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    INNOVATION             OUR DEPARTMENT'S INNOVATION PRODUCTS


What is Innovation? Why Innovation is important? To find the answer, you should look at the sources like books, internet and others, but you can find very different explanations.

For example, The Medical Device R&D Handbook authorized by Theodore R. Kucklick.

INVENTION, INNOVATION, AND CREATIVITY

Science and Discovery

Art and Design

Finding the Need

In medical device R&D what are we setting out to accomplish? We are seeking practical solutions to clinical problems — solutions with clinical utility. This seeking will involve several unsuccessful attempts before a solution is found. Once that solution is found, it then needs to be turned into a solution that is safe, effective, reliable, repeatable,scalable, and profitable.

From a business point of view it helps if the solution is unique and patentable, so that a company can charge enough for this solution to recoup the cost of finding it, developing it, testing it, and protecting it, and still have enough left to pay a return to the investors who put up the money to make it possible — and maybe a little left over for you, the innovator.

Let us start with a few dictionary definitions (from the Oxford Universal Dictionary, 1955 edition):

Invent: From the Latin invenire, to come upon, find, or discover. To find out in the way of original contrivance, to devise first a new method or instrument, to find out or produce by mental activity, to find out how to do something.

Innovate: From the Latin innovare, to make new. To change into something new, to alter, to renew, to introduce novelties, to make changes in something established, a new shoot at the end of a branch.

Create: From the Latin creare. To bring into being, cause to exist. To form out of nothing, to call into existence.

We see from these definitions that the emphasis of invention is discovery. The emphasis of innovation is change. Here we have a basic conflict between the terms invent and create. To invent and innovate requires that you start with something to be able to put it into a new form. To create means you start with nothing. As Thomas Edison once said, "To invent, you need good imagination and a pile of junk."

If Edison had not had his pile of junk to start with, he would not have been able to get anything done. Artists talk all the time about creating a work or being creative, yet we know this is not literally true. An artist, inventor, or innovator may be the first human being to put certain preexisting elements into a form that another human being has not donebefore, make a discovery that another human being has not made, or produce a solution to a problem, but this is very different from calling something into existence from nothing. God creates from nothing. People form and make from that which exists, whether physical objects and forces or from abstract mental processes.

  I invent nothing, I rediscover. 

                                          Auguste Rodin

 An inventor is a person who makes an ingenious arrangement of wheels, levers and springs, and believes it civilization.

       Ambrose Bierce, The Devil`s Dictionary

The other part of the Edison story most people know is how many thousands of unsuccessful attempts were made before a reliable light bulb was produced. The process of trying many different approaches in a systematic way with a clear goal in mind is an essential ingredient in producing innovation.

Failure is the preamble to success.

                                               Thomas J. Fogarty, M.D.

Design is a stepwise iterative process. Design starts with a need, and then applies technology until the need is solved in the best way possible given the time, resources, talents, and specifications available. This is the way medical device development usually occurs.

An inventor is simply a person who doesn’'t take his education too seriously. You see, from the time a person is six years old until he graduates from college he has to take three or four examinations a year. If he flunks once, he is out. But an inventor is almost always failing. He tries and fails maybe a thousand times. If he succeeds once then he’'s in. These two things are diametrically opposite. We often say that the biggest job we have is to teach a newly hired employee how to fail intelligently.We have to train him to experiment over and over and to keep on trying and failing until he learns what will work.

                                                                                                                                      Charles F. Kettering

SCIENCE AND DISCOVERY

Archimedes produced an innovation by matching a physical phenomenon to a problem he needed to solve. He uncovered this phenomenon through his keen powers of observation. Developing these powers of observation and the ability to apply these observations to problems is a key skill of the innovator.

For what study is there more fitted to the mind of man than the physical sciences? And what is there more capable of giving him an insight into the actions of those laws, a knowledge of which gives interest to the most trifling phenomenon of nature, and makes the student find:

Tongues in trees, books in the running brooks,

Sermons in stones, and good in every thing?

                                                             Michael Faraday

ART AND DESIGN

Another pair of terms that are often used interchangeably are art and design. Again, some definitions:

Art: From artem, to fit. Skill as the result of knowledge or practice, human skill, technical or professional skill, perfection of workmanship,application of skill in the areas of taste, poetry, music, architecture,painting. The quality, production or expression according to aesthetic principles (Old English Dictionary (OED),Webster’s). Webster’s (1828) makes a distinction between the polite, or liberal, arts and the useful, or mechanical, arts or trades. One emphasizes mental skill, the other manual skill.

