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Business Case for SmartFridge and Vaccine
Transport Container – Final Report
Project Scope, Objectives, and Methodology
3
Project Scope
This project consisted of a global assessment of the value opportunities for a Vaccine
Transport Container and SmartFridge. As part of this assessment, Harrison Hayes
sought to develop a business case outlining the opportunities for each product. Although
the primary focus of this project was vaccines, Harrison Hayes also sought to address
other unmet needs.
4
Project Objectives
The primary objective of this project is to develop a complete and thorough business
case for the introduction of a Vaccine Transport Container and Vaccine
SmartFridge. Specific objectives include:
q Identification of market opportunities, barriers, risks, and challenges.
q Assessment and analysis of market drivers and inhibitors.
q Identification and analysis of critical success factors.
q Determination of market adoption rates and product pricing.
q Identification of therapeutic areas outside of vaccines that may best be able to utilize
cold chain supply systems.
q Determination of the value that a Vaccine Transport Container and Vaccine
SmartFridge may provide.
q Identification of regions/countries and therapeutic areas that would provide the
greatest value.
5
Research Methodology
Market research for this project consisted of Primary and Secondary market research.
Primary research included the conduction of one hundred four (104) Key Opinion Leader
interviews on a global basis across a variety of specialties.
To supplement these Key Opinion Leader interviews, Harrison Hayes also conducted
secondary research from publicly available information and syndicated sources.
General Observations on “Cold Chain”
7
“Cold Chain” Defined
When Key Opinion Leaders were asked to define “cold chain” they answered with the
following:
 Key Opinion Leaders identified/defined two (2) areas: Food/Beverage industry
and Pharmaceutical/Healthcare.
 Key Opinion Leaders further defined the cold chain in food/beverage industry as
related to supermarkets, convenience stores, and end consumers.
 The pharmaceutical market consisted of the supply chain, physicians, and the
overall patient base.
8
WHO and “Cool Chain”
 Proper vaccine storage and transportation is a key issue in the developing world,
which presents numerous challenges.
 As such, the World Health Organization (WHO), has developed the Performance,
Quality, and Safety (PQS) system of cooling technology prequalification.
 WHO has identified the following three (3) categories within the “cool chain”:
1. Refrigeration
2. Passive Cooling
3. Temperature Monitoring
9
View of the “Cold Chain”
 Key Opinion Leaders viewed the cold supply chain strictly as a regional business
model.
 The interviewed Key Opinion Leaders noted that the industry is extremely
fragmented with a lack of consistent product/cooling technology, specifically in
the healthcare arena. There are too many marginal players in the space.
 A cooling transport solution was addressed by a majority of the Key Opinion
Leaders in unaided response.
 The biggest problems were product maintenance and product temperature.
10
“Cold Chain” Market Players
Global Market Players
 According to the WHO’s Product Information Sheets and Performance Quality and
Safety Sheets there are thirty seven (37) approved refrigerators and freezers.
 These refrigerators and freezers are broken down into compression units,
absorption units, and solar units.
 There are four (4) primary manufacturers: Dometic, Vestfrost, Sibir International,
and Zero Appliances.
11
Requirements in the Cold Chain
Logistics is the central component to successful cold chain initiatives, especially as it
relates to vaccines. Specific issues that must be taken into account include:
 Storage Conditions (temperature)
 Presentation (prefilled device, single dose vials, etc.)
 Packaging (volume based)
 Cost per dose
12
Cold Chain Distribution Models
The WHO identifies two (2) logistics models as it relates to the cold chain.
 Distribution System
 Collection System
The Key Opinion Leaders strongly believed that the Distribution Model was much more
likely to provide a successful solution over the Collection system. This opinion was
validated by the WHO.
Market Opportunities – United States
14
Market Size
Sales within the Global Refrigeration space is approximately $60B. The table below
outlines these figures. Of this amount, less than 1% can be attributed to vaccine cold
chain.
Vaccine Cold Chain Refrigerator sales are estimated to be $.566B worldwide.
Equipment Sales
Domestic Refrigerators $32.8B
Commercial Refrigeration
Equipment
$18.6B
Cold Storage $2B
Refrigerated Transport Vehicles $2B
Refrigerated Containers $1.2B
Total: $56.6B
15
Market Opportunities
When the Key Opinion Leaders were asked what they believe the key market opportunities
should be, they responded with the following:
 Big Box/Chain pharmacies/Wal-Mart
 Dermatologist offices
 Insulin and Liquid Antibiotic storage (inclusive of insulin)
 Neonatal centers
 Plastic surgery offices
 Prisons
 Pediatrician offices
 Third World Countries
 Veterinarians
16
Market Opportunities
The table below outlines the number of locations and potential market size for
SmartFridge and Transport Container.
*Only includes CVS, Walgreen’s, and Walmart.
Office Type Number of US Locations
Retail outlets (Big Box/Wal-Mart) 15,400*
Pediatrician Offices 6,000 – 7,000
Dermatology Offices Aprox. 3,000
Plastic Surgery Offices Aprox. 2,300
Neonatal Centers Aprox. 1,200
Federal Prisons 184
Total 28,084 – 29,084
17
Market Opportunities Con’t.
-
1,000
2,000
3,000
4,000
5,000
6,000
7,000
The chart outlines the number of locations and potential market size (not dollar based).
Number of Locations
18
Market Opportunities- Key Opinion Leader Perspective
Early Adopters/Adoption Rate/Pricing for SmartFridge
 The U.S. based Key Opinion Leaders stated that the Pediatric Physician space
represented the clear target opportunity.
 Dermatology Offices were mentioned as a secondary opportunity.
 A significant majority (more than 75%) of the interviewed Key Opinion Leaders
stated that early market adoption rates would approach 25% in Pediatrician
and Dermatology offices.
 NOTE: The market adoption rates assumes that the SmartFridge contains the
desired features/benefits and meets the market needs detailed in the “Critical
Success Factors” section.
 Key Opinion Leaders noted that a leasing option would be the most ideal; Leasing
amounts range from $100 to $200 per month.
19
Market Opportunities – Peds and Derms
The table below outlines the total dollar opportunity for the SmartFridge within
Dermatology and Pediatric offices in the United States.
**This assumes that each office will only lease one (1) SmartFridge.
Office Type Number of US Locations
Aprox. # of Derm/Peds Offices 9,500
Year One Market Adoption 25%
Monthly Lease Rate $150
Total $356,250
20
Market Opportunities – Peds and Derms
The table below outlines the total dollar opportunity for the SmartFridge within
Dermatology and Pediatric offices in the United States.
**This assumes that each office will only lease one (1) SmartFridge.
Office Type Number of US Locations
Aprox. # of Derm/Peds Offices 9,500
Year One Market Adoption 25%
Monthly Lease Rate $100
Total $237,500
21
Market Opportunities – Peds and Derms
The table below outlines the total dollar opportunity for the SmartFridge within
Dermatology and Pediatric offices in the United States.
