A Sigma Medical Technologies Offering

TABLE OF CONTENTS
Executive Summary 3
Problem Statement 4
Introduction 6
Analysis of the Facts 8
Expeditionary Marketing Tools 19
Summary of the Facts 27
Alternatives 30
Recommendations 35

I. EXECUTIVE SUMMARY
Founded in 2015, Sigma Medical Technologies (SIGMA) is located in the SE region of Albuquerque, New Mexico, in the Sandia Industrial Park area east of Kirtland Air Force Base on Eubank Blvd. SIGMA, owned by Dr. Remy and Mr. Bob Sachs (of TEAM Technologies), serves as the patent holder and developer of “Ozone”. UNM Anderson has been contracted to provide an expeditionary marketing study.
Ozone offers an invasive, defined space; gas based delivery system (generated by the product) to kill all living organisms in a room. It provides an affordable elimination and sterilization system for use by the Medical industry. It provides an additional layer of security against concealed germs, bacteria, and viral threats (pathogens). It may even be the cost effective solution to deliver solution based field units to disease hot spots that are engineered for quick and easy “Ozone” sterilization. The technology offers a “whole room” elimination solution (fills available defined space and kills pathogens) as opposed to standard “surface” based elimination systems (based on chemical wipe down style cleaning). Dr. Remy and his supportive team have a strong solution for a problem that has varying targets. As countermeasures are developed, potential pathogen threats evolve. The Ozone technology may offer a solution set that the pathogens cannot evolve to defeat.
The primary focus of SIGMA, involves patent work, research and development of the Ozone generation technology, sales, and market development. SIGMA is the first and potentially third step in the supply chain.
One primary consideration is to develop lead users of the Ozone product in order to break into the market. SIGMA must determine what market(s) or market segment(s) make the most sense to pursue and why. This targeted effort will allow them the best chance to gain market dominance in the medical industry. Therefore, Sigma Medical Technologies and any future teaming partners must determine which path will expand the use of Ozone detectors quickly.

II. PROBLEM STATEMENT:

Mankind is battling a number of mutating and emerging diseases. Sick people leave pathogens at treatment facilities that make other people ill. This is unsanitary, unsafe, and unwise! Illness is primarily spread by pathogens (bacterial, prionic, viral, fungal, and parasitic) and their ability to mutate to more effective vectors. Standard methods of sterilization may no longer be adequate for common diseases like Influenza (#1 killer in human history), Hepatitis, MRSA (Methicillin Resistant Staphyloccus Aureus), and MERS (Middle East Respiratory Syndrome). Even the rare but serious ones such as Ebola, Swine Flu (H1N1), Bird Flu (H5N2), Marburg, Hantavirus, Lassa, Rabies, Smallpox, and Dengue Fever will probably beat many common sterilization techniques.

This problem affects mankind in all areas and at all social levels. Wealth may limit your exposure, but it is not a guarantee that you will be immune or even treatable. Instead we need to attack the pathogens at the source and eliminate them from our treatment facilities. If we just eliminated this one source of disease spread, we may be able to eliminate some rare diseases and contain some common ones.

Several methods exist to combat the issue with varying degrees of success. Steam and chemical wipedown seem to be the most popular, but each pathogen has different vulnerabilities and may require different chemical mixes or temperatures. Ozone has been introduced as a potential solution that attacks the pathogens via elimination of gasses that keep them alive (and replacement with Ozone). If correctly placed it may be able to gain market share. We see the mobile field treatment facility (specially designed for Ozone) as the best and most likely to succeed in initial market entry. If successful, it could encourage expansion into mainstream and first world hospitals via facility redesign.

Use of Tools in Making Business Decisions:

We assist SIGMA with the process of expeditionary marketing using many tools in our presentation and paper. The primary emphasis to ensure your team understands is that these are proven to help organize creative thoughts. In the end only the wisdom of your team can make the appropriate decisions for your business. It is our hope to provide you with new insights and ways to view opportunities.

One elemental tool that provides the background for decision-making is the Kondratieff Wave. (Appendix 1) It shows the international cycle of prosperity, recession, depression, and economic improvement. While it won’t predict the day of a change in economic fortune, it does show that the cyclic nature of the economy is consistent and predictable. It also shows the effects of continuous government interference on the markets at the wrong points and the consistent outcomes (depression). By understanding the Kondratieff Wave and applying it towards medical practices, we can more deeply understand the problems generated by the Affordable Care Act to identify a potential “mini wave”. It has created a short cycle with opportunities specifically related to medical treatment efficiencies and cost cutting requirements. Managed care facilities must find efficiencies in an environment heavy on regulation but low on cost reimbursement. Indeed we can see that the Affordable Care Act (Obamacare) has not altered the nature of the market and government influence on it. If you can catch the tail end of that wave, you may be able to move existing and future product.

Small business entrepreneurial action is not easy, many businesses fail when they select an incompatible path. The three-bubble chart below demonstrates a potential mixture of right opportunity, right team, and right project for the team; all as one combined figure. This is a simple “first layer” look to determine if you have the right pieces in place, as a team, to move into the market. We think you might, but there are some caveats. These are discussed in greater detail with the Strategic Technology Firm Fit Audit Tool (STFFA) presented later. The Ozone product requires some improvements to meet the opportunity in the major markets (1st World), but may show greater potential as a mobile field treatment facility in the secondary and tertiary markets (newly rising economies, 3rd World, and bottom billion).
We are searching for an intersection of all three bubbles to determine if your opportunity fits into the window. You are most likely to succeed if there is an attractive “market pull” opportunity (someone is already willing to pay for the solution). Then your team has to have both the necessary skill sets and a passion to accomplish the project. Every problem is an opportunity to market a solution.

We provide the Six Steps to Acting Like an Entrepreneur and Basic 5 Step Process to Evaluate an Opportunity in the Appendix 3. The Basic 5 Step Process to Evaluate an Opportunity tool allows us to consider the product against a generic market background. If we run the product through this 5 stage question scenario, we can see the result is in limbo. Neither providing top market demands (too damaging to facilities, too dangerous) and the bottom billions capability to pay (cost is likely to be high). Using the Basic 5 Step tool will help solidify some of your targeted marketing efforts. The steps you take to compete in the US, EU, and top Pacific markets will differ greatly from strategies used to penetrate African, central Asian, and low development Pacific markets.

Is the strategy to embrace the bottom billion first? We think you are in a greater position to effect the long term impacts you envision (for a social bottom line), by first becoming competitive with the portable Ozone field facility in top paying markets and then using the future generations of product development to do low cost spin offs of the primary product. This two-step approach would allow organizations from 1st world nations with strong financial backing to purchase and use the ozone treated tents. Organizations such as Doctors without Borders, the Red Cross, the Red Crescent, the World Health Organization, and the United Nations are all likely to be lead users and future purchasers. As the technology is improved and efficiencies are created, true penetration of secondary and tertiary markets could occur. This allows you to make the style of returns necessary to attract investors, and yet work toward the positive social solutions you desire.
We believe you are in a greater position to affect the long-term impacts by first developing the mobile field treatment unit and getting 1st World health organizations to embrace them. A competitive product in the top markets will generate revenues that allow for market expansion through a low cost alternative, with enough features to attract the «bottom billion» niche to the Ozone treatment facility. This two-step approach would allow organizations from 1st world nations with strong financial backing to purchase and use the ozone treated tents. Organizations such as Doctors without Borders, the Red Cross, the Red Crescent, the World Health Organization, and the United Nations are all likely to be lead users as well as future purchasers. As the technology is improved and efficiencies are created, true penetration of secondary and tertiary markets could occur.
This gives a two fold gain, an ability to attract investors to generate returns, and work towards positive social solutions. In the remainder of the document we discuss the tools used to generate specific lead users and targeted markets. Our analysis aspires to provide your team with recommendations for lead users, markets, and industry expansion.

III. INTRODUCTION:

We face an epidemic of viruses and bacteria in our daily lives. Hospitals are designed as a place for sick people to get better, yet often remnants of their illness are left to linger in the hospital facilities. While numerous methods are in place to deal with this, none seems 100% effective. To address this, new technology is being tested by Sigma Medical Technologies, in partnership with TEAM Technologies; to test and eliminate lingering pathogens.

