COVID-19 Research From
A Systems Perspective

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COVID-19 Systems Perspective

Develop a systems perspective framework to be used to perform this and other future COVID-19 rapid response research. The purpose is to maximize the effectiveness of future rapid response research. The potential impact is that critical research is performed and transferred to use as soon as possible to save lives from the COVID-19 outbreak. The work done in Privatization A Systems Perspective is a template to follow for all other areas attempting to gain a systems perspective. Additional systems perspectives are in Systems Practices and Systems Design.

TOC

  1. COVID-19 Systems Perspective
    1. A Systems Approach to Research
      1. Fundamental and Applied Research
      2. Problem Solving in a Body of Knowledge
      3. Journalism
      4. Industrial Revolution Research Development and Product Development
      5. Systems Engineering
      6. Applied Research Labs
      7. Federally Funded Research And Development Centers (FFRDC)
      8. Research and Development
    2. Industrial Base
      1. Ventilators
      2. Small To Medium Sized Businesses Wanting To Manufacture Helmet Based Ventilators
        1. USA + Canada
        2. Outside USA
      3. Pharmaceutical Companies
    3. Systems Perspectives Triggered In this Research

Research


COVID-19

Return To Life

Systems Perspective

Ventilators


Systems

Systems Practices

Systems Design

Systems Perspective

System Architecture
(internal)

Systems Software
(internal)


A Systems Approach to Research

Systems engineering in the previous century was used to address new problems that were difficult to solve and the solution needed to be quickly developed. It is based on using an internal team and the vetting is done by the internal team up until the time when the first prototypes and production system elements are developed. This is why there are a large number of stakeholders on a system development team that even include the future users of the system. Eventually the system is deployed and it is either accepted or rejected as part of a verification and validation process that begins with the start of the project on day one.

Systems engineering uses modeling as much as possible. However, a major portion of systems engineering is qualitative in nature and relies on the system developers to make assertions about the system. This is referred to as key requirements, key issues, key observations, and key assumptions. This is an iterative process. As more is learned about the system the assertions come and go, some get backed up and others may never be backed up. The solution moves from broad abstraction views with little details to detailed specific views of the system. This is referred to as pealing the onion. The assertions are constantly updated as the system moves from high level abstractions to the details. The assertions are based on previous, current, and new:

  1. Engineering experience
  2. Scientific findings from fully accepted and vetted fundamental and applied research
  3. Information about all aspects of the system

These assertions are vetted by the system team. This is why it is critical to have a strong competent systems team well versed in their specialties and able to engage in critical thinking. The act of gathering all the facts and data to back up the assertions may take too much time and may not even be available because the area is new with little or no data. This approach relies on the judgment of the systems team because they determine which assertions survive and which fall by the way side. In the end the system will be verified and validated by the users, assuming there are no external forces making the users accept a poor or dangerous system solution.

A systems approach draws on work from 5,000 years of civilization. Obviously this includes various research activities:

  1. Fundamental and Applied Research
  2. Problem Solving in a Body of Knowledge
  3. Journalism
  4. Industrial Revolution Traditional Product Development
  5. Systems Engineering (itself)

The following is offered from Systems Practices As Common Sense:

What is Systems Engineering?

Imagine a place where you create things and make decisions where there are no hidden agendas and all stakeholders are treated equally. How would potential approaches surface, how would they be narrowed and selected, how would decisions be made? What tools and techniques would be used if they were not the greatest moneyed interests, the most politically powerful, or the most dangerous?

Systems Engineering is based on logical methods using reasonable techniques understood by reasonable people in a process that is fully transparent and visible to everyone. Everyone has a view of all the alternatives. Everyone has a view of all the decision paths. Everyone has an opportunity to impact the alternatives and decision paths.

Do not fall for the rhetoric that this is mob rule or design by committee. These are reasonable people using thousands of years of tools, techniques, processes, and methods to make informed decisions. There are no hidden agendas with vested interests or people who just give up and go silent or worse compromise. Everyone is comfortable with the decision because it is intuitively obvious to all. Everyone obviously has responsibility in such an endeavor. No one can ignore that responsibility.

The following was offered as a definition of Systems Engineering from Systems Engineering Design:

Discipline that concentrates on the design and application of the whole (system) as distinct from the parts. It involves looking at a problem in its entirety, taking into account all the facets and all the variables and relating the social to the technical aspect. -- Simon Ramo.

