Read more about the report, including the synopsis, here.
Read more about the report, including the synopsis, here.
|Metal-on-metal hip implants are at the center of controversy.|
The debate surrounding metal-on-metal hip implants is quickly becoming as inflamed as the osteolytic tissue critics claim they cause.
In addition to their reputation for causing tissue inflammation, thereby leading to implant weakening and discomfort, all-metal implants have been linked in some recent reports to tumor formation as well. Consequently, although metal-on-metal hip implants have drawn fire for many years, protests and calls for action have significantly increased in recent months.
The past several months has seen a headline-grabbing editorial in the Journal of Arthroplasty in January that suggested avoiding the use of metal-on-metal implants followed by a high-profile New York Times article in March detailing the issue. We at MPMN also examined the controversy about metal-on-metal bearing surfaces, as well as other material combinations in our April cover story.
A medical device alert issued last month by the UK's Medicines and Healthcare Regulatory Agency (MHRA), however, could be a game changer. In the alert, MHRA acknowledged that "early revision of poorly performing metal-on-metal hip replacements should give a better revision outcome." It also requested that metal-on-metal implant patients undergo various follow-up tests to ensure health and safety. As a result of the alert, several British orthopedics organizations are even recommending that patients with metal-on-metal hip implants should be contacted and informed of the alert. If carried out, expect a panicked patient population to ensue.
But patients aren't the only ones in panic mode. Orthopedic implant OEMs are also on the defensive. Makers of metal-on-metal implants are issuing public statements, trying to put out fires, and restore faith in all-metal bearing surfaces. The Daily News in Memphis, which boasts a strong orthopedic device presence, reports that orthopedic OEM Smith & Nephew issued a press release today in support of its Birmingham hip-resurfacing system, claiming that it "is not like other metal-on-metal implants."
Could metal-on-metal implants' days be numbered? Is the MHRA's alert a nail in their coffin? What's next? Sound off in the comments section and let us know what you think.
In addition, when the material was stretched with even more force, it dissipated and then returned to its original form.
The work is detailed in a recent issue of the journal Nature.
Mazzo is president of Abbott Medical Optics, heading up Abbott’s global vision care business. He was appointed to his current role in February 2009. Mazzo served as chairman and CEO of Advanced Medical Optics until it was acquired by Abbott. He also held various senior executive–level positions for Allergan prior to its spin-off of Advanced Medical Optics, including president of Allergan’s Europe/Africa/Middle East region. He has served on AdvaMed’s executive team for the past six years, most recently spearheading the association’s international efforts. He spoke to MD+DI editor-in-chief Sherrie Conroy shortly after being named AdvaMed chairman.
Q: There are many issues facing the industry right now. What is your vision for the future of the industry?
A: We’re always going to be facing issues. That’s part of our responsibility. But we never want to forget what we do as an industry. And that’s improving patient care through innovation. That’s our essence—that’s our reason for being. My goal as chairman is to always stay patient focused, ensuring that our innovation is not stopped, that it’s constantly improved under the rigorous standards that we have today across the globe. I also want to leverage our diversity. More than 70% of our member companies are $100 million or less. Sometimes when people think of the power and the strength of AdvaMed, they need to understand that our strength comes from our diversity. Having both large companies like Abbott and smaller entities is tremendously beneficial for this industry because we are able to get and support those divergent views.
Q: What are your primary goals heading into your term as chairman?
A: We have three fundamental goals that we’re going to be focusing on. First is supporting the FDA review process to ensure that patients continue to have timely access to safe and effective medical advancements. Second, as Medicare begins testing new healthcare payment and delivery system paradigms, we want to ensure that innovation thrives. Finally, we are focused on moving forward global harmonization efforts. We have to remember that we are a global industry. Many of our member companies to a large degree have operations across the globe. I led AdvaMed’s international efforts over the past couple of years and global harmonization, specifically in the Asian countries.
Q: Healthcare reform is undoubtedly on everyone’s mind. What guidance will you give to the AdvaMed membership and device industry as a whole going forward in order to address the tax on medical devices and other portions of the legislation that affect their business?
A: We continue to believe that this tax on medical devices is not positive for our industry. It’s going to present significant challenges for companies large and small. No matter what size, this will have a negative impact on research and development and jobs. There’s no doubt about that. We definitely appreciate the efforts that we’ve had from many members of Congress on a bipartisan basis to mitigate the tax by cutting it in half. It was as high as $40 billion and now it’s $20 billion.
We’ve been able to delay the start date until 2013 and, in making the tax deductible, we’ve made huge strides. But let me make sure you clearly understand, we’re not pleased with this. This has impact on the innovation we talked about. It has a tremendous impact especially for small companies that are living day to day on their bottom line. So reduction of jobs and reduction of technology is not positive for our industry. We’ve long supported as an industry patient access to affordable health coverage. But having a tax of this nature will definitely affect our innovation and jobs.
Q: As healthcare reform dominates the news surrounding healthcare, what will AdvaMed’s approach be to get its voice heard by the public in terms of the value of medical technology?
A: First off, having an industry association like AdvaMed is so critical. As you can imagine, with the diversity of companies, you have diversity of opinions, which is great. That’s what adds value. Being able to have ongoing communication amongst all of our members allows us now to have a clear, concise message back to the Hill. AdvaMed’s value of technology education program will continue to spread the word to help policymakers and the public understand the benefit and value of medical technology. We can’t allow the average individual who picks up a newspaper or watches Good Morning America to forget what medical technology advances have been able to do. With all the different messages that they are being bombarded with, we want to make sure people understand the improved patient outcomes and cost savings for the healthcare system that are the results of medical innovation. We also want to spread the word about how our industry is a vital segment of the U.S. economy. We employ and we invest in R&D right here in the United States. Medical technology delivers tremendous value, and we need to be able to clearly articulate that in one message. It goes back to having a strong industry voice of hundreds of thousands of people across the country.
Q: How will you ensure that “innovation thrives as payers and providers experiment with new healthcare delivery models” as stated in AdvaMed’s recent press release?
