Diversifying Cryonics Into Mainstream Corporate America

Chapter 1 posted here online 5/15/2007

Note:  While I have been fortunate to receive advice and editing assistance on this article, the opinions and ideas in it are my own and do not necessarily represent the opinions of my employer or others within the cryonics community, including those who provided advice.

In early 2006, Steve Bridge wrote an article where he asked if cryonics was on "the wrong path," i.e., if cryonics leaders had missed an opportunity for cryonics to be more closely identified with the field of emergency medicine, and he speculated that a different approach might have gained valuable acceptance for cryonics.  Steve identified an important problem with his article, but the article was short on identifying the practical steps to a new path.  I would like to thank Steve for providing this foundation for others to build on and for giving me the impetus to explore how my experience in cryonics might help provide some of the answers.

For those who are unfamiliar with me, I’ve been actively involved in cryonics for 12 years and a member since 1996.  I was employed at Alcor Life Extension Foundation from 1996 to 2005, where my responsibilities ranged from Patient Care and Facility Operations Manager to Director of Suspension Readiness, including participation in over 40 cryopreservation procedures.  I’m currently an Advisor to the Alcor Board of Directors, and my father is a suspension patient at Alcor.  As of 2005, I have been employed at Suspended Animation Inc., where my responsibilities include maintaining the operating room and lab readiness, participation in developing new stabilization and cryoprotection technologies, and maintaining relationships with vendors and sales representatives.

 

Chapter 1

Aligning with the Medical Establishment by Outsourcing

Introduction

Throughout much of our history, cryonics has been vulnerable and lacked stability due, in part, to limited options when potential cryonicists are looking for providers of cryonics services.  In turn, the few cryonics providers have had limited options when they were looking to hire individuals or to contract with companies to provide the specialized services that cryonics companies need. 

There have been attempts to alleviate this problem by inserting capitalism into cryonics by splitting off parts of the cryonics process into such private companies as BioPreservation, BioTransport, Kryos, etc.  None of these attempts have been particularly successful so far.  A common theme exists between these attempts and similar challenges others have had to face over the years -- a lack of fulltime medical professionals interested in being part of cryonics and committed to providing the best care possible.  This lack has resulted in the inevitable over-reliance on key individuals.  On several occasions, losing the one or two most knowledgeable and committed individuals has compromised the ability of organizations to stay in business and remain effective.  If cryonics companies had the positive reputation and the financial ability to hire and replace full-time medical staff as easily as a hospital does, the challenge would be reduced, of course. 

One way we can reduce the risk of being overly reliant on key individuals is to diversify the special knowledge and abilities available to us by means of "outsourcing."  By this, I do not mean creating new companies that specialize in an area of our business (and which are at least as likely to fail as other new businesses).  Instead we need to build relationships with existing corporations that have established track records of success outside of cryonics.  Long-term, we may need to work toward a full merger of cryonics with the medical establishment.

Current outsourcing

There are parts of this business which have, to a varying degree, already been outsourced such as the production of patient Dewars, neuro cans, whole body pods, utilization of an emergency answering service, use of contract medical professionals, etc.  Given enough time, one might expect the outsourcing of cryonics would naturally occur on its own where it is reasonable to do so, but I think it would be a great benefit for us to accelerate that process now.

Lessons learned and lost

There are plenty of challenges associated with trying to professionalize cryonics.  One is simply that of developing continuity of personnel.  During my ten years of being paid to do cryonics, I have gotten a new supervisor every six to twelve months and the process of watching people learn old lessons begins again.

As a relatively benign example, in the early days of cryonics the primary means of gaining access to medications was the equivalent of dumpster diving.  Cryonics companies arranged with medical facilities and medical supply companies to donate their expired and expiring medications for "research."  Early cryonics companies didn't have much money, and many manufacturers and suppliers were suspicious of cryonics and refused to sell medication directly to them.  Even though a medication may have officially expired, that does not mean it is necessarily bad and could not be used successfully on a patient.  For example, heparin is a clear solution and one way to know that it is appropriate to dispose of it is when it turns yellow; as long as it remains clear, it is still considered good.  Since the medications were to be used on what were legally "dead bodies," there were no legal implications. 

Part of the reasoning behind the difference of opinions in regards to expiration dates placed on medications by the manufacturer is that the manufacturers do not test the viability beyond the date listed. As you might imagine, there are allegations in the pharmaceuticals industry that there is a profit motive influencing expiration dates to improve sales.  This point of view would state that expired medications are probably just fine for years.

Then there are those on the other side of the debate in cryonics who say expired meds gives the wrong impression to the medical community when we interact with them.  Their opinion is that we give the appearance of not adopting professional standards on basic medical issues; therefore, they say that expired meds should not be used aside from training.

