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MEDRAD Innovation Journey--from start-up to Industry Standard: Mountain Climbing, Spelunking, Over the Horizon Home Runs, and creating a "DC-3 Effect".

INTRODUCTION

After a start-up, development, and market launch stage, MEDRAD grew the sales of its products and services at a compounded rate of 16.0% per year for the 25 years from 1982 to 2007. MEDRAD's products are primarily electromechanical injectors and associated disposables used to deliver fluids in imaging procedures. These products are used by doctors and medical professionals worldwide in a number of medical imaging and treatment modalities. MEDRAD grew as a privately held and then public company, and after an M&A exit, it became part of Schering AG and is now an integral part of Bayer Radiology, a global healthcare organization. The journey started with two doctors seeking solutions for problems that they and other doctors were encountering in performing a new medical procedure (an unmet need in an imagined market). The introduced and perfected some innovative products, and leveraged professional management to create an industry standard organization that was recognized, not once, but twice with the Malcolm Baldridge National Quality Award.

MEDRAD was started in the Pittsburgh, PA area in 1964 by two doctors, Dr. Steve Heilman (1) and Dr. Mark Wholey. In early 1964, Mark had just returned from 2 years in Sweden where he learned angiography. Angiography is a medical procedure for assessing the condition of blood vessels in the body by inserting catheters into and through the vessels, injecting liquid X-ray contrast, and then imaging the vessels with an X-ray system to look for blockages, narrowing, bleeding, or other problems related to the vessels. At that time angiography, was difficult. It was very hard to inject the viscous X-ray contrast agent through the long, thin catheters to get good images every time. There needed to be a better way to inject the contrast in angiography.

Steve Heilman agreed to work on this contrast agent injection challenge with Mark. The name chosen for the company to pursue commercialization was MEDRAD (MEDical Research And Development). While Steve Heilman worked as an emergency room physician, he and a team developed the world's first flow controlled injector. There were two powered injectors on the market at the time, but both set the pressure of the injection, which meant that the flow was not well controlled. Steve's key innovation was a flow controlled injector. A doctor could select the desired flow rate and the injector would develop whatever pressure was necessary, up to 1200psi, to deliver the contrast at that programmed flow rate. This was a technology breakthrough, although the whole procedure of angiography was still in its infancy. As with any innovation in an emerging market that is being created, growth was slow as innovators and early adopters provided the early market and the technology advanced. By 1974 MEDRAD had developed the Mark IV which became a worldwide leader for angiography injectors. One of MEDRAD's associated innovations was the use of a relatively transparent disposable plastic syringe inside a strong, transparent reusable pressure jacket. This allowed the doctor to visually inspect the syringe to confirm that no air would be injected into the patient. Air injections could be fatal. MEDRAD sold a new, sterile, single-use syringe for each imaging procedure.

In the late 1960's Drs. Michel Mirowski, Morton Mower and William S. Staewen invented and worked on the world's first implantable cardioverter defibrillator (ICD). They eventually obtained support from a major pacemaker company in 1970 to further develop the ICD. But after 2 years the company decided there was no market for the device. In 1972 Mirowski was introduced to Stephen Heilman. Heilman was excited by the concept of the ICD and immediately put some of MEDRAD's engineers at Mirowski's disposal. (2) A sister company, INTEC Systems, was formed to develop and commercialize the technology. It took until 1980 before the first human implant took place. FDA approval came in 1985 and the technology was sold to a pacemaker company, Cardiac Pacemakers, Inc., in 1986 (quoted from Wikipedia) (1).

During the 1970's MEDRAD patented and commercialized a flat-profile guidewire and worked on catheter improvements, both of which could be of use in their mainline business, the angiography procedure.

With the invention of CT in 1972, there was some concern that angiography would become obsolete, so MEDRAD launched an effort to develop an ophthalmic ultrasound imaging unit.

