by
Gernot Mueller, M.D., President, BioFutures Incorporated
930 Tahoe Blvd.#802, Suite 461 Incline Village, Nevada 89451
(530) 692-1945 ~ email: gngmueller@succeed.net
Abstract
BioFutures Inc. partners with management and professional staffs from companies in the medical devices, pharmaceutical and cosmetic industries, forecasting next-generation products in design detail. This capability allows BFI - and their partnering companies - to do the impossible: field breakthrough products of the future - now. Behind this capability lies a creative approach that is both rapid and highly accurate.
INTRODUCTION
THE EVOLUTION OF PRODUCTS All products are "technical systems," evolving over time. What evolves is the performance of technical systems, as may be discerned from the following seven examples representing different product areas:
S-CURVES DEPICT MARKET EXPANSION FOR PRODUCT FAMILIES All product families - including medical devices, drug delivery systems, shaving systems, and cosmetic products - follow certain patterns as they evolve. The first point on an "evolutionary time-scale curve" for a product is discovery - marking the "invention" of an entirely new - or significantly improved - product family.
For various reasons (lack of adequate investment capital, formidable technical challenges, apparent market disinterest, etc.), it normally takes years or even decades before the chief problems associated with a new product family are resolved. Only then is the product ready for the marketplace. The performance progress of a typical product family can be depicted by S-curves(1).
Such curves have been collected for many industries and are available in the book(2), Predictions : Society's Telltale Signature Reveals the Past and Forecasts the Future, by Theodore Modis (further remarks on Modis book are presented as an Appendix to this paper). The uniqueness of these product family curves is that they all follow the "S " shape - in spite of the fact that certain industries are affected by the war-torn years, by politics, by natural disasters, or by other major events.
Oral delivery is the primary form of drug delivery used today. It represents a multi-billion dollar industry. The performance of the industry as a whole can be measured by the total number of units (tablets, etc.) produced. This performance is illustrated below on a cost-independent S-curve.
Oral-medication drugs represent a rather mature family. As indicated by this generalized curve, at one point the industry went through a period of time during which little progress occurred, then reached a point where production began to rise rapidly, and finally approached a limiting level of production - which is the current state of the oral drug industry, as measured by this performance index.
A linearized version of an S-Curve plot shows that oral drugs (i.e., powders, tinctures and tablets) initially went through an "infancy" stage (discussed above), where little apparent progress occurred (behind the scenes, there was a sporadic, if ill-funded, effort to resolve the problems associated with this mode of drug delivery). After these problems were resolved, production rose rapidly.
During the "rapid growth" stage, competitors began producing similar products. Competition guaranteed a high rate of improvement. The product family (tablets) flourished in the marketplace. Significant technical strides were made, including "time released capsules," "low-friction coatings," and "sublingual and liquefied drugs." Manufacturing production methods were improved. Ultimately a "saturation" limit was reached, which fixed the market possibilities for oral medicines.
At this stage of the S-curve, drug manufacturers wanted to assure that their "cash cow" products would continue. This goal drove all further technical efforts associated with oral medications. The product had reached a certain "maturity" level. All truly innovative efforts are downplayed at this stage, or even halted. This is essentially the point that the oral-medications industry is at today.
Some small, new company (or perhaps the research department of an existing large company already in the business) may - at this stage - achieve a breakthrough that makes it possible to deliver literally all (formerly orally delivered) drugs in a non-invasive way that is "other than oral," and which is cost effective. Such a breakthrough will make orally delivered drugs (pills, etc.) relatively obsolete. This breakthrough initiates a new S-Curve. A brand new industry is born - perhaps with new corporate players. If existing pharmaceutical companies are not a part of the new breakthrough, they may not be among the new players.
S-CURVES DESCRIBE THE EVOLUTION OF PRODUCT PERFORMANCE As discussed above, the performance of an entire industry is measured in terms of the number of product units produced by that industry. However, the functional performance of an individual product is measured in units that are more "technical." Some of these "technical performance indices" are mentioned for products 1 through 7 above.
For example, transdermal drug delivery systems are technically limited to the range of molecular sizes of drugs capable of permeating the skin. The skin will not admit most larger-molecules. Therefore transdermal delivery systems can be "rated" in terms of the "limiting" (i.e., maximum) molecular weight that can be successfully delivered. This rating is the performance index of the system, which, when plotted historically against time, should yield an S-curve shape. As transdermal systems evolve, it is expected that they will become capable of delivering drug molecules of ever-increasing size and complexity.
The S-curve for transdermal drug delivery systems is shown below. The "X" point on the curve indicates that todays transdermal systems are in the "infancy" stage of their possible evolution. Designers, scientists and researchers have been working to discover how to deliver an entire range of larger-molecule therapeutic agents through the skin, in a way that does not increase costs to producers of transdermal patches and similar devices.
BioFutures has already discovered how to do this, using the Triads(3) and TRIZ approaches, as well as their own, proprietary, technology-forecasting algorithms, developed for the pharmaceutical and allied industries.
