis and reimbursement as well. In many cases these variables, and many others, are reviewed much later in the cycle, causing repeated work or the need for additional capital, as well as other [unforeseen] events. This can be mitigated through the use of the e-Zassi.com predictive analytics software platform. We have already received testimonials from our initial members that our software and services have led to value-added connections that have saved both time and money.
 
Do the challenges vary depending on, say, the medical use or class rating of the device?
 
Yes, the challenges vary significantly depending on the FDA or regulatory classification a product falls into. This is one reason the FDA Calculator feature is embedded into our InnoVision software. The regulatory classification of a new device technology alone can significantly impact the time and capital requirements of a technology by several years and millions of dollars. Without knowing the classification very early on, companies may be developing or negotiating in the dark.
 
How hard was it to come up with 5000 data points for search and matching purposes?
 
The 5000 unique attributes and traits we call “DNA” or Device Network Attributes are pivotal to the powerful capabilities of the e-Zassi software. They have taken years to develop, and they act similar to biological DNA in humans. As the human genome project has begun to usher in personalized medicine and care based on an individual's differentiating genetic features and traits, the e-Zassi system achieves the same by extracting and leveraging the differentiating DNA of its individual and corporate members and all medical devices technologies as well. This really changes the game and will create amazing new capabilities going forward.
 
Do you detect any device trends in the type of companies signing up to use either the matching site or the regulatory calculator?
 
All sectors and company types benefit from the search engine we have in place, but our InnoVision predictive analysis tool is presently best suited for those technologies in the minimally invasive surgery area, orthopedics, cardiovascular, and urological medical specialties.
 
How has the industry responded to the launch of e-Zassi.com? Do you find that skeptical company executives are worried about protecting their IP, for example?
 
Our system has been specifically engineered to address and navigate the paranoia element of our industry as it relates to intellectual property, so we get a good response from those that take the time to see how elegantly that has been addressed and how that is a game changing feature. On the other hand, the fact that for the first time in decades the medical device sector has been materially impacted by the global economic crisis, 2009 proved quite a challenging year to introduce e-Zassi.com. Now, as things improve a bit, industry participants are ready to look at new tools that enable them to work faster and more economically, so we are finding that we are really increasingly viewed as a welcome new-economy tool that saves time and money.
 
Does the site use proprietary algorithms for matching purposes?
 
Yes, all our coding and methodologies are proprietary and patent pending.
 
What are the benefits and the drawbacks of using social media for device companies?
 
Most existing social media forums are too shallow and broad for the very specialized life sciences industry. These social media sites can serve well as a means for direct-to-consumer conversations and certain basic B2B or P2P connectivity too, but being in a highly regulated and trade secret sensitive sector, we have special needs. Of most risk with existing sites is the potential for over-disclosure—whether intentional or inadvertent—of critical patentable data that could be catastrophic in terms of potential adverse events tied to social media sites. I think the Internet is a very viable medium to leverage, as our industry is very globalized and fast-paced. A site tailored to the fears and regulations of life sciences like e-Zassi may have a bright future, as the Internet becomes the dominant means of B2B collaboration and communication.
 
What steps can device executives take to maximize their company's efficiency in product launches, especially in this economy?
 
Speed-to-market and the effective communication of the safety and clinical and cost benefits of a new product are paramount in gaining rapid adoption. That's another reason why we felt it was imperative to develop a software platform that could provide predictive analytics early in the innovation and product development cycle while being able to foster faster and more synergistic connections among diverse sets of parties around the globe. Product life cycles are shortening, and we all have less time to capitalize on a window of opportunity, so even as devices become more complex and costly to develop, we need to find faster ways to execute.
 
What have you learned from your expertise in patents that has helped you design the matching site and regulatory calculator?
 