After a period of "mountain climbing and spelunking", MEDRAD in 1981 brought in a professional manager, Tom Witmer, to be the CEO and focus on growing MEDRAD's business. Tom was instrumental in the development of The MEDRAD Philosophy in 1983, stating that
"MEDRAD exists to
Improve the quality of healthcare
Ensure continued growth and profit, and
Provide an enjoyable and rewarding place to work".


This vision is consistent with a balanced scorecard philosophy and pointed the way to the creation of industry leading products, national recognition and ultimately acquisition. MEDRAD was a private company at that point, and this philosophy and metrics were used to assess the organization's success going forward. This leads to our reference to the "DC3 effect" term, coined by Peter Senge (3), and described more fully below -basically, the term refers to where one organization's innovation is happening in an ecosystem of innovations. Changes being made by many other, non-competing organizations, leverage "the dance of innovations" to create new, industry leading platforms or procedures.

One of the first product moves the new management team made was to adapt MEDRAD's injector from angiography to CT. At that time, it took 1 to 2 minutes to do a CT scan of a patient's head or liver. To assess the presence of cancer in the liver, a patient would receive a gravity-driven intravenous infusion (IV) of X-ray contrast while lying on a gurney in a waiting area. After 2-3 hours, their liver would be scanned. Many cancerous tissues would appear brighter or darker because cancer has a different uptake of the X-ray contrast than the normal liver tissue. Similarly, to assess a stroke, the patient was given gravity infused IV contrast. After a very short time, though, the patient was brought into the CT scanner and a scan taken, with the area of the brain affected by the stroke appearing whiter. A challenge was that if there was a delay in imaging the patient, the contrast continued to diffuse in the brain and caused an incorrect estimate of stroke size and location. MEDRAD believed that if an injector was used to inject the patient while they were on the CT scanner, just the stroke region would be seen and the inaccuracies from diffusion would be minimized.

MEDRAD's CT injector was a relatively simple adaption of the angiography injector. The only change was to the controls, to limit the flow rate to 10ml/S and the pressure to 300psi so the device didn't seem as intimidating to the doctors and hospital imaging technicians. Sales were expect to go well, but didn't. The doctors and technologists believed that they didn't have frequent enough problems with delay imaging after gravity infusions to make it worth buying a power injector. MEDRAD's warehouse had a very significant supply of CT injectors at one point. About a year after the CT injector was introduced, an unknown researcher figured out that by giving a slow, but steady IV injection over 1.5 minutes while the patient was being imaged, it was possible to look for cancer in the liver without the 3 hour delay. This became the "over the horizon home run" that caused a CT injector to be sold with every CT scanner. Each scanner needed an injector to perform this procedure, and once there was an injector on the scanner, it was much more efficient and effective to use it for every injection. This discovery of a new, faster, and better way to do the liver cancer procedure also significantly increased the number of these procedures performed, increasing the market for injectors and CT scanners. This discovery would not have been possible without an injector to try it. This is an example of the DC-3 effect, as imager improvements came together with injector improvements to make a new procedure possible.

In early 1980's MEDRAD applied for patents on a new injector and an improved way to connect and disconnect an angiography syringe plunger to an injector for use in their next generation injector, the Mark V. The Mark V was introduced in 1985 and became the market leader. It included a number of additional user and technical improvements. It became the basis for MEDRAD's next generation CT injector, the MCT. This for the first time provided patent protection on the disposable syringes that were used with MEDRAD's injectors.

With CT growing faster and becoming larger than angiography, MEDRAD decided to design an injector just for CT. Feedback from the customer resulted in a product that was much smaller, lighter, and had a newly patented plastic syringe that did not need a pressure jacket, so the syringe could be easily mounted and removed from the front of the injector. The EnVision[TM] injector was introduced in 1995 and continued MEDRAD's growth in CT.