The consequence is that one administration from the next changes the official position on what is permissible -- even though cryonics companies can now buy new medications off-the-shelf or minimize costs by using what they have in stock before ordering more.  This cycling of policy has sometimes resulted in the use on actual cryonics patients of medications that were much further beyond their official expiration date than would have been necessary with proper rotation.  As a result, I learned early on that expired medications which were being relocated to training supplies -- where the expiration dates stood out -- instead should be conveniently and quietly relocated to the trash without discussion.

This slow learning curve does not necessarily apply to everyone who has come and gone over the years, but the degree of turnover is unhealthy in my view.   There have been those who have had good credentials and healthy commitment to high standards; but often they end up running for the door or being pushed out by the amateurs who are determined to stay.  Part of the challenge is that those who uphold high standards want to fix everything and are inclined to burn themselves out.   Also, the more amateur cryonics employees may end up working against the professionalism of a new employee, perhaps because the skills that the professional brings to the job -- skills that may be necessary to meet higher, medical standards in cryonics -- may exceed the abilities or the commitment of the employees already in place.

Naturally, professionals seek competitive pay; but they also look for job satisfaction and want to make a positive contribution to our field.  They want to be able to practice their skills regularly and work in a professional environment.  They want their knowledge and experience to be valued and appreciated by both management and co-workers.  If we cannot provide this kind of work environment, it will be difficult to retain professional medical and science employees in cryonics, and we cannot expect the improvement in quality of service delivered to our patients that professionals could bring.

Fear of professionals  

This difference between the standards expected by medical professionals and the standards promoted by cryonics amateurs may result in the amateurs appearing to be intimidated by the professionals.  If a cryonics company hires a medical professional who expects and attempts to implement higher standards of cleanliness, accuracy, performance, etc., the older, more amateur employees of the company, including managers, can feel that their previous work is being demeaned or insulted.  For many people, these new perspectives and demands for improvements can be hard medicine to swallow.  The too frequent human reaction is to belittle the improvements as unnecessary, insulting the person who suggested the improvements.  The result is the continued dumbing down of cryonics procedures, keeping the procedures simple enough for lightly experienced amateurs, and a focus on maintaining the status quo.  Often it seems like the best way for the cryonics leaders to avoid this conflict is to make sure they hire new employees less capable than themselves.  While that avoids conflict, it does nothing to improve the results for our patients.

One excuse that has been used to avoid hiring professionals is that they often bring with them medical attitudes and habits that are opposed to what we are trying to accomplish in cryonics.  Sometimes pros need to unlearn a few habits in support of cryonics, but they are often a quicker study than those who are untrained in medicine and lack relevant experiences.  We can have problems with any employees.  This is not a reason to avoid hiring professionals.

This fear is also related to the suspicion of outsourcing.  Outsourcing aspects of our business in the same way hospitals do also gets medical and technical professionals involved, who have higher standards of quality than most of the employees in cryonics are capable of upholding.  This can threaten cryonics employees.  Equally important may be the fact that cryonicists and the other people in work in this field tend to be people who want a lot of individual control, and outsourcing tends to lessen that control.

Related to this are the cryonics employees' potential loss of status by losing duties that are the basis for maintaining one’s position in the business, and perhaps even the perception that improved quality and professionalism could threaten the less trained employees with the loss of their jobs.  Ironically for cryonicists, simple fear of change probably plays into this perception, as well. 

However, cryonics employees who are ready to adapt, as must employees in rapidly changing industries all over America today, should have little to fear.   There is an extremely long list of issues that need to be resolved before we can think about reviving any given patient, even under the best of circumstances using the latest protocols today.  Until cryonics is no longer necessary and all those who can be revived are revived, our mission is not complete and there is work to be done.  As long as we are committed to this field and are willing to exchange old responsibilities for new ones, there is ample room for continued employment.  There is perhaps a greater risk of job loss by refusal to change in cryonics, making the entire field eventually seem less relevant and less capable of fulfilling its promises.

Outsourcing Myself

From a personal perspective, if there is anyone exposing themselves to a loss of traditional duties within the industry, it’s me.  The areas I have looked into spinning off are the ones that I’m most familiar with and on which I have based my employment.  You might think that an attempt on my part to outsource my area of experience is equivalent to a soldier giving their location for bombardment when the enemy is on top of them.  However, cryonics is in such deep need for a revolution in the quality of care provided, that I think that is what is required.  I have enough confidence in my knowledge of the needs of cryonics that I can be part of the "integration team" and then eventually find new areas in cryonics to work on. 

The real enemy in our business has been a self-imposed monopolistic institution that is influenced by individual monopolies, due in part to limited membership growth and our lack of integration within the medical industry.  As a consequence, it is my belief that our business model has been largely stagnant over the past forty years compared to what could have been if we had chosen a true medical model.

Giving away one’s leverage so there is no leverage

One way we can break this inadequate business model is to give today's knowledge away freely and to allow individual technical tasks to take on a life of their own, similar to when the communications industry was broken up.  By outsourcing my own knowledge base and making my traditional position vulnerable in cryonics in the short-term, I believe this will ultimately stimulate the creation of more jobs with companies that operate in a professional manner and result in a better end product for our use. 