Below is a multipage table demonstrating just one illness (Hepatitis B) and associated outbreaks in managed care settings. Hepatitis B (HBV) Outbreaks by Setting | Setting | Year | State | Persons Notified for Screening2 | Outbreak-Associated Infections3 | Known or suspected mode of transmission4 | Comments | Long-term care 5 | Personal care home (1) | 2014 | PA | 49 | 8 | Unsafe practices related to assisted blood glucose monitoring | | Sub-acute unit of a skilled nursing facility (2) | 2014 | CA | 158 | 7 | Infection control breaches related to instrument sterilization during the provision of podiatry care were identified; however, evidence was insufficient to implicate a specific source of transmission. | Of the 7 outbreak cases, viral molecular sequencing of DNA from 4 acute infections matched into a cluster with one chronic case. Sequencing could not be performed for three cases with serology indicative of resolving acute infection. |
…Table continues through more outbreaks. http://www.cdc.gov/hepatitis/Outbreaks/HealthcareHepOutbreakTable.htm Health chiefs were today monitoring the outbreak of a virus infection at a city hospital. The Victoria Infirmary in Glasgow, which has also been at the centre of an unrelated salmonella poisoning outbreak in which three people died, is only accepting emergency cases for the time being. It follows an outbreak of winter vomiting and diarrhoea at the Victoria Infirmary and Mansion House, a part of the hospital, which has affected a total of 157 people so far. There were 30 new cases yesterday. http://www.dailymail.co.uk/news/article-95614/Hospital-remains-closed-virus-outbreak.html#ixzz3W5N7K08Q

Hospital Outbreak of Middle East Respiratory Syndrome Coronavirus
Between April 1 and May 23, 2013, a total of 23 cases of MERS-CoV infection were reported in the eastern province of Saudi Arabia. Symptoms included fever in 20 patients (87%), cough in 20 (87%), shortness of breath in 11 (48%), and gastrointestinal symptoms in 8 (35%); 20 patients (87%) presented with abnormal chest radiographs. As of June 12, a total of 15 patients (65%) had died, 6 (26%) had recovered, and 2 (9%) remained hospitalized. The median incubation period was 5.2 days (95% confidence interval [CI], 1.9 to 14.7), and the serial interval was 7.6 days (95% CI, 2.5 to 23.1). A total of 21 of the 23 cases were acquired by person-to-person transmission in hemodialysis units, intensive care units, or in-patient units in three different health care facilities. Sequencing data from four isolates revealed a single monophyletic clade. Among 217 household contacts and more than 200 health care worker contacts whom we identified, MERS-CoV infection developed in 5 family members (3 with laboratory-confirmed cases) and in 2 health care workers (both with laboratory-confirmed cases). http://www.nejm.org/doi/full/10.1056/NEJMoa1306742

In these examples we see a hospital that had to stop admitting new patients and had a cascading infection rate that reduced staffing levels of care workers. We see MERS-CoV had a mortality rate of 65% and a secondary infection spread to family members and health care workers. Even the Hepatitis B outbreaks indicate that managed care environments are a potential illness vector. Some of these might be preventable, if so, how does the medical industry justify not implementing known working solutions? Ozone may provide a solution set to address killing viruses, germs, and bacteria. The solution could be best controlled at the point of care, but could also be introduced to field hospitals, treatment facilities in “hot spots”, and in extreme cases at the point of origin.
Sigma Medical Technologies provides this unique “sterilization” solution for medical facilities. The solution is designed to thwart biological hazards (pathogens), contain them, or limit damage and mayhem caused by such attack forms. It may have other applications in pathogen threat deterrence. The African continent, central Asia, low development Pacific island nations, and remote parts of South America and Central America are all likely long term markets as the sources of most disease outbreaks. The threat cannot be underestimated though. Many new pathogens mutate or spawn in 1st world nations, but the spread is usually less due to better pathogen control measures. The over use of antibiotics is now allowing for some mutations to be resistant to most known treatment methods. The change in size and scope of the problem necessitate taking another look at alternative technologies, methodologies, and a change in our evolving solution sets.
Sigma Medical Technologies is intent on identifying areas for market penetration. There is a significant amount of research and usage in pathogen deterrence. We need to examine other potential opportunities also. We will also try to work ideas on growth, teaming agreements, and potential early exit strategies into the material.

IV. ANALYSIS OF THE FACTS:
We used a series of tools to help SIGMA identify lead users and unfilled market niches. This enables us to provide suggestions for SIGMA. Our plan is to identify potential lead users who are using industry standard products or no products. This indicates dissatisfaction with current offerings and a willingness to potentially try new products that may meet their market driven need to adjust for pathogen controls. First we utilize tools such as the Technology Readiness Level (TRL), Technology Marketing Matrix (TMM), the Marquis Model of Process Innovation (Marquis Model), Crossing the Chasm, Gartner’s Hype Curve, and the Bass diffusion model (Bass Model). In the following section we will expand by exploring business specific tools such as the NTCP Diamond tool, and the Strategic Technology Firm Fit Audit Tool (STFFA), and Porters Five Competitive Forces that shape market competition. This will assist you in identifying potential market position, allowing us to move into targeted suggestions on how to bridge the gaps to the market.
Using the Technology Readiness Level (TRL) Tool, we can identify product maturity. This gives a realistic view of its ability to go to market and gives a broad idea of stages of work needed to get there. The National Aeronautics and Space Administration (NASA) uses this as a guide for most new technology launches. (See Appendix 4)

TRL LEVELS Technology Readiness Levels (TRL) are a method of evaluating and estimating the overall technology maturity of technology elements or product lines. TRL are based on a scale of 1 to 9, each number representing a different stage of overall readiness, 1 being the lowest most basic stage of the process, and 9 representing a technology that is nearing completion and ready for launch and/or application. The 9 Technology Readiness levels are as follows: LEVEL | DESCRIPTION | TRL 1 | Research begins. Lowest level of technology development. This step can include papers, or examination of basic technical properties and theories. | TRL 2 | During this phase, invention process begins. Applications to observations begin to form. At this point, applications are largely speculative with little or no proof to support the assumptions. | TRL 3 | Advanced R&D is initiated. Can include analytical studies or laboratory studies positioned to validate earlier predictions of the separate elements of the technology. | TRL 4 | Primary Technical components integrated. This phase will identify which components are capable of successfully working together. | TRL 5 | The basic technical components are integrated with supporting elements so that active testing can occur in a simulated environment. | TRL 6 | Model/ Prototype is tested in relevant or modeled environment. This stage represents a major advancement in technological readiness compared to that of TRL 5. | TRL 7 | Prototype near, or at planned operational system, requiring successful demonstration of system prototype in an operational environment. | TRL 8 | Technology function is proven successful in desired environment. Technology is completed and validated through tests and demonstration. | TRL 9 | Final application of technology in its final form. Technology is proven through successful operations. | Through discussions with the customers, we have identified that the working understanding is that the Ozone product is sitting at a TRL Level 7. Though it is our groups understanding that without a prototype’s successful demonstration in an operational environment this level of readiness cannot be achieved. It is our group’s belief that the technology is currently sitting closer to a readiness level of 5, with the basic components being integrated with supporting elements; it is now necessary for testing practices to be designed and implemented in order to progress the technology to a higher readiness level. Currently, The Ozone technology is about the physical size of a desktop computer. Theoretically the product is to be placed in the center of the room, and once the room has been cleared of potentially harmful reactants, Ozone will disperse the compound to disinfect the room. However, lack of adequate testing has identified potential concerns with the technology. For instance, how can it be validated that the disinfecting compound has reached all crevices and surfaces of the room it has been placed in. This is one of hurdles the technology must overcome before it can successfully advance to a higher readiness level. The technology also has another potentially difficult obstacle to tackle before advancing. Ozone has been proven damaging to the structure of plastics and rubbers, greatly breaking down their structure with consistent exposure. It is imperative that a Material Safety Data Sheet (MSDS) be completed, as it is an integral part of technology stewardship. An MSDS would provide workers and other technicians in contact with the product with procedures for handling and working with the technology. There is very little margin for error regarding what elements or substances can be exposed during the decontamination process. Not only will Ozone break down materials like plastic and rubber, but it also poses a great threat to any person who is in the room at the time Ozone decontamination is initiated. The permitting process for successful implantation of this technology will be extensive and likely include Material Safety Data Sheets (MSDS) approval, inclusion in the Hazardous Communication Standards (HCS) by the Occupational Safety and Health Administration (OSHA), and potential inclusion in the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). Additionally, it is in the best interest of the technology to start pursuing research institutions that might be willing to implement the technology in their facilities to advance the testing and validation process. These might include such research institutions as the University of Texas’ MD Anderson Cancer Center, who is often identified as a technology leader in the industry.

Technology Matrix Marketing Tool:
The Technology Matrix Marketing Tool has been utilized to identify Sigma Medical Technologies’ position in the market. SIGMA is not entering a new business nor are they pioneering any efforts beyond pathogen control and elimination as a surface contaminant, they are simply using alternative technology and expanding on current capabilities. Dr. Remy has referenced his Intellectual Property (IP) patent but we have to determine exactly what that entails, and should probably update and renew the IP while acquiring an “acceptable use” letter. Analysis shows SIGMA is mildly disruptive but driven primarily through the use of alternative technologies (ozone to eliminate pathogen hazards) with a great need to develop expertise and knowledge regarding the technology use. They further need expertise in application safety and ability to navigate through the various government regulation processes to bring a chemical product to market.
Technology Marketing Matrix

The industry has numerous forms of disinfectant available to combat pathogens but each tends to have weakness to at least one (if not multiple) forms. They do not all battle bacteria, germs, and viral bodies equally. This may be the unique mix that Ozone fill. It is equally effective in combatting all 3 forms. The technology matrix-marketing tool is generally used to compare businesses. In the table above, we first look to the type of technology and can see Sigma Medical Technologies is improving capabilities of the existing sterilization techniques by expanding into technologies (ozone gaseous generation) that traditionally have not been used in the medical cleaning segment (expansion of technology). We can also view the market segment(s) related to disease prevention and control as having existed and while changing, they have been more of a continuation of the existing market (stability in scope with small expansion in size). This is mainly due to new requirements, alternative detection measures, smart monitoring, and the importance of cost savings due to shrinking budgets.