During the 1970's magnetic resonance imaging (MRI) was being developed. By the mid1980's it was starting to gain traction. MRI uses a very different imaging physics, and so could provide exquisite images of soft tissue, much better than X-ray or CT could do. There was the thought that MRI would replace X-rays, CT, and the need for X-ray contrast. If true, this presented a serious threat to the CT business. Contrary to that, Schering AG, a German manufacture of X-ray contrast saw an opportunity in MRI contrast. Similarly, some at MEDRAD believed that dynamic contrast injections would always play a part in selected diagnoses, so MRI would need an injector. Schering developed the world's first MR contrast agent and MEDRAD set to work to design an injector to work in the MRI suite. This was very difficult because of the high magnetic fields and the need for ultralow electrical noise performance. By electrically and mechanically adapting a Mark V injector, the world's first MRI injector was developed relatively simply and inexpensively. The Spectris[R] MR Injection System was introduced in 1996.

Over the decades since its discovery, CT systems went through several generations of improvements. This produced improvements in speed and imaging resolution and resulted in an increasing number of scanners each doing an increasing number of procedures daily. MEDRAD found that the revenue from the syringes grew much faster than the revenue from injector sales. In comparison, even though an MR injector is sold with every MR scanner, the rate of use of MRI injectors has remained significantly lower than for CT for several reasons. MRI systems are much more expensive, the imaging procedures are much longer than CT, and hand injections are practical for many MR procedures because timing is not as critical.

The Stellant CT injector was MEDRAD's first formal ethnographic effort. Table AA shows a partial list of multiple feature improvements based on and understanding of customer need. One of the improvements was a new, patented front load syringe which was even easier to install than the EnVision's bayonet mount. Another improvement was the option to have a second syringe for a saline flush. This was included because during the ethnography, a few users were seen to be reducing contrast cost by putting 100ml of contrast and then 50ml of saline into the single injector syringe rather than using 150ml of contrast. It was thought that the dual syringe might appeal to only 5% of the purchasers because the injector head was more expensive as were the two syringes used per patient (as compared to a single syringe per patient).

When the Stellant debuted in 2003, after initially brisk sales, there had to be a slowdown in sales because MEDRAD could not keep with the demand for syringes. Contrary to expectations, most sites were purchasing the dual injectors. This happened because between Stellant's concept definition and the product launch, additional improvements had been made to CT scanners, specifically faster rotation times and wide beam CT. These additional improvements enabled CT angiography (CTA), which is the imaging of the coronary arteries via the IV injection of X-ray contrast rather than the more invasive angiography. To accomplish this, the IV contrast injection must be followed by a saline flush. Thus every new wide beam CT needed a new dual syringe injector, and once a dual injector was sold, two syringes and saline flush were usually used for all the imaging procedures, effectively doubling the syringe use. This is a second instance of the DC-3 effect in which MEDRAD's innovation of a dual syringe injector coincided with the imagers improvements to enable CTA.

MEDRAD continued using ethnography to understand customer/user need as they designed and launched the MEDRAD Avanta[R] Fluid Management Injection System for cardiovascular procedures in 2005 and the Intego[TM], the first automated FDG delivery system for use in PET imaging in the U.S in 2008. And, the efforts are continuing.

In addition to the innovation progression described above, MEDRAD went to great lengths to build and maintain an excellent company culture. MEDRAD made use of Design Thinking and the Balanced Scorecard before they had been formally named as such.

DISCUSSION

From the beginning, MEDRAD was going after blue oceans, or at least "blue puddles" or lakes (Blue Ocean Strategy had also not yet been developed formally). Angiography started as a small opportunity, but Drs. Wholey and Heilman believed that it would grow. MEDRAD found a key way to improve it, by adding flow control, were awarded a patent and developed the product. MEDRAD grew with the imaging modality. The implantable defibrillator was a very large, difficult opportunity. This was more an effort in mountain climbing than in blue ocean finding. Everyone could see the tremendous market need. It's just that the climb to success was so very daunting that no one else was trying. When you reflect back on the decisions of the pacemaker company to stop the project and of MEDRAD to pick it up, from their individual perspectives, both were right. It was a long time and a significant investment before the ICD would become practical and become a significant business compared to the existing pacemaker business. And as a small, private company dedicated to MEDical Research And Development, MEDRAD was doing what it was founded to do.