The downside from the perspective of some might be that amateurs entering this field in the future would only be given jobs in accordance with their actual educations and skills.  We would no longer be creating surgical assistants out of librarians, computer programmers, and real estate managers.  But if you look at cryonics from the point of view of "you as prospective suspension patient," this is a very good change.  And if you are serious about cryonics, what other point of view is valid?

Eventually, decisions on medical and technical questions will be assigned to those who are duly qualified.  Those who have little or no understanding of medicine will no longer be allowed to make the most important medical decisions of our patients' (and our own) lives.  This last point cannot be overemphasized, because in today's cryonics organizations the final decision on what is best for any given patient can easily rest with someone who not only has no formal medical background, but who may have little practical experience in cryonics.

Self-imposed limits on vendor communication

A problem in the past has been how to communicate with vendors about what cryonicists do and why we need their products.  There have been at least two conflicting approaches within cryonics.  One is between people who think that we need to carefully follow all federal regulations and limitations, sensible or not, and those who have a sort of “ultra-libertarian” approach that says we should do whatever we think is useful whenever we want, as long as we think it is good for the patient and for cryonics.  In the short run, this second approach might make us feel good about our independence; but such defiance serves to alienate the professionals we need to reach our ultimate goals, especially since we often cannot know if those decisions really were better for the patient.  We do more to gain the respect and support of professionals when we take the time to learn rules and regulations and demonstrate how we are making progress in those directions.  In my experience, when we have been willing to do what it takes to get the job done right, we have gained a payoff in having major corporations not only signing on to help us with our business needs, but even changing their corporate policy to make the relationship possible.

The second vendor communication conflict has been that between those cryonics leaders who feel we should hide everything and tell very little and those who feel that we really need to be more open with vendors.  Then we can choose to do business with those who are willing to work with us.

Early on in my career, I was warned to be careful when dealing with vendors not to divulge what it is we do out of fear they would refuse to do business with us.  This restrictive attitude was probably necessary in some cases when cryonics was less well known.  One of the experiences that led to this attitude was the failed relationship between cryonics and the main manufacturer of cryonics whole-body Dewars in the 1970s.  The small company was purchased by a larger group that was unhappy when they discovered what these containers were being used for.  They refused to build any more cryonics-specific Dewars, leaving Alcor and other companies scrambling for another source.

For quite a while, even telling other companies or vendors that we were doing cryonics was viewed by some as act of sin.  Therefore, my first position when I started working in this field was to be extremely conservative when approaching other companies or vendors.  But times are changing, and there is value in testing the waters to see how far one can go, so we have learned there is ample room to push our business model to new frontiers.

Dealing with vendors today

Today, it is a little easier to educate vendors by letting them know that interest and research in the field of cryonics has resulted in blood plasma expanders that are helping to save the lives of wounded soldiers in the field in Iraq or the average person on the street.  One of the things I mention when speaking with new manufacturers' reps is that science is looking into the possibility of re-growing new limbs and organs.  I ask them to imagine an amputee who has lost an arm and then imagine how we will someday use science to trick the genes at the end of the stump to think it is in fetal development and regrow a new arm.

Another future possibility that I mention to them is that one day they may go into their doctor’s office and provide a DNA sample.  Then the doctor's team turns around and grows them a new heart, liver, kidney, etc.  Research is going on now in support of growing specialized cells in vats and then "printing" them one layer at a time to build new organs.  One day these organs might be cryobanked for emergency use if or when there is a need for those individuals to receive an overhaul of primary organs.  I note the possibility of one day regenerating their own organs; but maybe an even better approach might be to engineer something better and swap out aged and worn organs for superior, enhanced organs that would work better and last longer.  Those organs could even be stress-tested in advance of cryobanking to certify their ability to function and to self-repair under challenging circumstances.

Biotechnology research is moving so rapidly today that a surprising number of the manufacturers' reps do not perceive this talk as science fiction.  For us, cryonics is not science fiction, of course; it is more similar to hanging out in the Wright Brother’s garage before the invention of flight without knowing whether or not it will work.  The average rep out there now makes this connection.  On numerous occasions I’ve heard from them that they see us as modern day pioneers out on a new frontier.

I note that even though these people may not have any personal interest in cryonics itself, they are curious about the science and technology.  They understand that developments in these fields may be part of the progress that improves their own health and the quality of their lives someday and they want to know more.

As a result, we have a lot more leverage today then when I first started --enough to be able to exert some pressure when dealing with larger corporations.  The advantage with dealing with a larger corporation is that if you are not getting satisfaction with a local Rep, you can contact the regional manger for information.  The way to approach it diplomatically is to tell them that the Rep must be busy and you need the information to get approval for making a purchase or to generate a report that might result in you making a purchase.  This process is different with small businesses, which may not have management levels you can use.  However, smaller businesses can be eager for new business and may be more flexible entrepreneurs.  If not, you move on down the road to one of their competitors. 