A: We’ve got to ensure that early adopters are not penalized. We’ve got to prevent disincentives for more novel and more expensive products. There was an interesting study by the University of Chicago that found improvements to life expectancy from advances in cardiovascular care added $2.6 trillion per year to our nation’s wealth between 1970 and 1998. We’re adding to the nation’s wealth because we’re making people more productive. We want to make sure patient and physician choice in medical treatments is preserved so that these kinds of benefits can be realized.
Q: AdvaMed has issued its recommendations for improving the 510(k) process. What role does AdvaMed hope to have going forward?
A: First of all, there are some misunderstandings that this 510(k) process is broken and needs an overhaul. That couldn’t be further from the truth. We surely recognize that any process can be improved, but the basic structure of this process is sound and has stood the test of time. The 510(k) review process provides an extremely rigorous and efficient framework to really determine the safety and effectiveness of incremental changes to medical devices. Our objective is to maintain and improve the 510(k) as a viable path for both low- and moderate-risk devices and diagnostics. Our main concern is that you have an exaggeration and an interpretation that it’s severely broken. We want to improve, but let’s be careful of changing something that has stood the test of time. It has allowed innovation to progress but never at the expense of patient safety. We’ve made several recommendations to the agency to improve the clarity and consistency of the 510(k) process. There’s an internal FDA review under way, and a longer-term review by the Institute of Medicine, and we welcome those reviews because we think they will clear up a lot of the misconceptions associated with the 510(k) process.
Q: You’ve actively led the charge to improve the medical device approval processes in Japan and China as well as in emerging markets. Will this continue to be a priority for you as chairman, and if so, what will be your next steps in these markets?
A: One of my key goals as AdvaMed chair is global harmonization. We can’t forget that a lot of our companies have product lines and entities across the globe. We were able to overcome an extremely difficult environment in Japan and now Japan is starting to take steps to address the device lag. Two years ago my predecessor, Mike Mussallem, would have told you this is a major concern for our industry. Now we’ve opened that channel of communication. It’s not perfect but it has changed tremendously. I am now more concerned with other Asian countries, specifically China. We are encouraged by the steps China has taken to reform its healthcare system to expand patient access. But we’ve got to ensure that the country’s new health system appropriately values advanced medical technology. It’s one thing to ensure that we have access, but we need to ensure that they appropriately value and support new innovative technologies. So, we’ve been urging the State Food and Drug Administration to follow internationally recognized practice and phase out of its country of origin requirement by accepting a variety of foreign clinical data. We want them to accept these clinical data and place a greater reliance on the quality management system approach. We’re seeing glimpses of hope but it’s still gives me a little bit of concern.
Q: This has been the toughest economic recession in years worldwide. What role will or can AdvaMed members play in helping the economy rebound, and moreover, in creating jobs?
A: We believe we are an extremely vibrant part of the U.S. economy. Our industry generates more than 350,000 jobs., and we pay 30% more than the average U.S. job. We employ and pay a high salary to those people because we know the high standards we must have as we deliver these products. Every medtech job generates an additional 4.5 jobs across the United States. It goes back to improving patient access to get out great technologies by allowing device companies to innovate, which leads to more spending on R&D and manufacturing jobs. We tend to use a lot of biomedical engineers, so engineering institutions such as the University of California, Irvine, and Purdue are a great source of employees. What we don’t want to have to do is curtail these jobs because of the device tax.
Q: FDA has been in turmoil over the past year and now has a new director, Jeffrey Shuren. What does the agency need to change (or not) to improve its image and work best with industry? What will be your approach for working with FDA to help it achieve its goals?
A: We definitely understand that FDA has a tough and important job. We have a lot of respect for what they do. A lot of our companies employ ex-FDA people so they bring those values and standards to our companies. It’s important in industry that FDA be seen as providing effective oversight, so a strong FDA means a strong industry. We will continue to work with FDA. We’ve always had open communications with the leadership at FDA. We just want to make sure that they clearly understand that patients need timely access to our technologies. We don’t want them to destroy or fundamentally change a system that has worked quite well in protecting American patients.
Q: What other priorities will you be focusing on over the next two years?
A: Another priority is AdvaMed Dx. We constantly are looking at ways to improve the association. And one of our new entities—and I give AdvaMed’s president, Steve Ubl, a lot of credit here—is this new division in AdvaMed focused exclusively on in vitro diagnostics policy issues and advocacy. Scott Garrett, chairman and CEO of Beckman Coulter, is going to lead this. It’s going to have its own C-level board of directors and its own staff. In vitro diagnostic issues have unique aspects apart from other devices. This new division will really be able to raise the awareness of [those issues]. We are looking to find ways to add more value for our members, and AdvaMed Dx is one of those. It provides AdvaMed with an enhanced value proposition for our members and a way to recruit new members, so it’s really one of those win-wins. I talk about our global harmonization; I talk about our ability to continue to innovate; I talk about our open communication with FDA. But having this new sector is providing great value to AdvaMed’s members and hopefully at the end of the day, it provides value to the consumer.
Drawing inspiration from the muscle protein titin, a group of researchers from the University of British Columbia (UBC; Vancouver, BC, Canada) has developed biomaterials that demonstrate some of the mechanical properties of natural muscle. The rubber-like materials may be suitable for future tissue engineering, materials science, and other applications.
Responsible for the passive elasticity of natural muscle, titin contributes to the combination of strength, extensibility, and resilience exhibited by muscle in the body. In an attempt to mimic these desirable properties, the UBC researchers engineered artificial elastomeric proteins that replicate the molecular structure of titin. This synthetic version of the protein consists of chains of beads that are 100 times smaller than natural titan, however.
To create the muscle-like materials, the scientists photochemically cross-linked and cast the artificial proteins into a solid biomaterial. "These biomaterials behave as rubber-like materials, showing high resilience at low strain and as shock-absorber-like materials at high strain by effectively dissipating energy," the researchers report in an abstract for a recent issue of the journal Nature. "These properties are comparable to the passive elastic properties of muscles within the physiological range of sarcomere length and so these materials represent a new muscle-mimetic biomaterial."