A simple color scheme can be used to show both Risk & Reward as a part of the TMM. Red is high risk and high potential reward. Dark green is low risk but also low reward (think established market with established product).
In the modified Technology Marketing Matrix table below we look at some of the competitor’s position within the expanded market and compare it to their technology position. This is where we can note our first potential problem. A number of firms with differing technologies are successfully in the market already and able to do many of the things Sigma Medical Technologies is offering to do. Look back to this tool again later on to select potential partners (teaming agreements) or buyers of your patents and technology. After we discuss some of the potential competitors or future partner opportunities, this tool can aid your team in making decisions about who could present the best opportunities for future development partnerships or outright sale.

Competitors
There are many competitors in the medical sterilization industry today. Several of them have comparable technology to the one that Sigma Medical Technologies has, offering gaseous based options such as vaporized hydrogen peroxide, ethylene oxide, and even ozone. The major players in the international market are Getinge (Sweden), Steris (US), Sterigenics (US), Sakura (Japan), 3M (US), Cantel Medical (US), and Advanced Sterilization Products (US). In addition to the known gaseous based competitors, there are a number of different technologies available to disinfect with.

Direct Competitors (using Ozone technology):
To the best of our knowledge, there are no companies who are using gaseous ozone in the way that Sigma Medical Technologies intends to. Medizone is the closest using gaseous ozone spread on surfaces to disinfect MRSA, let’s call it the “half room” concept. Guangzhou-Kangzen similarly uses Ozone gas to sterilize sheets, and other breathable materials.

Medizone International (Canada):
Medizone International which is located in Canada has reported successful trials of using ozone to disinfect rooms that are contaminated with the MRSA virus. Medizone is still a development stage company and does not have any current sales. They appear to be closest in concept and would be a competitor for a potential buyout by a larger market player.

Guangzhou-Kangzhen Medical Equipment Company (China):
A Chinese based company, Guangzhou-Kangzhen Medical Equipment Co. is currently using gaseous ozone for specific sterilization of mattresses, pillows, sheets, etc. that are used in hospitals. Guangzhou-Kangzhen isolates the mattresses, pillows, etc. in an enclosed space in which it is then able to disinfect the aforementioned materials without the risk of damaging potentially expensive medical supplies that could be damaged by ozone. It is interesting to note, that they do not do any full room disinfection using ozone.

Indirect Competitors (using other technology):

Getinge (Sweden):
Steam is one of the oldest, easiest to control, and best understood technologies for sterilization. Getinge adds state of the art surveillance and monitoring controls to its sterilizer product series. Yet they face the same problem Ozone does. If they were to repackage to clean rooms, the activity of generating Steam could and likely would damage the room’s infrastructure. Getinge is not likely to be a direct competitor to Ozone. http://www.getinge.com/healthcare/products/sterilization/ Steris (US):
Steris may be one of the most dangerous competitors for Ozone. They have already embraced the mobile solution and would be a few short steps from embracing a “whole room concept” device. We actually like them as one of the best partners to form a teaming agreement with. They have experience in a broad range of sterilization techniques from steam to chemical. They seem one of the competitors more likely to embrace a new technology. Steris might make an attractive partner for Ozone. http://www.steris.com/products/mobile-sterilization-solutions Sterigenics (US):
Sterigenics offers solutions that would kill issues through protective packaging, and could be modified to be a direct competitor. They focus on the use of Gamma Radiation, Ethylene Oxide (EO) gas, and electron beam technology. Gamma radiation has been used for over 50 years, is easy to understand, and provides consistent reliable results. It might not have the same application capabilities via room sterilization that Ozone provides. The safety parameters are easier to know and control though. EO gases provide a low density, low heat option for use with breathable barriers. The Electron beam technology is more of a concentrated radiation allowing low density, but high volume sterilization. All could be converted to compete, but none seems to be a direct offering that would compete with Ozone in the “whole room concept”. Sterigenics is unlikely to become a direct competitor, but it could convert some technologies to do so. They are currently for sale and an anticipated purchase price of around $1.5B is in discussion. http://www.sterigenics.com/Sterilization_Technologies/Gamma_Irradiation.php http://www.sterigenics.com/Sterilization_Technologies/Ethylene_Oxide.php http://www.sterigenics.com/Sterilization_Technologies/Electron_Beam.php http://www.reuters.com/article/2014/10/22/us-sterigenics-m-a-idUSKCN0IB16K20141022 Sakura-Seiki (Japan):
Sakura offers sterilization solutions in a broad spectrum of products. They offer heat, steam, Ethylene Oxide (EO) gas, and ultrasonic based solutions. The SCS-B2600 can be converted to a “room like” device and offers pressurized steam solutions in conjunction with heat. We don’t see this as a real competitor as the “room like solution” is more designed for mass sterilization of equipment rather than an operational room with sterilization built in. Their other pathology based tools are market alternatives but wouldn’t be direct competitors for room space sterilization. Sakura is unlikely to become a direct competitor of Ozone. http://www.sakurajp.com/english/products/pathology.html 3M (US):
3M is a prolific manufacturer of pathology exposure related products. They manufacturer detectors, preventative measures, protective materials, a wide variety of infection control and cleaning products, and even a “clean trace” post cleaning detection system. In EO gas, 3M offers a “Steri-Vac” system, the 5XL system. It uses Ethylene Oxide in an aerated chamber to sterilize small batch equipment. A known major industry player, their danger to Ozone is primarily ability to recognize the market potential and expand their offerings to take market share from Ozone. Since they already have a sales force and a presence in major hospitals, they may be able to take over market share. 3M has the background to become a direct competitor and a willingness to embrace new products. This might be a good place to form a teaming agreement or direct sale of the patent and technology rights. http://solutions.3m.com/wps/portal/3M/en_US/SterilizationStandardsPractice/Home/ Cantel Medical (US):
Through their subsidiary company “Medivators”, Cantel Medical offers a variety of sterilization products both onsite and as a contracted service. Their use of pressure chambers and gaseous solutions with the “Revox” product offers sterilization for tissue samples, medical devices, biologicals, and implantable devices. They also have a wide offering of water and dialysis sterilization options. Cantel has not made the leap to the “whole room” concept we are pushing for Ozone, so they may be more of a future competitor in waiting. We identify them as they might be able to easily make changes to compete with Ozone and then beat you to market share through their established channels. Cantel Medical is unlikely to become a direct competitor, but they could retool some devices or processes to do so. This is another company to consider for a teaming agreement. Although further outside the comfortable range than 3M or Steris, they are well positioned in the market and have shown a willingness to embrace new technology. http://www.cantelmedical.com/medivators.html Advanced Sterilization Products (US):
ASP seems to focus on chemical and heat based sterilization of endoscopic equipment. They maintain portable units and offer some surface cleaning alternatives, but seem to be a niche player with a specific sub segment they are trying to capture. We would not rate them as true competition to the Ozone product offering, but a potential future competitor if they expand into the gaseous market. https://www.aspjj.com/us/product/high-level-disinfection Other uses for Ozone (US):
A new sterilization process, which uses ozone as the sterilant, was cleared by FDA in August 2003 for processing reusable medical devices. The sterilizer creates its own sterilant internally from USP grade oxygen, steam-quality water and electricity; the sterilant is converted back to oxygen and water vapor at the end of the cycle by a passing through a catalyst before being exhausted into the room. The duration of the sterilization cycle is about 4 h and 15 m, and it occurs at 30-35oC. Microbial efficacy has been demonstrated by achieving a SAL of 10-6 with a variety of microorganisms to include the most resistant microorganism, Geobacillus stearothermophilus.
The CDC has reported that “A gaseous ozone generator was investigated for decontamination of rooms used to house patients colonized with MRSA. The results demonstrated that the device tested would be inadequate for the decontamination of a hospital room946.”
There are multiple companies in existence that use gaseous ozone injected into water for industrial and municipal water purification. One company, Biozone, has a portable ozone generator that is used for mobile water treatment. Another company called Ozonia does municipal water treatment using ozone. The market for municipal water treatment using ozone is well established, having been used in Indianapolis to treat over 125 million gallons per day since 1985.

The Marquis Model
Utilizing the Marquis Model to analyze Ozone is challenging because we lack clarity on the final product (goal) of Sigma Medical Technologies, LLC. As Donald G. Marquis would phrase it, “Whenever he heard someone begin to talk about innovation, he immediately tried to answer two questions: Does he/she understand the distinction between innovation and invention; and if so, what kind of innovation is he/she talking about?” According to Dr. Walsh, this is quite clearly the best innovation tool to use. The company has proven innovation has begun with a technically feasible idea, but still has to prove that demand for the product exists.

Above, we see the typical Marquis innovation model flow. Ideas coming from a place of technical feasibility begin on the top and ideas driven by market pull begin from the bottom of the model. SIGMA was definitely driven by a discovery of technical feasibility when attempting to model a product able to defeat pathogens for field use.