Whether they realize it or not, the company that adapts to new business opportunities is more likely to survive over the long run, unlike businesses of the past who felt it was important to continue to make horse and buggy whips at the peak of their market.  Those who get this venturous perspective are more inclined to work with companies with unique needs, either because they are betting that new opportunities can help ensure their long-term survival or because that kind of attitude comes from people who are excited about new and interesting angles for their business.  I’ve heard both from small businesses and international corporations that cryonics seems like a pioneering field and that the idea of being on the cutting edge appeals to them. 

One of the things I’ve come to appreciate over the years in working with vendors is that their motivations are about the same as everyone else's.  They have a job that may or may not interest them and then they go home to their personal lives.  Strong companies can have poor sales reps; weak companies can have highly motivated reps. Some reps are more interested in their customers in general than other reps; some may become more personally interested in what our company is doing.  Sometimes you can overcome a poor rep by talking with superiors; sometimes the only solution is to wait until the inevitable personnel turnover occurs.  But often the best approach is simply to be professional and organized yourself, to show them how you can both get to "yes" in a manner that makes their lives easier. 

Remember, our goals are more long-term that those of a sales rep.  We can stay committed to what we are trying to accomplish and continue to look for a manufacture or a sales rep who will provide what we need.  Most reps simply want to make a sale with the least hassle possible before and after the sale, so they can move on to the next one.  Generally, selling to us is simpler and more straightforward (assuming we help make it so) than arguing with us about cryonics, so even sales reps who are not interested in our ideas are likely to take the easy path and make the sale.

Outsourcing results in higher quality, medically certified products

In the near-term, outsourcing will result in higher quality products for our use.  For example, the tubing pack used for heart bypass surgery at your local hospital may have also been made by the same corporation willing to provide washout and cryoprotection tubing packs for cryonics.  That corporation can produce these packs under medically certified standards, which no cryonics provider can currently offer.  By working with established professional companies that specialize in tubing packs, we could have the added advantage of using heparin-coated products in re-circulating the blood prior to washout when quick access is possible.   Heparin-coated tubing helps mitigate the blood's negative response to having foreign objects inserted into the blood stream.

The manufacturer can only assemble heparin-coated tubing packs as a complete sterile tubing pack.  The heparin coating itself is a complex nine-step process.  If we attempt to assemble and re-sterilize the heparin-coated products, the re-sterilization damages the heparin coating. 

Since our field is currently providing for a blood washout prior to recirculation, it is possible that we don't need heparin-coated tubing, because we have already eliminated the blood.  There maybe scenarios that would make this product valuable to us, but the details are not important in this chapter.  This is an example to show that working with professional companies to obtain tubing packs and other supplies gains us access to many improvements that we could not otherwise discover or obtain for ourselves.

Dealing with inaccurate production of outsourced tubing packs

A valid concern that has been expressed about outsourcing tubing pack production is our inability to verify the accuracy of the assembly, since the packs are delivered in opaque protective covers.  But accuracy is not only a concern for outsourcing; it is also true for in-house production.  Based on my experience over the past decade, errors do occasionally slip through even after in-house tubing packs have been verified prior to sterilization.  If the washout personnel are familiar with tubing pack construction, these errors can generally be fixed during the preparation for washout.  Still, we really want the opportunity to examine the assembly before we open it up, if possible.

Fortunately, the issue of being able to verify the accuracy of tubing packs has been resolved by replacing tubing covers with .2 micron gas filters.  In the past, tubing covers were used to help keep dust and bugs out, but were vented to allow the expansion and contraction of air and to allow ethylene oxide to enter for sterilization.  The downside was that a small amount of dust or particulates and biological contaminates could pass through the covers if they were not properly maintained in a sterile package.  Also, the tubing covers had a tendency to excrete oil from the plastic, becoming greasy, and adding a possible source of contamination.  By replacing the tubing cover with a .2 micron filter, tubing packs can be inspected after sterilization without internal contamination of the circuit (depending on the design of the circuit in question).  Naturally, the tubing pack should be treated with appropriate care when handled during the inspection process.

I have questioned companies as to whether the tubing packs are properly sterilized while using the .2 micron filters, out of concern that the ethylene oxide molecules might stick to the fibers of the filters; but the manufacturers have had no opinion on this.  Other people in the cryonics field have given their opinions that the molecules are small enough to make such concerns a non-issue on this particular application.  In any case, it seems we have lived with this in the past, since some of the ethylene oxide molecules will settle out and remain within a tubing circuit as a general rule when the filters are not used. 

Dependence on outsourcing and unprofessional insourcing

An issue of concern might be that we would be dependent on an outside supplier to deliver the washout and cryoprotection tubing packs in a timely fashion.  I don't think this is a valid worry.  We are already dependent on the manufacturer to supply us with components, assembled or not.  The only way we can free ourselves completely from outside dependence is by manufacturing all the components ourselves, which is not a realistic expectation.  The key to avoiding being dependent on any one vendor in our supply chain is to have more than one vendor capable of providing the same services. 