**This assumes that each office will only lease one (1) SmartFridge.
Office Type Number of US Locations
Aprox. # of Derm/Peds Offices 9,500
Year One Market Adoption 25%
Monthly Lease Rate $200
Total $475,000
22
Market Opportunities - Derms and Peds Con’t.
On the Small Dollar Amount
 Based on the previous three (3) tables, initial dollar revenue is extremely small, at
less than $.5M. This estimate is based on the fact that each office would only lease
one (1) SmartFridge
 It is important to note that Pediatrician market is extremely price sensitive and
that any new technology that is introduced must show cost savings.
 Therefore, assuming the SmartFridge is successful and limits the amount of
vaccine waste, Pediatricians will then adopt the SmartFridge much more quickly.
23
Market Opportunities- Transport Container (USA)
Transport Container in the United States
 The U.S. based Key Opinion Leaders very easily understood the practicality and
applicability of the vaccine SmartFridge, but were not as impressed with the
Transport Container.
 It was unanimous among all Key Opinion Leaders that vaccine transport
needed to be improved, but physicians could not see how such a solution would fit
into their existing business model (i.e. they do not want to pay for this).
 U.S. based physicians noted that they typically assume that vaccines are safe upon
arrival; if refrigeration problems do arise, they assume the issue occurred in the
office setting rather than transport.
 In the United States, there is a relatively high level of confidence in the vaccine
transport system. This is not the case in the developing world.
Merck Vaccine Transport
Container
Market Opportunities – Developing World
25
Market Opportunity – Developing World
Developing World
 There is a clear need for updated vaccine refrigeration in both transport and in
the clinical setting in the developing world.
 Unlike the United States, the primary buyers of a vaccine SmartFridge and/or
Transport Container in the Developing World are UNICEF and a corresponding
country’s Ministry of Health.
26
Market Opportunity – Developing World Con’t.
Developing World
 Based on information from UNICEF, roughly 200,000 vaccine refrigerators are
currently used in immunization programs in the developing world.
 UNICEF vaccine refrigerator purchases make up roughly 85% of the market;
Between 1997 and 2003 UNICEF refrigeration expenditures totaled $77M.
 Ministry of Health refrigeration expenditures over the same period was
estimated at $15M.
 Countries with the most active Ministries of Health include India, Indonesia, and
Japan.
27
Market Opportunity – Developing World Con’t.
Developing World Market Behavior
 Developing countries typically do not spend more than 10% of their EPI on cold
chain equipment.
 Most financial decisions regarding cold chain are made during the fourth (4th)
quarter each year.
 South American countries, more than any other region, typically rely on
refrigerators that are intended for home use.
28
Market Opportunity – Defined
Defining/Describing the Opportunity
 In many areas of the developing world, electricity is not readily available. This
has led to a vaccine distribution model.
 Vaccines are held in a “cold room” at a central location and distributed through
transport coolers.
29
Market Opportunity – Defined
Recently Proposed Solutions
 In the developing world, there is a clear focus on the construction of “cold rooms”
rather than using vaccine refrigerators.
 These cold rooms will need to be outside of existing buildings/structures and
have adequate power supply.
 “Cold Rooms” will be larger than 40m3.
 Air/Freight shipping containers will need to be larger than those currently
available and have the ability to keep vaccines between 2 and 8 degrees Celsius
for a minimum of ten (10) days.
30
Market Opportunity – Defined
Recently Proposed Solutions Con’t.
 In cases where refrigerators must be used, Ice-Lined Refrigerators (ILRs) are
the most acceptable. These ILRs must have a capacity of at least 400 liters.
 Key Opinion Leaders in developing countries believed traditional “cold boxes”
may no longer be appropriate.
 Instead, Passive Container Systems (similar to those used in supermarkets) may
represent the best known solution.
 Traditional Ice Packs will be too heavy for people to carry given the increase in
the volume of vaccines.
Passive Container
System
Ice Lined Refrigerator
31
Market Opportunity – Defined
Direct Competitor to the Transport Container
 PATH is currently exploring the possibility of using a high-performance insulated
container with a replaceable or rechargeable cooling device instead of
refrigerators.
 One such example is the Zeolite System, which can provide cooling on demand.
Zeolite System
32
Market Opportunity – Cooling System Competitor
Zeolite
 The Zeolite System is currently being developed and produced by Dometic.
 Zeolite is a mineral that has the property to absorb water vapor while releasing
heat.
 This system has the ability to store energy and transform it in heating or cooling
agents.
 Additional information on Zeolite can be found in the attached, separate
document.
Zeolite System
Market Opportunities – Product Areas
34
Market Opportunity – Product Specific
When the Key Opinion Leaders were asked what products would most benefit from
SmartFridge and Transport Container like devices, the following answers were given:
1. Vaccines
2. Insulin
3. Injectables
4. Re-fill Devices
5. Antibiotics
Note: This is a stack ranking in regards to number of responses.
35
Market Opportunity – Product Specific
Vaccines and Insulin
 Vaccines were mentioned as the primary product area of focus by every Key
Opinion Leader interviewed, regardless of background.
 Insulin was mentioned by all physician/healthcare specific Key Opinion Leaders
mentioned.
 Vaccines and insulin were by far the most important products the Key Opinion
Leaders believed to have the most applicability to a SmartFridge and/or
Transport Container.
 There was equal distribution of the other responses, none of which were a
significant threshold.
36
Market Opportunity – Additional Products
The following products were mentioned by less than five (5) Key Opinion Leaders:
 Dermatology fillers
 Misc. dermatology products
 Plastic Surgery materials
 BoTox
Market Drivers
38
Market Drivers – Overview
Based on Key Opinion Leader feedback and Secondary research, the following items
were mentioned as the primary market drivers for Cold Chain improvement:
1. Vaccine Wastage (Cost)
2. Rising Cost of Vaccines
3. Existing technology inadequate
39
Market Drivers – Wastage
Vaccine Wastage:
 Not surprisingly, vaccine wastage was identified as the primary market driver of
driving the need for improvement in the cold chain.
 Depending on the source, between $400 and $500M is lost on vaccine wastage
each year. Half of this amount is directly related to breakdown in the cold
chain.
 The primary causes of this vaccine wastage include:
 Cold chain issues
 Expired vaccines
 Damaged vials (broken during transport)
 Doses diverted from target population
 Accidental waste (throwing away good vaccines)
40
Market Drivers – Wastage
Vaccine Wastage Con’t.:
 In the practice of immunization, the number of vaccine doses used is always
higher than the number of patients immunized.
 The expected wastage rate is the proportion of total losses within the quantity
consumed; it is not standard across all vaccines.
 The tables on slides 40 and 41 outline the WHO’s maximum wastage rates for the
estimation of lyophilized and liquid vaccine needs.