In the span of a year the systems team accesses and reviews thousands of pages of documents, dozens to hundreds of studies, and places all the information in an Engineering Notebook Library (ENB) that is used by new staff as they enter the project or program. As part of systems engineering - models are developed, various analysis is performed, prototypes are developed and understood, products are reviewed, site surveys are performed, stakeholders are included, etc. Every 3-5 days the staff present their findings to each other for review and discussion. This leads to new insights and new paths of research that lead to accessing more documents, studies, research, existing products information, etc. It is all placed in the ENB. Today we have the memex. Eventually a system solution starts to surface as part of an architecture description and then eventually an implementation. This solution is completely beyond any patents, non-disclosure agreements, and non-compete agreements because it is a breakthrough solution made up of elements from 5000+ years of civilization. Today some may view this as big science or big engineering. In the past this was viewed as just normal systems development done by very capable organizations able to organize the vast resources needed for such an activity. Entities that used patents, non-disclosure agreements, and non-compete agreements were viewed as bringing little to nothing to the table and they could be easily invalidated in any court of law. If something did become part of the system solution, the high tech ethical entities compensated the appropriate entities. They would be purchased outright or infused with massive money in a partnership arrangement to go to the next level and bring their critical new technology to market.

Author Comment: By 1980 many concluded that there was massive fundamental research and technology sitting on the table that needed to be accessed and converted to working systems. The estimates in the halls of some companies suggested that there was up to 20 years of research and technology that needed to be harvested and converted to working solutions and the only way to do this was to use systems engineering. Many also concluded that the massive research and technology was no longer attributed to a single or handful of inventors but hundreds of participants suggesting that the patent process no longer applied in the new complex world that surfaced after World War II. Instead the objective was to be the first to market rather than to seek patents that would be difficult if not impossible to defend. During that time the costs of computers and other machines dropped to a level where anyone could purchase computers and other equipment; The barriers of entry had all been removed. Massive capital investments were no longer needed. The society had become that efficient. Anyone could research, develop, and bring to market an infinite set of solutions. The "business / financial system" reacted and the result was the resurgence of patents and legal mechanisms to raise the barriers of entry and eventually block new work from all except those able to establish the new massive legal frameworks. By the end of the century fast food workers needed to sign non-compete agreements just to get a minimum wage job while assembling hamburger and French Fry meals. By the 21st century technical society publications were removed from all company libraries and the only way to access information was to become a member of hundreds of societies or work for very large universities that would provide library access. This eliminated 99% of the people from the social system that previously contributed to the research, development, technology, working products, and systems. The competition was effectively eliminated. Now we have to deal with the COVID-19 disaster and it remains to be seen if the 99% of the people locked out of the solution space will be able to participate like they did in the last half of the last century.

Fundamental and Applied Research

Fundamental research or pure research is research that everyone acknowledges may not lead to immediate benefits other than increasing the body of knowledge in a particular area. Basic research tends to be performed in universities and non-profit organizations with a research charter. Applied research deals with solving practical problems. These problems may be the result of a market analysis or other system needs analysis. It also may be the result of inspiration while engaged in or examining fundamental research. However the purpose is always to further some practical goal. This is in contrast to basic fundamental research, which is to discover new phenomena or new ideas of general interest. The steps in conducting research are:

  1. Identify research problem
  2. Literature review
  3. State purpose of research
  4. Data collection
  5. Interpreting data
  6. Analysis of interpreted data
  7. Reporting and evaluation of research

Research is vetted by peers that are spread across the world. Publication is how the research is vetted. This process by its very nature is slow. Because this vetting is long and complex it is critical to ensure that the research is backed up by significant amounts of data. One mistake in the data will cause the research to go back to the beginning of the publication and vetting process.  This delay can take years so years are spent internally vetting the research to ensure that it is rock solid.

Problem Solving in a Body of Knowledge

Problem solving in a body of knowledge is the act of solving a problem in a body of knowledge and publishing a paper on the work. This can be part of a technical conference or as part of a product development. In this case a simple set of questions are used to frame the content of the paper. They are:

  1. What problem is being potentially solved
  2. What are the current approaches to dealing with the problem
  3. What is wrong with the current approaches
  4. What are the alternatives to consider
  5. What is the proposed solution
  6. Why is the proposed solution better than the current approaches and the other possible alternative approaches

Problem solving in a body of knowledge is vetted by peers via publication in trade journals. Many do not wait to implement the approach to the problem that is being solved, instead they implement the solution. This is more of a disclosure process letting peers know what has been done to solve a particular problem. The actual solution is then accepted or rejected by the stakeholders that will depend on the solution.

Journalism

Journalists engage in research and the result is an information product that informs the reader. The elements that are always addressed in journalistic information products are:

  1. Who
  2. What
  3. Where
  4. When
  5. Why
  6. and the great works include How

The work of the journalist is vetted by all readers including other journalists. The challenge of the journalist is to ensure that all the facts are uncovered for each of the fundamental questions being asked and addressed. Propaganda, disinformation, misinformation are not journalism. Those information products may contain a large amount of journalistic elements but it is compromised with the introduction of just one element that pushes an agenda rather than discloses facts about the situation.

