Paging Dr. Eric Topol: 10 Minutes with a Healthcare Revolutionary

Paging Dr. Eric Topol: 10 Minutes with a Healthcare Revolutionary

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Cardiologist Eric Topol, MD was recently honored as the most influential physician executive in the United States by Modern Healthcare magazine. Included in the list of the top 50 physicians leaders were National Institutes of Health director Francis Collins and FDA commissioner Margaret Hamburg.

A big factor in Topol’s rise to the top of the list is his acclaimed book, “The Creative Destruction of Medicine: How the Digital Revolution Will Create Better Health Care.” In writing that work, Topol, who is the chief academic officer of Scripps Health in San Diego, has helped kickstart a healthcare revolution. As the title indicates, the book argues that the field of medicine must undergo “a positive shake-up,” as he recently explained in an interview with MD+DI.

Many people seem to agree with the overall themes in the book. It has received glowing reviews in publications such as the New York Times, Forbes, The Atlantic, The Economist, and Wall Street Journal. The CEO of Medtronic Omar Ishrak is also a fan. As is distinguished Harvard professor and economist Clayton Christensen. Qualcomm Life vice president Don Jones has hailed the book as a textbook for digital healthcare for the next five years.

The Promise of Personalized Medicine 

One of the themes that Topol puts forth in the book is that healthcare must move away from the one-size-fits-all approach towards a model that truly considers the needs of patients as individuals. The main driver of this transition to personalized medicine is the digitization of humans.That is being made possible through advances in genomics, wireless-sensing and imaging technology, as well as health information systems.

Another important part of the puzzle is that patients themselves must step up to help drive this transformation by pushing for game-changing medical technology and becoming more invested in their own healthcare. As that happens, they can begin to partner with their physicians instead of just following doctors' orders.

In the interview that follows, Topol shares his thoughts on the roles of everything from Twitter to IBM’s Watson in catalyzing the creative destruction of medicine as we now know it.

MD+DI: What does it mean to you to have been named the most “influential” physician executive?

Eric Topol, MD: It was a big shock. I think [the fact that I was chosen] is a reflection that I have a lot of great people I get to work with every day at Scripps and in San Diego. We have a lot of collaborators in academics and the life science industry here. That is what gave me the perspective to write the book. And it seems like the book was one of the major reasons why I was selected. The book intended to introduce some new thinking and hopefully catalyze a real, positive shake-up of medicine.

I have never worked so hard in anything in my career as the book, and I really felt that it was a unique opportunity to try to crystallize some perspectives and thoughts about how we can really radically change healthcare, hence “The Creative Destruction” term popularized by [Austrian economist Joseph] Schumpeter. This will be a radical change that ushers in a precise new kind of medicine. I really thought the analogy to Schumpeter with the old and new economy one hundred years ago was apropos to the old and new medicine of today. And the hope is we will let it happen as a medical community; it is usually the case that we [as physicians] are resistant to change.

Creative Destruction of MedicineMD+DIIs the book having the effect that you initially hoped it would when you first sat down to write it?

Topol: I think it has greatly exceeded that! [laughter]. I have never done a book for the public and this was a whole new experience for me. I’ve learned a lot. But when you do something like this, you put your work and your thoughts out to the peer review of the whole-world readership. So you get people sending you notes and putting comments on Amazon and all sorts of stuff. It is not like peer review where you are publishing a medical article. The book was really designed and directed for the public—for the consumers. It has been gratifying to get such a positive response.

MD+DIWhat are your thoughts on the physicians’ reaction to the book?

Topol: It has been far better than I expected. I was concerned that I would be seen as some type of rebel or that I was unfairly or unnecessarily taking on the status quo. The major reviews of the book, many of them have been written by physicians—like in the New York Times, the Wall Street Journal, the Boston Globe. And I think they have been uniformly very positive. The medical community that has responded, at least, has been very strongly embracing these concepts—many of them, of course, are long overdue. But some are related to new tools that we didn’t have before as physicians. I think the whole concept of being able to use genomic data and wireless sensor data to track the common maladies of people—from blood pressure to diabetes to heart rhythm and whatnot—I think this is really a new and exciting time. Physicians are identifying with it and that is really gratifying.

MD+DIYou have expressed the need for the public to step up to help drive the transformation of healthcare. Patients need to be clamoring for new technology, you have said. What are the most important things happening in medicine that you would like the broader public to know about?

Topol: I think the main thing is the shift away from the population medicine to the individual approach. Each time something is happening in medicine in someone’s healthcare, the question is: is it right for that individual or is that what is drawn from evidence of the thousands or tens of thousands of people, which are from clinical trials that are not necessarily reflective of any individual? [The concept of population-based medicine] goes through every aspect of healthcare.

What I am hoping to drive is this consumer revolution where patients say: ‘What about me?’”

What I am hoping to drive is this consumer revolution where patients say: ‘What about me? Can I have my data on my smartphone: my DNA data, my sensor data for whatever relevant metric? And I should also have my lab tests, I should have the results of my scans, and on and on.’

MD+DIWhat else do you think should patients know about?

Topol: The idea that, for example, people are sent for all sorts of nuclear radiation procedures and they are not even [informed about] the dose of radiation that they are being exposed to. A large proportion of patients get a nuclear profusion scan with an exercise test every year, which is the equivalent of 2000 chest x-rays. 

Patients should demand information about things like this. Whether it is a drug or a test or getting the genotype for a medicine that is relevant for that person. That will only happen if consumers are educated and activated; they have to drive this.

The pharmaceutical world learned that consumers can drive prescription drug use with the ‘ask your doctor’ direct-to-consumer campaigns. I am suggesting that patients can partner with their doctor. They can even tell their doctor: this is my data, what do you think?

Patients are going to be in medical domain for the first time. They should rightfully be in that domain: It is their body. It is their information. That is a big shift in medicine, of course. It is fundamental.

MD+DIIs there anything in particular you would like to convey to professionals at medical device companies?

Topol: There are a lot more device solutions than anybody even envisioned. Now we are even seeing a potential device solution for high blood pressure. Who would have thought?

I think devices are really central to the future of medicine and, obviously, there will be more with respect to that data potential going to the individual in certain devices. But the main thing is to think of the devices will play in this consumer-centric new model.

“No one has a more vested interest in this themselves than the patient herself or himself.”

I’ve had the privilege of meeting the famous patient Hugo Campos who has a defibrillator but can’t get his rhythm data. He is rightly upset that he can’t get it. We shouldn’t have that kind of thing anymore. Everyone is entitled to get his or her information. It is theirs.

In this new era, there will be demand for [patients to have access to their own data]. No one has a more vested interest in this themselves than the patient herself or himself. If they don’t want the data, that is another matter. But if they are asking for it, why shouldn’t it be provided? Why is it only given to the doctor?

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Do’s and Don’ts When Cleaning Fiber Optics

Use the do’s and don’ts of cleaning fiber optics below to help you during the education and training process. And always remember to inspect, clean, and inspect.