As for SIGMA’s idea formulation, recognition of technical feasibility has been integrated into a design concept, but lacks full capability to meet a market style pull demand. Both elements are essential for success in this phase. According to Marquis, “The design concept is only the identification and formulation of a problem worth committing resources to work on.” It appears that the idea was productized prematurely in an effort to close sales and capture market share before the product was fully prepared for market entry.

The Problem Solving phase for Ozone is extremely important. Search, research, and development took place, but seem to be paused (in retrospect). Ensuring future success relies on recognition and anticipation of existing problems and their impact on the future product. Solutions and development will be necessary to drive Ozone toward market success. The Marquis Model emphasizes problems will arise and solutions are necessary to drive forward. This is the stage in which SIGMA needs to attempt to resolve uncertainties with respect to market demand. Activity will need to fall back to this point if the decision to pursue a product for market is made. Through search, research, and development activities; prepare the product for market entry. Productize it and add effective safety features for the open market.

The Utilization and Diffusion Phase does not bring any guarantee’s. According to Marquis, “this is the stage in which the solution is first utilized and difused in the marketplace. Only one or two new prodcuts out of five actually achieve sales whose profits provide a break-even return on investment.” In regards to Ozone, there are many idea’s that can help them to “main street”, the most profitable appear to begin with the portable field treatment facility for the consumer market. This has probably the single greatest profit potential. This process will require a new Marquis analysis necessary in identifying the essentials toward crossing the chasm. This may be achieved much more easily by way of leveraging the supply chain of a partner firm already in the marketplace and situated to sell if the Ozone product was added to their inventory as an upgrade to their product line. (See Appendix 5)

We see this clearly illustrated in the new Marquis Model designed for the Sigma Medical Technologies product “Ozone”. We can see continuity of technical feasibility leading to a design concept, running through research and development, and ending on a product. The product was fabricated and now a prototype unit is available for field testing. The downside is that the market pull wasn’t great enough (or government regulations made the market pull exceedingly difficult to meet) to pull the product into field acceptance. So we are stuck on solution. We need to get to market adoption and then implementation and use (and finally true market diffusion). To accomplish this we can look at our next tool for “Crossing the Chasm”

Crossing the Chasm
Crossing the chasm is an important step for Sigma Medical Technologies, but not to the industry. Sometimes a new industry can help bootstrap a company across and vice versa. In this case, the “pathogen control” related industries are mature, have good market penetration, and medium growth. The Ozone product will be forced to differentiate itself to break into the market. It has elements of that necessary in design (Ozone as a gaseous pathogen control technology), in price point (potential savings in long term use for the market), and ease of use (can train someone with a first grade education and visual recognition of colors to operate the item). The price point differentiator might not be overcome unless strong safety measures are implemented. It might even be able to gain an edge with treatment facilities in the areas predominantly managed by the “bottom billion” through efficiencies, portability, and further price reductions. Again, we stress the importance of lead users and product field testing to prove its value to the marketplace.
There are other viable mainstream uses for the Ozone generator, but it is important for SIGMA to pick one potential niche market to pursue in order to get across the chasm. Theoretically Ozone provides greater benefit when eliminating pathogens lingering in treatment facilities. This creates an ability to take a purpose built facility to regions suffering from outbreak. The efficiencies in containing the spread of disease are gained by mixing Ozone with other technologies to create a purpose built, mobile, self-contained field treatment facility. The medical sterilization industry has a large market influence due to its size, significant buying power, and in North America the establishment of government agencies such as the Centers for Disease Control (CDC) and the Federal Emergency Management Agency (FEMA).
Sigma Medical Technologies should focus on getting one or two government agencies or one of the major aid organizations mentioned earlier to become lead users for Ozone. This may involve supplying free mobile treatment facilities to the lead users for testing and study themselves. SIGMA may also need to pay for independent studies, work closely with these entities to help perfect symbiotic relationships among the differing technologies, and/or help their market development groups understand and promote the benefits and efficiency gains provided by Ozone gaseous pathogen control systems.
Once Sigma Medical Technologies is able to help at least one lead user to successfully promote and push Ozone gas protocols into the market, that end-user’s consumers will be drawn to the benefits of a symbiotic layered pathogen defense. Once there is a market draw and a proven track record, other companies may follow suit and request the Ozone field unit (or customized facilities as new builds or retrofit). Alternately, they may develop competing products (especially pragmatist-type organizations). Without protectable IP, SIGMA faces a battle to maintain market advantage for long. This could serve as another reason to update features and attempt to get a patent extension to protect entry to market. Geoffrey Moore refers to this as the bowling alley.
Once Ozone is successfully across the chasm in the form of a symbiotic partnership (via mobile treatment facility or another teaming agreement), it will be easier to move other potential uses for Ozone across the chasm. In an unusual twist for a “crossing the chasm” model, this is a limited benefit. Usually crossing the chasm creates brand name awareness, opens doors for other users of similar technology, and creates a mass effect of increased adoption pace (Moore called this the tornado). With Ozone, none of these are likely to occur. The industry is mature and the idea of pathogen control is into the late majority / laggards phases, it is well accepted, few are willing to bear the individual cost of a more expensive methodology (such as O3 gasses), and interest in the specific technology behaviors is low (unless you are a researcher or disease control specialist). Unless we can prove this technology is substantially cheaper or much more effective, it is likely to create little if any mainstream market splash on its own. This is another reason to form a teaming agreement with a more established supply chain and then “riding the coattails” of that of that chain to establish this technology.
A better model may be one that includes the Gartner “Hype Curve” overlay to determine both where your technology is, and where it is in relation to the chasm. Various technologies could be plotted in relation to Ozone to give a better understanding of public awareness (hype) and technology adoption. As demonstrated in Appendix 6, many up and coming technologies exist, but they exist alongside proven methods of pathogen destruction. These new methods must differentiate themselves, prove efficiency, better effect, or substantial cost savings in order to be adopted and capture market share. We think the combination model (below) best proves the theory that devices created to meet an existing demand have an easier journey to adoption than those created because the technology was available.

The Bass Model of Technology Diffusion
If we combined the “flow” of all the models taken to this point, we could begin to build a picture of what some of our issues and constraints will be upon market entry. Innovators will adopt new technology or products to meet a need they feel. These purchasers influence others (imitators) to some degree. Imitators will also further influence new buyers to join the market, and if your product is good at meeting these new consumer’s needs, they will likely move more imitators to your product offering.
The Bass model looks at the typical population of innovators (those adopting to meet a previously unmet need and free of influence by other adopters) and imitators (those influenced by previous adopters) and compares it to the total potential marketplace. Well-known names like Amazon and Facebook have largely met success with the Bass Diffusion model. Where innovators drove imitators who drove other new adopters.

http://pubsonline.informs.org/doi/abs/10.1287/mnsc.1040.0300 http://pubsonline.informs.org/doi/abs/10.1287/mnsc.33.9.1069 Bass found that his model fit the data for almost all product introductions, despite a wide range of managerial decision variables, e.g. pricing and advertising. This means that decision variables can shift the Bass curve in time, but that the shape of the curve is always similar.
Although many extensions of the model have been proposed, only one of these reduces to the Bass model under ordinary circumstances.[4]
This model was developed in 1994 by Frank Bass, Trichy Krishnan and Dipak Jain:

where is a function of percentage change in price and other variables http://en.wikipedia.org/wiki/Bass_diffusion_model This model predicts that we may increase the likelihood of success by creating a teaming agreement with an existing medical supply chain or by expanding the market demand for Ozone based pathogen controls in general. We could do this by proving greater efficiency at the price point. Of further value, if we can find a couple mainstream locations (Israel, USA, Europe, Central Asia) to adopt or even place into trials the Ozone product, it may generate imitators and new adopters in secondary and tertiary markets. Thus leading to some of our recommendations where the product may see more success in entry.

V. EXPEDITIONARY MARKETING TOOLS:
We will provide many tools in our presentation and paper for your team. The primary emphasis is to ensure your team understands that these are proven to help organize creative thoughts. Previously we looked at tools that shape the marketplace. In this section we will expand by exploring business specific tools such as the NTCP Diamond tool, the Strategic Technology Firm Fit Audit Tool (STFFA), and Porters Five Competitive Forces that shape market competition. These will allow you to see if the market is right for your product. It is our hope to provide you with new insights and ways to view opportunities. In the end only the wisdom of your team can make the appropriate decisions for your business.