Hydrated and biodegradable, the material also promises design flexibility, according to the researchers. The mechanical properties of the biomaterial can be tailored to mimic different muscles to best suit an application.
"There are obvious long-term implications for tissue engineers," says Hongbin Li, associate professor in the university's department of chemistry an coauthor of the study. "But at a fundamental level, we've learned that the mechanical properties we engineer into the individual proteins that make up this biomaterial can be translated into useful mechanical properties at the larger scale."
“Representative,” you say into the phone. The machine voice, indifferent to your request, leads you through the same menu. “Representative!” you say again as you push a random number in your handset hoping to reach someone. A new, less-relevant menu is dictated to you by the annoying robot on the other end. After enough pleas for a representative and punching the “0” and the “#” keys, you finally reach someone. And you know how it goes from there…transfers, wait times, and often, no resolution to your problem.
As consumers, we recognize and appreciate good service. And, more pointedly, we loathe bad service. Consumers have proven that they will pay a premium for products with little differentiation if they are presented as part of a quality experience (see Virgin Atlantic, Starbuck’s Coffee, and Nordstrom). These companies have capitalized on creating a compelling experience out of the act of consuming, and they have been rewarded handsomely for it.
Medical device and diagnostic companies have been slow to get into the service game. This is due in part to the fact that their primary customers are intermediary decision makers (physicians, clinicians, hospitals, and nonclinical administrators), not the patients, so ensuring that the experience is good is less critical. For these customers, product quality and trouble-free services are far more important decision criteria. Much has been written about product quality for medical devices, but service quality has been relatively overlooked. With product commoditization becoming more relevant, companies should be targeting service quality as a differentiator to keep customers from defecting to lower-cost producers.
So how would a medical device or diagnostic company develop a trouble-free, reassuring customer experience from initial sales to customer service? The service side of the business is learning what marketing and R&D departments learned back in the 1990s—quality won’t improve unless you understand it from the customer’s perspective. Voice of the customer (VoC) methods can be effective tools for adopting a quality consumer service program.
VoC techniques include interviews, surveys, focus groups, and ethnography. These have proven highly effective in identifying unmet customer needs and developing sound requirements for product development teams.1,2 Consequently, leading medical device companies allocate substantial portions of their annual marketing and R&D budgets for this purpose. Despite their extensive use in product development, VoC techniques are seldom used to design differentiated technical and customer services. This is especially surprising given that close to 80% of the U.S. economy is services-based, and even for product-based companies, services are the fastest (or oftentimes, the only) growing part of the business.3,4
Designing differentiated services requires a structured approach consisting of—at a minimum—the following steps:
? Identify target customers.
? Map out the current process and identify failure points.
? Collect VoC data.
? Prioritize needs.
? Redesign the processes.
? Mitigate risks at key touch points.
? Manage change.
The process typically requires a cross-functional team consisting of representatives from customer service, marketing, operations, sales, quality, information technology, and engineering. A cross-functional team is needed because delivering consistent, differentiated customer service experience requires coordinated efforts of all customer-facing personnel.
|Table I. An example of a sampling interview plan.|
Although it may seem obvious, confirming and defining customers is a critical step. Often, service personnel are unsure of who their current customers are, let alone who the target customers are. And because most medical device firms are increasing their use of distribution channels and strategic partners, this is a far more common problem than it would appear.
|Figure 1. The number of customers to be sampled depends on accuracy and cost requirements. Click here to expand.|
A one-page tool called a SIPOC (Suppliers Inputs Processes Outputs Customers) can help address this issue by identifying the customers and clarifying what is delivered to them. In this framework, the customer is defined as a person or organization that receives an output (product or service) from the company. This framework also helps define what value is actually received by the customer. It is interesting to note that for products, the receiver of the device is without exception the customer and the supplier is the company. For services, the customer in the usual sense is both the supplier and the customer. Recognizing this subtle, yet important distinction is key in designing customer-centric services. It enables the organization to actively seek customer feedback at all touch points, not just during complaint handling or annual customer satisfaction reporting.
After initial customer segments have been identified, a sampling plan is drawn up. This is used to collect feedback from a statistically satisfactory number of customers to confirm the initial segments. Table I shows an example of a sampling interview plan.
Determining the number of customers to contact in each segment is more an art than a science. The data collection method (e.g., interview versus focus group) and the difficulty of obtaining the data affect the practicality of the data collection. The practitioner must balance the need for data with the cost of collecting them. Pragmatism should guide such decisions. As a first approximation, the authors use research by Griffin and Hauser on the number of customers to contact (see Figure 1).5 For example, if the goal is to identify 80% of the needs of a customer segment, the research suggests either interviewing approximately seven customers from that segment or conducting four focus groups.
|Figure 2. Order-entry process for disposables for existing customers at a large diagnostic equipment manufacturer. The red process boxes indicate those areas in which service quality was considered suspect. Click here to expand|
For each segment, the approach and the information wanted may vary. For example, the types of questions for users would differ from those for procurement personnel at hospitals. An often-overlooked trove of information is from customers who have defected. Most customers defect without saying why. Companies frequently make an error of omission by interviewing only current customers and target customers while ignoring former customers. Seek them out. More valuable information can be gained by learning why customers leave than why customers stay.
Understanding the current state of the service delivery process is imperative if improvements are expected. Create a detailed process map and identify specific areas in which known failures occurred. Figure 2 shows an example of a service process at a company that designs and distributes sophisticated diagnostic equipment, software, and disposables to large hospitals. The red boxes indicate areas in which service quality was suspected of failing. In the authors’ experience, most of the service-related failures occur at interfaces between personnel, between systems, and between the system and personnel.
For example, a medium-sized medical device company whose product quality was considered best in the industry boasted on-time order fulfillment rates near 95%, which at face value seemed like an acceptable statistic. Deeper digging, however, reveals otherwise. Because of the limited shelf life of the product, delivery dates were tightly synchronized with surgery dates. A late delivery often equated to a delayed surgery. Canceling surgeries due to logistics was unacceptable to the physicians and many of them defected to competitors’ products despite inferior quality. That is, the statistic meant that 5% of all product sales were unacceptable to the customer. It was unacceptable to management as well.