Inspect

  • Don’t look directly at the laser-energized fiber optic termini with your eyes, and don’t expose skin to direct or scattered radiation. Most laser and LED light sources used in fiber optics operate in the near-infrared and infrared wavelengths. While they are invisible to the eye, they can cause significant damage in the form of corneal, retinal, or skin burns. Only view the termini with equipment engineered to safely inspect fiber optic endfaces. Be safe and always treat all termini as though they are laser-energized.
  • Return to
    Contamination Beware: Cleaning 101 for Fiber Optics
  • Do learn what each type of contaminant looks like. It is important to know which contaminants you are working with in order to properly clean the fiber optic termini.
  • Do a thorough examination to find the type of contaminant(s) on the endface. It might just be one particulate or a laundry list of dust, oil, and salts combined. Understand what you’re facing in the beginning to ideally eliminate the source of contamination and reduce the number of cleaning rounds.
  • Do determine which cleaning technique is appropriate for the contaminant and the instrument termini. Do you need a wipe, a swab, or cleaning fluid? Know what you need in order to perform an efficient cleaning process. Consider purchasing a ready-to-use fiber optic cleaning kit that includes everything needed to clean most commonly used connectors.
From left to right, the geometry of two snap-in type connectors, a Small Form Factor LC connector, a SC connector, and a screw in SMA high power connector.  Each presents unique cleaning challenges due to their endface geometry and service requirements. Image courtesy of MicroCare, Sticklers.

Clean

  • Do thoroughly wash your hands before handling the fiber optic connector and the cleaning supplies. Clean hands will be less likely to transfer dirt and oils that can compromise the cleaning process.
  • Don’t apply a moisturizer or lotion to your hands prior to cleaning the termini. This will attract more contaminants and cause oils to transfer onto the cleaning wipe or swab, and potentially the endface you are trying to clean.
  • Don’t wipe the endface of the fiber optic on your gown or other clothing. This is not an appropriate cleaning mechanism and will only cause the endface to be dirtier than when the cleaning process started.
  • Don’t wear gloves when working with wipes and swabs. While you may think that wearing gloves will protect the cleaning materials from the oils in your skin, you will actually be adding more particulates. Gloves, like your clothing, are a carrier of all kinds of microscopic contaminants. It’s best to simply wash your hands prior to cleaning a connector.
  • Do throw away all wipes and swabs after each use. This will ensure that the contaminants picked up by the cleaning materials won’t end up back on the endface.

Inspect

  • Don’t forget to repeat the inspection process. This is a critical step to make sure that the fiber optic connector is clean and the system will perform at full potential.
  • Do make sure the termini endface is clear of any contaminants before it is put into service. If you notice any contaminants left on the endface, repeat the cleaning process with a new wipe or swab until it inspects as pristine clean.
  • Do perform routine inspections when installing new or servicing existing fiber optic connections. Clean connectors ensure that your system is running correctly and all information is being transmitted at its optimal speed.
  • Do it right the first time. Leaving contaminants on the end face can degrade performance or cause a violent reaction, leading to costly replacements of the connector or the system as a whole.

Contamination Beware: Cleaning 101 for Fiber Optics

Over the past decade, the use of fiber optics in the medical industry has steadily increased. From extensive medical
A fiber optic cleaning stick being used to clean an LC connector located in a mating sleeve.  The stick is engineered to reach down into the mating sleeve and clean the endface of a fiber optic termini located within. Photo courtesy of MicroCare, Sticklers.
applications, including light therapy, arthroscopic surgery, x-ray imaging, ophthalmic lasers, and lab and clinical diagnostics, to simple communication processes, such as transmitting patient information, fiber optics help medical professionals conduct procedures that were previously not possible.
 
Maintenance of the connector endface is imperative for the fiber optic instrument to work correctly. It is an exacting job: the microscopic termini that create a connection must meet at an exact place, and the glass cores need to be perfectly aligned in order to have signal transmitted to and from the device. In addition, the termini endfaces must be completely clean of contaminants to ensure minimal signal loss. One of the most basic and important procedures for the maintenance of fiber optic systems is to clean the fiber optic termini.

Contamination Challenges

Like many medical devices, cleanliness is crucial to the performance of fiber optic instruments. Any contamination on the termini endface can cause failure of the component or the system as a whole. Even microscopic particles on the endfaces can cause a variety of problems for optical connections. One of the biggest challenges of contamination is that it cannot be seen with the naked eye, and one must typically use a specialized 200x or 400x inspection scope to determine the cleanliness of the endface. A close inspection of the connector is critical to identify that particles and residue are completely eliminated, thereby ensuring that connections work to their full potential.
 

HELP!
Do's and Don'ts When Cleaning Fiber Optics

A variety of serious, undesired outcomes could occur if a contaminated fiber optic connection is being used, from deteriorated performance levels to ruined instruments. A dirty fiber optic endface will significantly degrade signal transmission and can result in blocking the signal all together. Even if a particle is only situated on the ferrule or the edge of the endface, it can cause an air gap or misalignment in the termini between the cores. This can result in back reflections, instability in the laser system, signal attenuation or even a system shutdown. Another potential issue is a scratched surface as a result of dust particles trapped between two termini endfaces. What’s more is that some fiber optic instruments, such as those using high-power Class IV lasers, generate a significant amount of heat, which, when in contact with contaminants, can spark a violent reaction or fire.
 
One of the biggest challenges related to cleaning fiber optic termini is finding a process that works. Improvising a cleaning process will almost certainly lead to failure, as previously outlined. The best advice is to inspect, clean, and inspect again. Repeat this process until you are absolutely sure the instrument is clear of all contaminants. Spending the time to clean it right the first time saves time and money in the end.

Cleaning Methods 101

Inspection scope photos at 400X magnification of a pristine clean termini endface. Note the actual glass fiber is enclosed in the small white dot seen in the clean and particulate views.
Inspection scope photos at 400X magnification of a termini endface contaminated with finger oil. The fiber is completely obscured. Note the actual glass fiber is enclosed in the small white dot seen in the clean and particulate views.
Inspection scope photos at 400X magnification of a termini endface contaminated with particulate. Note the actual glass fiber is enclosed in the small white dot seen in the clean and particulate views. Photos courtesy of MicroCare, Sticklers
Materials used to clean the endfaces must be pristine; otherwise you could make it worse by adding contamination. It may be intuitive to wipe the endface on your gown or a cloth, but under a typical fiber optic inspection scope, those items carry a large variety of contaminants that could soil the connector. Even touching the termini with your finger will cause it to be significantly dirtied with skin oil. To avoid further contamination, make sure to use a product that has been specifically manufactured for cleaning fiber optics. Always wash your hands prior to using cleaning materials to minimize the transfer of skin oil onto the cleaning surfaces.
 
There are two primary methods available to properly clean fiber optic termini: a specialty wipe for male connectors and a swab for female connectors. Particulates, oils, and salts are the three basic types of contaminants found on the endfaces, all of which require their own cleaning methods. Particulates are solids that are held on the endface by a static attraction. The best way to clean these types of contaminants is by dissipating the static charge that both attracts and holds them in place, which can usually be done with a specialty cleaning fluid. Cleaning fluids are also used to dissolve oils found on the fiber. Salts, on the other hand, are not necessarily fully removed by cleaning fluids alone. While cleaning fluids may quickly rinse away the oils, they tend to leave salt remains behind in the form of a white residue that can be very difficult to remove. Mechanical action that a wipe or a swab provides is usually combined with a cleaning fluid to fully eliminate oil and salt left on the termini endface.
 