The NTCP Diamond Framework:
After examining the competition, it is important that SIGMA look within and examine its own situational placement. The “Diamond” model is a nice tool to help us determine technological complexity of a project and focus on both the risks/benefits and ensure you have selected an appropriate management approach. By creating a visual representation showing our Novelty, Technology level, Complexity and Pace, we can compare management style needed with the project complexities faced by Sigma Medical Technologies. In the original design and development stages of the Ozone detector, our model probably looked like this. (See Appendix 7)
This model demonstrates our early development stages. The Novelty was a true breakthrough (new to the world). The Technology level was lowtech (most of the technologies are existing and well established). The Complexity was at assembly (a unit that performs a single function) level. . Finally at that point the Pace would have been fast/competitive (project is addressing a market opportunity or creating a new line).
Ozone brings a new idea to an existing, well established industry with heavy regulation. Instead of surface cleaning, you look to redesign facilities to be “sterilization” ready. Ozone gas offers one solution, but it would be theoretically compatible with others. With the recent rise in Avian flu, swine flu (H1N1), Ebola, and similar pathogen outbreaks; a recurring window of rapid Pace movement into time-critical (on a definitive time line to complete) or even blitz (most urgent, most time-critical, solve for crisis as fast as possible) should occur. It seems that the cycle repeats as media attention is directed to the latest “superbug”. Await one of these opportunities and then introduce product to market. Consider it riding the hype wave.
Our post “media blitz” model could more like Appendix 8.
Notice how the industry dynamics change by the simple addition of making solution sets time critical? It might mean expanding it from a derivative to a true system. This was a great opportunity to gain advantage, but it appears to have been missed for the Ebola crisis.
Our current state has to take into account changes in technology, the familiarization of SIGMA with developing Ozone based gas generators, the current business pace, and the current novelty level. This paints an entirely different picture… one showing smaller market potential.

The present state picture is a bit bleak and requires some adjustments to the business to bring it back to a better competitive state. However with change comes risk. Use your personal wisdom developed in the industry to decide if you are best served by developing the product further to enable market entry, or if you are best served selling your IP or partnering with another firm. To get to a better state for any of the above (create value), we recommend your team focus on fixing the safety issues (a move up the complexity scale), address the issues with partnering to hopefully strengthen the technology level, and push the novelty back up to platform level. This places us as a portion of an integrated system, designed into facility, at a higher overall tech level with a platform offering. Ride the hype curve the media creates to find success in the next pathogen based crisis to become fast/competitive again. This gives you a better chance of becoming attractive to a buyer, or making your product more attractive in the marketplace. Fix these things take place, our picture changes to look like this preferred future state. (Appendix 9)
This places SIGMA and the Ozone product into what we feel is the “ideal state” for market entry or acquisition of IP/company by a competitor for maximum gain. Once again, we urge caution and careful study of the best moves for the firm based on your own market experience and wisdom. In almost any of the scenarios, improving technology, novelty, and/or pace will create real value for the end goal, but that real value addition may not outweigh the costs required to create it.

The Strategic-Technology Firm Fit Audit (STFFA):
The strategic-technology firm fit audit provides quantifiable data to assist in identifying Sigma Medical Technologies’ potential within new and current markets. This tool helps identify missing knowledge in a manner that allows you to seek out and acquire subject matter expertise necessary for the venture. Instead of a full blown industry comparison, we have chosen to modify the tool to best suit your current needs; namely what knowledge bases do you have (left column) and which ones do you need (right column) to strengthen the company for market entry. See all tiers in Appendix 10.
Tier I: Sigma Medical Technologies offers a product (with a potential for follow on services (training and maintenance), that removes pathogens from environments likely to contain high cluster numbers and thus requiring above average prevention and control of infection methodologies. Dr. Remy serves as a critical person at SIGMA. He is the creator and one of a small team managing the company. For true market entry opportunities, he may want to create a more binding infrastructure and offer remuneration. Knowledge is embedded in all other areas identified within the STFFA.
However, deterrence of pathogens offer additional potential product sales locations and follow on services. We have identified an opportunity to enter major markets and bridge to secondary markets by targeting international health organizations as lead users. These groups are likely to have the resources to pay for and model the device in a purpose built field facility and model it in secondary markets to attract future sales amongst the “bottom billion”. We create opportunities to outclass the low end sellers working in those regions, but still offering a good product at an attractive price point. Referring back to the TMM, these markets require more risk but also offer greater reward as a result.
This will require expanding knowledge on the physical product and potentially on fabrication & assembly and vectored air disbursement (turbulence). Acquiring such knowledge will create short term efficiencies that help lower the price point or better target quality delivery at the price point the product can deliver. If Sigma Medical Technologies can develop low price training to accompany a very simple visual indicating system, then people with low education can be trained to operate the device(s) and people with moderate education could be trained to maintain them. This opens a secondary income stream of after sales service and support.
Tier II: Managerial emphasis identifies SIGMA possesses specific capabilities in research, fabrication & Assembly, Operations (Mr. Sachs) and items with a moderate number of processes. If you can find someone experienced in productizing “technology use as a derivative”, you could also make headway in advancing the unique sales points and differentiators of the Ozone offering.
Finally it is imperative to understand the difference between a technology push and a market pull. A technology push indicates a technology has become available to solve a potential problem and we should see if the market will pay for it. A market pull indicates a problem exists that the market will pay for if resolved. The Market pull is the greatly preferred avenue to pursue (as it tends to generate higher returns and easier entry). At this point it appears that the Ozone offering is more of a Technology push type solution (or a solution waiting for the market to recognize its application to an existing problem).
Tier III: Sigma Medical Technologies requires many technology competencies for safety of use purposes. The team lacks an appropriate amount of knowledge to work on the biological, chemical and civil engineering requirements. The team seems adequate to the engineering task at hand for the basic product, but does not seem to fully understand the implications of its use, and cascading issues. See Appendix 11 for a Failure Mode and Effects Analysis (FMEA). The fabrication and assembly is likely to be outsourced, so core competencies are mainly required for research and development of the product.
Tier IV & V: These areas identified additional specified needs and skills. As previously discussed, knowledge of biological, chemical, and civil engineering are all required for the solution you are trying to bring to market. These specialties will have a large impact on usage and awareness of Ozone within mainstream markets. Specific engineering skills will be required to fully enhance the product and make it market ready. Pathogen control, Hazmat safety, MSDS Design, and technical writing will all play a vital role in overcoming safety issues when working with an inherently unsafe gas outside of a research facility. A better understanding of Ozone’s effect (as an oxidizer) on various materials is also likely to play a role in deciding where it is safe to use Ozone as a commercial product.
Partnerships with existing medical sterilization companies could help speed up the move forward and cross the chasm to the mainstream market(s). This model also helps to identify what weaknesses the firm has and may need to be given priority to develop quickly. As previously discussed, safety of use is going to be a paramount metric and attention should be given to safety engineering as the priority. Reviewing the competencies, it is evident there is a need to document processes and create technical writing for various levels of user markets (and translation services once sales are arranged). We could argue that Ozone has not moved much beyond existing opportunities due to limited use and awareness of the technology solution offered. Due to the relatively low price point it should be easy to combine with other technologies as part of a mobile treatment facility.
The Strategic Technology Firm Fit Audit (STFFA) tool helps establish what capabilities the firm has and determined what capabilities are needed. With that information we are better prepared to look at the opportunity itself and determine if you are developing a solution the market demands (pull solution), or developing a solution based on technical ability (push solution). The theory of push (the market demands this and will pay for it) vs push (You are able to do it and hope to sell it) creates issues for many businesses. To better understand the potential, we next offer Porter’s Five Forces that shape industry competition.

Porter’s Five Forces that Shape Industry Competition:
Porter’s Five Forces assists in determining the effects of technology on the industry and competition. To build a process for “deep market penetration” it is necessary to review barriers to entry, potential supplier issues, existing competition, byers, alternate buyer groups, and threats from substitutes. The model below illustrates one approach Sigma Medical Technology has on the industry and competition. The model in Appendix 12 visualizes Porter’s Five Forces, identifying potential industry expansion and the vulnerability /profitability of Sigma Medical Technologies’ position in the pathogen elimination industry. SIGMA is identified in this model as a late entrant and developer of Ozone based gaseous elimination. There is some controversy ion the effectiveness of Ozone as a pathogen elimination technique. Dr. Remy addressed this with plans to create both higher pressure with concurrent higher risks. We are suggesting the addition of a “turbulence” element to disperse gasses to the corners and alcoves of a space. SIGMA can be found in the central piece, which frames the company and its competitors. Findings and analyses from Porter’s Five Forces are as follows:
Point of Entry Barriers:
As Sigma Medical Technologies market awareness increases as a known “gaseous pathogen eliminator” technology product, competition will increase, resulting in increased threat of market entry. SIGMA is a late entrant and faces threat to entry not only from other gaseous technologies but from other substitute technologies as well. You can strengthen your existing economies of scale (offer better results compared to others at the price point, or similar results at a lower price point) or prove a greatly increased effective “kill” ratio in field testing conditions. This seems to be the best entry point for Ozone. Being the quality leader is almost always a better position than being the “price leader” in an industrial niche. You may be better served to look instead for secondary and tertiary markets who remain underserved at any price point. These markets may be open to better entry and testing while fighting major pathogens such as Ebola.

