|
|
|
The theoretical foundation of Directed Evolution includes the following, postulates based on the history of technological evolution and other areas of human activity. Postulate 1. Patterns of
Evolution The first of the eight Patterns of Evolution (listed earlier), entitled "Stages of Evolution," can be represented by the classic s-curve (Figure 1), which illustrates the life cycle stages of infancy, growth, maturity and decline.
To illustrate how the s-curve can be used, consider the characteristic of airplane speed with respect to the development of the airplane. According to the s-curve, a new concept should have been introduced before 1930 (Figure 2). Looking at several related curves on a single graph allows us to plot the position of a current design in order to predict development before it takes place. Understanding the pattern entitled "Non-Uniform Development of System Elements" explains why aircraft industry designers were short-sighted in continuing to develop the engine while ignoring the airframe.
The total life cycle of a system is composed of several s-curves. Continued success of a product or process is sustained when new systems are incorporated during the growth of the existing system (Figure 3).
Postulate 2. Market-driven
Evolution
where: The Directed Evolution Process The Directed Evolution process can be summarized by the steps shown below. The process utilizes multiple Lines of Evolution for technology, marketing, organizations (enterprises), etc. for the purpose of determining multiple scenarios/directions of system evolution. These scenarios are then analyzed from various points of view, and the most promising ones are then selected. The remainder can be considered for future use or disregarded as nonviable. Future directions for development may be patented, thus becoming part of a patent fence. Once the best direction is identified, financial and staffing decisions can be made. The chosen direction may take lead for an extended time period until the technical concept's resources are exhausted. Meanwhile, it is necessary that the next generation of the system is developed in order to sustain increased performance. 1. Analysis
2. Identify Technological Capabilities for Evolution
3. Identify Market Input
4. Plan and Implement Develop a schedule for research, marketing, development and implementation of selected ideas including:
Directed Evolution is an ongoing process. The evolution of a system should be monitored in order to incorporate emerging technologies and materials that offer improvements. Directed Evolution is a way to control the destiny of a product, technology, process or organization. CASE STUDY Endoscopic Surgical Instrument Ideation International scientists conducted a preliminary Directed Evolution (DE) of the endoscopic surgical instrument (linear cutter family). During the process, numerous valuable Solution Concepts were discovered, some of which will directly impact how surgery will be performed in the future. These concepts have been documented in laboratory books and are under legal protection. A summary of the DE process follows: Wound Closure An Historical Perspective The following is a brief history of sutures and mechanical devices used in would closure. The development of two methods of wound closure, coupled with endoscopy, have resulted in two separate billion dollar plus worldwide markets, dominated primarily by Johnson & Johnson. Needles, Sutures, and Sterilization Ever since man has stood upright, the need to close wounds has existed. In the beginning, bone needles and animal sinew were used. With the discovery of copper, bronze and iron came the invention of eye needle used with various fibers found in nature such as stalk fibers, flax, linen, silk and cotton. In the late 1800s, with the help of men like Joseph Lister, we began learning about sterilization and disinfectants (the first of which was carbolic acid). Later, sutures were placed in small glass bottles and dry heat was applied to kill the bacteria. In the 1920s and 1930s, steam and chemical sterilization methods were developed. In the 1960s, gamma radiation sterilization became a standard process. Needle and suture materials continued to evolve in parallel with sterilization. Fine steel needles were used, which were curved and sized according to the suturing procedure, then chemically polished. The string of suture material was attached by flattening the non-pointed needle end, wrapping the flat metal around the suture, then crimping it in place in a process called "swedging." In later methods of wound closure, a hole was punched in the end of a needle and the suture strand was inserted and glued in place. Today, a laser is used to drill the hole. Over the 20th century, suture materials changed from silk and cotton to polymers, both absorbable and non-absorbable, which were braided or extruded as monofilament. Nowadays there is a suture material to fit every procedure. Also important is suture packaging, which serves as a sterile barrier and whose physical configuration also affects suture performance. A broad-based inventory of sutures is a mainstay for any modern operating suite, and is expected by todays surgeon. Mechanical Devices The modern internal stapling device was invented around 1905 by a Hungarian surgeon and his brother. Their goal was to prevent the leaking of bowel contents (which were believed to be very infectious) during surgical resection. The device consisted of fine silver staples that were forced through the tissue and formed into a suture. The staples were left in the body after surgery with no ill effects. In the early 1930s, the Hungarian surgeon Von Petz invented the staple delivery device that carries his name. Until the 1950s, this was the only internal stapling device available to surgeons. In the early 1950s, Stalin commissioned an institute in Moscow to continue the development of surgical staples. This institute developed reusable skin staplers, internal staplers of various sizes, linear cutters that lay down four rows of staples while cutting between them, and circular staplers for reattaching bowel sections. Produced by hand in small quantities, the patented staplers were available only to a few surgeons. In 1958, an American surgeon brought a stapler back from Russia and showed it to the founders of U.S. Surgical (which incorporated in 1964). U.S. Surgical built a business around their reusable surgical stapler. Then, in 1978, Ethicon marketed its first disposable stapler and the race was on. During the next 15 years, a billion dollar mechanical and endoscopic market developed. Applying the Patterns of Evolution (Example) Apparent Directions for Cutter Evolution The evolution of linear cutters indicated that the predominant method for increasing the system's ideality has been to increase each tool's level of specialization. Based on patent research, almost all developers are following this approach, and for that reason, this part of the project will not be shared. Non-Apparent Directions of Evolution for Sutures Another way to increase a system's ideality is universalization. According to the I-TRIZ Patterns of Evolution, systems become more universal through an increase in dynamism and a transition to the micro-level for realization of the system's functions. This suggests that tissue interaction would be affected by a formless medium (liquid or jelly) that could take any shape, rather than by pre-shaped objects such as staples or sutures. Sewing vs. Stapling The right side of Figure 4 shows the two threads of a sewing machine prior to the formation of a stitch. A sewing machine creates nearly continuous pressure on the two sides of the material. A staple provides a discontinuous pressure because there is space between the staples if they are in a simple row.