Developing and holding more than a dozen medical device patents myself, I can say that that experience was critical in [designing] the e-Zassi software [architecture]. The majority of all patents awarded end up merely being fancy plaques on the wall, while only a small percentage are viable enough to attract the backing to get through the development gauntlet and eventually provide improvements to patient care, create revenues, jobs, and returns for shareholders and investors. It was clear that a new approach was needed. Patents are expensive to prosecute, develop, maintain, and defend. And without embedding developmental and commercial aspects and thinking into a patent estate, they risk being challenged and potentially infringed or bypassed as an effective barrier to entry. Patents really need to be forward thinking and broad and increasingly include real market elements so that they are more commercially viable and actually protect the intended and finished product on the market and not just some theoretical claims on a concept.
 
Finally, you probably get this question a lot, but what's the origin of the company name “Zassi?”
 
The name “Zassi” was first used for my medical device company back in 1997 when I was 28 and struggled to invent and develop a new medical device to help my sister, Saskia, who my family affectionately called Zassi. She was seriously wounded and in a coma due to a head accident when she was in her twenties. I wanted to form a company that was patient- and family-centric and we ended up successfully innovating two new technologies for infection and continence control.
 
Unfortunately, it was not in time to save her. After I licensed and sold off the two medical technologies in 2006, my dream was to build a system that would transform the industry and make sure more great innovations made their way through the development gauntlet and to the patient's bedside. What better way to pay tribute to the ultimate “customers” we all serve by naming this important company after a patient who passed before benefiting from innovation. Her spirit lives on and serves as a powerful moral compass for us here at e-Zassi.com.

A Seat at the Strategy Table

Rita E. Numerof
Bill Ott
Several signs already show us that the old formulas for success aren't going to work that well anymore. One of the most significant signs is the growing complexity of the buying decision for healthcare products. What was once the sole domain of the physician has now become a decision reflecting the various needs of payers, hospitals, regulators, and a more involved consumer regarding product efficacy and cost.
Business indicators also portend a need for new strategy. Revenue and market share growth have stagnated for most healthcare product manufacturers, as an increasing number of new product developments seem to at best just retain share. Margins continue to erode as the price-setting power shifts from manufacturers to payers. Despite these business challenges to the industry's traditional leaders, the market continues to attract new competitors lured by the financial potential of the largest component of our national GDP.
Unstable Markets
These market dynamics have conspired to change the basis for competition. The winners in this market will be those companies that offer the strongest economic and clinical value (ECV).
Some of the most critical decisions a business makes are about its lifeblood—the stream of products it develops to generate revenue. Decisions on this product portfolio have traditionally been the functions of the R&D and Marketing departments in most companies. R&D introduces new product ideas in terms of what is possible from a technological perspective. Then, Marketing helps select the best projects by determining the upside potential for the new product concepts.
This approach works in stable markets lacking any disruptive new technology or new variables that affect buying decisions. However, it has some potentially fatal flaws in a more turbulent market, such as the one we're facing today. The biggest flaw is the assumption that the market will continue behaving as we have known it to behave. Sales projections are based on expectations that the demand for the company's products will remain the same. They tend to disregard the potential for disruption by nontraditional competitors or the possibility of “watchful waiting” as a product care option.
Customers will continue to pay what they did last year. The demographics of the market—as we have known it—are used to extrapolate future business and financial decisions for new products, which themselves are often just an extension of existing technology. As a result, product portfolio decisions can become a fictional exercise increasingly disconnected from a market heading in a different direction.
In fact, it is already a very different market. The escalating cost of healthcare has reached the breaking point. This economic reality underlies the Obama administration's healthcare reform push. Suddenly, economic and clinical value is the new the basis for business competition. Payers want hard evidence that new products are worth a premium over comparable, older products. Hospitals are standardizing those products that best enhance the ECV of their service line offerings. Even consumers are demanding value and price information as they take on an increasing burden of paying for healthcare out of their own pockets.
Bring Back-End Forward
This is the new world your company is competing in. To make the best decisions for your product portfolio you will need much more insight into this world and the implications for your products.
Because the basis for competition in the market is shifting, the base assumptions for making product portfolio decisions must change. There are three functions that can provide invaluable insight into the shifting needs and demands of the healthcare market and the implications for your company's portfolio of products. They are clinical affairs, regulatory affairs, and health economics and reimbursement.
These functions have traditionally been back-end resources for developing and launching new products. These company functions typically are used to conduct the clinical research necessary to get regulatory approval and carry the sales message to payers. In the current climate, though, they should be at the forefront of portfolio decision-making as well. These functions can provide invaluable insight into the shifting needs, new buying decision considerations, new evidence expectations, or hidden costs that could lead to very different portfolio decisions.
By using these functions solely as tactical resources, companies risk giving insufficient consideration to key issues such as:
 