Buyer beware, it’s fair to say that some cleaning products on the market can leave the endface dirtier than when you started. To avoid this situation, look for products that offer engineered solutions formulated to rid the termini endface of particulates, oils, and salts. Avoid using aqueous (water-based) cleaning solutions or pure isopropyl alcohol (IPA), as violent reactions could potentially occur. Aqueous products are slow to dry and can leave moisture on the endface. In cold ambient temperatures, the moisture may actually freeze on the endface and alignment sleeve. If the moisture is not completely removed before the fiber is connected in the sleeve, the laser-energized fiber will instantly vaporize the remaining liquid into a gas, causing an explosion through sudden expansion of the vapors. As with water-based cleaners, IPA may explode or catch on fire when left on a highly energized fiber endface. Adding insult to injury, IPA also frequently leaves a hazy film behind when it dries. What you should look for is a fast-drying, high-purity fluid engineered specifically for cleaning fiber optics.
 
High-purity cleaning fluids can and should be used with both wipe and swab applications. However, beware of presaturated cleaning materials. Presaturated wipes and swabs often contain microscopic contaminants drawn from the plastic packaging, which will transfer to the endface during the cleaning process and result in further contamination problems. Instead, carefully apply a small amount of high-purity cleaning fluid on the corner of a dry wipe or the tip of the swab and then apply to the fiber optic termini. A well-engineered cleaning fluid will not only dissolve oils found on the endface, but will help to eliminate the electrostatic charge generated when the applicator is pulled out of its packaging. Be sure to not touch the area of the wipe or swab you will be using with your finger or your clothing. Should you touch this area or drop it on the ground, discard the wipe or swab and start over. Once the cleaning process is complete, discard the wipe or swab and inspect the endface to make sure all contaminants have been eliminated.

Bottom Line: Performance Critical Cleaning

As fiber optics usage continues to grow in the medical industry, it is imperative to clean the termini endfaces properly the first time around with the right products the proper way. The consequences of an unclean fiber optic can be detrimental to your business operations. Medical professionals can’t afford to have a blocked connection, a fire, or a complete system shutdown when there is a patient on the table. Use the correct cleaning solutions and closely inspect the endface to avoid these costly mistakes. Investing the time, energy and money into the cleaning process at the beginning will end up saving you in the end.
 
Jay Tourigny is vice president of operations at MicroCare Medical. He has 25+ years of industry experience and holds numerous U.S. patents for cleaning-related products that are used in medical, fiber optic, and precision cleaning applications. He holds a Bachelor of Science degree from Massachusetts College of Liberal Arts. Reach him at JayTourigny@microcare.com.

China and India: Comparing Two Fast-Growing IVD Markets

Both China and India have fast-growing IVD marketsThe late Angus Maddison, an economist from the University of Groningen, compiled data that suggests China and India were the biggest economies in the world for almost all of the past 2000 years. They only lost this position during the Industrial Revolution. It now appears that China will regain its place as the world’s largest economy, overtaking the United States, sometime during the next decade.1
The IVD markets of China and India, two countries that account for approximately one-third of the world’s population, have demonstrated remarkable growth during the past 15 years. The IVD markets in what is coming to be known as “Chindia” have seen steady growth rates of 10-20% per year during most of that time, although the growth in India is starting from a substantially lower point. Recently, the pace of growth for both countries has increased, with China at around 25% and India at about 18%. This article will examine the similarities and differences in these two markets, the fastest growing large IVD markets in the world.
China
According to official figures, China’s economy has grown at an average rate of 9.1% during the last decade, but the real growth could be even greater. The Chinese economy has also been remarkably steady, and the increasing prosperity is one of the main drivers of IVD market growth in China. The other main driver is urbanization. Factory workers and office employees are more likely to be customers for diagnostic products than farmers in the countryside.
India
India’s economy has grown at an average annual rate of 6.1% during the last decade. Twenty years ago, faced with a financial crisis, India went to the International Monetary Fund (IMF) for help, and as part of the assistance package, India agreed to open its economy, lower tariffs, reduce licensing requirements, and allow more foreign ownership of companies in India. The result has been a remarkable increase in labor productivity and prosperity. Even though progress in economic reform has slowed down, it does continue, and Goldman Sachs has predicted that India will be the world’s third largest economy by 2050.
During the last 15 years, India’s IVD market has, like China’s, grown continuously. While the annual growth rate was around 10% a decade ago, it has increased and is currently at approximately 18%. The same two key drivers (increasing prosperity and urbanization) that are propelling China’s market have also contributed to India’s impressive growth in IVD spending.
Population
With 1.33 billion people, China currently has the world’s largest population. However, sometime between 2025 and 2030, China’s population will be surpassed by India’s, which currently has 1.14 billion people. This is because India’s population

Figure 1. Revenue figures for China's IVD market, 1995-2011, in billions of U.S. dollars.

growth rate is 1.27% while China’s, which is constrained by their single-child policy, is 0.61%. This difference in growth rates has resulted in India’s having a much younger population. Only 20% of China’s population is under 15 years old, while 31% of Indians are under that age.
It has often been said that China will be the first country to grow old before it grows rich because its working-age population (15-60 years old) will decline during the next twenty years. On the other hand, India’s younger population will result in an increase in workers throughout that period.
Both countries, albeit China to a much greater extent, will start to see increases in health problems from chronic diseases (e.g., diabetes, heart disease, and cancer), which are common in developed countries. This will be the result of an aging population, changes in lifestyle and diet, and increased economic prosperity.
Economy
The global economic crisis of 2008-2009 had much less impact on China or India than on the world’s developed economies. Both China and India saw a temporary drop in growth followed by a rapid recovery, and neither country has the continuing problems still seen in the United States and Europe. China’s current GDP growth rate is 8.2%, and India’s is 7.8%.2
Both China and India are members of the World Trade Organization (WTO). India joined in 1995; China in 2001. Therefore, both nations are parties to the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement. While difficulties in enforcing and protecting intellectual property (IP) rights exist in both countries, China and India are now developers of intellectual property and will increasingly view IP rights as important to their growth. Continued, gradual improvements in IP enforcement are expected to be seen.
IVD Market Size
McEvoy & Farmer’s 2011 report on China’s IVD market estimates the size of the market to be $2.1 billion with a growth rate of about 25% (see Figure 1). Other reports give higher estimates for both market size and growth rate. McEvoy & Farmer’s 2011 report on India’s IVD market estimates the market size to be $531 million and growing at approximately 18% (see

Figure 2. Revenue figures for India's IVD market, 1996-2011, in hundreds of millions of U.S. dollars.

