Knowledge and experience diversity for IVD innovation

 By using product development teams with experience gained from industries beyond the IVD world, IVD companies can draw on trends from seemingly unrelated fields to deliver breakthrough ideas that enable them to leap ahead of their competitors and redefine markets.

 Many of the world’s greatest inventions have often drawn inspiration from other diverse industries. For example, two-dimensional color flow Doppler imaging, a major breakthrough in cardiac diagnostics, came about through military radar engineers teaming up with Japanese physicians. The Coulter Counter, which revolutionized hematology by enabling the counting of blood cells, was invented as a result of technical experience gained through exposure to a number of global industries. This approach of fuelling innovation through cross-pollination from diverse industries may hold the key for many

Figure 1. The TearLab Osmolarity System, a point-of-care system that diagnoses 

dry eye syndrome, imported ideas, skills, and experience from the parallel worlds 

of nanotechnology, IVD instrument development, and consumer product innovation.

IVD companies to gain a jump on their competitors and reshape markets.
If done well, innovation comes about through neither luck nor serendipity. Rather, it is the

result of a thoughtfully composed team working on clearly identified challenges using a

carefully managed process. This article explores and illustrates principles of how to build and

manage development teams capable of drawing on trends from a variety of seemingly

unrelated fields to deliver breakthrough ideas in IVDs that can capture a market.
Looking for Fish Leads to Cardiac IVDs
The development of ultrasound technology in Japan began when Heiichii Nukiyama returned to Tohoku University in 1919 after spending two years at Harvard studying electric transduction.

He was instrumental in founding the faculty of engineering at Tohoku and ensuring that ultrasonics was part of the curriculum. His students went on to develop ultrasound for a range of purposes including underwater detection systems and non-destructive metal testing. In addition, they took the study of ultrasonics into the engineering programs at other major Japanese universities, creating a broad technology skill base among Japan’s graduating engineers.
In the 1940s, Kenji Tanaka, a professor of neurosurgery at Juntendo University in Tokyo, wondered if the ultrasound waves that are used to detect the discontinuities in acoustic impedance in the sea around schools of fish could also be used to detect similar acoustic boundaries surrounding brain tumors. He contacted the Japan Radar Company (JRC), a manufacturer of marine detection systems, and established a cross-functional collaboration between Toshio Wagai, a resident neurosurgeon at Juntendo; Yoshimitsu Kikuchi, an ultrasonic engineer from Sendai University; and Rokuro Uchida, the chief engineer at JRC. They began work on the use of ultrasound in the diagnosis of intracranial lesions, and their efforts proved so successful that by 1950, JRC had renamed itself Aloka and refocused the business onto ultrasonic applications.
Aloka continued to harness the power of cross-functional teams, accessing their experience in military radar to develop Doppler ultrasound for blood-flow detection. This presaged the use of phase detection and autocorrelation, both well known in radar applications, in the 1984 invention

of real-time 2-D color flow mapping for cardiac diagnosis. This breakthrough marked the

culmination of a powerful set of steps that began with a search for fish and were all built on skills and technology from well beyond the realm of diagnostic medicine.

1Varied Knowledge Sparks Modern HematologyAt the age of 22, Wallace H. Coulter’s college education in electronics was cut short by the Great Depression. Undeterred, he joined General Electric X-Ray in Chicago as a sales and service engineer for medical equipment. In this role,

Coulter gained insights into hospital lab testing procedures, and when a rare opportunity to work in Asia arose, he grabbed the chance to extend his experience.
In the lead-up to and during World War II, Coulter’s business travels took him to medical facilities in Hong Kong, Macao, Canton, Shanghai, and Singapore, where he gained familiarity with a wide range of medical traditions and standards. By the end of the war, Coulter returned to the United States and worked in electronic development for Press Wireless in New York and later participated in electro-medical instrumentation development for Raytheon Manufacturing Co.
Returning home to Chicago, Coulter continued his passion for electronics, taking on roles at several major electronics companies. Not fully extended by his work, he began experimenting with applications of optics and electronics in the basement of his home. While under contract to the United States Navy in the late 1940s, Coulter developed a technology for counting and sizing particles using impedance measurements.
With this accomplishment and motivated by the events that ended the war, Coulter used his knowledge and varied technical