• The likelihood that customers will arbitrarily reduce payment for existing products or reject new technology in favor of older, less expensive care therapies in the absence of any economic and clinical evidence to the contrary.
• The need to operate within an overall clinical strategy that manages predictable cost, leverages a collective body of disease state and technology research, and ensures that the evidence needed for commercial success can be feasibly generated.
• Consideration of realistic regulatory paths, time frames, and comparative evidence expectations beyond traditional efficacy and safety requirements.
 
In addition to ensuring decision-making consistent with shifting market demands there is another reason for moving these functional perspectives to the forefront of your discussions for new product strategy. In this market no company can afford to waste its resources. Considerable infrastructure, resources, and expense go into the work of clinical affairs, regulatory affairs, and reimbursement. These efforts must be efficiently leveraged over the entire product portfolio. Without an integrated view of product portfolio needs, companies are likely to overextend themselves. This leads to approving one-off, new product projects that seemingly are justified on their own but in fact collectively require resources beyond the company's capacity to provide them.
It is not enough to give clinical, regulatory, and reimbursement functions a seat at the strategy table. Without changes in how company executives view these functions they are unlikely to deliver on the reason they've been invited to pull up a chair.
Typically utilized for tactical purposes, the capabilities of these functions have been developed accordingly. In order to contribute to up-front strategic market analysis and portfolio decision-making, these functions will need to build new capabilities or infrastructure.
Global Information Required
For example, most companies will need to build a global information system, one that defines and captures data about the constantly changing clinical, regulatory, and economic evidence requirements across established and emerging markets. Currently, many global companies have people on the ground in their chosen markets but no structure in place for these assets to consistently capture the data needed.
To utilize this information, companies need to use these key functions for planning new product strategy. Performing well in this role will require employees capable of discerning trends in the data and inferring the strategic implications for the company's portfolio management. These global strategists will also require a high level of business acumen that will enable them to articulate how using these formerly back-end processes will influence the development of the product portfolio and overall business strategy.
Finally, global strategists must be able to lead their own functions in the development of an integrated, wide-ranging strategy that efficiently and effectively addresses clinical, regulatory, and reimbursement needs for commercial success.
Defining these roles, developing the skills of people to perform them, and developing supportive processes make up the infrastructure necessary to enhance strategic portfolio management with critical guidance from these functions.
Optimize Limited Resources
In summary, there are three requirements to improve your company's ability to compete in a market demanding better healthcare outcomes at lower cost.
The first requirement is to establish a truly strategic process for managing your product portfolio, one that can optimize the use of limited resources to produce a stream of product lines and growth platforms that compete based on ECV. This is the strategy table.
The second is to put all the right resources at that table, including clinical, regulatory, and reimbursement perspectives that can ensure decisions are made in light of a comprehensive understanding of the market's requirements.
And the third is to build the capabilities in these functions so that they can provide their important market perspective as intended with their seat at the strategy table.
Rita E. Numerof, Ph.D., is president and William F. Ott Jr., MBA., is a senior consultant at Numerof & Associates Inc. (NAI). NAI is a strategic management consulting firm focused on organizations in dynamic, rapidly changing industries. Information: www.nai-consulting.com. Numerof can be reached at info@nai-consulting.com or 314/997-1587.