Figure 2). Aside from the difference in size, several characteristics of these IVD markets vary, which are discussed in more detail below.
IVD Instrumentation
While both countries are buying and using large numbers of automated IVD systems, China is a better market for instrumentation, particularly automated chemistry systems. While the total IVD market in China is roughly four times as large as India’s, its total number of automated chemistry systems is more than six times as high.
There is also a difference in the semi-automated chemiluminescence immunoassay (CLIA) market. These systems are converting low- and medium-volume labs from enzyme immunoassay (EIA) testing to CLIA testing and are keeping some of the market growth from going to imported closed immunochemistry systems. China has a vibrant domestic CLIA sector, with more than 13 local manufacturers that have supplied the market with roughly 8,000 instruments and the reagents they require. Of these systems, about 98% are semi-automated, but at least three local IVD companies have developed automated CLIA systems and are selling them aggressively.
In India, the CLIA sector is smaller, with about 2,300 semi-automated instruments. A single company, Lilac Medicare, is responsible for most of this market. There may be some local assembly of these systems, but for the most part, they are imported.
Molecular Testing
China and India have substantial differences in their molecular testing markets. At $112 million, China’s molecular market is more than ten times the size of India’s. This is due to the large volume of PCR testing for infectious diseases done in China using domestically produced kits. These tests account for about three-fourths of China’s molecular market, which sell at prices that no foreign IVD company is willing to match. As a result, the multinational companies are mostly selling instruments. However, emerging disease areas such as oncology will start to give international firms a greater presence in the molecular reagent market since there is no significant local competition.
Qiagen is the one exception to the local dominance of China’s molecular market. The company is active in two very different ways. First, Qiagen’s purchase of Digene gave it almost 100% market share of the domestic HPV market, and even though that share has been slipping due to increased competition, it is still the leader in this segment. Second, Qiagen acquired local PCR manufacturer PG Biotech of Shenzhen, the number-two supplier of PCR kits in China.
A lot of research and development activity in the area of microarrays and gene chips is taking place in China, but they are not yet a significant part of the molecular market. Such activity started in October 8, 2001, when China’s English language newspaper, the People’s Daily, reported that the country’s first Gene Chip Research Center had been established in Tianjin. Five government-funded national chip centers in China are now located in Beijing, Shanghai, Tianjin, Chengdu, and Xi’an. A proliferation of about 100 private companies has also been pursuing chip-based technologies.
India’s molecular market is the opposite of China’s with foreign products accounting for approximately 80% of the market, including both instruments and reagents, and about 20% coming from domestic production and homebrews. While India’s total molecular market is one-tenth the size of China’s, the international portion is only about one-third the size.
Clinical Labs
The structure of clinical laboratories in each country is quite different. China’s healthcare system continues to demonstrate uniformity that originates from its communist past. Historically, IVD testing has been done at hospitals where the labs served both inpatients and outpatients. The laboratory was the hospital’s second most important profit center, behind drugs and ahead of medical services, so the hospitals were unwilling to send tests out. All hospitals were owned by government bodies at various levels, state-owned enterprises, or the military. Doctors were not allowed to set up private practices, but instead worked for the hospitals.
While this is still the general structure of the healthcare system and IVD testing in China, there have been some changes. Private hospitals now exist, but they are mostly small specialty centers that account for less than 5% of the total beds in the country. Private medical practices appear to be on the upswing, but they are still a very small component of China’s healthcare system.
The total number of clinical laboratories in China is estimated to be around 20,000, which corresponds to the number of hospitals in the country. Almost all of these labs have automated chemistry systems. Many other healthcare facilities in the country, including clinics in small towns and the Chinese Center for Disease Control labs, also do some IVD testing. China continues to build new hospitals, adding about 500 per year.
Private labs also now exist in China, and they are becoming more important in the market. In most countries, private lab chains have emerged when a regional leader buys many smaller labs in the area and then continues to purchase other similar labs in other parts of the country. However, since there were no small private labs in China, new private companies are setting up their own labs around the country.
Four major groups are building national laboratory chains in China. Kingmed (Guangzhou, China) is the leader with 19 labs. Adicon (Hangzhou, China) is second with 15 labs. They are followed by Da An (Guangzhou, China), the leading supplier of locally made PCR kits with five labs, and Lawke (Beijing). While private laboratories have been slow to enter the marketplace and they still do only a modest proportion of China’s IVD testing, they will grow in importance in the coming years.
India’s laboratory structure is more complex, due to the long history of diverse institutions. There are hospitals that are run by the government, charities, and non-profit organizations as well as a group of world-class private hospitals. In addition, there is a rapidly growing number of private lab chains.
India is estimated to have more than 30,000 active clinical laboratories (other sources estimate as high as 40,000). The number of laboratories continues to grow, which is true for not only automated labs but all types of labs as new laboratories of all sizes continue to open. For example, the number of automated chemistry laboratories in India has grown from approximately 700 in 2004 to about 2,700 today. At some point, the private-sector portion of the lab market is expected to change with smaller laboratories coming under pressure from the rapidly expanding national lab chains.
Super Religare Laboratories (SRL) is India’s largest chain with 57 labs. Second is Dr. Lal PathLabs with 56 laboratories. Thyrocare is following a different path for expansion by implementing the Federal Express business model. It consolidates all of its testing in Mumbai, with specimens flown in from 20,000 local collection points during the day and testing done at night. But unlike the other labs, they are not growing via acquisition. Thyrocare is the largest processor of thyroid tests in the country and has added ToRCH to its specialties. Quest Diagnostics has established a 70,000-square-foot laboratory at the edge of New Delhi, but it is not known how well it is doing in the local market.
IVD Product Registration
IVD product registration is an area in which the two countries differ greatly. Product registration is going to get more difficult in India, but it still remains relatively inexpensive and rapid. India’s government is making changes in the regulations for medical devices and IVD products. According to industry contacts and Ministry of Health officials, a notification is expected that would bring a group of medical devices and IVDs under the regulatory framework. The authority regulating medical devices and IVDs will be the Central Drug Standard Control Organization (CDSCO) in the Ministry of Health.
In China, the situation is very different. The State Food and Drug Administration (SFDA) is responsible for regulating drugs and medical devices. Both IVD instruments and reagents must be registered, and all products must be re-registered every four years.
Two different SFDA branches are involved in IVD product registration. One is responsible for drugs, and the other for medical devices. The pharmaceutical branch originally registered diagnostics, but in July 2007, it became official that IVD products, with some exceptions, would be regulated as medical devices. (Only blood screening, RIA tests, human tissue cell reagents, and bio-chips continue to be registered by SFDA’s pharmaceutical branch, which remains more expensive and time consuming.) Eventually, it is expected that SFDA’s medical device section will also take over the remaining tests.
Products made domestically in China follow a registration process that is different for imported products. As such, the registration of locally manufactured products is considerably easier and faster than foreign products.
It takes 1-2 years to register an IVD product in China (closer to two years if the product has to be registered as a drug). However, this assumes that the application is done correctly. If there is any problem with an application, SFDA will return it, and the process will take longer. This is quite common since it is safer for an SFDA official to return an application for an error than to accept the responsibility for approving it. This issue came to light with the 2007 death sentence for Cao Wen Zhuang, one of the drug approval directors. He had approved products that led to several deaths in the country.
One of the commitments China made with its accession to WTO was to make all processes like product registration transparent and only as costly as is needed to administer them. This clearly has not yet happened in the case of IVD product registration. While it is expected that at some point all IVD products being sold in China will be registered at reasonable speed and cost, it is difficult to make a prediction as to when that will happen.
Local IVD Manufacturing
Local IVD manufacturing is a second area in which the two countries are very different. While there is local manufacturing of IVD products in both countries, China is much more prolific in this area. For example, McEvoy & Farmer’s recent report on India profiled 32 local manufacturers, while a similar China study had 138 local manufacturer profiles. In total, more than 300 Chinese companies are making IVD products.
Also, Chinese IVD companies have a greater presence in other countries around the world. For example, Mindray has an office in Brazil, while Brazilian companies distribute products by Autobio, ABON, IND, URIT, Dirui, Sunostik, Cornley, Beijing Blue Cross, and Sinnowa. Meanwhile, no Indian company has an office in Brazil, and it appears that only Transasia/Erba Mannheim and Span are present in the market.
Similarly, Mindray has an office in Mexico, and while Mexican companies distribute products by InTec, Rayto, Sinnowa, Dirui, and IND. The only Indian companies in Mexico are Transasia/Erba Mannheim and PMC, a company making rapid HIV tests.
Emerging IVD Companies
While there is more IVD manufacturing in China, both countries have impressive IVD exporters. The two companies discussed below are the best examples of what the rest of the world can expect to see from these countries in the coming years.
Mindray Medical. Mindray Medical is based in Shenzhen and is located across the border from Hong Kong. The company was established in 1991 and is listed on the New York Stock Exchange. It has more than 6,000 employees and manufactures IVD, patient monitoring, radiology, and ultrasound systems.
Historically, Mindray’s strength in the IVD markets has been hematology systems, but it has also added chemistry, urinalysis, and EIA systems to its product line. The company exported its first IVD products to the United States in 2007 and now has offices in 16 countries. Its 2010 sales totaled $704 million, of which IVD products accounted for $175 million.
Transasia Bio-Medicals. Founded in 1979, Transasia Bio-Medicals of Mumbai is a privately held company that is managed by its founder. The company is a distributor as well as a manufacturer, and has a long-term relationship with Sysmex. It represents Medica, Diesse, IMMCO, Wako, and Gen-Probe, among others.
For years, Transasia has been India’s leading IVD company. Now the company is becoming an exporter of IVD products and is growing by acquisition. ERBA Diagnostics Mannheim GmbH, a subsidiary of Transasia, manufactures chemistry instruments and has recently acquired three other IVD companies. The first was Lachema Diagnostika of the Czech Republic, which has a subsidiary in Russia; the second was the U.S. company IVAX with its immunology focus; and on January 14, 2011, Transasia announced the 100% acquisition of Diasis Diagnostik Sistemler Ticaret Ve Sanayi AS of Turkey. Diasis focuses on chemistry, hematology, and urinalysis.
Conclusion
Both China and India are inspiring success stories, lifting millions of their citizens out of poverty, providing better healthcare, and positioning themselves to play major roles in the global IVD market in the future. The growth rates of the IVD markets in each country have been very impressive during the last 15 years. It is sometimes asked if this growth will slow down in the future. As long as the two main market drivers—increasing prosperity and urbanization—continue, strong growth in the Chinese and Indian IVD markets is expected for many years. Even after 15 years of growth, the two countries combined are spending only about one dollar per person per year on diagnostics. Compared to the $25-30 per person per year spent on diagnostics in developed countries, it is clear that the IVD markets in Chindia are nowhere near market saturation.
References
1. “Becoming Number One: China’s Economy Could Overtake America’s Within a Decade,” The Economist, September 24, 2011.
2. “The World in 2012,” The Economist. Available online at http://www.economist.com/theworldin/2012.