Design: From the Latin de signo, to seal or stamp (Webster’s, 1828). To delineate by outline or sketch, to plan; the preliminary conception of an idea that is to be carried into effect by action (OED). Organization or structure of formal elements, composition, plan, blueprint (Webster’s Unabridged, 1989).

Design helps to make a product logical, usable, and understandable to the end user. Good design is invaluable in making medical technology usable and even safer. It is part of providing complete utility and a satisfying and appealing experience for the user. Design is putting things together in a planned and purposeful way. It can be utilitarian mechanical design, aesthetic design, or a combination of the two. Design can range from the cool rationality of the Bauhaus to exuberant technological Rococo. 

In art, the emphasis is on skill applied to aesthetics. Aesthetics is what appeals to the senses or feelings. Aesthetics is primarily subjective and emotional.

In design, the emphasis is on planning and organization. It is primarily a logical and objective activity. It is producing purpose and order.

Why is the artist important to the scientific innovator? Because art communicates and also appeals to the emotions.

Art is a vital way to communicate scientific information.

In art, in taste, in life, in speech, you decide from feeling, and not from reason.…… If we were obliged to enter into a theoretical deliberation on every occasion before we act, life would be at a stand, and Art would be impracticable.

                                 William Hazlitt

FINDING THE NEED

Necessity, who is the mother of invention.

                                                          Plato, The Republic

Restlessness and discontent are the first necessities of progress.

                                                                                         Thomas A. Edison

Medical innovation usually starts with a need, and then matches an appropriate technology to solve the problem. This is the way the vast majority of medical innovations occur. Some innovations are technology driven. However, according to Beckie Robertson, cofounder of Versant Ventures, a major life science investment fund, these technology-driven products are by far in the minority.

The ability to find and understand important clinical needs is an essential skill of the medical device entrepreneur. One of the ways to find needs is from thought leaders in a field. This approach has been formalized by Eric von Hippel of MIT into the lead user method. These lead users are leaders and early adopters who anticipate where a technology may be going, translating this information into a product that one of these early adopters will use is one thing. Making a product that the early and late majorities will adopt is another. Between these early adopters and the majority market is a gap, the so-called valley of death that many  technologies fail to cross.

Need finding is not as easy as it sounds. One would think that all you have to do is ask people what they want. Some of the most important needs are latent needs, where people do not know what they want and do not what they are missing. Market research is especially ill-suited to finding latent needs. How do you predict market share for an innovative product where no comparable product yet exists? Balloon angioplasty and magnetic resonance imaging are two breakthrough technologies initially thought to have no market. Doctors, for many reasons, will seldom admit that they have a need. To admit a need is to say that they are not providing the best standard of care. Gathering and interpretingclinical needs information is another art in itself. For example, Dr. Thomas Fogarty, in a talk on this subject, stated that "What a doctor wants, what they say they want, what they need, and what they will pay for are alldifferent things."

Technology-driven products have a seductive appeal. These are products with intriguing technology, with a wide range of potential uses, but ill-defined clinical utility. The problem with the technology-driven approach is the panacea trap. Medical lasers had this problem. When laser technology became available for medical use, it was applied to a widerange of products. Few of these products were ultimately successful. The most successful medical device products and companies have compelling technology appropriately focused on a very specific clinical need, not solutions in search of a problem, and not science projects. Two responses to a new medical technology that you do not want to hear are "that’s interesting" or "you have a great solution to a problem I don’t have."

Innovation, by definition, is practical, applied, and meets the needs of people. Applied science, invention, applied art, and design work together to produce innovations, solutions to human problems that have commercial value. Peter Drucker writes the following:

Above all, innovation is not invention. It is a term of economics rather than technology. Non-technological innovations — social or economic innovations — are at least as important as technological ones. Innovation can be defined as the task of endowing human and material resources with new and greater wealthproducing capacity. Managers must convert society’'s needs into opportunities for profitable businesses. This too, is a definition of innovation.(Drucker, Peter F., The Essential Drucker, Harper Business, New York, 2003, pp. 22–23.)