Those cryonicists who are fearful of dependence upon professional outsourcing need to understand that they currently have an equal dependence on in-house capability, and this in-house service can provide even fewer guarantees of consistency and quality.  In cryonics today -- and probably for years to come -- there is still a large turnover (or job rotation) of employees and those who manage them.  Knowledge of past procedures, previous failures, and lessons learned can be easily lost or ignored as new employees move into those roles.  And the field of cryonics has not developed either consistent standards or a pool of qualified and trained individuals to provide continuity.

In cryonics today, tubing packs could be produced in any old room and those who assemble them might do so with their bare hands.  One might sterilize a tubing pack, but it does not eliminate the oils and debris that are left behind during the assembly process, which can be easily picked up by the surgeon’s gloves.

The tubing pack manufacturer I have spoken with produces 2,300 different custom tubing packs for hospitals worldwide. They assure me they are accustomed to the need to produce them accurately, to specific standards, and in a timely fashion.  If they did not do so, hospitals would not do business with them.  Hospitals experience a degree of liability exposure well in excess of what cryonics organizations have been exposed to.  If hospitals prefer to have their tubing packs produced by the same vendors who are willing to work with us, then we perhaps we should learn that lesson, too. 

New options such as outsourcing tubing packs do not take away from our capability, but add another tier over what currently exists.  In an emergency, we can still build tubing packs in-house; and that capability should be retained to ensure we could provide service without interruption.  Still, the ideal option is to have them produced under standards that pass FDA regulation, which is not something you will find among any of the current cryonics related service providers.

Outsourcing benefit -- free documentation

With the dynamics of changes to protocol and rotation of employees in cryonics, we do not document our procedures and changes as well as we would like.  To a varying degree, efforts have been made to document the details necessary to maintain good SOP in many cryonics systems.  However, many of these efforts have been half-hearted; and even when the original work was good, documentation of subsequent changes has frequently been overlooked or ignored.  So many critical changes may only be known by a couple of people who perform the tasks.  With outsourcing, including tubing pack production, free documentation is provided as a standard part of the service.  Not only do these professional companies produce clear documentation, they do it much more quickly than we ever have in cryonics.  

The step-by-step process of outsourcing tubing pack production

Because both sides are not typically sitting down together to discuss it, the process of outsourcing tubing packs is not as efficient as I would like it to be.  My first preference would be to build a tubing pack to my specifications, and send it to them to reverse-engineer.  However, I can see that this would not seem efficient from the other company's point of view.  They already have a system of documenting the design and construction of tubing packs in place that works for them.  It turns out that, once we learn to speak the same language, the remainder of the effort required to build what we need is not too hard. 

The process starts out on our end when we produce a legible diagram and send it to the tubing pack company.  The drawing is converted into CAD or similar software, and then they turn around and ship a completed tubing pack from their diagram.  

Once the tubing pack arrives, we are expected to inspect it for errors and write-up a change list and submit it to them.  They follow with a new tubing pack along with an updated diagram.  This process continues until they ship a tubing pack that meets our expectations.  The work up to this point is done free of charge.  There isn’t a catch to this nor is there an obvious profit motive for the construction of tubing packs other than to move product.  As a result of competition in the industry, these tubing packs are shipped out at close to cost.  It appears that much of the benefit to the manufacturer is in keeping business away from their competitors.  This adds another benefit for cryonics in that we piggyback on economies of scale.

The following diagram shows one page of several which was submitted to me by the tubing pack manufacturer, along with a tubing pack.  The diagram is inaccurate, and we didn't proceed with this because we quickly came up with several new ideas, but it gives an example of what is provided for free.  It is definitely superior to hand-scribed diagrams or even those that have been generated with computer software in-house:

Tubing pack 

Outsourcing other related equipment, example one

Sometimes we need other custom-made products for cryonics, including thermocouples.  We now have established a relationship with a thermocouple manufacturer, and this company has made Type “T” thermocouples that fit into thermo wells.  This thermocouple is compatible with standard perfusion circuit ports that hospitals use, so we can use standard systems instead of trying to invent new ones.  This type of thermocouple also allows for an increase in the accuracy of the reading as a result of metal-to-metal contact with a thermal break, over and above using insulated thermocouples glued down into thermo wells.  Having a thermal break reduces or eliminates the consequence of room temperatures giving a false reading that is warmer than what is being measured as a result of the conductive path of the metal hardware functioning as a heat sink.  For most of our tasks, we are content to have the readings roughly within one degree of accuracy, so the non-grounded thermocouple is a reasonable option.  The accuracy of the reading can be improved with grounding, but then it adds the possible complication of creating a feedback loop when used with computer monitoring systems.  See diagram below that was provided for free.

Thermocouple

Outsourcing other related equipment, example two

Also along this theme, a relationship with a biochemical bag manufacturer has been established to provide sterile bags for tubing packs and for the production and storage of washout solutions and cryoprotectants.