Molecular Biometrics Closes $12.5 Million in Series B Funding

According to the company, the financing allows it to accelerate the global launch of ViaMetrics-E, a rapid, noninvasive procedure that is designed to enhance in vitro fertilization (IVF) outcomes. Funding will also enable to firm to implement manufacturing and product enhancements, and complete an ongoing FDA clinical study for the product. ViaMetrics-E is designed to help identify viable embryos that have the greatest reproductive potential, thus improving pregnancy rates in IVF, and ultimately reducing the number of embryos transferred, along with reducing possible complications and the healthcare costs that accompany multiple births.

MarketPulse: Vice President and “C” Level Executives Changing Jobs in 2010

Legacy Medsearch recently posted results from its survey among medical device professionals. An astounding 44% of vice president and “C” level executives indicated a “strong possibility” that they will change jobs in 2010. “With the capital markets and economic pressures constraining bonuses and incentives—and many stock options essentially worthless—many VPs and CEOs have shared confidentially that 2010 may be the year to start a new job with a clean slate,“ noted Paula Rutledge, president of Legacy MedSearch. “Once quarterly earnings are posted, there could well be a significant shuffle in the executive management ranks—both voluntarily and involuntarily. Many companies are talking to us about making changes at the top as well, so we sense our 2010 VP and C-level searches to out-pace 2009.” Poll Results were collected January 19, 2010. Source: Legacy MedSearch

Responding to a Cease-And-Desist Letter

The medical device industry is one of the more litigious when it comes to patents. The legal scenario described next is all too common. A competitor sends you a letter asserting that your company's new medical breakthrough device infringes its patent. In all likelihood, it will be one of your blockbuster products. The letter may include a request to begin negotiations to license your device. More often than not, the letter demands that you cease making and selling the product in question under a threat of patent litigation if you do not comply. Immediately.
 
After reading this cease-and-desist letter, you check to see the current orders and sales projections for your accused product. Orders are coming in from the factory, and your device is being shipped to customers.
 
This device is the lifeblood of your company. How should you respond?
 
First, ignoring a cease-and-desist letter is a perilous decision. It could provide a basis for the plaintiff to seek a tripling of the monetary damages if he wins at trial and you are found to have “willfully” infringed the patent. If the monetary damages do not wipe out your profits, the trebled damages for willful infringement almost certainly will.
 
The best course of action is to have a patent attorney assess the patent, form a well-reasoned and informed opinion as to whether the accused product infringes any valid claim of the patent, and then advise you on how to respond to the cease-and-desist letter.
 
Monetary Damages
 
A patent can cover a product, its method of manufacture, or its method of use. It is an important and powerful form of intellectual property for protecting a company's technology. But a patent does not give the patent owner, or patentee, the right to make, use, or sell an invention. Instead, a U.S. patent gives the patent holder the right to exclude others from making, using, importing, offering for sale or selling the invention in the United States until the patent expires.
 
The “claims” in a patent define the scope of protection for the invention disclosed in the patent. If a patent claim covers the disputed product, then that product is said to infringe that patent claim.
 
The patentee can file a lawsuit to enforce the patent against accused infringers. Sometimes the patentee will send a cease-and-desist letter beforehand to give notice of the patent, but there is no requirement that the patentee give any such warning. If a cease-and-desist letter is sent, the patentee in later litigation can claim monetary damages for each accused product sold afterwards because the letter gave actual notice of the patent to the accused infringer. Even where no actual notice was given, a patentee can still claim damages for past sales if the patentee's own products were marked with the patent number. The patentee also can seek to obtain an injunction to force the accused infringer to stop selling the accused device. A preliminary injunction may be obtained before the case even goes to trial if the patentee can convince the court that his patent case is so strong that he is likely to succeed at trial. Even if the patentee does not seek a preliminary injunction, when the patentee prevails at trial, courts traditionally have awarded a permanent injunction afterward.
 