Innovation is about finding and solving the real needs of real people, and generating economic wealth in the process. It is taking all of the skills and talents of the scientist, doctor, engineer, artist, businessperson, and technician to bear on solving the medical needs of patients and building a viable business.

An idea in and of itself has no value. It’'s when you implement an idea, by means of an innovation, then you create value for society.(From “Celebrating a Lifetime of Innovation” reception program at Stanford for Thomas J. Fogarty, 2000 Lemelson–MIT Award for Invention and Innovation.)

                                                                                                             Thomas J. Fogarty, M.D.

To really solve a medical problem, and get it to the people who need it, you cannot do it all alone. To produce a product of real value, it takes the combined, committed, and organized efforts of people with a range of skills and talents. To get these people to work together and organize their efforts takes skilled management, and this art of management requires very different skills than most innovators have. It takes meticulous science. It takes people with skill at negotiating an ever-changing regulatory landscape. To bring these people together takes capital, and if successful, produces more capital that can then be put to work solving other problems. Managing capital requires yet another set of specialized and very necessary skills.

Invention is a means to an end, not an end in itself. It does not matter how rapidly you are able to produce iterations of an idea, how cleverly you solve a problem, and how original you are at doing it; what matters in the end is the importance of the human clinical need you are solving and the effectiveness with which you solve it. One needs to get past having a technologically driven solution in search of a problem, or trying to market solutions to problems patients and doctors do not have. Medical innovation with real value is the matching of a well-executed solution with an important unmet clinical need.

Edison is known also for his prolific output of patentable ideas. He is credited with 1093 patents during his life. Edison was focused on patenting ideas with commercial value.

Anything that won’t sell, I don’t want to invent. Its sale is proof of utility, and utility is success.

                                                                                                                             Thomas A. Edison

There is a common misconception that all one needs to have is a patent, and this alone will produce wealth. The truth is that few patents make enough money to cover the cost of filing them. A patent is a fence. You can build a fence around a swamp or a gold mine. A swamp with a fence around it is still a swamp.

The purpose of patents is not to make inventors rich. It is to preserve a record of technology for the benefit of society, and for other inventors to build on. The social contract between the inventor and society is a temporary monopoly on the sale of the patented product. This is the compensation given to the inventor in exchange for making the details of his invention public. It is up to the inventor to practice his patent or sell it to someone who generates wealth.

Another more subtle, yet vitally important issue arises when it comes to patents and intellectual property. This is the concept of freedom to operate. Just because you have a patent on a technology does not mean you can actually practice your invention. A common tactic, especially in crowded fields, is the filing of blocking patents. These are meant to fence off key areas of technology that may not be the product itself, but some of the essential means of practicing the invention. Establishing intellectual property protection as well as verifying freedom to operate are essential to successfully commercializing a medical device innovation.

So, did Edison create the light bulb? According to the literal definition, no. Did Edison invent the light bulb by himself? No. On the contrary, Edison organized a large team of skilled technicians and researchers that made his innovations possible. Employees of Edison Laboratories searched the ends of the earth for a material that would make a reliable light bulb filament. They invented means to insulate and bury reliable electrical cables. They worked on the myriad of challenges to make electric lighting and electrical generation and distribution a reality. In fact, according to James Burke, one of Edison’s great innovations was the establishment and structure of Edison Laboratories, which became the prototype of the modern R&D organization. Edison states the structure of his method as follows:

Edison’'s Six Rules for Invention:

1. Define the need for innovation. If there is no market, don't start.

2. Set yourself a clear goal, and stick to it.

3. Analyze the major stages through which the invention must pass before it is complete.

4. Make available at all times data on the progress of the work.

5. Ensure that each member of the team has a clearly defined area of activity.

6. Record everything for later examination.(Burke, James, Connections, Little, Brown & Company, Boston, 1978.)

Was Edison even the first to invent the light bulb? Again, the answer is no. The light bulb had been invented some 50 years before. Several inventors, including Sir Joseph Wilson Swan in England, had already developed working light bulbs. Edison even had to share credit with Swan when first marketing electric lighting in England, calling his English subsidiary the Ediswan Company. In fact, the bayonet lock light bulb base used in automobile taillight bulbs today was an invention of Sir Joseph’s brother, Alfred Swan.