The previous generation of bags was purchased from a company that packages milk.  "Milk bags" are vulnerable as a result of the plastic material being thin and relatively easy to puncture, and they have a cap with a nipple for the tubing that can pop off if not properly cared for.  Once the cap is removed and replaced, it becomes highly susceptible to coming off thereafter; and this issue has previously proven to compromise the quality of care provided to patients in the field when trying to ship washout solution.  The utilization of milk bags for the storage and shipment of chemicals in cryonics is unsafe and out-dated technology that all groups should eliminate, if they have not already done so. 

The new biochemical bags are much stronger and do not have a cap that can pop off, resulting in a lower probability of spillage and contamination.  The chemical bags are manufactured in a clean room and shipped ready to go with all the necessary tubing, filters, and clamps in a package that has been sterilized using gamma radiation.  Also, the manufacturer has been willing to increase the size of the bags from 20 to ~28 liters in response to feedback from standby personnel who have requested the additional capacity for a thorough blood washout.  They are willing to make any other size within reason.  (We originally had 30 liters in the bag; but had to reduce the volume because of airline weight restrictions.)  Again, another diagram below was provided free of charge.  All these diagrams were sent prior to us making a purchase:

Tubing pack 2

Interrelatedness and efficient streamlining

In addition, corporations such as these can be notified of each other’s capabilities and what they have to offer where their work is interrelated in regards to our business needs.  All the various parts such as tubing, filters, thermocouples, and connectors can be ordered and assembled by one manufacturer, eliminating the need for us to have to work with multiple vendors on this product in the future.     Once the design is established, all that we will have to do is call up the “end product company” and give them a part number, making the process much more efficient.  Once our use of the product is finished, any hardware such as clamps or thermocouples that can be recycled is cleaned and then shipped back to the company to be reused.

A problem with chemical manufactures and outsourcing

In conjunction with the chemical bags and sterilization circuits, we also have to consider the possibility of outsourcing the solutions that are pumped through them.  Throughout 2006, I made efforts to establish relationships with chemical manufacturers with the goal of outsourcing MHP-2, our washout solution.  Initially, there was some interest by a couple manufacturers; but once the full formulae, mixing, and packaging protocols were submitted, they declined to give us a quote, without giving an explanation. 

After numerous phone calls spread out over months, I received nothing more than vague hints as to why we were getting nowhere with these negotiations.  One problem seemed to be that these manufacturers did not like the idea of filter sterilizing MHP-2 into our chemical bags; but even there I could get no further explanation.  It seemed that we might have hit a dead end. 

Don't give up.  Be prepared to change the approach.

Once all options in support of outsourcing MHP-2 appeared to have been exhausted, I let the subject rest for a while.  I then decided on a bit different approach.  We stripped the formula for MHP-2 down to its base components, which eliminated three of the medications.  Also, we decided not to list the description and part number for the (sterile) water used to provide most of the volume of the solution.  The end result was a base solution where the components could be easily purchased off-the-shelf domestically, simplifying the request being made on the manufacturer.

The paperwork was also simplified to be nothing more than a simple spreadsheet that listed basic details with individual chemical grams per liter and molecular weights, along with a direct web link to the manufacturer’s product.  In addition, the chemical necessary to balance pH to the desired range was listed.  All the steps necessary to mix and package the solution were deleted in hopes of allowing the proposed vendors to pick the path most convenient and comfortable for them.

Outsourcing path found for base solution

Fortunately, this strategy worked to establish a relationship with a chemical manufacturer willing to produce a base solution for MHP-2 (minus several chemicals that can be added when transfilling into our chemical bags for operating room or field use).  With the quote in hand, one of my first questions was to ask about the type of water.  They responded with a quote for use of deionized water.  However, our preference was to use Milli-Q water based on a recommendation from a research company, which is a high quality of sterile water and which offers a higher degree of purity than is currently being used for cryonics patients.

Milli-Q water is deionized water that is purified using an ion exchange cartridge, with the purity measured by the conductivity, and then is passed through a 0.2 micron filter.  On the other hand, deionized water is similar to distilled water, but the ultra pure version is used in many ways in science and industry.  I asked if it was ultra pure and their response was that it was sufficient for USP grade.  They then proceeded to provide a quote for Milli-Q water, which would increase the cost by roughly $10 per liter over the previous quote.  Interestingly, this step-by-step method of inquiry produced no negative reactions from the manufacturer and resulted in agreement on most of the details we required.

Expanding base solution to include more chemicals

Since the cooperation was going well, we proceeded to submit a quote request for MHP-2.  As part of our submission, I noted that we could have the medications drop shipped to them through our Medical Director, along with a chemical purchased overseas.  I told them that if there was an issue with them making up a batch of solution because of particular medications, they could subtract those items and we would then add them as we needed them.  Adding the medications later is not much of an issue, so if the quote request for MHP-2 had been rejected, we could deal with it.  Fortunately, the manufacturer approved our request, and didn't even increase the price. 