Carl McEvoy is a partner at McEvoy & Farmer (Seattle). He can be reached at carl@mcevoyandfarmer.com.

Spotlight on Cables and Connectors

Flat silicone surgical cables
Durable, flat silicone cables designed for use on surgical robotic systems are naturally more flexible than round PVC and stiffer flat PTFE cables. This property, according to their manufacturer, results in a tighter bend radius, decreased weight and size, greater current-carrying capacity, reduced noise, and longer flex life. Cicoil completely encapsulates each element in the solid, one-piece cable with halogen-free silicone to prevent rubbing wear during a lifetime of more than 10 million cycles. Small punctures in the silicone are self-healing, and any damage to the cable jacket can be easily repaired in the field. The lightweight cables incorporate a variety of power, data, and video conductors. In addition to every type of electrical conductor, they can accommodate single- and multilumen tubing for air or liquid transfer, fiber optics, and other design elements, such as the manufacturer's own fastening strip. The cables are contaminant free and rated for use in Class 1 cleanrooms as well.
Cicoil
VALENCIA, CA

Embedded electronics connector technology
Suitable for use in medical electronics applications, connector technology from Onanon integrates electronic components into connector plugs. By inserting full-fledged computers between connector pins, the embedded electronics connector technology enables OEMs to embed value-added, intelligent, microscale systems into their connector designs while enhancing the capabilities that engineers can introduce into medical devices from their connectors. The drop-in replacement connectors can also include small PCBs for performing device ID, use-limiter, EEPROM, and fine-tuning functions. The company's rapid wire-termination technology makes connecting wires to a PC board connector substrate easy as well. And by allowing users to replace the connector plugs using ordinary tools, the embedded technology simplifies the task of upgrading medical device systems. In addition, it dispenses with the use of solder, which can damage PCBs.
Onanon
Milpitas, CA

Radio-frequency connectors
A manufacturer of standard coaxial and triaxial radio-frequency (RF) connectors offers a custom design service for adapting these products into nonstandard medical connectors for use in specialized medical equipment. Intelliconnect USA LLC fabricates a series of triaxial connectors, for example, that are designed to minimize system noise while providing an isolated ground. Their clamping construction and weatherproof sealing optimize termination to various twin-axis and triaxial cables. The company additionally provides a series of rugged, waterproof microminiature connectors, along with multipin power- and signal-transmission systems. Capable of operating at temperatures ranging from -65° to 165°C, the customizable RF connectors are suitable for use in such medical applications as cochlear ear implants, RF cancer treatment, RF ablation, biomedical test equipment, and bionics.

Intelliconnect USA LLC
CROSSVILLE, TN

Disposable plastic connectors
Lemo offers the Redel-brand 2P disposable receptacle as part of its line of specialized plastic disposable connectors designed for use with electrosurgical devices. Suitable for critical applications, this biocompatible polysulfone (PSU) self-locking receptacle makes an OEM device compatible with the manufacturer's standard series of plugs. For electrosurgical catheters that must go beyond the standard 14 pins, this receptacle comes in 26- and 34-pin configurations. In addition, it is available with reverse-gender male contacts in 8-, 9-, 10-, and 14-pin sizes and comes with H or J keyways. A snap-on backshell made from ABS or PSU facilitates assembly, and an extended backshell can be supplied as well. The receptacle features an average retention force of 150 N, withstands 1000 latching cycles, and features a working temperature range of -50° to 150°C.

Lemo USA
Rohnert Park, CA

Hybrid circular connector-and-receptacle system
Combining optical and electrical signaling in one connector, the MediSpec hybrid circular mechanical-transfer (MT) cable-and-receptacle system from Molex Inc. minimizes the number of connectors required by medical equipment and devices. Using circular MT technology, the multifunctional connector provides three configurable MT ferrule-compatible ports for combining copper or fiber media to carry electrical power, low-speed copper signaling, and optical data or video signals. This integrated technology can be incorporated into a streamlined custom system that meets specific end-user requirements and simplifies installation. For the PCB or equipment side, the hybrid connector-and-receptacle system can be configured with any of several optical and electrical connectors. Other system features include connector housings engineered from a choice of metal or medical-grade polymer, an expanded-beam MT ferrule option to reduce optical loss due to contamination, and fiber counts ranging from 1 to 24 fibers per ferrule.
Molex Inc.
LISLE, IL

Power cords with retention system
V-Lock power cords from Schurter Inc. feature a cord-retention system that protects against accidental power disconnections. Offered with power entry modules with and without filters, the cord sets latch into an expanded range of equipment couplers and power entry modules according to IEC 60320 for styles C14 and C20. Featuring illuminated and nonilluminated integral switches, circuit breakers, and fuse and fuse drawer combinations, they are offered in front- or rear-side screw-on and snap-in versions. They are also available with a PCB mounting and with quick-connect, solder, and PCB terminals. Available with NEMA and other country-specific plugs, the cords can provide a safe, reliable power connection for portable medical devices.