Industrial Revolution Research Development and Product Development

In the previous century great thinkers like Woody Woodpecker and Mickey Mouse taught that the modern miracle of US production was based on research in a process that included:

  1. Research and Development
  2. Find a new market
  3. Develop a Design
  4. Manufacture the design
  5. Distribute the design
  6. Wait for the cash to roll in

As a child I laughed at this as trivial and obvious. It was just common sense. Today I am horrified to see that this basic common sense has been removed from the culture. No one knows this and if you state it they laugh. The next horror that I recently learned is that you can't fix stupid. Stupid people have access to knowledge but they refuse to accept it for reasons that are at best bizarre and insane at worst. The key is to ensure that stupid people never are in important positions of authority especially systems engineering.

Systems Engineering

When engaged in systems perspectives there is a process that tends to be followed. There are many words that are used to describe the process and there are variants to the process but there is a core or essence that tends to be followed:

  1. Identify the need
  2. Determine the system boundary
  3. Find the key requirements
  4. Ensure ethics
  5. Gather stakeholders and get their inputs
  6. Perform technology searches
  7. Understand technologies
  8. Identify alternative architectures
  9. Identify alternative designs
  10. Select a lead architecture and keep tracking other architectures
  11. Perform vendor searches and Request for Information (RFI)
  12. Perform all the tradeoffs to select the architecture and design details
  13. Design and implement the solution
  14. Deploy the solution
  15. Constantly perform verification and validation beginning day 1

The following is offered as a quick start guide for a small system. It is based on small projects. It is an iterative process. Each process is unique and bound to a solution and organization. These are broad suggestions for consideration.

  1. Define the problem
  2. Identify the goals and objectives
  3. Collect data and information
  4. Define the process or methodology
  5. Perform system analysis and modeling
  6. Identify evaluation criteria
  7. Develop alternative solutions
  8. Evaluate alternatives against evaluation criteria
  9. Finalize selected alternative
  10. Implement and test
  11. If needed change evaluation criteria
  12. If needed reevaluate alternative as needed
  13. Final solution - a prototype
  14. Constantly perform verification and validation beginning day 1

The following is offered as quick start guide for very large-scale systems. This is based on a process used at Hughes Aircraft Fullerton. The applications were air defense and air traffic control. These systems were delivered around the world in various physical and cultural environments. They were and are some of the most complex systems known to humanity. Each process is unique and bound to a solution and organization. These are broad suggestions for consideration.

  1. Identify system users, maintainers, and managers
  2. Identify system boundary and why it is the boundary
  3. Identify key requirements and why they are selected (top 10)
  4. Identify key issues and why they are selected (top 10)
  5. Identify alternatives and why they are selected (4 to 9)
  6. Draw picture of each alternative (1 page)
  7. Succinctly state essence of each alternative (1 page)
  8. Tradeoff each alternative (include support for 100 years, etc)
  9. Apply science and engineering to each spin of tradeoff (don't cook the books or lie to yourselves)
  10. Identify how each approach can be built (process, methods, tools, etc)
  11. Build proof of concept prototype (from paper to computer simulations to physical models)
  12. Mature prototype at a small operational setting (try it before you make a mistake)
  13. Roll out solution to the infrastructure (slowly and learn)
  14. There is beauty in diversity (nothing wrong with multiple approaches and companies)
  15. Do this like your life depends on it
  16. Constantly perform verification and validation beginning day 1

As we list the activities associated with research, problem solving in a body of knowledge, other areas, and the systems perspectives there are correlations that can be made. The big question is can the systems perspective inform research and result in more effective research.

In the case of fundamental research there is overlap but it is unclear if a systems perspective will provide benefits to fundamental research. This is because the system solution is working towards a working system. Fundamental research may or may not provide a working solution because failure is a key element of fundamental research.

In the case of applied research there are benefits when the systems perspective is considered. Understanding the need and stakeholders force the applied research to be useful. We also see that adding alternatives and some form of selection to first an architecture concept prevents wasted time if design solutions are cherry picked and selected because of external influences. Adding the reality of determining the ability for an architecture to be produced ensures that the applied research can be realized and not lost in a paper exercise.

In the past applied research was performed in companies. Unfortunately in the 1980's all the great company research labs in the US were shed from the revenue producing elements. The research labs were cast adrift with no connection to reasonable funding sources and no connection to the reality of meeting stakeholder needs. The companies themselves lost the pipeline that fed them new products and ideas. What replaced this system was a venture capital based system and university participation in applied research. Both these events removed the systems perspective to applied research that existed when it was performed in company research labs.

ref: Systems Practices . Systems Design

Although we can point to new systems, products, and technologies, we may never know what may have been if the system of applied research did not lose its connections to a systems perspective. There has been an attempt to understand how our progress in new systems has changed since 1945 but it was from the perspective of privatization of government. The suggestion is that we have suffered a loss, but the loss may be attributed to the change in the fundamental research system. It is possible that privatization might have been the root cause of companies shedding their research labs and that may have translated to the suggested loss.

ref: Systems Perspective

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Today we have many being forced to accept poor and dangerous system solutions because of a collapse in management that started in the late 1980s. The Boeing 737 MAX is a classic example. So while we need systems engineering to address a crisis like the COVID-19 disaster, we need to understand that it can be easily compromised. The alternative of waiting for the long research cycle to start to offer solutions will still need to be converted to working systems with compromised management still able to damage the solution and yield a failed or dangerous system.