Supply-side economies of scale are not favorable for Ozone when viewing the established market uses and ease of competitors changing process for product development to directly compete. If testing can prove the concept, you may face an uphill battle trying to beat competitors with existing supply channels into major treatment facilities. Potential benefits exist to beat other entrants in the secondary and tertiary markets, and in the unique entry of a portable treatment facility that is mostly self-sterilizing. The limitation to the supply exists in the various international government regulations, which may limit or demand Ozone technology use. This barrier exists for all entrants in the local and foreign market(s). Demand side benefits of scale are not favorable for SIGMA. Your TEAM Technologies connection provides an established connection with manufacturing processing plants. You have limited to no established contacts within health organization operations, published research in the industry, or reputation based on past performance. This equates to additional barriers to entry created by having a relatively unknown technology (technological uncertainty). Several discussions with Sigma Medical Technologies’ management team emphasized the importance of creating network relationships and seeking additional lead users, to allow for educating medical treatment facilities on the benefits of Ozone, and development of supply and demand cycles.
Finally, there is a large safety factor brought into play by the inherent dangers of O3 (Ozone gas). It has dangerous interaction as an oxidizer, creates health risks associated with exposure, and the worst of all has an explosive interaction with other substances (POL based lubricants and animal fats). This means potential facility damage (other than specially designed facilities), human health issues, and inherent cascading dangers.
Power of Suppliers
After reviewing the list of suppliers (internal and external), low-level concerns regarding ability of manufacturers to supply product in a timely manner exist. The device appears to be relatively easy to manufacture. This creates a concern that better positioned companies with ties to major treatment facilities and supply chains could rapidly prototype devices and enter the market. This could be done with or without supplier support of competing interests.
New Mexico has long been a center of innovative technologies with little financing and virtually no recognition (outside the atomic weapon). New Mexico based researchers invented revolutionary weapons, the idea of clean room technology, and many advances in chip and chipset manufacturing. This means a robust infrastructure for innovators should be in place, but it is remarkably absent.
Existing Competition
Several businesses exist in the international market(s) for cleaning and elimination of pathogen marketable products. Numerous technologies exist of varying effectiveness to deter or destroy pathogens with varying degrees of effectiveness. Some form of strategic alignment, coupled with symbiotic relationship with one or more competitors, maximizes market potential and strengthens business opportunities for all involved. A Co-Op approach helps push Ozone over the Chasm, if suppliers and operators in this industry work together.

Power of Buyers
The primary buyers of pathogen control products are within the governments of the world, international aid organizations, and major medical treatment facilities. Some are more responsive to a need for public safety than others. Attitudes vary about the value of human life (especially the value of any single life) across the globe. When attempting to sell in these markets, SIGMA must continuously push the “what’s in it for me” approach to the buyer. Value of life does not always have the same sales impact we would anticipate in North America. Analysis of current buyers indicates opportunity is abundant, but cost to convert existing facilities to efficiently utilize Ozone safely may be cost prohibitive. Additional buyer markets may exist with public transportation, and facilities doing pathogen research work.
Alternative Solutions
Unfortunately numerous solutions exist that can also deter or destroy pathogens. All seem to have limited effectiveness against one or more types. Ozone offers a potential best overall pathogen control measure. Many have limited time span of effectiveness.
Every problem is an opportunity to market a solution. Not every solution is worthy of being brought to market though. Review the market, your team’s capabilities, and then use a 6 step planning review tool to determine the internal structure of the problem you want to solve. Use the “Six steps to acting like an Entrepreneur” tool (Appendix 1) internally at Sigma Medical Technologies, your device allows for new applications of existing technology. It offers an increased value for fighting pathogens and offers another possible way to limit transmission vectors. The great market value may be as a relatively inexpensive tool that is easy to operate and can be placed in secondary and tertiary markets via a mobile hospital tent system. Consider these potential uses: * Single point effective portable method of attacking disease. * “Teamed” technology to increase effectiveness of other technologies (clean room entry in disease research facilities, a sterilization chamber for equipment before transportation) * A new way of sterilizing the dead of certain infectious diseases * UN or WHO portable labs to attack outbreaks at or near the source * A small “steamer” style ozone device to sterilize small items or area (needs testing to verify efficacy) * Tent and use to clean ambulances or hearses.
Here are some alternative venues that we have not explored in depth, but all known to use Ozone gas: * * Onsite small chamber sterilization of implantable devices * Air cleaner purifier type * Air conditioning system odors in buildings * Animal or urine odor source detection * Animal entry points in buildings * Animal or urine odor removal * Back drafting heating equipment * Back drafting & sewer / septic odors * Boat & car smells & odors * Car mold contamination * Car smell - mold deodorizing * Car smell & odor diagnosis * Carpet odor & mold tests * Carpet padding asbestos, mold, odors * Carpet stain diagnosis * Chemical odor sources * Chinese drywall hazards & odors * Concrete dust & odors * Concentrations of gases in air * Contracted services offsite (sterilization of equipment, sealing and return) * Disinfectants & sanitizers, sources * Duct & air handler odors * Fire & smoke odor removal * Floods in buildings, mold prevention * Formaldehyde hazards * Gas detection instruments * Gas test procedures * Gas exposure limits & standards * Gas lp & natural gas safety hazards * Glues adhesives, exterior construction * Heating system odors * HVAC system odors * Hydrogen sulfide gas * Indoor air hazards table * Methane gas hazards * Methane gas sources * Mold odors, musty smells * Mothball odors * MVOCs & moldy musty odors * Odorless chemicals / gases check * Odors gases smells, diagnosis & cure * Odors in air handlers & duct work * Odor diagnosis checklist, procedure * Odor diagnosis event log & checklist * Odor diagnosis six steps * Odor removing detergents * Odors, sulfur smell sources * Smell patch test to find odor source * Oil odor sources * Oil tank leak & odor causes * Outhouses & latrines * Ozone air purifier * Ozone generators for indoor air pollution * Ozone mold kill treatment * Ozone mold / odor treatment * Ozone tests * Ozone for water disinfection * Paints & coatings odors * Pesticide * Plastic odors-screens, siding * Plumbing system noise diagnosis & cure * Building drain odor sources * Clogged drain diagnosis & repair * Plumbing vent blockage odors * Drain line sewer odors * Drain odor sources * Drain piping & sewer odors * Fixture vs system drain blockage * Floor drain / trap odors * Island sink plumbing vents * Other odors blamed on septic / sewer * Outdoor sewer odors * Remedies for sewer odors * Methane gas hazards * Septic system odors * Drain field odors, failures * Indoor septic odor, outdoor causes * Remedies for septic system odors * Septic treatments & chemicals * Sewage pathogens in septic sludge * Cleaning sewage ejector / grinder pumps * Sewer gas odors in cold weather * Site weather or neighbor's sewer odors * Toxic gas test procedures * Urea formaldehyde foam insulation * Urethane foam deterioration, outgassing * Removing vinyl siding or window plastic odors * VOCs volatile organic compounds * Water odors, cause * Substitute for chlorine sources in drinking water * Softener adjustment & controls * Water odor treatments, cures – Sulphur * Water staining contaminants

Try not to become fixated on the hospital setting. Look also into any forms of labs, field treatment facilities, hospital ships, or places likely to have vectored disease threats. Compare underserved markets with enough financing to potentially be able to purchase your device alone or with a purpose built inflatable facility.

Moving Beyond the Models
Thus far we have equipped you with tools to help you apply your wisdom to making decisions about the best use of your IP, product, and future business plans. At this point we would like to further explore some of the market issues that open opportunities. Keep in mind that these opportunities could be driven by teaming with existing supply chains, via demonstrating higher efficiency in pathogen control, or by creating best value at the price point. VI. SUMMARY OF THE FACTS:
SIGMA serves as an emerging technology company within the medical industry. Dr. Remy and his associates have great need for experts in navigating regulation requirements of the US and foreign governments. Almost all their potential buyer channels (governments, large international health agencies, corporations, large pharmaceutical laboratories, national laboratories, and medical research facilities requiring layered pathogen defenses, etc.), have some form of guidance, regulations, or special requirements to do business. Their second level need is for a development capability to create and manufacture custom built inflatable facilities designed to be ozone resistant.
Limitations to market could be represented by: * Limited financial means of the potential buyers with immediate need * Need to provide training for operators * Safety concerns with product usage * Equipment mobility also makes it pilferable * Damage product does to materials (plastics, rubbers, and even metal materials) when not in a “purpose built” environment. * A detection capability to identify pathogens
Time and costs associated with international business * Compliance with national and international regulations * “Breaking in” to the sphere of influence of international buyers
The comparison industry structures ” 33911A Medical Instrument & Supply Manufacturing in the US Industry Report” and “33451B Medical Device Manufacturing in the US Industry Report” are regulation heavy, offers low assistance, but has a relatively medium to low profit margin (10.5% on $96.4 B in 2014). In addition to medium low profit margin, add a projected 5 year growth rate of 3.6% sustained and a low export rate from the US manufacturing market, become heavy barriers to entry with profitability.