The monetary damages that can be awarded for this infringement may be computed as a royalty (i.e., a percentage of your sales revenue) or as lost profits (i.e., the sales the patentee lost). A cease-and-desist letter that puts the accused infringer personally on notice of the patent can provide a basis for a later finding of willful infringement, especially if the accused infringer ignored the letter and did nothing until a patent lawsuit was filed against him. Sales of the accused product after receipt of the letter may be branded as willful infringement, and be subjected to enhanced damages. For example, monetary damages can be increased up to three-fold if the patentee proves willful infringement, and compensatory damages could also triple, which could more than wipe out any profit made the accused infringer.
 
Willfulness
 
To determine willful infringement, the judge or jury examines whether it would have been objectively “reckless” for a hypothetical “reasonable person” in the accused infringer's shoes to have continued selling the disputed product under the circumstances. The legal test for willful infringement includes both objective and subjective factors.
 
If they are sufficiently compelling, the objective merits of the defenses raised in the litigation—even if unsuccessful—could establish that there is no willful infringement. Another factor often considered is whether, after receiving notice of the patent, the accused infringer investigated the scope of the patent and formed a good-faith belief that the patent was invalid or not infringed, or both.
 
This investigation usually is performed by a patent attorney who has the legal and technical training to give a competent opinion. The timing of the opinion is another important consideration, because an opinion prepared before the start of litigation is often given more weight by a court than an opinion prepared after the lawsuit has been filed. Other factors affecting the legal outcome of willfulness include:
 
• Whether the company withheld any critical incriminating information from the patent attorney in arriving at his opinion.
• Whether the accused infringer deliberately copied the patented product or design.
• Whether the accused infringer took any remedial action.
 
Assuming that the accused infringer has obtained a timely and independent legal opinion from a patent attorney clearing the disputed product, the defendant in a patent lawsuit may rely on a competent opinion of counsel to show that it was operating in good faith in respecting the patent rights of others. This advice of counsel defense against a charge of willful infringement, however, requires that the defendant waive the attorney-client privilege with respect to its patent opinion counsel. The waiver of this fundamental right should not be taken lightly.
 
A patent attorney's opinion that no infringement exists does not free the accused infringer from blame, however. If litigation proceeds, a judge or jury may come to a different conclusion and find that the patent is valid and infringed and award damages. In this situation, however, good faith reliance on a competent opinion of patent counsel to continue making and selling the accused product often will provide a successful defense to defeat a charge of willful infringement, thereby avoiding enhanced damages.
 
Indirect Infringement
 
An opinion by a competent patent attorney also can provide a defense to a type of indirect infringement known as active inducement of infringement. A patent may be infringed directly or indirectly, and a claim of active inducement of infringement may arise where the defendant does not directly infringe the patent, but instead sells a product with instructions that would induce someone else to use the product in a manner that would infringe the patent.
 
This type of indirect infringement often arises when patent claims for a method or system are asserted against medical devices. By law, namely 35 U.S.C. § 287(c), patents cannot be asserted against doctors for practicing a patented medical or surgical procedure, but a medical device manufacturer may be liable for damages and subject to an injunction for selling a device that can to be used to practice that patented medical or surgical procedure.
 
For example, a patent claiming a new method of using a medical device such as a catheter may be indirectly infringed by a catheter that is sold with FDA-approved instructions for use that include the patented method. Such instructions for use by the manufacturer are often critical evidence in active inducement of infringement claims. While the doctor performing the patented surgical procedure using the catheter in accordance with its packaged instructions for use (IFU) cannot be sued for patent infringement, the medical device manufacturer that sold the catheter with the IFU could be liable for active inducement of the doctor's infringement.
 