Interestingly, although the manufacturer did not like the idea of placing our solutions into plastic bags, they suggested that they could package them in glass bottles.  These bottles are better for long-term storage of these chemicals and should increase their stability and shelf life.  We can transfer the solutions to plastic bags for transport when a suspension emergency occurs. 

So now, through a willingness to change strategies, we have discovered a way for cryonics companies to have the option of having their washout solutions and cryoprotectants professionally made using high quality Milli-Q water and stored in stable glass bottles.  I encourage cryonics companies to take advantage of this opportunity.

Private vs. labeled chemical production

According to one of the manufacturers' reps, the way chemical manufacturing works is that a company can produce a private production run for research purposes, or offer to place their name on the product; but the latter would require it to go through the regulatory process.  Naturally, we choose to pick the first option for the foreseeable future.  Maybe someday a new form of MHP-2 will be developed that could be used by hospitals for standard organ transplants.  In a circumstance like that, someone might consider going the regulator route instead of a private production run.  The day that we can pick up the phone and order our solutions and have come in with the manufacturer’s label, part number, and a certificate of analysis’s would certainly make a bold impression upon those of us who work in this field, not to mention medical hospital staff.

Another reason for professional manufacturing

Some of the challenges that have come with in-house production of perfusates and other solutions are not likely to be of much concern to a commercial chemical manufacturer, because this is what they do every day.  Commercial production should also provide for a higher degree of quality, reliability, and consistency, since we know this has been a concern with in-house production in the past.  As an example, this could reduce the probability of individual staff members of cryonics organizations making subtle changes to the solutions without going through some form of chain-of-command or oversight process.  Any changes to the chemical recipe would result in a new part number, and that would raise a red flag to those of us who work with the product.

We know that variant forms of solutions labeled MHP-2 have been used, without change of name.  By outsourcing through a professional manufacturer, at least some level of national standard can be established.  Naturally, this does not guarantee the solution will not be altered after the fact, but the odds of components being left out are notably reduced.

Having more than one vendor

Whether we use outsourcing or in-house production for our chemical solutions, we know we need to have agreements with more than one manufacturer in the event of supply problems.  In the past, we have seen such problems come from difficulties in the manufacturing process, from the unavailability of a critical component, and from changes in company policy that may prevent us from buying a particular chemical.  We can never lose track of our need to have multiple pathways in place to accomplish our critical mission.

Outsourcing field kit production

At some point, we may want to explore turning over aspects of our field kit production to companies that specialize in building various types of medical packs.  As the number of suspensions per year increases, it will become increasingly difficult for an organization to rapidly recover from one suspension and be quickly ready for the next one.  We have already seen strains in this area in the past when a long period with no suspensions is followed by several suspensions in short order.  I don’t know that it would be worth the effort to have them replenish kits after a suspension, since it is relatively easy to do; but the production of new kits can be time-consuming.  Having an outside company produce a portion of our field kits (at a minimum) to our specifications would save days of employee time, at a time when suspension teams are most exhausted.  Recovery could be both quicker and more accurate.  In any case, now is the time to explore this idea, not when the burden has already come upon us.

During my initial, limited investigation I got quick responses from medical supply companies that produce blister packs.  For those who are not familiar with blister packs, you can think of them as a TV dinner, where individual foods are allocated a space and sealed from each other.  The quick responses demonstrate that it is a highly competitive field.  Of course, once they understood our low volume expectations, their interest in working with us dropped off quite a bit. 

I have located one company that is interested in making blister packs in small volumes.  These would function similarly to SA’s med kit tubes or an older version of Alcor’s setup, which used Ziploc bags that contained the meds and associated supplies.  The downside is that blister packs from this company would not be assembled in a clean room.  Although a clean room is desirable and would be an upgrade over current preparation in-house, I don’t know that it is absolutely necessary.  Further research will need to be done to see what other options we might find.

Aligning with national medical standards

We all assume that as cryonics grows, state agencies will seek to regulate its practice, and standards will be required.  Some of these new relationships with manufacturers will make it easier to be in-line with regulations, since these companies are used to working with standards.  They already work with hospitals and research companies that are heavily regulated.  Having cryonics supplies certified as being up to standards ultimately makes these aspects of our business a part of mainstream corporate America.  As various aspects of our business walks through the door of legitimacy, so will the whole of our community.

Piggybacking on economies of scale

As our numbers grow, cryonics companies will be seen as a greater source of profits for the manufacturers.  Competition for larger volume purchases will increase our options to choose more innovative products and negotiate better pricing.  Even now, we piggyback on economies of scale already established within existing corporations, even when we may sometimes pay a premium for low volume purchases. Piggybacking on economies of scale results from the manufacturer's ability to make wholesale purchases where we can’t, and they have production efficiencies and quality controls we lack.  Overall, the costs associated with outsourcing are fairly competitive even now (except for very low-volume, specialized products like MHP-2), so we can sometimes save money and almost always gain an end product superior to anything manufactured in-house.  And by spreading the business of cryonics out among many corporations we establish a better level of stability and reduce risk, similar to investing into a diversified portfolio.