41
Market Drivers – Wastage
WHO’s Maximum Wastage: Lyophilized Vaccines
Vial Doses Wastage Rate
10 – 20 dose vials 50%
1 – dose vials 10%
42
Market Drivers – Wastage
WHO’s Maximum Wastage: Liquid Vaccines
Vial Doses Wastage Rate
10 – 20 dose vials 25%
1 – dose vials 10%
43
Market Drivers – Vaccine Cost
Vaccine Cost:
 Traditional vaccines (measles, DPT, Polio, etc.) have been on the market or
decades, which results in a low cost.
 These legacy vaccines general cost between $0.10 and $0.25, which makes them
very affordable and wastage is less of a concern.
 New vaccines come with significantly higher costs, generally between $4 and $15
per dose. Note: There are some vaccines that cost more than $15.
 The high costs of these vaccines has heightened the need to reduce vaccine
wastage.
44
Market Drivers – Vaccine Cost Con’t.
The image below portrays the increase in the cost of newer vaccines compared to
legacy vaccines:
Image courtesy of Project Optimize and PATH
45
Market Drivers – Vaccine Cost Con’t.
Vaccine Cost: Legacy Vaccines v. Current Vaccines
 When vaccines cost less than $1, the total cost associated with vaccine wastage
was manageable.
 With lower costs, problems with logistics and the cold chain could be addressed
by maintaining high stock levels. Due to the cost of vaccines, this is no longer
cost effective.
 The cost of vaccines has caused vaccine administrators to maintain lower stock
levels, forecast vaccine demand, better prevent vaccine breakdowns and reduce
overall wastage.
46
Market Drivers – Existing Cold Chain Solutions
Existing Cold Chain Solutions are Insufficient
 The Key Opinion Leaders interviewed in this study were adamant that the current
technologies related to the cold chain are inefficient. Specific problems mentioned
include:
1. Freezing
2. Heat
3. Moisture in refrigerator
4. Light Exposure
47
Market Drivers – Existing Cold Chain Solutions
Standard Refrigerators
 A significant majority (more than 75%) of the physician Key Opinion Leaders
interviewed in the United States noted that they use standard refrigerators to
store vaccines.
 In standard refrigerators, Freezing was noted to be the primary issue. Vaccines
placed at the back of the refrigerator typically freeze.
 The temperature variance is not uniform in standard refrigerators, which causes
problems with vaccines.
 Moisture was the second greatest concern when using standard refrigerators. In
many cases the Key Opinion Leaders noted that this moisture would often ruin the
vaccine, creating waste.
 Heat and Light Exposure was mentioned as areas of concern, specifically when
the refrigerator door is left ajar.
48
Market Drivers – Existing Cold Chain Solutions
Standard Refrigerators v. Vaccine Refrigerators
 All of the interviewed Key Opinion Leaders had a very low confidence level in
vaccine/healthcare specific refrigerators.
 Vaccine/Healthcare Refrigerators are used because they are “the best
available” according to the industry.
 Key Opinion Leaders believed that standard refrigerators were on par with
healthcare/vaccine specific refrigerators. The only difference is cost.
Vaccine Refrigerator Standard white refrigerator
Market Barriers, Challenges, and Inhibitors
50
Market Barriers, Challenges, Inhibitors
When the Key Opinion Leaders were asked what they believed to be the primary
market barriers/challenges/inhibitors related to cold chain, the following answers
were provided:
1. Lack of Viable Technology
2. Container Size and Cost
3. Reliability
4. Power Source
5. Storage
51
Market Barriers, Challenges, Inhibitors
Lack of Viable Technology
 Numerous technologies have been explored, examined, and tested but none to
date have truly stood out.
 Tested technologies include:
 Cool packs
 Peltier Element
 Insulation Materials
 Sugar Molecules
52
Market Barriers, Challenges, Inhibitors
Lack of Viable Technology: Peltier Element
q Due to the primary interest in the Peltier Element, Harrison Hayes specifically
explored the pros and cons of this technology.
q A majority of the interviewed Key Opinion Leaders were extremely skeptical of the
Peltier Element. “Peltier is not an efficient technology…I wouldn’t think it is an
applicable technology for cold chain improvement.”
q The primary issue with Peltier was the issue with heat; in general, Peltier
feedback was not positive.
53
Market Barriers, Challenges, Inhibitors
Lack of Viable Technology: Peltier Element PROS
 Compared to standard refrigerators, the Peltier Element does not have any
moving parts.
 When Peltier is used to cool electronic elements, it has relatively high reliability
rates.
 A “cascading Peltier” will enable electronic components to cool below freezing
temperatures.
54
Market Barriers, Challenges, Inhibitors
Lack of Viable Technology: Peltier Element CONS
 Peltier modules release a large amount of heat and require “heat-sinks” and fans,
which take up space.
 In the event that a Peltier module fails, the cooled space is isolated from the heat-
sinks. This leads to a extremely fast breakdown of the cool/stable temperature
and could cause overheating.
 Peltier cooling elements may cause moisture/condensation. This could
potentially harm the vaccines.
55
Market Barriers, Challenges, Inhibitors
Vaccine Container Size
 Unlike legacy vaccines, new vaccines are packed much differently in order to
minimize waste and be cost effective.
 Legacy vaccines are packaged in 10 and 20 dose vials; New vaccines are packed
in 1 and 2 dose vials to minimize wastage.
 In some cases, new vaccines are bundled with delivery devices requiring larger,
bulkier packaging.
 While cold chain research used to focus on creating smaller cooling apparatuses,
the need is really for larger more efficient solutions.
56
Market Barriers, Challenges, Inhibitors
Vaccine Container Size: How Pack-out is Affecting Cost
Image courtesy of PATH
57
Market Barriers, Challenges, Inhibitors
Vaccine Container Size Con’t.
 Today, a refrigerator full of new vaccines will destroy thousands of dollars
rather than a few hundred dollars as is the case with legacy vaccines.
 Additionally, the volume of vaccines that need to be refrigerated is expected to
grow eight-fold.
 This increase in packaging size and vaccine volume will create a need for larger,
efficient cold rooms and refrigerators.
58
Market Barriers, Challenges, Inhibitors
Vaccine Container: In Transport
 Today, vaccines are typically transported in cold boxes of 20 - 25 liter capacity. Of
this amount, 15 liters is made up of cold packs.
 Current cold box designs have extensive insulation, which further limits the
capacity of the cold box transport.
 Refrigerated transport is an option in some areas, but often times road
infrastructure is poor and refrigerated transport is extremely unreliable.
59
Market Barriers, Challenges, Inhibitors
Power Supply and Reliability
 A primary challenge is finding and implementing a reliable power supply.
 Power supply in the cold chain has consisted of the following:
 Electricity
 Kerosene
 Gasoline
 Solar Photovoltaic
 Note: These power supplies have been used for both refrigerators and
transport containers.
60
Market Barriers, Challenges, Inhibitors
Power Supply and Reliability: Electricity
 In the United States and developed world, electricity is the primary power supply.