To prove active inducement of infringement, the patentee must show that the defendant's actions induced infringing acts and that he knew or should have known his actions would induce actual infringements. Because a charge of active inducement of infringement requires that the defendant specifically intend to cause another to directly infringe the patent, an opinion of counsel that such use of the product would not infringe a valid patent claim may be relied upon to show that accused did not intend to cause infringement. In a recent court decision, Broadcom Corporation v. Qualcomm Inc., 543 F.3d 683 (Fed. Cir. 2008), the failure to obtain an opinion of counsel was used as circumstantial evidence of an intent to infringe, and the jury's finding of active inducement of infringement was upheld on appeal.
 
An opinion of counsel can be an important shield for medical device manufacturers against patent claims for a surgical procedure. For cases involving such surgical methods, a claim of active inducement of infringement against the medical device manufacturer is often the only available legal theory for liability. In addition to the good general business practice of obtaining a competent counsel's opinion to help navigate the thicket of patent issues, an opinion of counsel also can help medical device manufacturers avoid liability for active inducement of infringement.
 
The Gold Standard
 
As previously discussed, you should contact a patent attorney immediately after receiving a cease-and-desist letter, and invest the necessary time and resources for a proper investigation by the patent attorney into the patent and accused product. The patent attorney then can provide a reasoned and informed opinion of counsel and advise you on how to proceed, including possible strategies for settling or otherwise resolving the dispute.
 
The gold standard for dealing with a cease-and-desist letter is to have a patent attorney assess the patent and form an opinion as to whether the accused product infringes any claim in the patent. Patent attorneys have specialized skills and knowledge that other attorneys do not have. A patent attorney typically has both a law degree and a technical degree in engineering or science. Furthermore, in addition to the state bar license to practice law, a patent attorney is registered to practice before the U.S. Patent and Trademark Office (USPTO), which requires passing a separate patent bar examination. An attorney who is not registered with the USPTO is not a patent attorney.
 
The patent attorney will require a significant amount of time to properly study and investigate the patent and the accused product. This often includes obtaining and studying the patent's prosecution history, which is the written record between the USPTO and the patentee leading up to the issuance of the patent. The patent attorney often will inspect a sample of the accused product and obtain relevant technical information about the accused product. It is important for the patent attorney to have access to the relevant technical information regarding the accused product when preparing the legal opinion. The more complex the technology, or the more convoluted the prosecution history of the patent, the more time may be required to properly study and investigate the claim.
 
While damages may accrue in the interim, this investigation by the patent attorney is necessary in order to make an informed decision on how to proceed. During this investigative phase, the company engineers, in conjunction with the patent attorney, can also work at trying to redesign the product in order to circumvent the patent. If commercially feasible, these redesigns will give the company options in dealing with the patent infringement claim. Sometimes, designing around a patent leads to a better product having its own patentable improvements. In the end, the patent attorney's opinion will be invaluable for trying to design around the patent claims, and will be helpful in determining a case's settlement value and providing critical guidance for the company.
 
Good Faith Defense
 
If the patent attorney comes to the conclusion that the accused product is not covered by any patent claim, the patent attorney can provide a written opinion explaining why the patent is invalid or not infringed. The opinion may be written in letter form addressed to an executive or other decision maker of the company. The opinion letter should be well reasoned and state the basis for each conclusion, including a discussion of how the accused product is different from the invention claimed in the patent (i.e., non-infringement), or how the patent should not have issued because the claims cover something that is already in the public domain (i.e., invalidity).
 
A manufacturer may rely on a competent opinion of patent counsel to continue making and selling the accused product in good faith with respect to the patent rights of others. This is true even if a court ultimately disagrees with the patent attorney's legal conclusion of non-infringement or invalidity.
 
Moreover, a good faith belief provides a defense for a medical device manufacturer against a charge of active inducement of infringement of method patent claims covering surgical procedures. Because an opinion of counsel can be relied upon as a defense to avoid liability for this type of indirect infringement, opinions of patent counsel may be especially valuable for manufacturers in the medical device industry.
 