Figure 2.The Coca-Cola Freestyle fountain dispenser uses technology adapted 

from themedical industry to deliver accurately more than 100 beverages.

















experience to find a way to simplify and improve blood cell analysis to enable large populations to be 

screened quickly. In 1947, he had his first major breakthrough. Using his own blood and a hole in a 

sheet of cellophane, he discovered a variance between the electrical impedance on one side of the 

cellophane and that on the other side as red blood cells passed through the hole. Leveraging years 

of experience, Coulter determined that an electrical charge could be used to determine the size and 

number of microscopic particles in a solution, and he went on to develop the first Coulter Counter, 

revolutionizing the hematology industry.
T-Shaped Professional
Wallace Coulter exemplified what has now come to be known as the T-shaped professional: one who possesses a great depth of knowledge in a particular field coupled with 

broad exposure to a number of other fields.2 In Coulter’s case, this was his lifelong passion for 

electronics combined with his experience in medicine, Asian traditions, and international hospital 

laboratory practices. T-shaped professionals are valuable in innovation teams for their ability 

to knit together diverse experiences to produce unique solutions from known elements. 

T-shaped professionals are also well placed to access the already existing solutions that produce 

a breakthrough invention in a new sphere of application.
T-Shaped Teams
Stephen Shapiro of Innocentive is a veteran of innovation initiatives. He takes the “T” idea for 

fueling innovation one step further to advocate the T-shaped team, 

the same kind of team Tanaka put together for the intracranial ultrasound development work at JRC. 

By way of illustration, Shapiro suggests that adding one more aerospace engineer to a large 

team of rocket scientists at NASA may be far less effective than adding a concert musician.3 

With this approach, it is possible to manage the mix of experience in choosing which of the 

parallel worlds to draw on for innovative inspiration.
Even at the national level, diversity management is the keystone for innovation strategies. 

For example, Japan faces a nationwide need to break out of a strong tradition of conformity. 

Within Japanese corporate culture, people who think creatively are often called deru kui (the nail 

that sticks up).4 The fate of these nails has very often been to be hammered back into line. 

In postwar Japan, Honda, Sony, Aloka, and others were corporations in which the deru kui were 

nurtured and flourished to produce valuable innovations for their companies.

Today, Wako Pure Chemicals is pursuing a strategy to foster diversity and the development of T-shaped professionals at research facilities in Mountain View, CA and Osaka, Japan. At these two 

locations, the best of Japanese and American industrial practices are being carefully nurtured to 

produce IVD innovations. U.S. appointments to the team are carefully selected for lateral thinking 

ability, curiosity, and the ability to engage. In combination with Japanese strengths in detail 

management, quality engineering, and continuous improvement, a powerful synergy is generated 

and put to work. In the process, skilled individuals are exposed to new perspectives so that along 

with the products, the individuals also undergo significant development.
Managing Team Diversity to Optimize Innovation
For IVD companies embarked on the overall process of bringing products to market, it is easy to 

think of innovation as just one discrete event in the long sequence of activities needed to capture 

a market successfully. Such thinking can consign innovation processes to a cyclical pattern of use 

that is seen as peripheral to the core business.
There is a clear space here for pure innovation houses where management of innovation is the 

business.5 Innovation team members are carefully selected, and teams themselves are 

recomposed throughout a project to ensure domain expertise (the deep knowledge in a particular 

field) is on hand at the right moments in the development cycle, while maintaining the broad 

experience and diversity to inspire sought-after breakthroughs.

Careful management of diversity is essential to guarantee the best results for an innovation project. It requires mutual respect and the ability to recognize a good idea no matter where it comes from and to collect it at the right moment so that it can be acted upon. Managing the process and controlling the effects of diversity is its own skill set. Research shows that diversity in teams that lack skilled management can lead to miscommunication and extended time cycles, especially when attempts to insert innovative ideas into a project occur out of sync with the investment in the development, leading to significant departures from project plans.6,7 Successful innovation management requires so much more than just pulling together a diverse team and waiting for inspiration to arrive.
Nanofluidics Join Consumer Goods to Advance IVDs
TearLab’s research into dry eye syndrome had already produced a breakthrough in formulating a fast turnaround diagnostic test, and they were on the verge of being able to turn an idea into a viable IVD instrument. However, with the company’s core expertise grounded in medical research and clinical trial management, they needed external help to realize a user-friendly

Figure 3.Coca-Cola's development partners leveraged their diversity of skills in microfluidics, footprint reduction, 

and user-interface development that were honed on such IVD projects as Bio-Rad's BioPlex 2200.