 Electricity is typically reliable in both a refrigerator setting and in a cooled
transport setting.
 Electricity as a power supply in transport is reliable only as far as the reliability of
the highway infrastructure.
61
Market Barriers, Challenges, Inhibitors
Power Supply and Reliability: Gasoline and Kerosene
 Cooling technologies powered by gasoline or kerosene are extremely inefficient
and unreliable (according to PATH Key Opinion Leaders).
 As expected, these refrigerators are not environmentally compatible.
 Kerosene refrigerators were banned by the WHO in 2009.
 Gasoline powered refrigeration is forecasted to be the most expensive cooling
option over the next ten (10) years.
62
Market Barriers, Challenges, Inhibitors
Power Supply and Reliability: Solar Photovoltaic
 Solar photovoltaic technology may be a viable alternative to electricity, especially
in areas where electricity is unavailable.
 There is still much to be explored and studied within Solar photovoltaic
technology. It is soon to tell how this technology may truly affect the cold chain
and vaccines as a whole.
63
Market Drivers Con’t.
Storage:
 Concern regarding vaccines in storage facilities is an ever growing concern
according to the Key Opinion Leaders interviewed.
 “Stock levels are rarely accurate and it results in too many vaccines lying around in
warehouses where stock is out in places that desperately need it.”
 “Some 20-30% of warehouses do not conduct physical stock counts; only a third of
warehouses have correct stock and only half of those have stock counts in an orderly
fashion.”
Critical Success Factors
65
Critical Success Factors
Areas Examined
q In determining the critical success factors of the SmartFridge and Transport
Container, Harrison Hayes took into account:
§ Features and Benefits
§ Overall Construction
§ Financial Component
§ Supply Chain Elements
§ Wastage Reduction
§ Potential Partnerships
66
Critical Success Factors - Features
Features Sought by Key Opinion Leaders (Stack Ranking)
 RFID/Barcode Tracking
 Adjustable temperature zones
 Data collection interface
 Data monitoring software
 Defrost /condensation removal
 Alarms
 Remote monitoring
 Easy to use/visual controls
 Battery back-up
 Security option
67
Critical Success Factors - Features
Features Sought by Key Opinion Leaders: KOL Commentary
 Tracking vaccines via RFID or barcodes is extremely important to the Key
Opinion Leaders, especially due to the overall cost.
 Temperature monitoring and controls were important to the Key Opinion
Leaders especially while in transport and while in refrigerators.
 Key Opinion Leaders believed that with temperature control and remote
monitoring they could better prevent freezing and over-heating.
68
Critical Success Factors - Features
Key Opinion Leader Feedback
 A majority of the interviewed Key Opinion Leaders felt that the SmartFridge
needed multiple compartments with segmented temperature controls;
this would be a key differentiator from current vaccine storage models.
 Three sizes would be ideal: One big storage unit, intermediate unit, and a
small unit.
69
Critical Success Factors - Features
Notable Features and Benefits:
 Alarm system – must be known if a vaccine/drug becomes too hot or too cold
 The alarms may either be audible or visual
 There is a need for manual or automatic defrost technology
 Manual defrost is the preferred method
 Easy to read display panels that can be manipulated
 It would be preferred if product is cooled from the top down
70
Critical Success Factors - Features
SmartFridge Example:
 RFID Software that locates vaccines.
 Internal cameras that link with visual panels
or smartphones – see inside without opening
the refrigerator.
 Capacity data and information
 Cooling controls and protocol
71
Critical Success Factors - Benefits
Key Benefits Sought by the SmartFridge/Transport Container:
 Easy of tracking supply usage
 Reduce Manual process
 Reduction of stock-outs
 Measurable return on investment
 Accuracy in billing
 Standardize inventory
 Mistake reduction
 Efficient workflow
72
Critical Success Factors - Financial
Financial Component:
 Key Opinion Leaders were skeptical of the potential revenues and cost savings
component of the SmartFridge and Transport Container.
 It was most commonly noted that revenues can come from the manufacturers and
not the market. Manufacturers should compensate users for the units so that it
would make financial sense and be embraced by the market.
 In pediatric offices, cost savings must be clearly shown. “I do not want to spend
money on something that cannot show a return on investment.”
 In order to be successful in the pediatric market, Key Opinion Leaders stated that
a reduction in wastage should be at least 25%.
73
Critical Success Factors – Supply Chain
Inventory Control
 The inventory control component was viewed by Key Opinion Leaders as
particularly important.
“I think the big issue is the whole inventory control management within cold chain.
If inventory control could be added to a “SmartFridge,” that would make it
extremely attractive. Everything from reimbursement to patient coding, I could go
on and on. Add to that any type of tag/barcode, that would be a very effective
solution that I would really like to see.”
74
Critical Success Factors – Supply Chain
In the Supply Chain:
 It is critically important that the SmartFridge and Transport Container easily
assimilate into the existing supply chain. This was echoed with the introduction
of new vaccines.
 “Manufacturers should consider vaccine quantity impact packaging before
designing vaccines and introducing them into unfamiliar areas with limited
resources.”
 Within the supply chain, transport containers and cooling systems must be
reliable. The current “solutions” are not very good according to the Key Opinion
Leaders interviewed.
 “Cold storage must be reliable and transportable. Think of all the places that
vaccines are shipped where it can be damaged, exposed to light, or with great
temperature fluctuations.”
75
Critical Success Factors – Supply Chain & Partnership
Automation and Supply Chain:
 “An ideal solution would have a digital management system that automated the re-
ordering system and also handle reimbursement. If we could eliminate paperwork
and simplify everything for doctors and nurses, in combination with a reduction in
wastage, this may be worth the investment.”
 Several Key Opinion Leaders responded similarly and stated that there may be an
opportunity for the SmartFridge to be similar to a Automation System that is
provided by McKesson or CareFusion.
Potential Designs
77
Potential SmartFridge Designs
Futuristic Biopolymer Fridge
Four times smaller than a conventional refrigerator, the ultra slim Bio Robot is a biopolymer
based fridge without doors, drawers, or even a motor. Each item you put in the fridge is
stored in its own biopolymer vacuum bubble at its own optimal temperature by bio robots.
Designed by Russian industrial design student Yuriy Dmitriev, the fridge can be hung
vertically, horizontally, and even on the ceiling.
78
Potential SmartFridge Designs
Smart Fridge Concept
Smart Fridge is a concept that turns your fridge into a trust-worthy cooking companion. The
fridge can track the ingredients available inside it, make a menu list of all that can be
prepared with the available ingredients, and give a step-by-step instruction of the dish being
prepared. The Smart Fridge also tells you when you are running low on a particular
ingredient. The concept was conceived by Ashley Legg, while the visual impressions of the
gadget were done by Yanko Designs.