Schurter Inc.
SANTA ROSA, CA

Lighted hospital-grade cords
Using a standard-configuration transparent plug for its 10-ft hospital-grade power cord, Quail Electronics Inc. manufactures a version of the plug with a wired LED molded inside. When the 0310.120LT NEMA 5-15P cord is plugged into a power source, the plug at the equipment end lights up to provide a clear indication of the connection in a dim environment. The power cord uses an 18/3 AWG cable with a gray SJT jacket, and the clear connector at the equipment end complies with the IEC 60320 C13 standard. UL-approved, it is rated at 10 A and 125 V and carries the Green Dot marking, signifying that it has been tested for the hospital environment.
Quail Electronics Inc.
LIVERMORE, CA

Outsourcing Outlook: Molding Services

When selecting contract molding partners, medical device OEMs should be aware of several molding technologies, manufacturing processes, and quality systems to achieve optimal results. Tim Reis, vice president of healthcare business development at GW Plastics Inc. (Bethel, VT), sheds light on this topic.

MPMN: Which molding technologies and capabilities should medical device OEMs expect their molding partners to master?
Reis: The complexity of medical devices and the materials used to manufacture them determine which molding technologies an OEM requires. In general, however, capable contract manufacturing partners should embrace scientific injection molding principles and technologies to ensure robust component validation and production quality. Medical device OEMs are also increasingly embracing suppliers with expertise across a variety of advanced molding processes, such as multimaterial, micromolding, thin-wall, automated shuttle, rotary insert, and liquid silicone rubber (LSR) technologies. These processes help reduce postmolding assembly costs while improving device innovation, functionality, and ergonomics.

MPMN: What equipment, systems, and qualifications should the medical device OEM expect a contract molding provider to have in place?
Reis: Medical device OEMs should seek to partner with contract molders that have demonstrated healthcare industry expertise. For example, suppliers should be committed to maintaining programs for investing in cleanroom manufacturing facilities, state-of-the art molding equipment such as electric or hybrid-electric machines, along with advanced material handling and automation technology to ensure processing consistency. The ability of suppliers to ensure molding efficiency and energy conservation is also an important consideration. In addition to preferring suppliers with product development and in-house tooling capability to improve innovation, design for manufacturability, speed to market, and component quality, OEMs should seek to partner with contractors that invest in quality-critical technologies, including coordinate-measuring machines, optical gauging systems, cavity-pressure transducers, and press-side quality automation.

MPMN: What materials should medical device OEMs expect prospective contractors to process?
Reis: The past several years have seen a transition toward the use of higher-performance polymers that offer enhanced material properties and contain additives for specific requirements. For example, advances in liquid crystal polymer, PEEK, Ultem, polysulfone, and LSR--in addition to antimicrobial polymers and other reinforced engineering-grade materials--have become increasingly important to the healthcare industry because their high-performance characteristics encourage innovation while improving patient care and safety.

Metal injection molding services
Kinetics Climax Inc. employs proprietary advanced process quality planning practices, including its PCpk process modeling predictive analysis capability, to ensure consistent metal-injection-molding (MIM) services for medical device manufacturers. A net-shape process suitable for the production of solid-metal medical device parts, MIM results in material properties resembling those of wrought metal with the design flexibility of injection-molded parts. Predictive analysis capability, which allows the company to model process variations from injection molding through final inspection, enables the contractor to supply a summary of expected process outcomes ahead of tooling fabrication.
Kinetics Climax Inc.
WILSONVILLE, OR

Full-service plastics molding
Providing injection molding services to medical device manufacturers, Pharma Tech Industries (PTI) specializes in the production of distal stem centralizers in various sizes for use in orthopedic applications, particularly joint replacements. In addition to extrusion services, the company's molded-plastics division provides injection, injection blow, and compression molding services. Equipped to meet regulatory requirements for a range of product classifications and categories, the supplier can tailor part designs, product development, prototyping, mold building, tool refurbishment, validation services, production, and packaging to customer requirements.
Pharma Tech Industries (PTI)
ROYSTON, GA

Miniature molded bioabsorbable parts
Used in the company's contract molding operations, the Sesame injection molding machine from Medical Murray molds miniature medical devices with complex geometries from bioabsorbable polymers. The machine features fast, controlled injection and short material residence time. It also uses a pneumatically driven vertical plunger for plasticating material and a 1- to 2.5-mm-diam linear-servomotor-driven horizontal injection plunger. Capable of maintaining low melted volumes and performing controlled high-speed, high-pressure injection, the machine supports the manufacture of low-scrap bioabsorbable parts weighing as little as 2.5 mg and featuring dimensions as small as 0.10 mm. In addition to molding parts, the company provides product design and development services.
Medical Murray
NORTH BARRINGTON, IL

Mold-tooling development
Reny specializes in helping medical device manufacturers minimize time to market by designing modular tooling systems that simplify mold construction. The ISO 9001:2008-certified service provider offers modular predesigned double-slide systems, automatic unwind systems, and y-leg core-pull systems, all of which are built in compact molds. It has developed a hard-steel pilot mold insert that can displace the prototyping step during product development. In addition, the system allows customers to dispense with purchasing a mold base and is scalable for transfer into production. Equipped with scientific molding software for process development and capable of performing all qualification validations in an ISO Class 8 cleanroom, the company offers such medical device manufacturing capabilities as insert molding, nitinol overmolding, pad-printing, and laser marking.
Reny
BALDWIN PARK, CA

Injection molding services
A contract injection molder serving medical device manufacturers uses advanced medical molding technologies to optimize manufacturing processes and maximize supply-chain efficiency. GW Plastics Inc. offers robot-assisted thermoplastic and thermoset injection molding, including liquid silicone rubber molding, multishot and multimaterial molding, automated shuttle and rotary insert molding, thin-wall molding, and micromolding. Providing cleanroom assembly of such products as disposable surgical instruments, drug-delivery systems, and implantable medical devices, the contractor also has design for manufacturing expertise and in-house mold-tooling capabilities. In addition, it employs statistical qualifications throughout the life of the project to ensure consistent product across different molding machines, materials, or manufacturing locations.
GW Plastics Inc.
BETHEL, VT

Manufacturing Systems Today: Packaging

Medical pouch constant heat sealer/cutter system
Sealing and thermoforming machine manufacturer SencorpWhite Inc. offers what it claims are the first constant heat sealer/cutter systems for medical pouches. Available in two models, these CE- and ISO 11607-compliant systems allow medical device manufacturers to combine medical pouch sealing and cutting processes into one step following sterilization. The cut-off knife and sealing die operate independently so that the user can operate the system as a sealer only, cutter only, or combined sealer/cutter. The CeraTek 12-MPK/2 features a 12-in.-long seal die and can accommodate a pouch up to 11.5-in. wide while the 24-MPK/2 model has a 24-in.-long seal die and can accommodate pouches up to 23.5-in. The minimum distance from the outer edge of the applied seal to the cut location is 0.25 in.