James Juo is a partner at Fulwider Patton LLP (Los Angeles). He is a registered patent attorney specializing in litigating and prosecuting patents and trademarks. Mr. Juo previously served as a patent examiner at the U.S. Patent and Trademark Office in the technology area of television and facsimile machines. Mr. Juo earned his J.D. from George Washington University in 1993, and his Bachelor of Science in electrical engineering from Clarkson University in 1989. He is a member of the bars of California and Virginia and is registered to practice before the U.S. Patent and Trademark Office. Mr. Juo can be reached at jjuo@fulpat.com.

Aesthetics Firms Merge

Candela manufactures and distributes aesthetic laser and light-based systems that enable physicians, surgeons, and personal care practitioners to treat selected cosmetic and medical conditions. It has an installed base of more than 14,000 systems worldwide. The company markets and services its products in 86 countries from offices and distributors in the United States, Europe, and Asia.

 
Syneron manufactures and distributes aesthetic radiofrequency and laser devices used for hair removal, skin treatment, and dental procedures. Founded in 2000 and headquartered in Israel, Syneron has global offices and distributors, including North American headquarters in Irvine, CA., and Asia-Pacific headquarters in Hong Kong, which provide sales, service, and support.

Relying on Body Motions, Rubber Films Could Eventually Power Pacemakers and other Medical Devices

xxx
Process for deriving electricity from rubber films: The top image shows how piezoelectric nanoribbons are peeled off a host substrate and placed onto rubber. The middle image shows the piezorubber chip. The bottom image illustrates the energy harvesting circuit, which generates power when it is bent. (Credit: Michael McAlpine/Princeton University)

Engineers from Princeton University (Princeton, NJ) have developed power-generating rubber films that rely on natural body movements such as breathing and walking. The technology could eventually power electronic devices, including those used in medical applications.

Composed of ceramic nanoribbons embedded onto silicone rubber sheets, the material generates electricity when it is flexed and is highly efficient at converting mechanical energy to electrical energy. Shoes made from this rubber may one day harvest the pounding of walking and running to power mobile electrical devices. Placed against the lungs, sheets of the material could use breathing motions to power pacemakers, eliminating the need to replace batteries surgically.

Presented in "Piezoelectric Ribbons Printed onto Rubber for Flexible Energy Conversion," a paper published in Nano Letters, the Princeton team's work is the first to successfully combine silicone and nanoribbons of lead zirconate titanate (PZT), a piezoelectric ceramic material that generates an electrical voltage when pressure is applied to it. Able to convert 80% of the mechanical energy applied to it into electrical energy, PZT is the most efficient of all piezoelectric materials.

"PZT is 100 times more efficient than quartz, another piezoelectric material," remarks project leader Michael McAlpine, a professor of mechanical and aerospace engineering at Princeton. "You don't generate that much power from walking or breathing, so you want to harness it as efficiently as possible."

A piece of silicone rubber imprinted with super-thin material can generate electricity when flexed. (Credit: Frank Wojciechowski)
A piece of silicone rubber imprinted with super-thin material can generate electricity when flexed. (Credit: Frank Wojciechowski)

The researchers first fabricated PZT nanoribbons--strips so narrow that 100 of them side by side are 1 mm wide. In a separate process, they embedded these ribbons into clear sheets of silicone rubber, creating what they call "piezorubber chips." Because the silicone is biocompatible, it is already used for cosmetic implants and medical devices. "The new electricity-harvesting devices could be implanted in the body to perpetually power medical devices, and the body wouldn't reject them," McAlpine explains.

In addition to generating electricity when it is flexed, the material also flexes when an electrical current is applied to it. This opens the door to other kinds of applications, such as microsurgical devices, McAlpine notes.

"The beauty of this is that it's scalable," comments Yi Qi, a postdoctoral researcher working with McAlpine. "As we get better at making these chips, we'll be able to make larger and larger sheets of them that will harvest more energy."

The research was funded by the United States Intelligence Community, a cooperative of federal intelligence and national security agencies.