In the 1980s MEDRAD employed around 200 people. The key engineers had firsthand knowledge of the medical procedures in which the products were being used and connecting with the customers was relatively easy. MEDRAD worked with key customer sites to develop next generation CT and MR injectors as well as catheters, guidewires, and other potential or actual products. Design thinking just happened. No one knew it as anything different than good engineering practice at that time. It was how the company was started, working with doctors who needed better equipment although we didn't use them as much at this stage of evolution.

As MEDRAD grew, the Stellant injector was the first product to use a formalized ethnography process. Ethnography gave insights leading to the creation of quite a few improvements to better satisfy explicit and implicit (unarticulated) unmet needs. But as described earlier, the Stellant was an "over the horizon home run", a beneficiary of the DC-3 effect because it was the first injector with dual syringes at the time when improvement in CT scanners made CTA possible. The dual syringe was included as a response to a customer need to save contrast, but it turned out to be an enabler to a whole new procedure, CTA, that made it a market winner.

The publication of The Innovator's Dilemma 4,5 and the concept of disruptive innovation to compete "under the radar screen" to disrupt successful companies using these principles led us to think about why MEDRAD had not been disrupted. If MEDRAD didn't understand its reasons for being successful, how could success be sustained? As you read this story, you'll realize that MEDRAD has grown by moving to "blue ocean" adjacencies or "competing with non-consumption" and then growing due to finding a few "over the horizon home runs".

While this narrative discusses the very successful moves that MEDRAD made, many others were only moderately successful. A number of them are listed in Table BB. In many ways, the process MEDRAD was going through was closer to spelunking than mountain climbing. Find a "tunnel" that looks promising, that has a visible "business excuse" to justify entering it, and then go down it. Sometimes the tunnel opens into a cavern of breathtaking size and beauty. Other times it is a modest success. The rest of the time it breaks even or is a loss.

We believe that this apparent randomness is the result of the "DC-3 effect" and the fact that one organization's innovation is happening in an ecosystem of innovations and changes by many. Peter Senge in The Fifth Discipline coined the term the "DC-3 effect" (3). He uses the following example to explain the synergy that can happen in a system where the capabilities or benefits of the whole can be greater than the sum of the parts:
   On a cold, clear morning in December 1903,
   at Kitty Hawk, North Carolina, the fragile
   aircraft of Wilbur and Orville Wright proved
   that powered flight was possible. Thus was the
   airplane invented; but it would take more than
   thirty years before commercial aviation could
   serve the general public.

   Engineers say that a new idea has been "invented"
   when it is proven to work in the laboratory. The
   idea becomes an "innovation" only when it can
   be commercialized and replicated reliably on a
   meaningful scale at practical costs. If the idea or
   invention is sufficiently important (and provides
   significant user value), such as the telephone, the
   digital computer, or commercial aircraft, it is
   called a "basic innovation, or platform," used to
   create a new industry or transform an existing
   industry....

   In engineering, when an idea moves from an
   invention to an innovation accepted by the
   market, diverse "component technologies" come
   together. Emerging from isolation, developments
   in separate fields of research, these components
   gradually form an "ensemble of technologies
   that are critical to each other's success. Until this
   ensemble forms, the idea, though possible in
   the laboratory, does not achieve its potential in
   practice.

   The Wright Brothers proved that powered
   flight was possible, but the McDonnell Douglas
   DC-3, introduced in 1935, ushered in the era of
   commercial air travel. The DC-3 was the first
   plane that supported itself economically as well
   as aerodynamically. During those intervening
   thirty years (a typical period for incubating basic
   innovations in this field), myriad experiments
   with commercial flight had failed.. the early
   planes were not reliable or cost effective on an
   appropriate scale.