Applied Research Labs

Applied research labs were funded and controlled by companies in the previous century. They provided products and systems that addressed the massive needs of the commercial and industrial base that resulted in our modern civilization. Their notes of contribution are just a tiny sampling of what they provided. The following is a small sampling of these research labs.

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Federally Funded Research And Development Centers (FFRDC)

Federally Funded Research and Development Centers (FFRDCs) are public-private partnerships that perform research for the US Government. They are funded each year by congress. During World War II scientists, engineers, and mathematicians became part of the massive war effort and it was recognized that this led to winning the war. The key contributions included RADAR, aircraft, computing, and nuclear weapons. It was recognized that there was a need for organized research and development in support of the government. This was formally published in the paper Science The Endless Frontier [ref] and made into policy after the war. Government officials and their scientific advisors advanced the idea of a systematic approach to research, development, and acquisitions, one independent of the ups and downs of the economy and free of the restrictions placed on civil service. From these needs and resulting requirements the FFRDCs were established. FFRDCs are private entities that would work almost exclusively on behalf of the government, are free of organizational conflicts of interest, and maintain a stable workforce composed of highly capable talent. The RAND Corporation was established in 1947 and it supports the U.S. Air Force. MIT Lincoln Laboratory, was established in 1951, it originated from the Radiation Laboratory at MIT. The Navy's Operation Research Group evolved into the Center for Naval Analyses.

The Centers for Disease Control and Prevention (CDC) has undergone several name changes through the decades but it was formed in 1946 with roots that trace back to the Office of Malaria Control in War Areas in 1942. It is a Federal Agency, under the Department of Health and Human Services. Its mission is to protect public health and safety through the control and prevention of disease, injury, and disability both domestically and internationally. The CDC focuses on developing and applying disease control and prevention especially infectious disease and food borne pathogens. Other areas include environmental health, occupational safety and health, health promotion, injury prevention and educational activities for the purpose of improving the health.

There are many FFRDCs but there is no FFRDC to support the needs of the COVID-19 crisis. This is a list of existing FFRDCs by Agency, Sub Agency and FFRDC Name:

[ref]