Examination of the issue revealed that the enterprise resource planning system and the sales force automation system were not synchronized in real time. They were synchronized a number of times per day, but not in real time. Consequently, the sales staff did not always have the correct information of buffer inventory, resulting in sales that were greater than what the organization could deliver. Or, the sales team turned away orders thinking that the company would not be able to meet the delivery date when it had plenty of buffer inventory.
|Figure 3. Choosing the appropriate VoC technique requires assessing its potential against requisite effort.|
Make the most of face time with customers. To develop incisive questions that will lead to valuable information, the OEM must do its homework. Study complaint reports, corrective and preventive action reports, customer satisfaction reports, process maps, and other internal documents. If studies are limited, scan the company’s data repository. Most medical device companies are sitting on large amounts of transaction records and customer data. Take advantage of them by running correlation and trending analysis. Through such research, OEMs can develop a good sense of the extent of the issues and what additional data need to be collected.
VoC data can be collected through various means. The most common are surveys, interviews, focus groups, and ethnographic studies. The costs and benefits of each can be explained in terms of the ease of application and the quality of the information gleaned. A simplified graph in Figure 3 (p. 74) depicts how the techniques compare.
Most VoC practioners have experience with all of these techniques with the possible exception of ethnography. Ethnographic studies involve carefully observing customers as they interact with a device or service in native environments. Ethnography, developed first by anthropologists, can be a powerful tool, revealing needs that customers neglect to mention in interviews or are entirely unaware of.6 The downside, of course, is that it is time consuming and expensive.
One valuable point on interviewing that the authors have picked up over the years: when conducting interviews, take verbatim notes of the customers’ emotion-laden descriptions. Some of the greatest successes come from interviewing customers in pairs, with one person acting as interviewer and the other as note taker. Specific words that customers choose contain deeper feelings and emotions that explain their perception of quality and ultimately dictate purchase decisions. For example, when customers use emotional phrases such as, “I get angry when I get an answering machine,” let the customer elaborate further and, at times, digress. Emotional engagement from the customer often results in real insights.
It is best to not rely on just one VoC method. Using more than one method ensures that limitations of the techniques are minimized. For example, when using surveys, which are the most economical way to collect a large amount of information, it is valuable to complement them with some interviews.
The collection of VoC data is never finished. Changing customer needs and dynamics in the market mean that new opportunities are always presenting themselves. However, for efforts at service improvement, there is a point of saturation in qualitative VoC data. Once interviews or focus groups are no longer revealing new information, OEMs have the information they need to move on to the next step. For quantitative data collected through surveys, sample size calculations can indicate the degree of confidence in the results.
Because companies cannot meet all customer needs, prioritizing is required. To do so, customer comments are translated into need statements. For example, consider the comment “I deal with your customer service only when there are problems. So, it may not be fair, but I expect you to be available and to give me timely answers.” Such a remark could be translated into the customer need for availability during business hours and response within the same business day.
Once statements have been translated into needs, an affinity exercise is conducted to group together similar needs and remove redundancies. Performance targets and tolerances are then assigned to each major category of needs. Their values depend on the competitive landscape and the cost to satisfy the need.
Companies often use semiquantitative scoring tools (e.g., the Pugh matrix, prioritization charts, or Kano diagrams) to distinguish true differentiators from marginal ones. The author’s clients often prefer the Pugh matrix or some modified version of it due to ease of use.
After the requirements have been agreed on and prioritized, the process must be improved to address the requirements. A series of seminars or visits to nonmedical companies may help an OEM view its current process with a fresh perspective. The authors have discovered that visits to companies in the hospitality industry, financial services, and logistics are especially beneficial to cross-functional teams assigned to change the process.
A series of facilitated brainstorming sessions is an effective tool. Using information about the current process, new requirements from customers, and experiences with how other companies address these requirements, the team is challenged to be innovative. A number of brainstorming techniques are suitable for this, including the idea box, musical chairs, and SCAMPER (Substitute, Change, Adopt, Modify, Put, Eliminate, and Rearrange). One useful tool is the mind map.
The mind map begins with a focused statement written in the middle of a large writing wall. The goal of a process element, say “Maintain on-time delivery above 99.99%,” is the touch-off point for discussion. As ideas come up, they are written immediately adjacent to the center purpose statement. As ideas trigger other ideas, a line is drawn that connects related thoughts. In contrast to the normal brainstorming process of listing ideas, the connectedness provides a history of the thought process and proves fertile ground for idea incubation. This process is effective because it enables a team to think in parallel, not serial, a vital prerequisite for innovation.
After the ideas are collected, they are rationalized by the team. Does the idea make sense? Would it meet customer needs and enhance the service experience? Fleshing out the idea and developing high-level details can begin to breathe life into it. The ideas should be ranked to determine which ones the team will move forward with. A scoring mechanism is useful for this purpose. Each person is given a limited number of points and is allowed to vote, adding weight to the ideas and determining relative rank. The person may allocate all points to one idea or spread them across many. This can be done directly on the mind map or on a separate scoring matrix. Winning ideas are then assigned to a team member for development and refinement.
A follow-up meeting is held after team members have developed solutions. The centerpiece of the meeting is the development of the future state of the service process and the incorporation of the service solutions. The team should refer back to the current-state process map for this exercise (Step 2). While developing the new process, the team should keep in mind how the customer will experience the process. One effective tactic to ensure the customer perspective is represented is to assign a team member to think like a customer during process design. That team member’s job is to cognitively simulate how the process would affect the end-user experience.
|Table II. Risk priority number (RPN) ratings are used to identify service risks and mitigate them. The items highlighted in red are above the threshold limit for the process design team. They need to be addressed and reduced to an acceptable level.|
Once the new process is designed, identify all points at which customers interact with the company, similar to the exercise conducted in Step 2. These are the make or break points at which customer experience is ultimately determined. Using a risk management tool, the risk priority number (RPN), the team identifies the potential failures that can occur, what the likelihood of failure is, and the severity associated with it. All customer touch points with an RPN score above a certain threshold are subjected to a risk mitigation exercise (see Table II).