   The DC-3, for the first time, brought together
   five critical component technologies that formed
   a successful ensemble (in today's language they
   created a platform). They were: the variable-pitch
   propeller, retractable landing gear, a type
   of lightweight molded body construction called
   "monocoque", radial air-cooled engine, and wing
   flaps. To succeed, the DC-3 needed all five; four
   were not enough. One year earlier, the Boeing
   247 was introduced with all of them except wing
   flaps. Lacking wing flaps, Boeing's engineers
   found that the plane was unstable on take-off and
   landing and had to downsize the engine.


After sharing the 5 critical component technologies part of this story for a decade to help people understand MEDRAD's success, a gentleman who heard the above narrative explained the economic side of the story. Tom Petzinger, the author of Hard Landings 6 explained that it was the fact that the DC-3 carried 7 rows of 3 people whereas the Boeing 247 had 7 rows of 2 people that made it a success, a commercial success that is. This choice to carry 21 people was made in close consultation with C. R. Smith, the CEO of American Airlines, and is an example of Design Thinking. Before the DC-3, carrying air mail, not passengers, is what had made the airlines economical in the much larger market of transporting people.

While discussing this new perspective with Robert Uber, a private pilot, he explained that all planes of that time could achieve the effect of flaps by lowering both of their ailerons at the same time. The difference was that when the DC-3 added the 50% more passenger capacity, Douglas did not increase the wing size proportionally. Thus they had to use flaps for take-off and landings and needed the larger engines to fly faster and create the extra lift when cruising. This had the added benefit of decreased flight time, further increasing both customer satisfaction and airplane economics.

Reading further on the Boeing 247 in Wikipedia, the 247 didn't need flaps, or to use the ailerons as flaps, because it could fly at the very low speed of 62mph and the engines were downsized at the insistence of United Airlines pilots who were not used to the power.

This expanded "DC-3 effect" illustrates many important thoughts that are necessary for understanding innovation. The first is how hard it is to get the real, complete picture of any situation, and the number of perspectives that are necessary to approximate that. The second is that innovation takes place as part of an innovation ecosystem. The third is that what appears to be randomness to one participant is actually a "dance of innovation" among all the participants in an ecosystem, with each providing key parts of breakthroughs that only can be recognized as such in hindsight. MEDRAD's innovation ecosystem consists of imager manufactures, contrast suppliers, doctors, imaging equipment operators, and healthcare payers. With the first CT injector, MEDRAD provided the tool that enabled the discovery of a new way to assess liver cancer. Similarly, if MEDRAD had not had a dual injector when CTA became possible, the procedure probably would have had limited use until someone understood the need for saline flush and developed a dual injector to meet that need.

There are additional perspectives around MEDRAD's injector success, too. The head of marketing in the 1980's has commented that one of the things that increased injector sales was the reduction in the image reconstruction time. When the image could be produced within minutes of the scan, the doctors and technologists could see for themselves the benefits of injector use. Another perspective is that injector sales benefited from the CT scanner "slice wars", meaning the continual technical progress in scan speed and additionally the number of simultaneous slices that a CT scanner could do.

This recognition of a "dance of innovations" by different stakeholders and different companies in an innovation ecosystem is one thing that seems to be missing in the initial Clayton Christensen book, The Innovator's Dilemma (4). The hard drives that Christensen initially studied do not have much utility by themselves. They were generally part of computer systems. The other members of that innovation ecosystem were companies who made computers, integrated circuits (ICs), displays, and software to name some. The hard- drive innovations that ultimately became disruptive innovations were those that combined with equally "disruptive" innovations in the other aspects of the ecosystem to move the whole industry from mainframe to mini to desktop to laptop computers and on to handhelds. The losing disk drive manufactures and their customers, the computer manufacturers, were disrupted together.