  1. Department of Defense Department of the Air Force The Aerospace Corporation Aerospace Federally Funded Research and Development Center nonprofit institutions other than universities and colleges Systems engineering and integration centers
  2. Department of Defense Department of the Army RAND Corp. Arroyo Center nonprofit institutions other than universities and colleges Study and analysis centers
  3. Department of Defense Office of the Under Secretary of Defense for Research and Engineering MITRE Corp. National Security Engineering Center nonprofit institutions other than universities and colleges Systems engineering and integration centers
  4. Department of Defense Office of the Under Secretary of Defense for Research and Engineering MITRE Corp. National Security Engineering Center nonprofit institutions other than universities and colleges Systems engineering and integration centers
  5. Department of Defense Department of the Navy The CNA Corporation Center for Naval Analyses nonprofit institutions other than universities and colleges Study and analysis centers
  6. Department of Defense National Security Agency/Central Security Service Institute for Defense Analyses Center for Communications and Computing nonprofit institutions other than universities and colleges Research and development laboratories
  7. Department of Defense Office of the Under Secretary of Defense for Research and Engineering Massachusetts Institute of Technology Lincoln Laboratory universities and colleges, including university consortia Research and development laboratories
  8. Department of Defense Office of the Under Secretary of Defense for Acquisition and Sustainment RAND Corp. National Defense Research Institute nonprofit institutions other than universities and colleges Study and analysis centers
  9. Department of Defense Department of the Air Force RAND Corp. Project Air Force nonprofit institutions other than universities and colleges Study and analysis centers
  10. Department of Defense Office of the Under Secretary of Defense for Research and Engineering Carnegie Mellon University Software Engineering Institute universities and colleges, including university consortia Research and development laboratories
  11. Department of Defense Office of the Under Secretary of Defense for Acquisition and Sustainment Institute for Defense Analyses Systems and Analyses Center nonprofit institutions other than universities and colleges Study and analysis centers
  12. Department of Energy Iowa State University Ames Laboratory universities and colleges, including university consortia Research and development laboratories
  13. Department of Energy UChicago Argonne, LLC Argonne National Laboratory universities and colleges, including university consortia Research and development laboratories
  14. Department of Energy Brookhaven Science Associates, LLC Brookhaven National Laboratory nonprofit institutions other than universities and colleges Research and development laboratories
  15. Department of Energy Fermi Research Alliance, LLC Fermi National Accelerator Laboratory universities and colleges, including university consortia Research and development laboratories
  16. Department of Energy Battelle Energy Alliance, LLC Idaho National Laboratory industrial firms Research and development laboratories
  17. Department of Energy University of California Lawrence Berkeley National Laboratory universities and colleges, including university consortia Research and development laboratories
  18. Department of Energy Lawrence Livermore National Security, LLC Lawrence Livermore National Laboratory industrial firms Research and development laboratories
  19. Department of Energy Triad National Security, LLC Los Alamos National Laboratory industrial firms Research and development laboratories
  20. Department of Energy Alliance for Sustainable Energy, LLC National Renewable Energy Laboratory nonprofit institutions other than universities and colleges Research and development laboratories
  21. Department of Energy UT-Battelle, LLC Oak Ridge National Laboratory nonprofit institutions other than universities and colleges Research and development laboratories
  22. Department of Energy Battelle Memorial Institute Pacific Northwest National Laboratory nonprofit institutions other than universities and colleges Research and development laboratories
  23. Department of Energy Princeton University Princeton Plasma Physics Laboratory universities and colleges, including university consortia Research and development laboratories
  24. Department of Energy National Technology and Engineering Solutions of Sandia, LLC Sandia National Laboratories industrial firms Research and development laboratories
  25. Department of Energy Savannah River Nuclear Solutions, LLC Savannah River National Laboratory industrial firms Research and development laboratories
  26. Department of Energy Stanford University SLAC National Accelerator Laboratory universities and colleges, including university consortia Research and development laboratories
  27. Department of Energy Jefferson Science Associates, LLC Thomas Jefferson National Accelerator Facility universities and colleges, including university consortia Research and development laboratories
  28. Department of Health and Human Services Centers for Medicare and Medicaid Services MITRE Corp. CMS Alliance to Modernize Healthcare nonprofit institutions other than universities and colleges Study and analysis centers
  29. Department of Health and Human Services National Institutes of Health Leidos Biomedical Research, Inc. Frederick National Laboratory for Cancer Research industrial firms Research and development laboratories
  30. Department of Homeland Security Science and Technology Directorate RAND Corp. Homeland Security Operational Analysis Center nonprofit institutions other than universities and colleges Study and analysis centers
  31. Department of Homeland Security Science and Technology Directorate MITRE Corp. Homeland Security Systems Engineering and Development Institute nonprofit institutions other than universities and colleges Systems engineering and integration centers
  32. Department of Homeland Security Science and Technology Directorate Battelle National Biodefense Institute National Biodefense Analysis and Countermeasures Center nonprofit institutions other than universities and colleges Study and analysis centers
  33. Department of the Treasury Internal Revenue Service MITRE Corporation Center for Enterprise Modernization nonprofit institutions other than universities and colleges Systems engineering and integration centers
  34. Department of Transportation Federal Aviation Administration MITRE Corp. Center for Advanced Aviation System Development nonprofit institutions other than universities and colleges Research and development laboratories
  35. National Aeronautics and Space Administration California Institute of Technology Jet Propulsion Laboratory universities and colleges, including university consortia Research and development laboratories
  36. National Institute of Standards and Technology MITRE Corp. National Cybersecurity Center of Excellence nonprofit institutions other than universities and colleges Systems engineering and integration centers
  37. National Science Foundation University Corporation for Atmospheric Research National Center for Atmospheric Research universities and colleges, including university consortia Research and development laboratories
  38. National Science Foundation Association of Universities for Research in Astronomy, Inc. National Optical Astronomy Observatory universities and colleges, including university consortia Research and development laboratories
  39. National Science Foundation Associated Universities, Inc. National Radio Astronomy Observatory universities and colleges, including university consortia Research and development laboratories
  40. National Science Foundation Association of Universities for Research in Astronomy, Inc. National Solar Observatory universities and colleges, including university consortia Research and development laboratories
  41. National Science Foundation Institute for Defense Analyses Science and Technology Policy Institute nonprofit institutions other than universities and colleges Study and analysis centers
  42. Nuclear Regulatory Commission Southwest Research Institute Center for Nuclear Waste Regulatory Analyses nonprofit institutions other than universities and colleges Study and analysis centers
  43. United States Courts Administrative Office of the United States Courts MITRE Corp. Judiciary Engineering and Modernization Center nonprofit institutions other than universities and colleges Systems engineering and integration centers

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Research and Development

MITRE has stepped up to the COVID-19 challenge. At the request of the Mayo Clinic, they have formed the COVID-19 Healthcare Coalition and they have redirected internal resources [ref] to deal with the COVID-19 crisis. The challenge is to link MITRE to commercial industrial companies. That link is missing and it is critical that this link be established because Applied Research has no value unless it is connected to Development and ultimately Manufacturing.

Research and Development

Why is the previous Hughes Aircraft discussion so important today. It is critical to understand that rich people today are not like Howard Hughes. There is no equivalent to Hughes Aircraft. There is also no equivalent to RCA. The reality is only nation state resources can address massive problems especially the COVID-19 crisis. They have the money and the power to organize the people and the industrial base.

The following is sourced from: Privatization a Systems Perspective.