In this exercise, process elements, potential issues, and root causes are identified. Their severity, occurrence, and detection are scored on a 1–10 scale. They are multiplied for a combined RPN rating. A score of 1000 represents the highest risk. Process elements with scores above the typical threshold value of 200–300 are reviewed to improve control measures. This is similar to how RPNs are used to identify and mitigate health hazards. With the new process designed and risk mitigation strategies in place, the process is ready for implementation.
As with any major change, the service process needs to be managed. One of the prerequisites for success is executive commitment. It has to be seen as an important goal, which means that top management needs to be involved intimately throughout the process. Secondly, the implementation team needs to be involved in designing the solution. This will not only create a sense of ownership, but facilitate a smooth transition between functions as work is handed off.
Depending on the scale of implementation, conducting a small pilot implementation can be effective to try out the process in a managed environment, solicit feedback, and fine-tune the process before full-scale implementation. During the pilot of one process improvement effort, the authors received more than 150 ideas to improve it from employees involved in the process. We were able to incorporate 60 of the ideas, resulting in a more robust and effective final process.
Increasingly, customer service is becoming a significant or, oftentimes, the only growth opportunity for product companies. Excellent service delivery is hard work and operationally difficult. It requires explicitly defining what customers want, measuring how well the company delivers on customer requirements, and ensuring the company has the right people to provide that exemplary service. VoC techniques, when used in a structured way, enable companies to deliver superior, differentiated customer experiences.
1. G Churchill and C Brodie, Voices into Choices (Madison, WI: Joiner Publication, 1997).
2. T Kelley, The Art of Innovation (New York: Currency Books, 2001).
3. US Bureau of Economic Analysis.
4. B Auguste, E Harmon, and V Pandit, “The Right Service Strategies for Product Companies,” McKinsey Quarterly 1 (2006): 41–51.
5. A Griffin and R Hauser, “The Voice of the Customer,” Marketing Science 12, no. 1 (1993): 1–27.
6. S Wilcox, “Ethnographic Research and the Problem of Validity,” Medical Device + Diagnostic Industry 30, no. 2 (2008): 56–61.
Sung Pak is partner at Value Creation Institute. Ben Yoder is business process designer at Knowledge Universe Technologies.
These industries are driven by a number of market and technological pressures, both. Both the consumer and medical electronics markets continue to innovate and introduce new features and applications. What sets implantable electronics apart is the need for absolute reliability in addition to performance, size, and cost.
Over the last decade, double-digit revenue growth has been the norm in the medical implantable industry. The market for pacemaker-type products expanded in both application and geographic market. But in recent years, the growth rate has dropped below 10%. And in the past 10 years, the implant industry has become highly competitive and undergone consolidation. In addition, a healthcare environment of cost containment, managed care, large buying groups, government contracting, and hospital consolidation has added pressure to drive down costs. Significant investment in research and development is necessary to introduce new products. What can be done to drive the implant market back to double-digit growth?
Electronics have been used in implantable pacemakers since the invention and production of transistors in the late 1950s. The pacemaker grew in functionality and acceptance throughout the 60s and 70s. The implantable cardioverter-defibrillator (ICD) was first implanted in humans in 1981. Together, these two products compose the life-critical cardiac rhythm management (CRM) market segment. Throughout the history of CRM electronics, circuits and components have changed very slowly, with good reason. With lives on the line, patients and caregivers can’t be worried about the reliability of electronics inside the body. But the pressure for smaller size, increased functionality, and extended battery life requires improvements in the current packages.
Miniaturization is the key growth driver for implantable medical devices.1 To the patient, a small device is less intimidating than a large one. The incision is smaller, the procedure is less obtrusive, the body heals more quickly, and the implant is less noticeable. Moreover, with smaller electronics, more options can be fit into the package. Increased features in pacemakers and ICDs include RF transceivers for wireless communication, advances in sensors to optimally time pacing and defibrillation shocks, and backup systems in case the main system fails. Processing power and memory have also increased, and integrated circuits (ICs) are being stacked on top of each other. However, in most cases, the discrete components remain unchanged. With such innovation, discrete packaging has become a critical concern.
This article touches on the market pressures CRM manufacturers are facing and what is being done to address the market. Moreover, it explores innovative options in electronic packaging that enable discrete devices to improve in performance, size, and cost, while maintaining reliability.
|Figure 1. The market for electronics in treating chronic diseases continues to expand.|
The aging of the world’s population will play a key role in the need for implantable electronics. By 2050, more than 2 billion people will be over the age of 60 and more than 2 million will be over 100 years old according to the World Health Report. The average age of a pacemaker recipient is 70. These demographics continue to drive the implant market.
Worldwide expenditure for healthcare is on the rise. The United States spends nearly $7000 per person per year on healthcare. The Office of the Actuary estimates that U.S. healthcare spending is approximately 16% of the gross domestic product (GDP) and it is expected to continue its historical upward trend, reaching 19.5% of the GDP by 2017.
Remote and emerging markets are becoming increasingly affluent and will be one of the largest opportunities for implantable device growth. China healthcare expenditure increased from 3.7% of the GDP in 1995 to 5.6% in 2007. Currently, China spends $300 per person on healthcare, but as part of its stimulus package, it will spend $124 billion in healthcare upgrades in the next three years. Taiwan’s national healthcare expenditure increased to 6.3% of the GDP in 2005.2 India’s government proposed in 2008 to increase public expenditure on healthcare from 1% to 3% of the GDP. These countries do not produce their own advanced medical supplies and respect U.S. firms’ brand recognition, reliability, and technological superiority.
The 2009 medical electronics market is estimated at $2.54 billion.3 The medical diagnostic therapy market segment containing CRM electronics is estimated at $550 million and is growing at a 14.7% compoound annual growth rate. In comparison, due to pricing pressures and the lack of new applications, the CRM market growth is expected to remain below 10%.