As Christensen has described, only IBM was able to successfully thrive in the mainframe, mini, desktop, and laptop computer markets (4). They did that by starting fully separate divisions for each of these transitions. This separation was needed to allow for the very different business models, with different cost, product, and service structures, which enable success in the new business. This change in business model is what makes the transition so difficult within a single business. (Christensen's Innovators Dilemma led to the Innovators Solution thru a separate but related business unit with a different business model and approach to innovation) (5).

The DC-3 effect does for business what chaos theory does for physical systems. James Gleick published "Chaos: Making a New Science" (7) which became a best-seller and introduced the general principles of chaos theory as well as history to the general public. The DC-3 effect explains the apparent sudden emergence of a breakthrough innovation from a number of seeming small innovations. Chaos explains how small changes in initial conditions can create tremendous and apparently random changes in macroscopic system behavior. (7) There are chaotic systems that are perfectly deterministic mathematically, if we knew all the initial conditions with sufficient detail. But in the real world, this can never be known, ultimately because of the Heisenberg uncertainty principle that limits what can be known; the position and the velocity of an object cannot both be measured exactly, at the same time, even in theory (8). The existence of an ecosystem of innovators creating innovations somewhat independently, unknown and unknowable to the others, may be the business equivalent of the Heisenberg Uncertainty Principle. Perhaps it could be termed the "Business Innovation Unknowability Principle". The interested reader is referred to a previous article in this volume authored by the Special Edition Editor and contributor. Boni discussed the inability to achieve algorithms to predict business outcomes, and instead the need to rely on patterns, screens or heuristics. He stated that, "the last stage (or predictability, which is) seldom achieved in business, is the desired end point, or the ability to predict the outcome precisely.

Clayton Christensen, the authors of this paper, and many others decry the apparent randomness to new product success. Given better theories and the execution of the right actions, we all want to believe that randomness can be reduced, if not eliminated. And it is a goal of this paper to help you reduce the downsides of relying on chance and increase your rate of success. But, there will always be a measure of indeterminism in new product success. This is due to the DC-3 effect amplifying the variability from the "Business Innovation Unknowability Principle".

One final note: MEDRAD's successful, enduring products are the injectors for angiography, CT, MR, and most recently nuclear medicine, all of which have a razor-razorblade business model. MEDRAD has stopped making several products that it created and/or brought to the market that did not involve a razor-razorblade business model. So while MEDRAD has successfully innovated products many times over the decades, they all have operated according to that same general business model.

CAVEATS AND POST SCRIPT

As with all case studies or exercises in looking back, there is a risk of hindsight bias. (9) Patterns can be seen that were not actually there or could not be known as time unfolded. Similarly, as is heard on many investment advertisements, past performance is no guarantee of future performance. What worked in the past will not necessarily work in the future. The innovator's dilemma is actually an example of that. The rules of "normal" project choice work most of the time, but "normal" investment prioritization fails when a business is faced with a disruptive innovation, although this happens very seldom and may only be visible in hindsight.

The principles of design thinking, customer/user centricity, a balanced scorecard, and the others discussed here are useful guides or models, but do not guarantee success.

If a blue ocean, i.e. an opportunity is easy to reach, it would quickly become red because others would be there, too--building a sustainable competitive advantage is necessary. Our view is that blue oceans come in two varieties. The first are those that you can reach by mountain climbing--moving successively from Tier 1 to Tier 2, to Tier 3 markets with their attendant challenging product improvements demanded by downstream market segments (as described elsewhere by Boni in this monograph). The results of success are relatively knowable, but the path to success (the climb) is very difficult and has many unknowns to be resolved. Often times this is an iterative path guided by the convergence of customer/user input and observation, technology advancement, and product/market fit validation. This path was illustrated by MEDRAD's implantable defibrillator. Most biopharma/medtech development projects are "mountain climbing projects". The second variety are those that come through spelunking, exploring blue puddles and lakes to see if any of them have tunnels that lead to blue oceans, to mix the metaphors. In this latter case, the oceans are still blue because they were previously unknowable.