This same technology forecasting capability has also been applied to the cosmetics industry. The cosmetics industry enjoys an advantage that pharmaceutical companies making prescription drugs does not have. Over-the-counter cosmetic substances are not subject to the same, rigorous, time-consuming requirements imposed by outside agencies on prescription drug companies.
BioFutures is actively engaged in applying lessons learned in transdermal delivery technology to cosmetics.
PREDICTING NEXT-GENERATION PRODUCT BREAKTHROUGHS
DISPOSABLE RAZORS Disposable razor blades for shaving represent a huge world-wide marketplace. A real driver in this industry is cost-reduction. Some producers of disposable razors believe that significant cost reduction is not possible without compromising technical performance features of their products. Others believe that further breakthrough-level performance increases are not possible. BioFutures next-generation, product-forecasting algorithm predicts that both are possible: significant cost reductions and next-generation, disposable shaving systems.
BioFutures applied its proprietary technology-forecasting algorithms to disposable razor blade design and manufacturing. Results indicate that unit manufacturing costs can be significantly reduced, while also conceiving next-generation design breakthroughs in performance.
BioFutures algorithms make use of the "Triads" and TRIZ creativity approaches. These approaches assist designers in eliminating or reducing habitual barriers to creating breakthrough designs. Altshuller(4) calls these barriers "psychological inertia." One form of psychological inertia is the belief that "the current design has already been optimized, and is close to the ideal design."
For a typical disposable razor sold on the shelves, this belief is not true. BioFutures design and cost algorithms demonstrate that the efficiency of the main performance function for this system - "cutting" - is still quite low, and can be significantly improved. It has also been demonstrated that unit manufacturing costs of most disposable razors currently on store shelves can be reduced by a minimum of ten to forty percent.
BioFutures has already conducted a cost and performance analysis of disposable razors, and is now planning to ally with a major disposable razor producer in order to field next-generation disposable razor designs, while simultaneously achieving significant cost reductions. The analysis was conducted by using invention software produced by the Invention Machine Corporation. This software is called TechOptimizer 3.0, and it contains several very useful problem-solving and invention modules. Three modules employed by BioFutures on disposable shavers are called (1) "Effects," (2) "Product Functional Analysis," and (2) Feature Transfer.
CASE STUDY: USING TRIADS TO PREDICT
AND CONCEIVE NEXT-GENERATION PRODUCTS
For proprietary reasons it is not possible to disclose further information about next-generation razor blade systems. However, the following case study example on defibrillation systems serves as an example of how BioFutures uses the Triad Approach for the prediction of next-generation designs(5).
NEXT-GENERATION DEFIBRILLATORS The main function of a defibrillator is to re-start the heartbeat of a heart-attack victim through the application of an electrical shock. The passive object is the heart. The active object is the defibrillator system. The enabling object is an emergency team member. The essential functions are:
DEFIBRILLATOR ELECTRICALLY SHOCKS HEART.
EMERGENCY TEAM MEMBER ACTIVATES DEFIBRILLATOR.
These three objects (heart; defibrillator; and emergency team member), and their interactions, form the triad shown below.
If one of the objects of the triad are pruned (i.e., eliminated), then that objects functions need to be considered.
For example, suppose we decide to "prune" the emergency team member.
Eight key questions emerge from this decision:
The answers to these eight questions are not easy. Some of them may appear to be ridiculous. Others may in fact actually be ridiculous. Nevertheless, as a collection, they lead to next-generation revival systems - in a manner that also leads to the ideal final system.
Eight more questions arise if we decide to prune the defibrillator:
SOLUTIONS
If we consider the 16 questions listed above as a whole, certain creative paths - and features of creative solutions - come to mind. The following is a list of potential solution features (along with the question number above that stimulated each solution feature):
STEP-BY-STEP PROCEDURE: DISCUSSION AND RESULTS Its easy to miss important results that can be gathered by the steps that we just went through - even though we have not yet completed the entire procedure. I want to stop at this point, therefore, and review - from a generic point of view - what we just did, and also review some of the conclusions and results that have come from what we just did. Well start with a generic description of the procedure used, referring to the defibrillation system case study for clarification.
COMMENTARY If we have gone this far in analyzing a problem situation, then we are already pretty far along. We usually have three interactions to examine. Each of these can be improved in various ways, and there are several tools of the TRIZ approach that can assist us in improving these interactions. For example, we could apply the laws of development of technical systems to the objects and actions in this triad. Or, we could look at the interactions between any two objects and further develop the problem in terms of a conflict, and use Altshullers conflict matrix to locate inventive principles that we can apply to the objects and actions of the interaction. Or, we can follow the entire ARIZ procedure for a particular interaction in the triad - usually ARIZ is to an interaction between the active and passive object.