SencorpWhite Inc.
HYANNIS, MA

Validatable band sealer
A band sealer offered by All Packaging Machinery Corp. is supplied with verification ports for FDA validation of pressure, speed, and temperature. The unit seals Tyvek pouches at speeds of up to 40 ft/min with a 3/8-in.-wide hermetic seal. In addition, a pressure wheel can be added for more-difficult-to-seal film and to provide flat seals. Dual heating and dual cooling bars can offer faster sealing of difficult materials as well. Featuring self-contained compressed air, the floor model is mounted on a heavy-duty stand with crank handle for height adjustment of the sealing head. A tabletop model is also available for lightweight products and smaller pouches.
All Packaging Machinery Corp.
Ronkonkoma, NY

Medical device packager
A medical device packager provided by Van der Stähl Scientific combines in-process visual inspection and destructive testing on one integrated packaging machine for sterile packaging applications. The MS-451PV medical pouch sealer controls all critical packaging attributes in order to ensure seal-to-seal consistency. The packager also allows users to program required stop and test functions into the system. This feature serves to automatically stop production and prompts the operator to perform a visual seal inspection with the company's low-angle-of-light 3×-magnification visual inspection tester. In addition, the sealer manages the platen's thermal environment with a K-type thermocouple that is configured to sample pouch environment.
Van der Stähl Scientific
REDLANDS, CA

Thermoforming packaging machine
The compact R 145 Clean Design thermoforming packaging machine has been engineered by Multivac Inc. to meet the special requirements of the medical device and pharmaceutical industries. Its precision feeding system, optimized lifting units, and cleanroom-compliant construction and materials are designed to ensure that the system packages medical sterile products in compliance with GMPs. With forming and sealing dies configured for fast format changes, the system can efficiently package sterile devices in virtually any batch size. It packages products within a modified atmosphere with a controlled oxygen content and accommodates diverse packaging materials. The machine also offers process reliability and reproducibility, process and access control through user identification, and traceability of parameter changes. Designed for ease of use, the system provides process visualization on the touch screen control.

Multivac Inc.

KANSAS CITY, MO

Robotic blister-loading cell for syringes
The high-speed TaskMate robotic blister-loading system from ESS Technologies Inc. loads syringes into preformed blisters such as those created by thermoformers or those placed by blister packaging machines. A custom syringe-feeding system orients the syringes in a hanging position, after which a star wheel places them onto a conveyor with carriers. Next, a robot with line tracking and end-of-arm tooling designed by the manufacturer picks multiple syringes and places them into the blisters. The robot is capable of 25 cycles or 300 to 400 syringes per minute, depending on syringe size and collation or pick pattern. This compact, automated blister loader can also easily be integrated with any model of thermoformer or blister packaging machine, according to the manufacturer. Capable of handling multiple sizes of product with minimum tooling, the robotic cell can package other types of medical devices as well.
ESS Technologies Inc.
BLACKSBURG, VA

Form and Function: Karten Design and Vessix Vascular Emphasize Aesthetics

Consumer-inspired design is not just for consumer-facing products. Vessix Vascular’s V2 Renal Denervation System shows how traditional cardiovascular device manufacturers can learn a lesson from consumer electronics companies about creating excitement through design.
 
 
In consumer design, where potential customers are faced with a wide variety of options and often make final purchase decisions based heavily on a split-second emotional reaction, aesthetics is a critical success factor. Consumer companies have made an art out of this split-second emotional reaction. Procter & Gamble has popularized it as the First Moment of Truth. It’s roused by a product’s looks, packaging, and the overall message that it communicates. If the message connects with the customer, this impression often leads to a purchase.
 
But how often do you feel compelled to reach out and touch a medical device? When is the last time you’ve looked at a medical monitor and breathed a reverent “Wow!”? Chances are it hasn’t happened in your career. 
 
Medical devices are traditionally driven by functionality: if it accomplishes the intended clinical result with a reasonable amount of ease, then the device is a success. Over the past 10 years, design has become a more significant consideration in medical devices. However, business-to-business medical devices have been slower than their consumer-oriented counterparts to embrace aesthetic design as an integral part of the product development process.
 
The recent partnership of Vessix Vascular and Karten Design illustrates the power that a development approach emphasizing aesthetics and emotion can have even for a traditional medical device company.

Appearance is Everything

Vessix Vascular is a pre-revenue stage company developing novel radiofrequency balloon catheter technology. This year, Vessix Vascular introduced the V2 Renal Denervation System—a percutaneous catheter-based system now in clinical trials for the treatment of drug-resistant hypertension.
 
Renal denervation is a procedure that uses a short blast of radiofrequency (RF) energy, delivered through a catheter, to disable the nerves surrounding the arteries leading to the kidneys, thus treating hypertension at one of its physiological sources. The results of the first in-human clinical study, conducted by a company called Ardian and published in The Lancet in 2009, proved that this procedure can significantly reduce blood pressure in up to 83 percent of people who suffered from drug-resistant hypertension.
 
Today, Vessix Vascular is one of the fast followers that have entered the field and are competing to define the next generation of renal denervation.  But standing out and commercializing its new technology in an emerging field would be a challenge.
 
Despite the tremendous promise of renal denervation, this highly specialized and relatively new process can be difficult to communicate to a non-technical audience. Vessix realized that evoking the excitement and potential of its system—creating a powerful First Moment of Truth— would be a critical component to success as it sought funding and support from the medical community.
 
When CEO Raymond Cohen joined Vessix in 2010, he evaluated the engineering prototype of the company’s RF generator, the system used to navigate and generate power, and decided that it lacked the desired emotional impact. To look at the “square, typical, plastic box,” as Cohen describes it, one would never guess they were looking at a new technology capable of changing the quality of life for millions of patients.
 
Cohen saw an opportunity to design a system purpose-built for renal denervation—one that would generate excitement and help advance the procedure in the medical world. To make people understand the system’s value, Vessix was going to have to let them see it for themselves. That’s when Karten Design became involved.
 

Starting with a Strategy

At the highest level, Karten Design’s goal was to use design to attract investment and build the level of trust with the medical community that would be necessary to quickly advance Vessix’s new technology toward commercialization.
 
Before designers put pencil to paper, Karten Design’s first step was to understand the advantages that the Vessix system offered over its competitors. In this case, the advantage was speed (able to accomplish renal denervation in just 30 seconds per artery), which means less discomfort and less exposure to radiation and toxicity for the patient, and time and money saved for the hospital.
 
“I want this thing to look fast,” Cohen told Karten Design. “It has to communicate that this is the second generation of Renal Denervation—the ultimate. I want people’s first reaction when they see this device to be WOW!”
 
To create a powerful First Moment of Truth, we approached designing the RF generator—the face of the system—the same way we would approach a consumer product, with a focus on high-quality materials and finish, and an evocative, emotional form. Like the technology itself, the design had to be new and different, jarring people from their expectations and routines.
 
The design seeks to arouse an unusual emotion in the medical field: intrigue. Breaking from the tradition of boxy medical equipment, the V2 Generator has a sweeping, parabolic form that takes advantage of the cart-mounted configuration. Because the generator would never have to sit on a table, it didn’t need a flat bottom. Cantilevered beyond the cart pole, the RF generator appears to be hovering—an effect that adds to the device’s intrigue.
 