The tone and policy of the US between 1945 and 1980 was set when President Roosevelt requested a report from the Office of Scientific Research and Development on what can be done after the war. This resulted in the report Science the Endless Frontier [NSF]. The government architecture was as shown below: Pre-Privatization US Federal Government.

Pre-Privatization US Federal Government

After 1980 there was a new set of policies that started to surface and became entrenched by 1987. Privatization of the US Government began in 1987 when President Reagan signed Executive Order 12607. This resulted in the report, Privatization Toward More Effective Government. This set the tone and policy in the US that still exists today. In their day even Hughes and Sarnoff at RCA would have contacted the Federal Government to offer  help but they clearly would have stated that they could not deal with this challenge and that the Federal Government must step in to marshal the needed resources in a coordinated systematic way. Unfortunately the industrial base and the government architecture have changed as shown below: Post Privatization US Federal Government.

Currently the National Governors Association is the focal point for dealing with the US COVID-19 disaster.

Post Privatization US Federal Government

There is now evidence suggesting that privatization has led to systemic government shutdowns and other negative unintended consequences including serious damage to the industrial base, colleges, universities, and the citizens of the United States. [ref] Has privatization also broken the research, development, and manufacturing process that existed in the previous century? Is this why the USA is struggling and performing so badly when dealing with the COVID-19 Pandemic?

Systems Architecture Big Picture

There is the big picture of the total system that includes both government and industry where industry encompasses everything including Universities and All Research. When the big picture system is examined there are new insights that surface.

The big picture system has inputs and like all systems it has outputs based on a transfer function . The transfer function is based on laws, regulations, international agreements, enforcement, and available natural resources. As the transfer function changes, the outcomes change. This is a massive system so any changes in the transfer function have a large hysteresis. Most of the transfer function changes manifest themselves in the outcomes over years or decades. We also know that this is a complex system with massive internal dependencies, and it is difficult to predict the outcomes when there are changes. In most instances all we can really do is observe the outcomes. If the outcomes are bad, we can tweak the system in some direction until the outcomes move away from a bad condition. If the outcomes are good, we can still tweak the system to get even better outcomes.

The outcomes can be identified and tracked using quantitative and or qualitative data. The ultimate check comes with the citizens who control the system by votes and participation in the system.

The system should respond to the outcomes in a causal loop, but it does not in all instances. If the outcomes are ignored for a very long period and the population suffers long enough the system self corrects with a revolution. The big issue is the outcome levels between an ideal system and a poor system. The citizens may suffer but not enough to move into a revolutionary state.

The transfer function in the system might be reasonable or even the same as in other high-performance systems but the system outcomes may be very poor. In this case the system is compromised and the transfer functions while written down and institutionalized may not be used by the actual system. Instead hidden stakeholders have implemented hidden transfer functions to game the system in their favor at the expense of everyone else. This is a compromised system.

The US previously led the world in dealing with crisis situations. This was viewed as sound policy to ensure a safe and stable world. As the Federal Government has stepped away from its leadership role in the US the USA has stepped away from its leadership role in the world. Just like the states depended on the Federal Government to properly lead the COVID-19 crisis response, the rest of the world depended on the USA to take on that lead. Is it possible that the world wide COVID-19 pandemic is a direct result of the loss of US Federal Government leadership? What will history write?

Moving forward when addressing the concept of a COVID-19 Rapid Response Research effort, will the research be effective and will a Systems Perspective help to make the research more effective? If so, who or what will add the systems perspective to the COVID-19 research especially the Applied Research, Development, and Manufacturing?

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Industrial Base

Ventilators

Projections suggest the US needs 900,000+ ventilators and the current supply is completely inadequate. Further the US has limited manufacturing capacity to deal with this shortfall. The Society of Critical Care Medicine estimates about 960,000 COVID-19 patients in the U.S. might need a ventilator. But there are only about 200,000 machines available. The potential impact is that millions of people may die unless the ventilator need is satisfied immediately. The major manufacturers are outside the US and unable to handle the demand.

ICU ventilators

Country

Market

Getinge Sweden 22%
Hamilton Medical USA, Switzerland 22%
Drager Germany 16%
Mindray China 10%
Medtronic Ireland, USA 5%
Lowenstein Medical Germany 3%
Vyaire Medical USA 3%
GE Healthcare USA 3%
Philips Respironics Netherlands 3%
Others 15%

Major manufacturers 2019 [wiki ref].

       

Mobile ventilators

Country

Market

Drager Germany 24th
Weinmann Medical Germany 21st
Hamilton Medical USA, Switzerland 18th
Vyaire Medical USA 5th
Customs Japan 4th
O Two Canada 4th
Smiths Medical USA 4th
Medtronic Ireland, USA 4th
Air Liquide Healthcare France 3rd
(and 13 other vendors)

The reality is that the rich around the world have purchased their own machines for their personal needs. Even if the US government imposed controls it would be of no value. The only alternative is to search for Small to Medium Sized Businesses (SMB) with capabilities close to what is needed for low tech ventilators. Asking an automobile company to retool to start to manufacture ventilators is irresponsible and shows a complete lack of a systems perspective. However, they should start Ford . GM. But in addition the SMBs need to be mobilized to also begin production of Ventilators.