CLIA-waived test as well as nanofluidics expertise to manage reliably samples of tear fluid as small as 50 nl.
Tear Lab teamed up with a number of innovation companies to import ideas, skills, and experiences from the parallel worlds of nanotechnology, IVD instrumentation, and fast moving consumer goods (FMCG) product development.
Expertise in IVD instrumentation was an essential skill in this development project, and TearLab was able to benefit from FDA- and QSR-compliant development processes refined on previous instrument development projects. Further expertise garnered from work on lab-on-a-chip applications and nanofluidics simplified and improved the reliability of sample collection and integrated the test platform.
The instrument ultimately produced was built on expertise from at least five parallel worlds: nanotechnology, IVD instrumentation, FMCG, ophthalmology, and clinical trials (see Figure 1). Crucial contributions from these fields included the following:

• Nanoliter sample size eliminates the need for provoking tear production to collect a testable sample.
• Nanotechnology test card prevents evaporation and volume, and minimizes diagnostic variability.
• Disposable test cards incorporate packaging and manufacturing features common to FMCG products.
• Ease-of-use considerations, vital to product success in the FMCG world, were imported and used in achieving CLIA waiver status.

Managing communications among these diverse contributing areas was key to the successful outcome.
Beverage Delivery Benefits from IVD Instruments
The Coca-Cola Co. is in the midst of revolutionizing the delivery of carbonated beverages with the introduction of the Coca-Cola Freestyle fountain dispenser (see Figure 2). The Coca-Cola Freestyle uses proprietary PurePour Technology that enables accurate dispensing with much higher levels of concentrated ingredients. The dispenser uses technology adapted from the medical industry to deliver the beverages accurately.8
Coca-Cola engaged a number of technology partners to help bring the Freestyle concept to fruition. Its development partners included an innovation company that leveraged its diversity of skills in microfluidics, footprint reduction, and user interface development. Such skills were honed on such IVD projects as Bio-Rad’s BioPlex 2200 and bioMerieux’s Previ Isola. (See Figure 3.) The development partner also used a project manager who had 17 years’ experience developing kiosks and ATM equipment for the banking sector. The next-generation fountain beverage dispenser is the beneficiary of this eclectic mix of technology and development skills from a number of parallel worlds.
Mosquito Repellent Device Informs IVD Consumable Design
In a recent example, a world-leading IVD company wanted to reduce as much cost as possible from its consumables without compromising quality. In order to find a way to do this, the company turned to its outsourced innovation partner, which subsequently called on its recent experience in designing a mosquito repellant device for the consumer market. The skills used to design the mosquito repellant device, which used a capillary action through a ceramic wick to deliver consistent, small fluid volumes to a heated mat, were transferred to produce a highly effective IVD consumable with the required shelf life and climate robustness. Most importantly, the intense design focus on unit cost that was learned in the consumer product world paid off handsomely by significantly reducing the cost of the IVD consumables that are intended for use in high-throughput pathology labs.
There are countless examples of how diverse experiences have fuelled innovations, which have led to industry-changing breakthroughs. By tracing the history of color flow Doppler for cardiac diagnosis and modern hematology, it can be seen that the diversity of skills in people and teams has provided the genesis to changing the game.
The key messages for IVD companies looking to redefine markets include the following:

• Use T-shaped professionals who posses both breadth and depth of experience.
• Build T-shaped teams that amplify the creativity of a group.
• Do not rely on luck. Manage the people and the process to direct their efforts and harvest ideas.

Today, companies like Wako Pure Chemicals are cleverly combining eclectic cultures, including the best of U.S. and Japanese engineers, to drive innovation. Bio-Rad, Coca-Cola, and TearLab all successfully borrowed ideas from parallel worlds to turbo-charge their product development and leap ahead of their competitors.

Knowledge and experience diversity for IVD innovation