http://clients1.ibisworld.com.libproxy.unm.edu/reports/us/industry/default.aspx?entid=881 http://clients1.ibisworld.com.libproxy.unm.edu/reports/us/industry/default.aspx?entid=764 http://clients1.ibisworld.com.libproxy.unm.edu/reports/us/industry/default.aspx?entid=1587
Of this, the global sterilization market is currently valued at $3.1B (2012) with estimated growth to $4.2B by 2017 (CAGR of 6.1%). A combination of aging populations in the US, Europe and Japan is pushing the demand for healthcare services. These in turn are driving a demand for more efficiencies such as low cost equipment and patient area sterilization.
With the introduction of technically enhanced instruments in the market like endoscopes and analyzers, there has been an increased need for advanced sterilizers that are compatible with the same. This has brought about a drastic shift from steam sterilizers to low temperature sterilizers with its wide range of technologies such as ethylene oxide (EtO), vaporized hydrogen peroxide (VHP), hydrogen peroxide gas plasma, and ozone gas based sterilization.
U.S. and Europe are the major markets for sterilization, as a majority of the market leaders are based in these regions. Yet, the Asian market is expected to display favorable growth in the coming years, primarily due to rise in awareness, growth of aging population, increase in number of surgeries, and growth in per capita income. http://www.marketsandmarkets.com/Market-Reports/sterilization-equipment-services-market-642.html Potential Lead User Analysis: After understanding the three unique segments that Ozone could be utilized in (existing treatment facilities, specially designed treatment facilities, and mobile field units), it is key to understand that market acceptance and long-term success depend heavily on the lead users that adopt and implement the technology. It is in the best interest for Sigma Medical Technologies to focus its market entry strategy for ozone around institutions that have exemplified a concentration in cutting edge and innovative medical technologies, for they will be the most likely to invest in the infrastructural changes necessary to host the Ozone technology. The University of Texas’ MD Anderson in Houston Texas would serve as an excellent target for initial adaptation of Ozone. MD Anderson serves as one of the nation’s premier teaching hospitals, offering advanced programs covering subjects such as cytogenetic technology, histotechnology, cytotechnology, molecular genetic technology, diagnostic imaging, radiation therapy and molecular genetic technology (TMIH).
The center’s concentration on cancer research and treatment lends well to the interest in disinfecting and sterilization because of the increased risk of cancer patients’ health being compromised by various health threats. Chemotherapy, biological therapies, and radiotherapy can temporarily weaken the immune system by causing a drop in the white blood cell count. Additionally, steroids used in the treatment of certain cancers have also been linked to a weakened immune system (Cancer Research UK). A higher concentration in patients with weakened immune systems as well as a strong research environment contusive to technological advancements makes MD Anderson an excellent candidate for early implementation of Ozone.
Johns Hopkins Hospital in Baltimore Maryland would also be an excellent candidate for early adoption of Ozone. In March of 2014, Top Masters in Healthcare identified Johns Hopkins Hospital as a member of the top 3 most technologically advanced hospitals in the world as well as consistently receiving top honors from U.S. News & World Report’s Best Hospitals list across numerous concentrations (TMIH).
John Hopkins Medicine dean and CEO described the May 2012 opening of Charlotte R. Bloomberg Children’s Center and Sheikh Zayed Tower facilities (with a total cost of $1.1 Billion) as “a transformative milestone in the history of Johns Hopkins Medicine” (TMIH). The hospitals dedication to technology and constant improvement exemplifies that it could support, and be capable of devoting the time and capital resources in to the necessary renovations required by implementing Ozone throughout the campus.
A third option for a hospital setting suited to adopt Ozone might be El Camino Hospital in Mountain View California. In 1971, El Camino partnered with Lockheed Martin to launch the original computerized medical information system (TMIH). El Camino also appeared in the number one slot for Top Masters in Healthcare’s most technologically advanced hospitals. The hospital’s campus is in the heart of Silicon Valley positioning them close to an abundance of technology, providing them with the necessary resources to identify and implement properly aligned developments as they become available.

Another component of Ozone’s potential lead users incorporates utilizing the inflatable roving unit for hot spot treatment. Potential lead users in this segment include The World Health Organization and Red Cross as these organizations have a vested interest in advancement of sanitation and sterilization efforts. Most recently, The World Health Organization contributed greatly to the efforts to fight Ebola epidemic in Western Africa in 2014. Ozone possesses the capability of greatly reducing the risk of transferring the disease via compromised treatment centers. The World Health Organization serves as an incredible resource for educating and facilitating the user growth of the technology.
The World Health Organization is the directing and coordinating authority for health within the United Nations system. It is responsible for providing leadership on global health matters, shaping the health research agenda, setting norms and standards, articulating evidence-based policy options, providing technical support to countries and monitoring and assessing health trends (World Health Organization).

http://www.who.int/about/en/ http://www.topmastersinhealthcare.com/30-most-technologically-advanced-hospitals-in-the-world/ http://www.cancerresearchuk.org/about-cancer/what-is-cancer/body-systems-and-cancer/the-immune-system-and-cancer

VII. ALTERNATIVES
Numerous alternatives exist to provide competition or entry barriers for Sigma Medical Technologies. We will examine some opportunities in North America among the mainstream market, some opportunities to partner with other firms, and some secondary foreign markets. First, we need to assess the risk of these actions.
Risks
Going into new markets or changing a product offers some risk and some potential benefits. The larger the diamnond gets, SIGMA will have a higher potential for profit, but also there is a potential of higher risk. We have listed some risks below that are important to take into account when making strategic decisions. We have divided the risks into two categories: Entering foreign markets and Partnering with other firms or technology. The risk for each market may vary a lot. Going into Nigeria or Afghanistan exposes Sigma medical Technologies to more risk than entering the Norwegian or Israeli market.

Entering foreign markets:
Entering foreign markets creates uncertainty. Thus, there is a risk of: * Possible corruption in foreign markets
Mitigation Strategy: Stay away from corrupted markets. * Unstable economies and unstable competitive environment.
Mitigation Strategy: Focus on markets with stable economies. * Breach of contract or risk of offshoring.
Mitigation Strategy: Breach of contract can always happen. To reduce the risk SIGMA should make sure they have a legal contract that will ensure the other party will take full responsibility in the case of breach of contract. The contract should be reviewed by an attorney familiar with international law as applied in the destination nation(s) before signing. * Currency Exchange rate risk.
Mitigation Strategy: Look for possibilities of sharing the risk with buyer/partner. Focus on regions where currency movements are more stable and predictable.

Partner (Teaming) agreements with other firms/technologies:
Increased technology may increase the complexity of the product: * Increase the overall technology for the product results in a higher technology, which means there is a higher risk of technical failure.
Mitigation Strategy: Higher technology requires higher technical skills. SIGMA therefore needs to hire technicians or partner with a firm with technical skills. * Additional investments might be needed to increase the product performance or partnership. Investments are always exposed to risk.
Mitigation Strategy: Prepare and do good research before investing in technology. * Partnering up with other technologies may cause difficulties with hardware and software integration.
Mitigation Strategy: Higher technology requires higher technical skills and a higher degree of integration and coordination. SIGMA therefore needs to hire technicians or partner with a firm with technical skills. Develop a plan for integration and coordination. * Launching a new product to the market, such as a pathogen sterilizer, can lead to customer rejection due to product inherent dangers.
Mitigation strategy: The higher the novelty, the less you can depend on marketing research because the customers can’t tell if they like the product or not until after they have used it. Therefore, SIGMA should obtain customer feedback quickly using early prototypes. Focus on early adopters.

Existing Alternatives to clean high risk treatment spaces:
Bleach (hypochlorite)
The use of hypochlorite is likely to continue to be used in hospital settings due to its rapid efficacy, low-cost, and relative ease of use. In recent years, evidence has emerged that chlorine based disinfectants can be carcinogenic. Additionally, some chlorine based disinfects are not effective against certain viruses and other pathogens and are an irritant to the mucus membranes of the lungs and other areas of the body.
Hydrogen Peroxide Vapor (HPV)
Bio-decontamination within a room or chamber is achieved by depositing an even layer of 'micro-condensation' of hydrogen peroxide vapor over all surfaces. The term micro-condensation may be defined as a microscopic film of HP Vapor, which being at a sub-micron level is invisible to the naked eye. Scientific research has proven that it is this low temperature, 'residue-free' deposit that actually deactivates micro-organisms during the gassing process.
The micro-condensation process ensures that the optimum conditions for biological inactivation are achieved. When the process reaches the dew point the time required for a log reduction of activity (the D-Value) is shortest. This occurs when the kill kinetic curve plotted against time is steepest. The transition between the shallow curve and the steep section coincides with the onset of micro-condensation. http://www.bioquell.com/en-us/about/technology/hydrogen-peroxide-vapour/ HPV offers a technology substantially similar to Ozone in behavior, dispersion, and methodology. It does so with lowered risks and potential damage to facilities. This may be a major competitor. Ozone may maintain advantage with their purpose built field facilities.
Alcohol
Two forms of water-soluble alcohol are used in medical sterilization (isopropyl alcohol and ethyl alcohol). Alcohol tends to denature the proteins within pathogens thereby causing death or at least long term lag in reproduction. Alcohol is not recommended for medical and surgical instruments because it is very weak against spores.
Enzymes
Enzymes are added to cleaning mixtures to destroy organic based pathogens. These are not disinfectants and can often be delayed or destroyed by germicides. These also create breathing hazards in humans and animals.
Chemical Germicides
Chemical germicides must be cleared as a sterilant by the Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA) for use in the US. These chemical mixtures may be marketed as sanitizers, general disinfectants, or even sterilizing products. The FDA actually regulates these as a medical device to prevent cross approval attempts across multiple permission requests.

