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
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
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:
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.
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:
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
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 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.