79
Potential SmartFridge Designs
IceCloud Fridge
IceCloud Fridge by Fanni Csernátony is a futuristic makeover of Nigeria’s zeer pot for the
year 2050 when space, energy and water will be our most precious treasures. The fridge uses
evaporating water to keep things cool naturally. The hanging structure makes it perfect
choice for houses with limited space.
80
Potential SmartFridge Designs
Neff Portable Fridge
To reduce the energy consumption for cooling, German designer Stefan Ulrich has decided to
harvest the leftover energy from the kitchen to power the fridge through an innovative
combination of new materials. Dubbed as Neff, the portable fridge can either be mounted on
the wall or placed on the table.
81
Potential SmartFridge Designs
Electrolux Flatshare Fridge
The Lego-like fridge design is Stefan Buchberger’s
solution to the food conflict between roommates
who share one fridge. The Flatshare fridge
consists of up to four stackable modules on top of
a base station which allows each roommate to
have his or her own secure and secluded
refrigerator space. Each module can be further
customized with add-ons like bottle openers or a
whiteboard.
82
Potential SmartFridge Designs
Celsius Stackable Modular Refrigerator
Designed by Angeline Meloche, Celsius is a conceptual stackable fridge with individual rooms
for different items such as vegetables or beverage, meats or fishes. You can purchase the
basic one-shelf version and expand the refrigerator by stacking one to each other. It features
controls 5 temperature settings which can be controlled by a touch sensitive front panel.
83
Potential SmartFridge Designs
Koolie Shopping Cart Fridge
Koolie is a space-saving fridge design which doubles as a shopping cart or a picnic basket.
The fridge features a built-in RFID field that detects all the new food items placed inside and
charges a predefined credit or debit card automatically when you leave the store through
cashier gates.
84
Potential SmartFridge Designs
Window Fridge
It’s not uncommon for us to open the fridge door and waste several minutes thinking about
what you want to get. To help you save time and energy, the Window fridge comes with a
transparent door which helps you make a decision before opening the door. It also comes in a
long tube design that makes it a snap to turn on the inside.
Key Takeaways and Recommendations
86
Key Takeaways
Key Takeaways for the SmartFridge and Transport Container
 There is a clear need for improvement in the cold chain.
 SmartFridge would be of great value on a global basis.
 The Transport Container seems to have more applicability in developing
countries.
 The SmartFridge/Transport Container must be easily assimilated into the
overall vaccine supply chain.
 Several key features must be included.
87
Recommendations
Recommendation I - WHO
 It is imperative that the Vaccine SmartFridge and Transport Container meet the
World Health Organizations Performance, Quality, and Safety Standards sheet.
 Meeting these standards is extremely important when selling/leasing devices
internationally and specifically to UNICEF.
88
Recommendations
Recommendation II – More Research is Needed
Ø Harrison Hayes recommends to conduct additional research to specifically
examine SmartFridge and Transport Container size. This is especially true in
developing countries.
Ø Harrison Hayes recommends technologies outside of the Peltier Element be
explored. There was an overwhelming negative reaction to this type of
technology.
89
Recommendations
Recommendation III – Features to be Included
 There are several features that must be included.
 Remote temperature monitors
 Visual and Audio Alarms (temperature related)
 RFID System
 Different temperature zones
90
Recommendations
Recommendation IV – Find a Partner
Ø It was extremely important to Key Opinion Leaders that the SmartFridge and
Transport Container be automated.
Ø A specialized, automation partner would be of great benefit in developing this
type of system.
Ø Potential partners may be McKesson (Robot-Rx technology) or CareFusion with
Pyxis technology.
Ø “Mini-Bar” may also be a viable partner, but would not be as respected as a
McKesson or CareFusion.
91
Recommendations
Recommendation V – Proof of Technology
Ø Proof of concept must show that it will reduce vaccine wastage by an
absolute minimum of 25%.
Ø 25% appears to be the threshold for market viability on a global basis.
Ø The dollar amount of this will vary depending on the vaccine.
Ø Proof of technology must also show that it will save time for nurses and
physicians.
92
Recommendations
Recommendation VI – Entering the Market
Ø Harrison Hayes would recommend a “phased” approach to entering the market.
Ø In the United States the pediatric space is the initial target audience and appear
to serve as the “early adopters.”
Ø Dermatology offices represent a secondary market.
Ø Assuming the cold chain solution reduces cost and wastage, a national roll-out to
pharmacies and general practitioners would be advised.
Ø Company should develop a Leasing Option for domestic customers.
Ø Globally, a partnership with PATH and UNICEF must be created in regard to the
cold chain solution.
About Harrison Hayes
94
About Harrison Hayes
Harrison Hayes is a strategic consulting firm to the life, chemical, and material
science industries. Specific areas of expertise reside in our unique and
proprietary research methodologies that support strategic and tactical decision
making processes for our clients.
www.harrisonhayes.com
Phone: 704-906-3402
Email: wsmith@harrisonhayes.com
95

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Vaccine smart fridge business case study sanitized

  • 1. Business Case for SmartFridge and Vaccine Transport Container – Final Report
  • 2. Project Scope, Objectives, and Methodology
  • 3. 3 Project Scope This project consisted of a global assessment of the value opportunities for a Vaccine Transport Container and SmartFridge. As part of this assessment, Harrison Hayes sought to develop a business case outlining the opportunities for each product. Although the primary focus of this project was vaccines, Harrison Hayes also sought to address other unmet needs.
  • 4. 4 Project Objectives The primary objective of this project is to develop a complete and thorough business case for the introduction of a Vaccine Transport Container and Vaccine SmartFridge. Specific objectives include: q Identification of market opportunities, barriers, risks, and challenges. q Assessment and analysis of market drivers and inhibitors. q Identification and analysis of critical success factors. q Determination of market adoption rates and product pricing. q Identification of therapeutic areas outside of vaccines that may best be able to utilize cold chain supply systems. q Determination of the value that a Vaccine Transport Container and Vaccine SmartFridge may provide. q Identification of regions/countries and therapeutic areas that would provide the greatest value.
  • 5. 5 Research Methodology Market research for this project consisted of Primary and Secondary market research. Primary research included the conduction of one hundred four (104) Key Opinion Leader interviews on a global basis across a variety of specialties. To supplement these Key Opinion Leader interviews, Harrison Hayes also conducted secondary research from publicly available information and syndicated sources.
  • 6. General Observations on “Cold Chain”
  • 7. 7 “Cold Chain” Defined When Key Opinion Leaders were asked to define “cold chain” they answered with the following:  Key Opinion Leaders identified/defined two (2) areas: Food/Beverage industry and Pharmaceutical/Healthcare.  Key Opinion Leaders further defined the cold chain in food/beverage industry as related to supermarkets, convenience stores, and end consumers.  The pharmaceutical market consisted of the supply chain, physicians, and the overall patient base.