The medical community is working to create new customers for CRM devices. Most patients who receive a defibrillator have late-stage heart disease. By conducting clinical trials on patients with early-stage heart disease, they hope to reveal whether implanting defibrillators will yield health benefits.4 If treating early-stage heart disease patients with these devices can provide better health and longer lives while keeping people out of the hospital, insurance companies are more likely to approve the procedure.
|Figure 2. A block diagram of an implantable cardiovertor defibrillator (ICD) shows the pulse generators, which contain all of the electrical circuits for the device. To see a larger version, click here.|
The top three producers of pacemaker and ICD systems—Medtronic, Boston Scientific, and St. Jude Medical—generated $26 billion in combined revenue in 2008. Nearly 35% or $10 billion of their revenue was generated from the CRM market. Compare this with 12 years ago when nearly 60% of revenue was created by CRM products.
Much of the new growth of these companies comes from efforts to expand the therapies they treat (see Figure 1).5 By modifying the electronics found in pacemaker products, new applications have been developed to treat the neurological system of the body. Neurostimulators do not cure underlying causes but instead mask or block symptoms. For example, devices block chronic back pain, leg pain, and migraines. Others modify behavior associated with depression, anxiety, obsessive-compulsive disorders, and bulimia.
Pacemakers replace the electrical pulses generated by the normal healthy heart sinoatrial (SA) node. Arrhythmias occur when the heartbeat is too fast, too slow, or irregular. The pacemaker unit delivers an electrical pulse with the proper intensity to the proper location to correct arrhythmias.6 During periods when the SA node produces its own electrical signal, the pacemaker does nothing but monitor. Some pacemakers are also rate-adaptive, meaning that they can monitor the activity level and change heart rate accordingly. A pacemaker may have one or two leads. A pacemaker with one lead is called a single-chamber pacemaker. Where the lead sits depends on where the signal problem in the heart is located. A pacemaker with two leads is a dual-chamber pacemaker, one lead in the right atrium, and the other in the right ventricle. Which type of pacemaker is needed depends on the kind of rhythm disturbance and the overall heart function.
ICDs have all the functions of a pacemaker but also send a high-voltage shock to the heart when the muscles lose their natural rhythm and start to fibrillate. Advanced electronics apply a large dc electric current to the heart that stops all erratic electrical activity and provides the SA node an opportunity to take control of the heart rhythm.
A block diagram of a typical ICD is shown in Figure 2. CRM housing typically contains a battery, a pulse generator, and a connector block. The pulse generator, shown in the block diagram, contains all the electrical circuits of a CRM device. Power management in a CRM device is critical. The goal is to have the battery last 5–10 years before replacement.
Sense and Control Components. The sense and control portion contains a microprocessor for computing, memory for storage, a pulse generator to supply the shocks, and a sense amplifier to monitor when shocks are needed. These components are combined into one or more ICs for size and cost savings. Most ICs operate at very low voltage to conserve energy; typically less than 3.3 V. These low-voltage circuits are sensitive to electrostatic discharge (ESD) and must be electrically isolated and protected.
Sensing technology is incorporated into the electrode or implantable sensors. Electrical impulses are transmitted to the heart via a lead, which is attached to the pulse generator via the connector block.
High-Voltage Charging. In the charging stage, power is taken from a lithium-based battery and is boosted from approximately 4 V to ultimately more than 700 V. The high voltage is used to defibrillate the heart. When a fibrillation episode is sensed, power is drawn from the battery to charge up one or more storage capacitors. This power is then released and directed via the switches to the heart leads. High-voltage rectifiers are used to steer the voltage in this stage.
Switching Electronics. Switches are used to route the high-voltage pulse from the charging stage to the heart leads. Various high-voltage devices are used in the switching stage including insulated gate bipolar transistors (IGBT), silicon controlled rectifiers (SCR), metal oxide semiconductor field effect transistors (MOSFET), rectifier diodes, and remote gate thyristors (RGT). Selecting which device to use requires the designer to choose between the complexity of the drive circuit, device performance, and device overall circuit board footprint.
Power switches have common characteristics. First, they are large; these switches can be rated as high as 1600 V and 50 A. Some have described them as silicon rocks. An ICD delivers an incredible energy pulse for a very short period of time, typically only milliseconds. There is little time for heat dissipation so the silicon must absorb the energy. Second, both sides of the die are electrically active and need connection, which presents assembly challenges. This is different from ICs, which have one active side and need electrical connection only on the top part. Third, a high voltage pulse has a will of its own and can arc to unwanted places. Spacing between components, wire bonds, and a protective coating becomes an important consideration.
Protection from Electrostatic and Transient Voltages. Transient voltage suppression (TVS) diodes are used to protect sensitive electronic devices. The diodes shunt to ground stray electrical pulses picked up inductively by the heart leads or the case. These pulses can come from straying too close to strong magnetic fields from sources like medical equipment, arc welding equipment, car engines, or external defibrillation devices.
Energy pulses generated inside the case are a concern. When the ICD releases its high-voltage pulse, the sensitive IC electronics must be protected. The control stage is protected by power switches that block any stray energy. These are called blocking switches and typically MOSFETs are used to control them.
|Figure 3. As electronics advanced, chip-on-board assembly paved the way for chip-on-chip and led to 3-D packaging. All three configurations are used throughout the industry.|
In September 2009, at a medical electronic symposium, Paul Gerrish of Medtronic Microelectronics Center commented that CRM device manufacturers know how to package ICs densely.7 Gerrish’s big concern was what else could be shrunk in the next-generation packaging products. Work is being done on shrinking discretes, transformers, capacitors, and batteries. The author wonders whether power discrete manufacturers are working on the right solution.
Improvement in substrate assembly has allowed medical device manufacturers to continually shrink CRM devices.8 Chip-on-board assembly, chip-on-chip, and now advanced 2-D and 3-D packaging are in use throughout the industry (see Figure 3). It is estimated that these techniques reduce the overall circuit space by 60–80%. Die stacking decreases interconnects, improves testing, and allows the mixing of wafer process technologies in a small area. The trade-off for the footprint reduction is cost. Expensive materials and cumulative yield issues tend to drive up costs.