Sub-conclusion

As I have discussed here, outsourcing aspects of cryonics raises a number of issues.  We have and will continue to be dependent on our vendors, which have proven to be challenging from time to time.  We are dependent on all the various components that make up such things as tubing packs and chemicals, so the individual components are just as important as the final product.  The keys are to have more than one vendor capable of performing the same duties, and then to ensure we have backup capability at home where possible.  Ultimately, this does not weaken our foundation but adds another layer of redundancy and capability to what currently exits.  As to the cost of any given outsourced product, sometimes it appears to be more expensive upfront; but my experience is that in-house preparations and products which appear to be cheaper often cost more and end up being of lower quality.

One of the more notable examples of delivery delays over the years has been the production of neuro cans.  The manufacturer only goes through a production run maybe twice per year, so orders need to be planned well in advance of need or we need to remanufacture off-the-shelf products in-house.  The timely production of tubing packs is much less of a concern than that of neuro cans, since the tubing pack manufacturer needs to be able to restock hospitals in a timely fashion.  Custom tubing packs are a normal part of their business.  As a general rule, the turnaround time for completed medically qualified tubing packs is one week.

There are individual cases where a price might jump dramatically; but this only shows up on a few line items here or there.  For instance, upgrading the milk bags resulted in a price increase from $0.70 to $57.90 each.  The price is increased by $8,271%; but having a chemical bag that is not as likely to rupture during shipment goes far beyond the $57 increase and is well worth the price change.  The overall price of the tubing pack does not increase much relative to the improvement in durability. 

An important consideration is the overall price for the washout solution, which is double that of in-house production.  While this may seem like a tremendous jump, there are several factors to consider.  First, while the quoted cost of in-house production included a mark-up factor for overhead and staff time, cryonics staffer are usually performing multiple duties.  While they preparing washout solutions, they cannot perform other duties – so the real cost of in-house production is probably higher than we think.  Second, any new process at a manufacturer starts out at a high price because of design and set-up considerations.  While speaking with the manufacturer they provided some hint that following orders might not be as high, but this is an unknown factor until a commitment is made to go through the manufacturing process.  Third, we are still talking about relatively low volumes of product.  Since we are not currently purchasing this product from the company we have negotiated with, we are not in any kind of position to negotiate future prices.  We will have to take the jump and deicide to pay higher prices at the beginning until our purchase volume increase or until other cryonics companies agree to participate and increase total purchases.

But please remember that current pricing is not the only consideration for switching to a professionally-made product.  We want the advantages of having washout and perfusion solutions that are not made by minimally-trained cryonics volunteers and staff.  If we are going to finally elevate cryonics permanently beyond what Mike Darwin once called "guerrilla theatre" into the realm of accepted medical procedures, we will need reliability of production and adherence to high standards.  If we can make this switch, then the quality of cryonics as a whole should be elevated, perhaps with the result of greater medical acceptability, and the further result of greater public acceptance.  That would allow us to negotiate lower prices.

Conclusion

It is my belief that cryonics is in a natural process of becoming engrained into the fabric of Corporate America, accelerated or not.  As the process of cryonics improves over time and ultimately becomes an accepted medical procedure delivered by hospitals, the relationships we are building now with medical corporations will increase our credibility and increase the ease of transition.  Once hospital personnel can pick up the phone and request a specific set of part numbers -- from the same companies they already order surgical supplies from, we will really have the new standard of medical care and a true unbundling of cryonics that many of us have envisioned for a long time.

Support for this position

If you have reviewed this article and wish to express your Supportive Comments (fully or partially) for the conclusions of this paper and for the adoption of these changes by the cryonics companies, please send an email to future2100@gmail.com.  Please include your name membership affiliation (if public), and any supporting titles (e.g., “Alcor Director,” “C.I. Director,” “Alcor Advisor”).  Your support will help encourage our industry to make the long-range changes necessary to improve the odds of survival for all of us.

 

Chapter 2 will be sufficiently long that my current expectation is to release it in sections once they are ready.

Chapter 2

Field Vitrification

Introduction

Field vitrification has been of interest to me throughout most of my career over the past decade and now that cryonics is more or less moving forward on the subject it is important to discuss what I believe the true or ultimate goal is for this development.  With the creation of small equipment that is readily transportable  aboard vehicles, be it ground or air, it will allow us to not only take our services to the patient at a local mortuary with appropriate facilities as an example, but also into most any hospital operating room.  Irrespective of hospitals willing to make room or even directly provide for cryonics related services, if we are ever to see such an evolution in service, we need the means to deliver that service and do so in such a manner that meets with the approval of the medical establishment.

As a caveat, this notion results in obvious challenges in making cryonics a true medical procedure and I realize what you read here may seem a bit optimistic at times, but to the extent these things are possible and there is sufficient support for them, could take some time for us to bring to fruition.  There is a fair amount of history here, important motivational lessons along the way, and progress in this direction.

 

kit graphique : kit graphique