  • 8. 8 WHO and “Cool Chain”  Proper vaccine storage and transportation is a key issue in the developing world, which presents numerous challenges.  As such, the World Health Organization (WHO), has developed the Performance, Quality, and Safety (PQS) system of cooling technology prequalification.  WHO has identified the following three (3) categories within the “cool chain”: 1. Refrigeration 2. Passive Cooling 3. Temperature Monitoring
  • 9. 9 View of the “Cold Chain”  Key Opinion Leaders viewed the cold supply chain strictly as a regional business model.  The interviewed Key Opinion Leaders noted that the industry is extremely fragmented with a lack of consistent product/cooling technology, specifically in the healthcare arena. There are too many marginal players in the space.  A cooling transport solution was addressed by a majority of the Key Opinion Leaders in unaided response.  The biggest problems were product maintenance and product temperature.
  • 10. 10 “Cold Chain” Market Players Global Market Players  According to the WHO’s Product Information Sheets and Performance Quality and Safety Sheets there are thirty seven (37) approved refrigerators and freezers.  These refrigerators and freezers are broken down into compression units, absorption units, and solar units.  There are four (4) primary manufacturers: Dometic, Vestfrost, Sibir International, and Zero Appliances.
  • 11. 11 Requirements in the Cold Chain Logistics is the central component to successful cold chain initiatives, especially as it relates to vaccines. Specific issues that must be taken into account include:  Storage Conditions (temperature)  Presentation (prefilled device, single dose vials, etc.)  Packaging (volume based)  Cost per dose
  • 12. 12 Cold Chain Distribution Models The WHO identifies two (2) logistics models as it relates to the cold chain.  Distribution System  Collection System The Key Opinion Leaders strongly believed that the Distribution Model was much more likely to provide a successful solution over the Collection system. This opinion was validated by the WHO.
  • 13. Market Opportunities – United States
  • 14. 14 Market Size Sales within the Global Refrigeration space is approximately $60B. The table below outlines these figures. Of this amount, less than 1% can be attributed to vaccine cold chain. Vaccine Cold Chain Refrigerator sales are estimated to be $.566B worldwide. Equipment Sales Domestic Refrigerators $32.8B Commercial Refrigeration Equipment $18.6B Cold Storage $2B Refrigerated Transport Vehicles $2B Refrigerated Containers $1.2B Total: $56.6B
  • 15. 15 Market Opportunities When the Key Opinion Leaders were asked what they believe the key market opportunities should be, they responded with the following:  Big Box/Chain pharmacies/Wal-Mart  Dermatologist offices  Insulin and Liquid Antibiotic storage (inclusive of insulin)  Neonatal centers  Plastic surgery offices  Prisons  Pediatrician offices  Third World Countries  Veterinarians
  • 16. 16 Market Opportunities The table below outlines the number of locations and potential market size for SmartFridge and Transport Container. *Only includes CVS, Walgreen’s, and Walmart. Office Type Number of US Locations Retail outlets (Big Box/Wal-Mart) 15,400* Pediatrician Offices 6,000 – 7,000 Dermatology Offices Aprox. 3,000 Plastic Surgery Offices Aprox. 2,300 Neonatal Centers Aprox. 1,200 Federal Prisons 184 Total 28,084 – 29,084
  • 17. 17 Market Opportunities Con’t. - 1,000 2,000 3,000 4,000 5,000 6,000 7,000 The chart outlines the number of locations and potential market size (not dollar based). Number of Locations
  • 18. 18 Market Opportunities- Key Opinion Leader Perspective Early Adopters/Adoption Rate/Pricing for SmartFridge  The U.S. based Key Opinion Leaders stated that the Pediatric Physician space represented the clear target opportunity.  Dermatology Offices were mentioned as a secondary opportunity.  A significant majority (more than 75%) of the interviewed Key Opinion Leaders stated that early market adoption rates would approach 25% in Pediatrician and Dermatology offices.  NOTE: The market adoption rates assumes that the SmartFridge contains the desired features/benefits and meets the market needs detailed in the “Critical Success Factors” section.  Key Opinion Leaders noted that a leasing option would be the most ideal; Leasing amounts range from $100 to $200 per month.
  • 19. 19 Market Opportunities – Peds and Derms The table below outlines the total dollar opportunity for the SmartFridge within Dermatology and Pediatric offices in the United States. **This assumes that each office will only lease one (1) SmartFridge. Office Type Number of US Locations Aprox. # of Derm/Peds Offices 9,500 Year One Market Adoption 25% Monthly Lease Rate $150 Total $356,250
  • 20. 20 Market Opportunities – Peds and Derms The table below outlines the total dollar opportunity for the SmartFridge within Dermatology and Pediatric offices in the United States. **This assumes that each office will only lease one (1) SmartFridge. Office Type Number of US Locations Aprox. # of Derm/Peds Offices 9,500 Year One Market Adoption 25% Monthly Lease Rate $100 Total $237,500
  • 21. 21 Market Opportunities – Peds and Derms The table below outlines the total dollar opportunity for the SmartFridge within Dermatology and Pediatric offices in the United States. **This assumes that each office will only lease one (1) SmartFridge. Office Type Number of US Locations Aprox. # of Derm/Peds Offices 9,500 Year One Market Adoption 25% Monthly Lease Rate $200 Total $475,000
  • 22. 22 Market Opportunities - Derms and Peds Con’t. On the Small Dollar Amount  Based on the previous three (3) tables, initial dollar revenue is extremely small, at less than $.5M. This estimate is based on the fact that each office would only lease one (1) SmartFridge  It is important to note that Pediatrician market is extremely price sensitive and that any new technology that is introduced must show cost savings.  Therefore, assuming the SmartFridge is successful and limits the amount of vaccine waste, Pediatricians will then adopt the SmartFridge much more quickly.
  • 23. 23 Market Opportunities- Transport Container (USA) Transport Container in the United States  The U.S. based Key Opinion Leaders very easily understood the practicality and applicability of the vaccine SmartFridge, but were not as impressed with the Transport Container.  It was unanimous among all Key Opinion Leaders that vaccine transport needed to be improved, but physicians could not see how such a solution would fit into their existing business model (i.e. they do not want to pay for this).  U.S. based physicians noted that they typically assume that vaccines are safe upon arrival; if refrigeration problems do arise, they assume the issue occurred in the office setting rather than transport.  In the United States, there is a relatively high level of confidence in the vaccine transport system. This is not the case in the developing world. Merck Vaccine Transport Container
  • 24. Market Opportunities – Developing World
  • 25. 25 Market Opportunity – Developing World Developing World  There is a clear need for updated vaccine refrigeration in both transport and in the clinical setting in the developing world.  Unlike the United States, the primary buyers of a vaccine SmartFridge and/or Transport Container in the Developing World are UNICEF and a corresponding country’s Ministry of Health.
  • 26. 26 Market Opportunity – Developing World Con’t. Developing World  Based on information from UNICEF, roughly 200,000 vaccine refrigerators are currently used in immunization programs in the developing world.  UNICEF vaccine refrigerator purchases make up roughly 85% of the market; Between 1997 and 2003 UNICEF refrigeration expenditures totaled $77M.  Ministry of Health refrigeration expenditures over the same period was estimated at $15M.  Countries with the most active Ministries of Health include India, Indonesia, and Japan.