UV light A company called Xenon has developed a robot which uses rapid pulses of UV light to systematically disinfect hospital rooms. It has been adopted in over 200 hospitals and clinical settings. Utilizing pulsed UV-C light, Xenon is poised as an alternate solution to Ozone gas. It works by causing damage at the cellular level. The four primary types of cellular damage caused by Pulsed XenonUV are photohydration (pulling water molecules into the DNA to prevent folding), photosplitting (breaking the backbone of the DNA), photodimerization (DNA damage that prevents replication), and photo crosslinking (cellular wall damage that causes cells to lyse). http://www.xenex.com/how-pulsed-uv-light-disinfection-works/#sthash.fDGWW8wn.dpuf

Trends - Alternative Markets/Industries (expeditionary marketing) Ozone has been used to purify municipal water systems since the 1970s. It is currently used to disinfect water for a variety of applications including disinfecting used water from agricultural and horticultural business. A potential growing market exists for ozone purification of agricultural water with the upcoming implementation of the Food Safety Modernization Act (FSMA) that for the first time will require vegetable farmers to measure the quality and purity of the water they use to irrigate their crops. Previously there was no standard that existed for pathogen levels in the irrigation water used to water crops that are commonly eaten raw and in contact with that water. With the increase of organic food production, it is likely that organic and ecologically minded farmers will look for a less toxic alternative than current chlorine based disinfection systems.
One of the most promising potential applications of the ozone generator, is the potential to design areas of mobile field hospitals to be easily disinfected without risk to medical tubing and other sensitive equipment. The cost to either design mobile field hospitals to be resistant to the corrosive effects of ozone, or for a disposable field hospital that could be thoroughly disinfected with ozone is much less than the cost to design conventional hospitals in this way. This makes this application more likely to be adopted than disinfection in a conventional hospital. Due to their typically smaller size and remote location, testing the ozone generator in mobile field hospitals may allow for easier penetration into existing hospitals.
Ozone has been successfully used to disinfect the water that is used in hospitals for a variety of purposes. A commonly neglected area of concern in hospitals is the cleanliness of the water that is used in mop buckets or the like for cleaning the floors in hospitals. This water accumulates varies pathogens as it is used in mopping and other cleaning of hospital rooms and floors. A small, mobile ozone generator that could continuously purify cleaning water would allow for more thorough cleaning and disinfecting of hospital surfaces. An alternative to continually disinfecting the cleaning water would be a dissolved ozone that does not degrade back into oxygen as rapidly as current ozone generators. This would allow the disinfected water to remain so for a longer period of time, thus significantly reducing the risk of spreading pathogens and other contaminants from room to room.
Ozone has the potential to treat water in emergency situations such as natural disasters and other situations in which clean water for drinking and other applications is scarce. As this kind of scenario is common in areas in which organizations such as the Red Cross is active, this application would be complementary to mobile field hospital deployment. There could be the potential to design an ozone generator, which is capable of disinfecting both water and surfaces all in one unit.
We have concerns over use in air treatment due to toxicity in humans. There exist problems with getting full dispersion throughout a room, unless the room can be completely sealed, and turbulence be introduced to encourage flow into nooks and corners.. This is a major problem, and would require expensive retrofitting for hospital applications.
As previously mentioned, one of the major reasons for which gaseous ozone has not been adapted as a whole room disinfectant is its corrosiveness (oxidation) when exposed to plastics and rubbers. A simple solution to this problem is to develop mobile sterilization units, which are completely self-contained, and do not have any of the potential issues associated with corrosion that a triage room in a hospital might have. These mobile units could be used for the complete disinfection of stainless steel surgical tools and other non-corrosive materials,
These recommendations provide SIGMA multiple opportunities to break into the industry. Sigma Medical Technologies’ team will continue to grow New Mexico’s economy in the area of manufacturing, research & development, exporting, sales, and training. SIGMA could directly affect NM taxation and revenue, the Federal Emergency Management Agency (FEMA), and the Centers for Disease Control. Ozone would create the largest local economic impact by finding ways to develop and manufacture within New Mexico.

VIII. RECOMMENDATIONS
We recommend three optional paths for Ozone that can be pursued independently. 1. Develop teaming agreements or partnerships with established companies to enhance their products and minimize market entry barriers. The larger brand name acceptance will enable SIGMA to strengthen its pursuit of secondary markets (recommendation #3). Failing to push Ozone into the mainstream pathogen control market, alternative use scenarios will likely also stagnate. As the opportunities to utilize SIGMA’s IP grow, pathogen destruction systems may flourish. Below we discuss 3M in depth (as a potential partner) but opportunities also exist with Cantel Medical and others listed in the competition section.

2. Develop IPs that expand usage of pathogen controls into existing and new build hospital facilities. This will necessitate major redesign criteria for the facilities to incorporate Ozone technology. This expansion will increase the use of the technology and position SIGMA as a key resource provider. Development of new IPs focused on Ozone and hospital design criteria, increases future opportunities in new markets. It also prepares SIGMA to gain more value from the sale of the IP to another company. In addition, utilization of SIGMA’s IP will generate greater protection through the life cycle of the product development.

3. Pursue entry into secondary foreign markets via the mobile field tent. Either lack of market penetration due to price point, or having better technology at the lower price point should create opportunity gaps in some of the remote areas near disease breakout “hot spots”. A large focus can be placed on the Middle East, Balkans, Africa, and remote Pacific/Far East region to target underserved markets. We believe a focus on technology continuous improvement, combined with exploring secondary and tertiary markets present the greatest profit potential if SIGMA chooses to maintain the IP. Conclusion: Teaming Agreements and/or Future Technology
There are companies on the fringe of the pathogen control industry that offer different sympathetic systems, which might be a potential partner for SIGMA. Cooperation with other firms might be a step towards a complete solution with several layers of security deployable solutions.

The 3M Company (3M):
3M might be a possible partner for SIGMA as they have an existing Supply Channel with well-developed clients for pathogen controls. 3M is active across international markets. They market a wide variety of products focusing on prevention, limitation of spread, hygiene, single use accessories, equipment, and consulting services. They are a major distribution channel with strong in place sales professionals, and a wide variety of complimentary products.

Ozone combined with a 3M product offering could be sold to foreign governments and aid societies, worldwide. 3M has the manufacturing connections to obtain good manufacturing pricing. They also have the funding and market clout to pursue development of a mobile field treatment center designed to work with Ozone. In the long run, 3M may be more interested in acquisition once the concept(s) are proven.

Final thoughts:
As described above there are several complimentary technologies and companies. We believe that partnering up with a company with a strong supply chain and market clout would be beneficial for both parties as the opens new doors for mobile pathogen controls. This solution would be a very cost efficient alternative and portable at the same time. We believe such a product could outcompete what is currently out there for mobile field treatment at outbreak “hotspots” as it brings underutilized technology into the market as something substantially different.

References:

S.T. Walsh, J.D. Linton, The Strategy-Technology Firm Fit Audit: A guide to opportunity assessment and selection 1-42.
M. E. Porter (1979). The Five Competitive Forces That Shape Strategy. Harvard Business Review, 25-41.
S.T. Walsh. Class Notes – Sessions 2 and 3.
Bass, Frank (1969). "A new product growth for model consumer durables". Management Science 15 (5): p215–227

William A. Rutala, Ph.D., M.P.H., David J. Weber, M.D., M.P.H., and the Healthcare Infection Control Practices Advisory Committee (HICPAC) (2008), Guideline for Disinfection and Sterilization in Healthcare Facilities, Centers for Disease Control (CDC)
Lippincott Williams & Wilkins (2001), Disinfection, Sterilization, and Preservation

Appendix 1:
Kondratieff Wave
Kondratieff Wave

Appendix 2:

(Technology Ventures, pg 6)
We are searching for an intersection of all three bubbles to determine if your opportunity fits into the window. You are most likely to succeed if there is an attractive “market pull” opportunity (someone is already willing to pay for the solution). Then your team has to have both the necessary skill sets and a passion to accomplish the project.

Appendix 3:
Six steps to acting like an Entrepreneur (Technology Ventures, pg 26) * Determining the entrepreneur’s capabilities and interests. * Identifying the opportunity * Evaluating the opportunity * Deciding to act on the opportunity or look elsewhere * Writing a summary of the concept * Testing the summary and the concept with potential customers and investors.

Basic 5 Step Process to Evaluate an Opportunity * Capabilities: Is the venture opportunity consistent with the capabilities, knowledge, and experience of the team? * Novelty: Does the product or service have significant novel, proprietary, or differentiating qualities? Does it create significant value for the customer – enough so that the customer desires the product and is willing to pay a premium for it? * Resources: Can the team attract the necessary financial, physical, and human resources consistent with the magnitude of the venture? * Return: Can the product be produced at a cost so that a profit is obtained? Is this expected return on the venture consistent with the risk of the venture? * Commitment: Do the entrepreneurial team members feel compelled to commit to this venture? Are they passionate about the venture?
(Technology Ventures, pg 37)

Appendix 4:
Technology Readiness Level (TRL):