As discussed previously, power discrete devices such as IGBTs, SCRs, MOSFETs, and rectifiers provide unique layout and packaging challenges to circuit designers. These include making electrical connections on both sides, controlling high-voltage arcing, and creating a small footprint. Moreover, remember that a large die size is necessary to handle the required power (silicon rocks). Discrete packaging needs to evolve into a chip-scale package that can be incorporated into stackable designs and at the same time be manufactured easily to help lower costs. There are various options for such packaging that OEMs can use, each of which exhibits benefits and limitations.
Chip and Wire. Chip and wire is the traditional packaging method for implant applications. It requires purchasing a thoroughly tested and inspected chip from a vendor, making a connection to one side by attaching it with conductive epoxy or solder to the circuit board, and connecting the other side into the circuit by using thin wire. A protective coating is placed over the die and wire bond to help prevent high-voltage arcing through air and to secure the wire bond firmly in place. Chip and wire is one of the most cost-effective ways to attach power devices. The major drawbacks are the extra space for wire bonding and the reliability of the wire bonds. Other common challenges with chip-and-wire packaging include handling, marking, pick and place, breakage, and conformal coating.
Chip and Clip. Chip and clip is used in power package technologies. The clip is a ribbon of copper connecting the top side of the die to the circuit board. The copper ribbon expands the contact region allowing for larger current-carrying capability and improved heat dissipation. Performance improvements when using a clip are negligible for CRM devices due to the short duration of the pulse. Arcing remains an issue because the clip lies flat on the die, limiting the space between the terminals.
|Figure 4. A power silicone on insulator (PSOI) enables designers to eliminate back-end manufacturing steps.|
Conventional Epoxy Molded Packaging. A plastic (epoxy) surface mount, ball grid array (BGA), and quad flat pack no leads (QFN) solve some of the problems of chip and wire, but generate others. Internal wire bonds bring the front and back of the die to the same surface. Epoxy encases the die, which helps prevent high-voltage arcing. Moreover, the epoxy covering protects the die during shipping and can withstand standard pick-and-place equipment. Reliability can be ensured with the proper inspection, burn-in, temperature cycle, and testing. There is a shared economy of scale with the commercial world, although medical OEMs have to be wary of product life cycle differences. (Commercial cell phone models last only a few months and are quickly replaced with new designs.) The major drawback is again size. Adding a lead frame, wire bonds, and an outer epoxy package increases the overall footprint of the device, especially for power devices.
Sidewinder Epoxy Molded Package. Sidewinder is an unconventional plastic surface-mount package that turns the die on its side and connects it directly to the lead frame. The greatest benefit it offers over a standard plastic package is an x-y footprint with reductions up to 60%. The trade-off is that the height of the package may grow up to 50% because the die is essentially flipped on edge. Moreover, because it is a nonstandard packaging technique, it is more costly than standard plastic.
Flip Chip. Flip chip describes a chip-scale package if all the contacts of a die are on the same side. The engineer applies solder and simply flips the die over and reflows the solder making attachment to the board. Since CRMs are a power device in which the backside is active, such a connection poses a problem. This technology is used in the CRM industry today, but so far it has primarily been introduced in low-voltage products (less than 30 V).
One method is to solder the die on a metal carrier to bring the backside contact to the front. The copper carrier is bent into an inverted L shape, which brings the backside contact to the same plane as the die. Solder bumps are placed onto the die and the carrier to allow for flip chip attach. The method complicates the x, y, and z planarity because the die can move or tilt when soldering to the carrier. For high-voltage applications, arcing from the die to the metal carrier is a concern.
To eliminate the planarity problems created by the carrier, another method to bring the backside contact to the front is to create a path through silicon. The die size is expanded to include nonactive silicon adjacent to the active silicon region. A channel is created through the nonactive silicon by creating a sinker or a heavy dope region through the epitaxial (epi) layer. This provides the path to bring the backside of the wafer to a front-pad location. By applying backside metal, current can flow from the active region, through the channel, to the front side. The die size is larger, but not as much as when a carrier is used. This method works for low voltage and a couple of amps, but it isn’t feasible for a 1000-V, 50-A pulse.
There are no flip chip high-voltage packages on the market, so something new must be developed to use this technology in CRM. The major difficulty is creating a conduction path for high current flow. One solution may be the use of metal plated through-hole vias.9 Using plated through-hole vias is a proven manufacturing process.10 A specialized metallization process prevents the conducting metal from migrating and contaminating other process steps. The top of the die is conducting current, so stacking die must be done carefully. A second option for high-voltage flip chip is an epi mode diode. This method uses standard processing steps. Standard die thickness of 12–20 mils would be incorporated. The issue is that the epi would be thicker and larger than standard processing, thereby adding to the cost. Moreover, the common problems with handling, marking, pick and place, breakage, and conformal coating still apply.
Power die stacking is applied today. It requires starting with two or more known good die and soldering the die together by the use of a solder preform that fits in between the die.11 The final die stack is soldered on the bottom and wire bonded on the top, like a typical chip and wire, but only requires half the board space. It allows mixing of wafer process technologies in a small area. The process dramatically reduces the x-y footprint over other approaches, but at a higher price. The stacked-die manufacturing yields are a function of the yields of the die being packaged. Naturally, cumulative yield losses drive costs higher.
Process Integration of Power Discretes. This process would solve many of the packaging challenges faced by medical OEMs, e.g., combining the high-voltage rectifier with an IGBT or SCR. Such integration could result in fewer components, simplified testing, higher reliability, and improved cost structure. So why isn’t it practical? Basic wafer process steps are needed to form active regions on a particular device. The process steps of forming a rectifier and a SCR are different enough to prevent combining the two parts into one component.