Using Adhesive In TRIZ terms, the process of using adhesive to close wounds can be characterized as follows: USEFUL EFFECT: Attaches tissue HARMFUL EFFECT: Contact with adhesive damages surface layers of tissue CONTRADICTION: Adhesive should be present between the two layers of tissue to attach them. There should be no adhesive present between the tissue layers so as not to damage them. To demonstrate the utilization of the Patterns of Evolution, one of many possible conceptual designs for a future surgical instrument is described below. This concept is the result of joining the benefits of sewing and stapling with the pattern "Evolution Toward the Micro-Level." With the development of this conceptual design, it is possible to create the next generation of instruments, along with an associated and highly effective patent fence. Description The components of the instrument include a housing, closing anvil, and cartridge in the shape of a reservoir containing a liquid polymer. The reservoir has a nozzle and is connected to a pressure source. Under very high pressure, the polymer is extruded through the nozzle in a narrow knifelike stream, pierces the tissue, and comes in contact with the anvil. Upon contact with the tissue, the polymer solidifies (polymerizes). Angular application in two directions forms a V on the underside. This continuous system of triangles holding the tissue together is seen at the bottom of Figure 5.
For this device, polymers that have already been approved for medical applications can be used. The polymer may contain additives that make the material stronger or more conductive. Magnetic or chemically reactive additives, for example, could enhance interaction with the tissue. Implementation Polymer solidification may be based upon:
Different polymerization techniques can be combined with different homeostasis techniques (temperature, chemical or radiation protein denaturation in the seam's proximity). Sewing may be combined with cutting, either by a mechanical blade or by a pressurized liquid (possibly using the same polymer extruded in the form of a continuous wall, thereby creating a layer of separation between the tissue). Current Approach
Directed Evolution Approach
The Complete Process The complete process would include several Lines of Evolution, including the ones identified as being used by the competition. Depending upon the resources of an organization, patent fences can be built to render the competition's current Line of Evolution a "dead end." By looking at several Lines of Evolution, an organization can protect the important end points, as well as the path along the way. A good strategy would be to introduce a new model that is competitively better but not as far along the Line of Evolution as is possible. Because the organization already knows the next three or four model changes, resources can be shifted to other areas of development. The Importance of Directed Evolution All we know for certain about the future is that it will be different from the present. Products, organizations, skills and attitudes that serve a business well today may have little relevance under the conditions of tomorrow. If a business is to survive, it must change. This change must be timely and appropriate to meet the needs of the future. Forecasts related to Directed Evolution provide important input to the process of strategic planning. These predictions have been used to gain a better understanding of the threats and opportunities likely to be faced by established products and markets. Consequently, the nature and magnitude of necessary changes can also be assessed. Reliable forecasting enables a business to pro-actively plan for the future as opposed to merely reactively responding to critical events. During recent years, numerous techniques for technological forecasting have been developed in order to obtain the maximum use from the information available. Because technology is responsible for many of the most important changes in our society, forecasting future advances in technology and the associated impacts can be as vital for top management in their formation of corporate strategy as it is for the technologist reviewing his research and development program. Technological change may result in bottlenecks or the redefinition of an industry or market. Drawn from the Ideation/TRIZ Methodology, Directed Evolution helps management obtain a more accurate picture of the future and, consequently, improve decision making. Thus the effort this process requires is justified. This could be the only real justification for Directed Evolution. Decisions are only definitive for the present. The question that faces the long-range planner is not, "What should we do tomorrow?," but, "What do we have to do today to be ready for an uncertain tomorrow?" The question is not, "What will happen in the future?," it is instead, "What future events do we have to factor into our present thinking and action?," What time spans do we have to consider?," and, "How do we make decisions about the future as we simultaneously make decisions in the present?" The planning horizons for most companies are relatively short: on the order of 5 to 10 years. It is just as important to apply Direct Evolution to short-term and long-term decisions, since many significant changes can occur in a decade. The time period for which Directed Evolution is necessary should match the planning horizon of the company. This is a function of the rate at which company activities can respond to change rather than the rate at which the environment itself is changing. Directed Evolution assists business
decisions in the following ways: When attention is focused on need
rather than ability to pay, the importance of Directed Evolution is
obviously a significant business consideration, particularly for smaller
businesses. The large firm in a mature industry is unlikely to be
overwhelmed by a sudden technological development, though its effects may
be catastrophic. For such a company, Directed Evolution could be confined
to monitoring the business and technological environment for early warning
of the occasional advance. Only when monitoring alerts the company of some
new development will more defined forecasts be needed. But, a company
adopting an offensive strategy should devote correspondingly more
resources to Directed Evolution.
As the pace of technological progress continues to increase, so will the need for Directed Evolution. Any growth is likely to be hindered by exaggerated claims of achievement. Since the benefits from research and development decisions are gained in the future, it is incumbent upon the research and development manager to be satisfied that the results of the investment are relevant to the market needs and the competitive technologies at the time they will reach fruition. All research and development decision makers must take a conscientious view of the future. Directed Evolution cannot enable decision-makers to predict the future with certainty, but it can assist them in defining their choices. |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Become An Inventor Copyright © Team C006094 |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||