In closing, there are a number of lessons learned, and key takeaways that are worthy of inclusion in this paper focused on medtech innovation.

Patents are a key part of growth and success in any biopharma/medtech business. Aggressively filed and defended patents on innovations with broad claims are needed in this field. They provide one important form of competitive advantage. If you're going to be successful, plan on your patents being challenged by incumbents and prepare for legal remedies albeit expensive. Some sage once said that "patents are only as good as the money that you have to defend them".

Cook Medical: Bill Cook founded Cook Medical in 1963 https://www.cookmedical.com/about/history/). Cook Medical along with Medrad are good examples of long-term innovators. Cook Medical made guide-wires and catheters while MEDRAD made the injectors and syringes. (parenthetically, Schering AG and others made the X-ray contrast, and Siemens, General Electric and others made the imaging equipment). Cook would build what a doctor sketched on a napkin, and then when it worked the way that he wanted, Cook would commercialize it with that doctor's name (brand) on the product. So, both are customer centric innovators.

MEDRAD has brought to market many new and innovative products over the decades. They have all been focused around medical imaging and image based therapies. Some have not been successful, such as an injector for ultrasound contrast. Looking with a DC-3 and innovation ecosystem lenses, one thing that is missing in ultrasound imaging is operator independent imaging. The author believes that this dependency on the skill of the operator is one of the limit's to ultrasound's success. A second innovation that ultrasound needs is standardization and improvement in the speed of the examination. Perhaps some of today's portable ultrasound imaging innovations will recognize this missing element.

The lessons of Built to Last were commonly known and applied by MEDRAD senior management, especially the "Genius of the AND". Jim Collins (10), the author of Built To Last and Good To Great, has a powerful tenet in his thinking. It's called "the genius of the 'and'". Collins states that the truly visionary companies of the 21st century are able to embrace both ends of a continuum: continuity and change, stability and revolution, predictability and chaos, heritage and renewal, etc. Pursue productivity and sustaining innovations along with disruptive innovations. MEDRAD pursued all of innovation frameworks described by Christensen, and as he predicted, very few of the innovations were truly disruptive innovations (most were sustaining). See Table BB for reference.

In 1990 MEDRAD started using Total Quality Management in the organization to help a now much larger organization maintain or refocus on our customers, process improvements, and an explicit balanced scorecard. Winning the Malcolm Baldridge National Quality Award (11) twice, and their continued growth demonstrates that this focus on customers, process and improvements was worthwhile. There is nothing wrong with growing at or just a little above the overall market rate when you have a significant market share and are helping the market grow faster than GDP or other, broader growth metrics.

REFERENCES

(1.) Heilman and Steve. https://en.wikipedia.org/ wiki/M._Stephen_Heilman.

(2.) http://www.bcmj.org/article/implantable-cardioverterdefibrillator-mirowski-its-current-use.

(3.) Senge and Peter(2006). "The Fifth Discipline: The Art and Practice of the Learning Organization"), 2nd edition.

(4.) Christensen and Clayton. (1997) "The Innovators Dilemma", Harvard Business Press.

(5.) Clayton Christensen. "Where does Growth come from"? At Google August 8, 2016. https://www.youtube.com/ watch?v=rHdS_4GsKmg&t=12s.

(6.) Petzinger, Jr. and Thomas.(1996) "Hard Landing: The Epic Contest for Power and Profits that Plunged the Airlines into Chaos", Crown Business.

(7.) Gleick, Peter and Chaos Theory. Also see https:// en.wikipedia.org/wiki/Chaos_theory.

(8.) Heisenberg Uncertainty Principle.

(9.) Cook, Woods and Miller. (1998) A Tale of Two Stories: Contrasting Views of Patient Safety, Chicago, IL: NPSF, (available as PDF file on the NPSF web site at www.npsf.org).

(10.) Collins and James C. (1994) "Good to Great", William Collins Publisher, 2001 and "Built to Last" (with Jerry Porras), Harper Business Press.