Power Silicon on Insulator (PSOI). PSOI is a sealed chip-scale package that takes a different approach to bringing the electrical connections to the same side (see Figure 4). PSOI develops the active regions on the same side using standard processing steps but joins the regions with a top metallization. The top side is then sealed and protected by attaching a top side insulator. The die can then be sawn in any form (e.g., single, duals, and quads). The concept is to eliminate any back-end manufacturing steps. After sawing in wafer form, simply test and ship the product in containers (waffle or gel packs) for automatic pick and place.
Top, bottom, and side insulators isolate the junction from environmental contaminates and moisture sensitivity. The process eliminates wire bonds and protective coating, reduces overall chip size, and can be manufactured with through-hole vias for stacking. It provides desirable thermal characteristics (i.e., thermal resistance path of <40ËC/W) and provides small size while maintaining surge performance. This process provides die-to-die electrical isolation and reduces parasitics. Overall yields have to be on par with standard wafer yields to match costs. Depending on the technology, overall circuit footprint can be reduced 20–55%.
New CRM products are packed with new features and benefits, but maintaining a clear competitive advantage grows more difficult in today’s market. There has been a drive to take CRM devices and diversify into new markets. Coupled with the aging world population and the increase in medical spending in developing countries, CRM remains a strong market for implantable medical devices.
Miniaturization, performance, and quality remain as leading technological challenges for today’s design engineers. Reducing the size of power devices cannot be accomplished using the next-generation lithography node. It requires advanced 3-D circuit packaging and stacking of flip chips on flexible substrates. Stacking power devices is a proven—but high-cost—method due to the accumulation of electrical and mechanical yields. A new chip-scale package that can handle high voltages and bring contacts to the same surface is needed. It must have reliability, manufacturability to generate good yields, space efficiency, even with the required high-voltage spacing, and cost-effectiveness.
Several options exist for creating planar contacts on a power device. What looks most promising to meet these criteria are metal plated through-hole vias, epi mode diode, and PSOI packaging technologies.
1. R Srinivasan, “Implantable Devices: Challenges and Opportunities,” Medical Device Technology 13, no. 9 (September 2009).
2. “Technological Change and the Growth of Health Care Spending,” Congressional Budget Office (Washington, DC: January 2008): 13–15.
3. “Implantable Medical Devices,” American Institute in Taiwan (Taipei, Taiwan: 2005).
4. P Benesh, “Medical Device Maker Looks Forward to Expansion of Heart Market,” Investor Business Daily, May 6, 2009. Available from Internet: www.investors.com/NewsAndAnalysis/Article.aspx?id=476091&Ntt=.
5. P C Tortorici, “Keynote Address: Implantable Medical Devices; Past Successes, Current Status, Future Possibilities and Challenges,” MEPTEC and SMTA Medical Electronic Symposium (Tempe, AZ), September 2009.
6. Case History “The Rhythm of Life,” The Economist Technology Quarterly (London: March 2009).
7. P Gerrish, “Keynote Address: Implantable Medical Electronics: A Leading Application for Integrated 3D Systems,” MEPTEC and SMTA Medical Electronic Symposium (Tempe, AZ), September 2009.
8. K Takahashi and M Sekiguchi, “Through Silicon Via and 3-D Wafer/Chip Stacking Technology,” Symposium on VLSI Circuits Digest of Technical Papers (Honolulu, HI, 2006).
9. J Van Olmen, et al., “3D Stacked IC Demonstration using a Through Silicon Via First Approach,” The Interuniversity Microelectronics Center, August 2009.
10. S Ramaswami et. al., “Through-Silicon Via Technologies: Challenges and Solutions,” Panel Discussion, Semiconductor Today, May 2009.
11. J Ohneck, “The Shrinking World of Implantable Medical Electronics,” Medical Electronics Manufacturing, Fall 2007.
Tom Zemites is strategic marketing manager for Microsemi in the Scottsdale, AZ, office.
You can read more of the survey results here.
Nanowerk News reports that a group of scientists at Boston University (BU) has developed a new way to detect and control terahertz (THz) radiation using optics and materials science. Composed of electromagnetic waves, this type of radiation can pass through materials safely. Based on this work, it may be possible one day to develop safer medical scanners.
Led by Richard Averitt, the researchers have long sought devices that could control THz transmissions, enabling information to be sent via THz waves. While THz waves resemble x-rays insofar as they can pass through solid materials, they differ from x-rays insofar as they do not damage the materials through which they pass.
The BU team's breakthrough approach to THz waves is based on the use of metamaterials, which exhibit the unusual property of interacting with light, a property that natural materials do not have. The resarchers use metamaterials to interact with and change the intensity of a beam of THz radiation. Their device consists of an array of split-ring-resonators, a checkerboard of flexible metamaterial panels that can bend and tilt. By rotating the panels, the team can control the electromagnetic properties of a beam of THz energy passing by them.
Arrays of metamaterial panels could potentially function as pixels on a camera for detecting THz radiation, Averitt remarks. Absorption of THz radiation would cause the panels to tilt more or less depending on the intensity of the THz bombarding them. However, marshaling THz for future detection applications will require more-powerful THz sources, such as quantum cascade lasers.
More information on this technolgy can be obtained from Nanowerk News.
In a filed document, the plaintiffs argued that patenting of the genes associated with breast and ovarian cancer (held by the University of Utah Research Foundation and licensed to Myriad) “impedes crucial research and interferes with medical care, to the detriment of patients, doctors, nonprofit organizations, and researchers.” The document also stated that genes were not eligible for patents because “nature is free to all and can be reserved exclusively to none.” Judge Robert W. Sweet agreed with the plaintiffs.
Responding to the ruling, ACSP says, “The patents limited the availability of diagnostic tests due to the fact that laboratory scientists were prohibited from performing genetic tests because of patent enforcement.” Additionally, ACSP says that the high cost of Myriad’s product limited access to testing for the uninsured—a cost that would likely go down once other firms were allowed to develop products.
In a release on Myriad’s Web site, Peter Meldrum, president and CEO, says, “we are confident that the Court of Appeals for the Federal Circuit will reverse this decision and uphold the patent claims.” He also says that the lawsuit is unlikely to financially hurt Myriad —the case challenged only 7 of its 23 patents