  • 27. 27 Market Opportunity – Developing World Con’t. Developing World Market Behavior  Developing countries typically do not spend more than 10% of their EPI on cold chain equipment.  Most financial decisions regarding cold chain are made during the fourth (4th) quarter each year.  South American countries, more than any other region, typically rely on refrigerators that are intended for home use.
  • 28. 28 Market Opportunity – Defined Defining/Describing the Opportunity  In many areas of the developing world, electricity is not readily available. This has led to a vaccine distribution model.  Vaccines are held in a “cold room” at a central location and distributed through transport coolers.
  • 29. 29 Market Opportunity – Defined Recently Proposed Solutions  In the developing world, there is a clear focus on the construction of “cold rooms” rather than using vaccine refrigerators.  These cold rooms will need to be outside of existing buildings/structures and have adequate power supply.  “Cold Rooms” will be larger than 40m3.  Air/Freight shipping containers will need to be larger than those currently available and have the ability to keep vaccines between 2 and 8 degrees Celsius for a minimum of ten (10) days.
  • 30. 30 Market Opportunity – Defined Recently Proposed Solutions Con’t.  In cases where refrigerators must be used, Ice-Lined Refrigerators (ILRs) are the most acceptable. These ILRs must have a capacity of at least 400 liters.  Key Opinion Leaders in developing countries believed traditional “cold boxes” may no longer be appropriate.  Instead, Passive Container Systems (similar to those used in supermarkets) may represent the best known solution.  Traditional Ice Packs will be too heavy for people to carry given the increase in the volume of vaccines. Passive Container System Ice Lined Refrigerator
  • 31. 31 Market Opportunity – Defined Direct Competitor to the Transport Container  PATH is currently exploring the possibility of using a high-performance insulated container with a replaceable or rechargeable cooling device instead of refrigerators.  One such example is the Zeolite System, which can provide cooling on demand. Zeolite System
  • 32. 32 Market Opportunity – Cooling System Competitor Zeolite  The Zeolite System is currently being developed and produced by Dometic.  Zeolite is a mineral that has the property to absorb water vapor while releasing heat.  This system has the ability to store energy and transform it in heating or cooling agents.  Additional information on Zeolite can be found in the attached, separate document. Zeolite System
  • 33. Market Opportunities – Product Areas
  • 34. 34 Market Opportunity – Product Specific When the Key Opinion Leaders were asked what products would most benefit from SmartFridge and Transport Container like devices, the following answers were given: 1. Vaccines 2. Insulin 3. Injectables 4. Re-fill Devices 5. Antibiotics Note: This is a stack ranking in regards to number of responses.
  • 35. 35 Market Opportunity – Product Specific Vaccines and Insulin  Vaccines were mentioned as the primary product area of focus by every Key Opinion Leader interviewed, regardless of background.  Insulin was mentioned by all physician/healthcare specific Key Opinion Leaders mentioned.  Vaccines and insulin were by far the most important products the Key Opinion Leaders believed to have the most applicability to a SmartFridge and/or Transport Container.  There was equal distribution of the other responses, none of which were a significant threshold.
  • 36. 36 Market Opportunity – Additional Products The following products were mentioned by less than five (5) Key Opinion Leaders:  Dermatology fillers  Misc. dermatology products  Plastic Surgery materials  BoTox
  • 38. 38 Market Drivers – Overview Based on Key Opinion Leader feedback and Secondary research, the following items were mentioned as the primary market drivers for Cold Chain improvement: 1. Vaccine Wastage (Cost) 2. Rising Cost of Vaccines 3. Existing technology inadequate
  • 39. 39 Market Drivers – Wastage Vaccine Wastage:  Not surprisingly, vaccine wastage was identified as the primary market driver of driving the need for improvement in the cold chain.  Depending on the source, between $400 and $500M is lost on vaccine wastage each year. Half of this amount is directly related to breakdown in the cold chain.  The primary causes of this vaccine wastage include:  Cold chain issues  Expired vaccines  Damaged vials (broken during transport)  Doses diverted from target population  Accidental waste (throwing away good vaccines)
  • 40. 40 Market Drivers – Wastage Vaccine Wastage Con’t.:  In the practice of immunization, the number of vaccine doses used is always higher than the number of patients immunized.  The expected wastage rate is the proportion of total losses within the quantity consumed; it is not standard across all vaccines.  The tables on slides 40 and 41 outline the WHO’s maximum wastage rates for the estimation of lyophilized and liquid vaccine needs.
  • 41. 41 Market Drivers – Wastage WHO’s Maximum Wastage: Lyophilized Vaccines Vial Doses Wastage Rate 10 – 20 dose vials 50% 1 – dose vials 10%
  • 42. 42 Market Drivers – Wastage WHO’s Maximum Wastage: Liquid Vaccines Vial Doses Wastage Rate 10 – 20 dose vials 25% 1 – dose vials 10%
  • 43. 43 Market Drivers – Vaccine Cost Vaccine Cost:  Traditional vaccines (measles, DPT, Polio, etc.) have been on the market or decades, which results in a low cost.  These legacy vaccines general cost between $0.10 and $0.25, which makes them very affordable and wastage is less of a concern.  New vaccines come with significantly higher costs, generally between $4 and $15 per dose. Note: There are some vaccines that cost more than $15.  The high costs of these vaccines has heightened the need to reduce vaccine wastage.
  • 44. 44 Market Drivers – Vaccine Cost Con’t. The image below portrays the increase in the cost of newer vaccines compared to legacy vaccines: Image courtesy of Project Optimize and PATH
  • 45. 45 Market Drivers – Vaccine Cost Con’t. Vaccine Cost: Legacy Vaccines v. Current Vaccines  When vaccines cost less than $1, the total cost associated with vaccine wastage was manageable.  With lower costs, problems with logistics and the cold chain could be addressed by maintaining high stock levels. Due to the cost of vaccines, this is no longer cost effective.  The cost of vaccines has caused vaccine administrators to maintain lower stock levels, forecast vaccine demand, better prevent vaccine breakdowns and reduce overall wastage.
  • 46. 46 Market Drivers – Existing Cold Chain Solutions Existing Cold Chain Solutions are Insufficient  The Key Opinion Leaders interviewed in this study were adamant that the current technologies related to the cold chain are inefficient. Specific problems mentioned include: 1. Freezing 2. Heat 3. Moisture in refrigerator 4. Light Exposure
  • 47. 47 Market Drivers – Existing Cold Chain Solutions Standard Refrigerators  A significant majority (more than 75%) of the physician Key Opinion Leaders interviewed in the United States noted that they use standard refrigerators to store vaccines.  In standard refrigerators, Freezing was noted to be the primary issue. Vaccines placed at the back of the refrigerator typically freeze.  The temperature variance is not uniform in standard refrigerators, which causes problems with vaccines.  Moisture was the second greatest concern when using standard refrigerators. In many cases the Key Opinion Leaders noted that this moisture would often ruin the vaccine, creating waste.  Heat and Light Exposure was mentioned as areas of concern, specifically when the refrigerator door is left ajar.