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Small To Medium Sized Businesses Wanting To Manufacture Helmet Based Ventilators

The following is a list of companies and funding sources expressing interest in manufacturing Helmet Based Ventilators. It is included here to illustrate that there is something very wrong with US industrial policy and its response to the COVID-19 crisis. There is also something very wrong with Applied Research in the USA. This may be an example of the collapse of Applied Research in the USA.

USA + Canada

  1. Alaska ACI Industries LLC Engineering Engineering, Design & Build firm in Alaska interested in manufacturing the helmets kenofak1@gmail.com
  2. Arizona Arizona Governor's Covid-19 Task Force Funding, Manufacturing Interested in producing/manufacturing the helmets. Have access to funding companies that are willing to help. eric.miller@padtinc.com
  3. California https://www.linkedin.com/in/robross VC, manufacturing Have connections with possible funding and contacts with manufacturers that can help in producing the helmets
  4. California pro-dex.com medical device manufacturer Medical device manufacturer in CA, can help assemble the helmets and have potential funding available jamie.rudy@pro-dex.com
  5. Canada UBC Sprint Open Source Emergency Ventilator Project working DIY prototype Their team produced a working DIY prototype but they need professionally made mass manufactured version. They are also looking for potential collaborators with manufacturing and prototyping capabilities. vkgusti@gmail.com
  6. Canada Thomas Fox Helmet Expert Helmet expert providing information on NIV in the management of the COVID 19 patients.
  7. Canada aon3d.com 3d printers thermoplastics. Helping to fabricate proof of concept of the helmet device in Quebec. Looking for connections and design support that they can use so they can make it locally. andrew@aon3d.com
  8. Illinois MacLean Fogg engineered plastics Interested in producing/manufacturing the helmets. They have a division specializing in engineered plastics.
  9. Illinois Heather L Natal manufacturing Can connect with Illinois Manufacturer's Association. Have connections with equipment and 3D printing suppliers that can help in the production of the helmets heathernatal@gmail.com
  10. Illinois/Pennsylvania https://ambifi.com/ Clinician Virtual Assistant partnered with the U of Chicago to create a hands-free digital assistant. Go to https://ambifi.com/ and click on COVID-19. james.sharpe@ambifi.com
  11. Iowa GuttenbergIndustries.com custom plastic injection molder Plastic injection molder manufacturing firm based in Iowa that can help produce the rings or other parts of the helmet GYoko@GuttenbergInd.com
  12. Michigan T. A. Systems Manufacturing Automation and assembly company in Michigan specializing in plastic welding and assembly equipment. They would like to help in manufacturing the helmets tmartin@ta-systems.com
  13. Michigan STEWART Industries US Manufacturing Medically certified manufacturing company in Michigan, FTZ and can help with mass production sworden@stewartindustriesusa.com
  14. Michigan CSErickson.com manufacturing Electrical and technology contractor in Michigan, interested in assisting with producing the helmets. Have connections with different manufacturers in Michigan that can also help in this endeavor. bobby.roush@cserickson.com
  15. Michigan Lisa Markman, MD doctor Physician from Michigan who have connection with a manufacturing firm that can help produce the helmets lisarachelmarkman@gmail.com
  16. Nevada Jeffhallsales.com aerospace Manufacturing firm in Nevada that has the tooling, work space, quality control, testing, and skilled workforce to assemble the helmet. jeff@jeffhallsales.com
  17. New York R4 Incorporated manufacturing Have open floor manufacturing space and manufacturing support equipment in Maryland that can be converted to ventilation helmet manufacturing facility dlewis@r4-inc.com
  18. Rhode Island Videology Imaging Solutions manufacturing Electronics manufacturing firm in RI, interested in helping out with the production/manufacture of the helmet-based ventilators. rnadeau@videologyinc.com
  19. Texas Creaninc.com "Aerospace
  20. Engineering" Can assist manufacturing firms in set up and expanding operations and can also connect with suppliers of equipments and logisitics bspecchio@creaninc.com
  21. USA American Airlines Manufacturing Maintenance division of American Airlines with manufacturing capabilities and can help in production of the helmets Stacey.L.Brown@aa.com
  22. USA https://www.ecolab.com/ manufacturing Manufacturing firm that makes hand sanitizer dispensers that have multiple assembly locations across the US , can help in producing the helmets. pat.barrios@ecolab.com