Details such as texture and contrast draw people deeper into the product, encouraging closer examination. We employed a new palette of materials that suggest consumer electronics more than hospital equipment. Made from CNC-machined aluminum, the generator is designed to take advantage of the manufacturing process to achieve stunning details, such as the interlocking diamond texture of the device’s side housings. Designers worked with the machine shop to define a precise cutter path, run at a 45-degree angle in either direction, creating a series of ridges and valleys. A polished, black-anodized finish reflects light from every angle, providing a high level of contrast to the matte, bead-blasted main enclosure.
 
A brilliant, full-color screen is the heart of the design. As the component that communicates with the world, a custom-designed graphic user interface reinforces the simplicity of the 30-second procedure. With dimensional, gel-like forms and light, glowing graphics on a dark background, the crisp interface takes aesthetic cues from the XBox gaming console and the futuristic, fictional world of Tron.
 
A series of six minimal screens guides users visually through the procedure. Before treatment is initiated, it confirms when catheter electrodes are optimally positioned inside the patient and prompts the user to deliver therapy. After the therapy is performed, the display summarizes relevant information for reporting. Key to the system’s ease of use, designers provided a visual distinction between information that’s displayed for knowledge and information that requires action. Color, layers, and size create an information hierarchy that emphasizes action points. 
 
 

 

A Purpose-Built System 

Lessons from the C-Suite:

Vessix Vascular CEO Raymond Cohen shares his strategies for success that any medical device manufacturer can adopt.

Designing the Vessix V2 System from the ground up gave us the opportunity to tailor its functionality to the needs of end users in the cardiac catheterization lab.
 
Karten Design went into hospital catheterization labs to observe procedures and interview doctors, learning about cath lab layouts and workflow and the ceremonies familiar to doctors and technicians. Along the way, we considered questions such as, how will the catheter and generator relate? How will doctors see the progress of the catheter and its positioning in the renal artery of the patient? How will the treatment be activated and delivered? The goal was to make the system very simple, integrating familiar ceremonies into a new technology to ensure usability. We used this information to evaluate several use case scenarios and hone in on the most efficient one.
 
Functional features resulting from the research reinforce the brand strategy of simplicity. They include the decision to position the device outside of the sterile field, where it would be operated with minimal effort or training by a non-sterile nurse or technician, in order to keep clutter out of the critical sterile field. The team decided the RF generator should be operated with a push button on the front of the device, eliminating the potential for too many cords and clutter that could come with a foot pedal. Research also informed the decision to implement the generator as a pole-mounted, cart-based device, giving it the flexibility to accommodate different cath labs’ procedures for operating and storing the equipment.
 

The Real Moment of Truth

Cohen describes the impact that design has made in public presentations to investors and in medical forums, “The main benefit is that people get the message. It comes screaming out of the design of the product. It gets people’s attention even though we haven’t sold a unit and don’t have clinical results for the product. People take us much more seriously. This is important, especially when you’re a fast follower and there are others who would like to get in on the prize. We’ve been able to successfully position Vessix as THE fast follower in this space.”
 
Vessix’s V2 System is currently in the middle of a REDUCE-HTN in-human clinical study at 10 international clinical sites. The study is expected to be completed this year, and Vessix anticipates receiving a CE mark by summer 2012, which will allow it to begin marketing the product. Cohen expects an official product launch in Europe as early as 2013, making this procedure available to the wider number of people suffering from drug-resistant hypertension.
 
 
 
Anne Ramallo is the Manager of Marketing at Karten Design, a product innovation consultancy creating positive experiences between people and products, where she helps connect medical device and consumer health companies with strategic product innovation. She is a graduate of the University of Redlands whose writing on healthcare, design, and business has appeared on Karten Design’s blog and in Fast Company’s Co.Design.

Lessons from the C-Suite

Beyond the unique design of the Vessix Vascular V2 Generator, the product was a success because of the design process and the partnership between the manufacturer, its engineers, and the designer. Vessix Vascular CEO Raymond Cohen shares his strategies for success that any medical device manufacturer can adopt.
 

Be Involved

Cohen believes that successful product development requires executive involvement. Companies that have made their mark on design usually did so because a designer had a strong relationship with the company’s founder. The relationship between Jonathan Ive and Steve Jobs is the most recent example of such a success story. “Steve Jobs was involved in every product that came out of Apple,” Cohen emphasizes. “If it was good enough for Jobs, it’s good enough for me.”
 

Suspend Your Beliefs

At the beginning of the project, Vessix leaders suspended any beliefs they had about what would make their system successful and sent designers into the field to conduct research with qualified potential users. This, according to Cohen, provides an opportunity not only to let the design team find out important insights that inform product design, but to create esprit de corps between design, management, engineering. It incorporates designers into the mix so that they become a strategic part of the team, not just someone who draws pretty pictures.
 

Set Parameters

Karten Design and Vessix started this project with a strategy. It began with stakeholder interviews, in which key Vessix employees and board members had an open forum to voice their opinions about the system’s needs and goals. The team established a criteria for success based on research and, by the time they gathered to select the system’s final design, each team member understood the objectives that the design should achieve, and they felt confident that they’d made the right decision.
 

Know Your Message

The simpler the message, the more powerfully it can resonate. For Vessix, this message was “simple and fast.” The restrained design of the V2 system resists the temptation to communicate other messages, instead focusing on the core differentiators.
 

Invest Wisely

Karten Design presented several concepts to the Vessix team, ranging from mild to wild. Vessix purposely veered away from more traditional design, opting for sensational over sensible. This decision was validated by Vessix’s business model, in which customers would purchase one generator and hundreds or even thousands of disposable catheters. Because the RF Generator was a low-volume product even in the most successful scenario, the cost per unit was not a big limitation. The investment in a high-design enclosure was likely to pay off. Keep product volume in mind when making design decisions, letting it inform how much you spend on the enclosure.
 

Trust your gut (and your designer):

In the end, Cohen went with his gut in making the final design decisions. After working with Karten Design for more than 2 decades, the trust built into our relationship gave his intuition a boost.
 

Be consistent

If you want design to inform how product functions and how easy it is to use, let your designers guide the entire process. Once your engineers have provided a footprint (dimensions, communication ports, technical specs), then let designers take these elements and make them sing. When your product, GUI, packaging, and every other touch point consistently align with your brand message, the result is nothing short of spectacular.

Germany Remains Innovation Leader in the Medical Device Technology Arena

A recent trend report published by German industry association Electrical, Electronic & Information Technologies (VDE) states that Germany continues to hold its leading position internationally in important key and cross-sectional technologies, including medical device technology. For the VDE trend report Electro- and Information Technology 2012, VDE surveyed 1300 of its member companies as well as universities. The study reports that 57% of respondents consider Germany to be the world leader in medical device technology.

The report notes that 88% of those surveyed believe Germany leads the world when it comes to innovating in production and automation technology, while 80% see Germany as the international leader in the electrical engineering sector. When it comes to nanotechnology and ambient assisted living, however, Germany and the United States are head-to-head, with a small lead for the United States in nanotechnology and Germany slightly ahead in ambient assisted living sector.

Last but not least, the report states that––while there will be some minor erosion––Germany will maintain its top ranking until 2020.

––Yvonne Klöpping