All of these "ways leading to creative solutions" are admissible, but there is a way that leads us to the ideal final result not only "ultimately" - but quite rapidly. This way involves "pruning" (i.e., removing) a part, or the whole, of one of the objects in the triad.
The step called "pruning" rapidly leads us towards the ideal final result. The system also becomes simplified (not made more complex). By pruning a system, one or more measures of "ideality" of the system are increased.
If one of the objects in a triad is pruned, then we have a problem: we no longer have a function, because there is no triad. The minimum requirement for any function to exist is that there have to be three objects (active, passive and enabling). So after pruning occurs, we truly have a conflict:
The object must be pruned, in order to simplify the system and move towards ideality, and the object must not be pruned, so that we retain the function.
Well continue the "Triads plus Pruning" procedure with step 4 below.
COMMENTARY This is about as far as we have gone in the process of "Forming a triad and then pruning," with the defibrillator example. If you recall, we generated sixteen generic solutions - some of which appeared to be very similar to each other. Then we considered each generic solution, and through the application of "abstract thinking," generated specific solutions (A through P). Lets attempt to summarize the features of specific designs that are generated by our procedure:
FEATURES OF NEXT-GENERATION "REVIVING" SYSTEMS
Sensing devices can be described as being "electro-sensory," recording one or more of the patients vital signs or signals, and transposing them into a signal, which is transmitted to a miniaturized defibrillator also attached to the patient (see Feature 4, next).
The above characteristics of next-generation defibrillator devices are only a few, among many, that can be realized by using all the tools of TRIZ. They are, however, major characteristics and features that move current defibrillators closer to "the ideal design."
TRIADS AND PRUNING ON A MICRO-LEVEL
It is also possible to apply the "Triads and Pruning" procedure to defibrillators (or to any product or process) on a micro-level. For example, one of the problems associated with defibrillators is "chest area burns" associated with the energy absorbed during shock delivery. Medical research dictates that the shape of the electrical Power-Time profile delivered has to have a certain shape for maximizing the probability of reviving the patient. The area under the power-time curve is energy, and unfortunately, this excessive energy causes the harmful side effects mentioned above.
The passive object of this triad is the heart. The active object is an electrical shock having a certain power-time profile shape. The enabling object is an electrical power supply system. Let us divide the electrical power-time profile into two "parts" - a useful one and a harmful one. If the harmful part of the electrical shock profile (the one that contributes to patient burns) is pruned, we are left with the useful part (the essential part of the electrical shock profile that revives the patient).
This is where the tools of TRIZ can be used. Lets express the physical contradiction:
The profile shape of the electrical shock has to be unchanged, to maximize the probability of reviving the victim, and the profile shape of the electrical shock has to be changed, to reduce the area (energy) under the power-time curve.
This conflict can be resolved in several ways, including the following:
Lets discuss what was accomplished. We first formed a Triad. Then, the original power-time profile was pruned, and replaced by a pulsed power-time profile having the same shape. A modification of existing system resources was used to solve the problem.
CURRENT PROJECT ACTIVITY
BioFutures application of "Triads + Pruning" to disposable razor blades has resulted in a project to build disposable razor prototypes that have both superior performance as well as significantly lower unit-manufacturing-costs. This project is already in the testing stage and the results are very promising. BioFutures plans to form a strategic alliance with a major disposable razor producer to manufacture the new disposable razor systems in the near future.
I hope that this brief introduction to Triads and Pruning has helped you to understand more about the Triads approach. The Triads approach is particularly useful for predicting - with high accuracy - next-generation design configurations for any product family you choose. At BioFutures we welcome inquiries from medical-device, shaving system and cosmetic companies seeking to conceive and produce next-generation products of the future - now.
Thank you.
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REFERENCES
APPENDIX. S-CURVE COMMENTARIES
Predictions : Society's Telltale Signature Reveals
the Past and Forecasts the Future, by Theodore Modis
Citing experts at the International Institute of Advanced Systems Analysis as the source of the information he presents, Theodore Modis, a physicist (formerly from the Digital Equipment Corporation), examines technical, economic, and social trends. He describes growth curves that predict how competing animal species survive in the face of competition for limited resources. Modis goes on to explain how these same curves - and the equations upon which they are based - can be applied to nonbiological phenomena - inventions, sources of energy, and human activities, ranging from an artists productivity to the spread of diseases.
Modis explores two types of curves that the above-mentioned systems and their associated phenomena follow:
The plots presented in Modis book address motor-vehicle deaths, world-wide energy-source competition and substitution, the output of geniuses, economic cycles, and innovation.
Some readers might view what Modis has to offer with so much skepticism, that they are likely to miss the key points of this book. Nature follows certain laws. Human beings - and their output and results - are a part of nature. Humans too, are subject to these same laws. Knowing the laws means being able to predict phenomena associated with nature and human beings. The phenomena of specific interest to this audience include inventing (product and process conception), problem-solving, product and process improvement, technical forecasting and anticipatory failure analysis. Modis laws and equations apply to these phenomena.