Outside USA

  1. Honduras biomedical engineer biomedical engineer Biomedical engineer looking for more information about the helmet based ventilation. They have a cpap equipment and wanted to know more about the helmet masks.
  2. Taiwan & China PQD International manufacturing Design, engineering, and manufacturing firm with global presence in the USA, China, Taiwan, and Vietnam williewu@pqdusa.com
  3. India Raunak Khandelwal doctor Doctor in India asking for contacts for manufacturers that can supply to India. Looking for designs they can submit to local manufacturers so it can produced locally instead. raunakrkhandelwal@gmail.com
  4. Ireland Keith Garland Open Source Ventilator Project Looking for designs they can liaise with local manufacturing companies to enable them to start producing locally in Ireland. Also asking for resources for 3D printing of parts cagiest@gmail.com
  5. Israel sionbrands.com medical device manufacturer Medical device manufacturer from Israel asking where they can get the specs/design to produce the helmets nadav@sionbrands.com
  6. Brasil Viviane Teleginski Mazur developing helmet They are developing a simple helmet in Brazil and needs technical information regarding the helmet based ventilation so they can copy it. teleginski@gmail.com
  7. Poland Marek Macner developing helmet Developing helmet + CPAP + turbine constant flow ventilator. info@idiab.dev

[ref]

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Pharmaceutical Companies

There are hundreds of pharmaceutical companies that form the industrial base. A list of  pharmaceutical companies is maintained at [wiki ref]. The following is a list of the top 25 companies by sales.

Company Country Sales
($ million)
Pfizer USA 45,083
GlaxoSmithKline UK 40,156
Sanofi-Aventis France 38,555
Roche Switzerland 27,290
AstraZeneca UK, Sweden 26,475
Johnson & Johnson USA 23,267
Novartis Switzerland 22,576
Merck & Co USA 20,375
Wyeth USA 16,884
Lilly USA 15,691
Bristol-Myers Squibb USA 13,861
Boehringer Ingelheim Germany 13,860

Top 25 Drug Companies 2006 [wiki ref]

Company Country Sales
($ million)
Amgen USA 13,858
Abbott Laboratories USA 12,395
Bayer Germany 10,162
Takeda Japan 8,716
Schering-Plough USA 8,561
Teva Israel 7,821
Genentech USA 7,640
Astellas Japan 7,390
Novo Nordisk Denmark 7,087
Daiichi Sankyo Japan 6,790
Baxter International USA 6,461
Merck KGaA Germany 5,643
Eisai Japan 4,703

The manufacturing of the drugs may be outsourced to China and India. The FDA regulations are different for US versus non US manufacturing facilities. This is a significant issue because of quality problems that surface during manufacturing. This has been detected with the COVID-19 test kits ordered by individual US states to deal with the crisis. Test kit orders originating from Chine have been defective and US states have been stuck with useless products. This is not just a US problem it is international.

Spain returned more than 600,000 flawed kits to its manufacturer, a Chinese company Shenzhen Bioeasy Technology. Spanish health authorities didn’t seem concerned that the company isn’t permitted to sell them in China itself. When microbiologists pre-trialed the kits on a sample of known COVID-19 patients and only 30 percent were accordingly diagnosed, Health Minister Salvador Illa tried covering his department’s back by claiming Bioeasy was licensed to sell kits across the EU but provided no evidence to prove it.

The Czech Republic purchased 300,000 kits for $1.83 million to carry out 900 daily tests but they were only 20 percent accurate. The EU Medicine Agency’s guidelines, on par with the U.S. Centers for Disease Control and Prevention’s (CDC), require that tests be 80 percent accurate on average.

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Systems Perspectives Triggered In this Research

The key systems perspectives triggered for each project are shown below.

A: Project - Systems Perspective

B: Project - Ventilators

C: Project - Return to Life Systems

Systems Perspectives Triggered

A
Systems
Perspective

B
Ventilators

C
Return to Life

Systems Approach 04/01/2020 04/05/2020 04/22/2020
System Design Theory Philosophies and Art 04/01/2020 04/05/2020 04/22/2020
Ethics 04/01/2020 04/05/2020 04/22/2020
Needs Analysis 04/18/2020 03/21/2020 04/22/2020
Stakeholders Analysis 04/18/2020 03/21/2020 04/22/2020
Systems Boundary 03/21/2020 04/22/2020
Key Requirements Analysis 03/21/2020 04/22/2020
Creativity Process 04/18/2020 03/21/2020 04/22/2020
Technology Assessment and Management 04/04/2020 04/22/2020
Architecture Identification 03/24/2020 04/22/2020
Tradeoffs & Decision Making 04/05/2020 04/22/2020
Systems Library 04/05/2020 04/05/2020 04/22/2020
Quality / Test / Certification
Human Factors 04/22/2020
Architecture Tradeoffs 04/09/2020 05/03/2020
Architecture(s) selection 04/09/2020 05/03/2020
Vendor Search 04/06/2020 05/03/2020
Vendor Request For Information (RFI) 04/06/2020

As time moves on other systems perspectives will be triggered. The dates intend to capture the triggered times. It is interesting to see the large number of systems perspectives triggered with just the inception of this research. As time moves on it is anticipated that new systems perspectives and more depth will be added to each of the triggered systems perspectives.

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