(11.) MEDRAD (2010) Baldrige application summary http:// asq.org/public/conferences/quest-for-excellence-2011/ medrad_baldrige_app_2010.pdf.

Arthur E. "Ned" Uber, III

Fellow at Bayer, Pittsburgh, PA

Correspondence:

Ned Uber, Bayer, US. Email: neduber@gmail.com
Table AA: Ethnography Prompted Innovations Designed
into Stellant

Saline Flush               Auto Docking

"Prime tube"               Profile Review

Pressure Monitor           Remote "check for air"

Remote "Arming"            "Swab able" Valve Transfer Set

Bottle Holder              Multiple disposable kits

Robust System              Color Touch Screen

Configuration

Integral Auto load         Four different models, one
                           with dual syringed
Orientation Independent
Syringe

Table BB: History of MEDRAD Innovations

1964    Doc Heilman created the first
        angiographic injector in the kitchen of
        his home. In 1967, it would become the
        Heilman-Wholey Injection System.

1969    The Heilman-Wholey became MEDRAD's first
        commercial product.

1970    Mark[TM] II Injection System launched.

1972    Mark[TM] III Injection System launched.

1974    Mark[TM] IV Pedestal Injection System
        launched.

1976    Angiographic Guidewires introduced.

1978    Mark[TM] IV rack mount Injection System
        launched.

1980    MEDRAD[R] (Intec) brings to market the
        first commercial ICD

1985    Mark[TM] V Injection System launched.

1985    CT202 Injection System launched.

1986    Omniplane[TM] Film Changer launched.

1988    MEDRAD[R] enters Mr market by designing
        an MR-compatible TMJ device

1988    Angiography presence expanded with
        introduction of the omniplane Film
        Changer product.

1988    MCT[TM] Injection System launched.

1989    MRInnervu[R] endorectal coil introduced.

1991    Introduction of Mark V Plus[TM].

1991    MEDRAD revolutionizes vascular injection
        by introducing the first-ever Front Load
        Syringe (FLS), marketed as Qwik-Fit
        Syringe[R] Disposable.

1991    FluoroVision/Pathfinder products
        introduced.

1991    MCT Plus[TM] launched.

1995    Introduction of EnVision CT[TM]
        Injection System.

1996    Introduction of Spectris[TM] MR
        Injection System.

2000    MEDRAD acquires MR monitoring products
        from MRE Corporation.

2001    MEDRAD Pulsar[TM] ultrasound Injection
        System is introduced.

2002    MEDRAD introduces Continuum, the first
        MR-compatible infusion pump.

2003    Spectris Solaris[R] MR Injection System
        introduced.

2003    Stellant[R] CT Injection System
        introduced.

2005    MEDRAD Avanta[R] Fluid Management
        Injection System launched for
        cardiovascular procedures.

2005    Veris[R] MR Monitoring System launched
        in the U.S.

2006    Stellant DualFlow introduced.

2006    MEDRAD launches first prostate eCoil[TM]
        for 3.0T MR magnets.

2006    MEDRAD installs 5,000th Stellant[R] and
        5,000th MEDRAD Vistron CT[R] Injection
        Systems.

2007    MEDRAD launches XDS[R] Extravasation
        Detector for Stellant.

2008    MEDRAD introduces its first application
        for P3T[R] (Personalized Patient
        Protocol) for Cardiac.

2008    MEDRAD[R] and Possis[R] Medical sign
        definitive merger agreement.

2008    MEDRAD launches and installs Intego[TM],
        the first automated FDG delivery system
        for use in PET imaging in the U.S.

2008    MEDRAD introduces Continuum Wireless MR
        Infusion System.

2009    MEDRAD launches the Certegra[TM]
        Informatics Platform.
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Article Details
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Author:Uber, Arthur E. "Ned", III
Publication:Journal of Commercial Biotechnology
Article Type:Report
Geographic Code:1USA
Date:Jan 1, 2018
Words:5970
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