  • 48. 48 Market Drivers – Existing Cold Chain Solutions Standard Refrigerators v. Vaccine Refrigerators  All of the interviewed Key Opinion Leaders had a very low confidence level in vaccine/healthcare specific refrigerators.  Vaccine/Healthcare Refrigerators are used because they are “the best available” according to the industry.  Key Opinion Leaders believed that standard refrigerators were on par with healthcare/vaccine specific refrigerators. The only difference is cost. Vaccine Refrigerator Standard white refrigerator
  • 50. 50 Market Barriers, Challenges, Inhibitors When the Key Opinion Leaders were asked what they believed to be the primary market barriers/challenges/inhibitors related to cold chain, the following answers were provided: 1. Lack of Viable Technology 2. Container Size and Cost 3. Reliability 4. Power Source 5. Storage
  • 51. 51 Market Barriers, Challenges, Inhibitors Lack of Viable Technology  Numerous technologies have been explored, examined, and tested but none to date have truly stood out.  Tested technologies include:  Cool packs  Peltier Element  Insulation Materials  Sugar Molecules
  • 52. 52 Market Barriers, Challenges, Inhibitors Lack of Viable Technology: Peltier Element q Due to the primary interest in the Peltier Element, Harrison Hayes specifically explored the pros and cons of this technology. q A majority of the interviewed Key Opinion Leaders were extremely skeptical of the Peltier Element. “Peltier is not an efficient technology…I wouldn’t think it is an applicable technology for cold chain improvement.” q The primary issue with Peltier was the issue with heat; in general, Peltier feedback was not positive.
  • 53. 53 Market Barriers, Challenges, Inhibitors Lack of Viable Technology: Peltier Element PROS  Compared to standard refrigerators, the Peltier Element does not have any moving parts.  When Peltier is used to cool electronic elements, it has relatively high reliability rates.  A “cascading Peltier” will enable electronic components to cool below freezing temperatures.
  • 54. 54 Market Barriers, Challenges, Inhibitors Lack of Viable Technology: Peltier Element CONS  Peltier modules release a large amount of heat and require “heat-sinks” and fans, which take up space.  In the event that a Peltier module fails, the cooled space is isolated from the heat- sinks. This leads to a extremely fast breakdown of the cool/stable temperature and could cause overheating.  Peltier cooling elements may cause moisture/condensation. This could potentially harm the vaccines.
  • 55. 55 Market Barriers, Challenges, Inhibitors Vaccine Container Size  Unlike legacy vaccines, new vaccines are packed much differently in order to minimize waste and be cost effective.  Legacy vaccines are packaged in 10 and 20 dose vials; New vaccines are packed in 1 and 2 dose vials to minimize wastage.  In some cases, new vaccines are bundled with delivery devices requiring larger, bulkier packaging.  While cold chain research used to focus on creating smaller cooling apparatuses, the need is really for larger more efficient solutions.
  • 56. 56 Market Barriers, Challenges, Inhibitors Vaccine Container Size: How Pack-out is Affecting Cost Image courtesy of PATH
  • 57. 57 Market Barriers, Challenges, Inhibitors Vaccine Container Size Con’t.  Today, a refrigerator full of new vaccines will destroy thousands of dollars rather than a few hundred dollars as is the case with legacy vaccines.  Additionally, the volume of vaccines that need to be refrigerated is expected to grow eight-fold.  This increase in packaging size and vaccine volume will create a need for larger, efficient cold rooms and refrigerators.
  • 58. 58 Market Barriers, Challenges, Inhibitors Vaccine Container: In Transport  Today, vaccines are typically transported in cold boxes of 20 - 25 liter capacity. Of this amount, 15 liters is made up of cold packs.  Current cold box designs have extensive insulation, which further limits the capacity of the cold box transport.  Refrigerated transport is an option in some areas, but often times road infrastructure is poor and refrigerated transport is extremely unreliable.
  • 59. 59 Market Barriers, Challenges, Inhibitors Power Supply and Reliability  A primary challenge is finding and implementing a reliable power supply.  Power supply in the cold chain has consisted of the following:  Electricity  Kerosene  Gasoline  Solar Photovoltaic  Note: These power supplies have been used for both refrigerators and transport containers.
  • 60. 60 Market Barriers, Challenges, Inhibitors Power Supply and Reliability: Electricity  In the United States and developed world, electricity is the primary power supply.  Electricity is typically reliable in both a refrigerator setting and in a cooled transport setting.  Electricity as a power supply in transport is reliable only as far as the reliability of the highway infrastructure.
  • 61. 61 Market Barriers, Challenges, Inhibitors Power Supply and Reliability: Gasoline and Kerosene  Cooling technologies powered by gasoline or kerosene are extremely inefficient and unreliable (according to PATH Key Opinion Leaders).  As expected, these refrigerators are not environmentally compatible.  Kerosene refrigerators were banned by the WHO in 2009.  Gasoline powered refrigeration is forecasted to be the most expensive cooling option over the next ten (10) years.
  • 62. 62 Market Barriers, Challenges, Inhibitors Power Supply and Reliability: Solar Photovoltaic  Solar photovoltaic technology may be a viable alternative to electricity, especially in areas where electricity is unavailable.  There is still much to be explored and studied within Solar photovoltaic technology. It is soon to tell how this technology may truly affect the cold chain and vaccines as a whole.
  • 63. 63 Market Drivers Con’t. Storage:  Concern regarding vaccines in storage facilities is an ever growing concern according to the Key Opinion Leaders interviewed.  “Stock levels are rarely accurate and it results in too many vaccines lying around in warehouses where stock is out in places that desperately need it.”  “Some 20-30% of warehouses do not conduct physical stock counts; only a third of warehouses have correct stock and only half of those have stock counts in an orderly fashion.”
  • 65. 65 Critical Success Factors Areas Examined q In determining the critical success factors of the SmartFridge and Transport Container, Harrison Hayes took into account: § Features and Benefits § Overall Construction § Financial Component § Supply Chain Elements § Wastage Reduction § Potential Partnerships
  • 66. 66 Critical Success Factors - Features Features Sought by Key Opinion Leaders (Stack Ranking)  RFID/Barcode Tracking  Adjustable temperature zones  Data collection interface  Data monitoring software  Defrost /condensation removal  Alarms  Remote monitoring  Easy to use/visual controls  Battery back-up  Security option
  • 67. 67 Critical Success Factors - Features Features Sought by Key Opinion Leaders: KOL Commentary  Tracking vaccines via RFID or barcodes is extremely important to the Key Opinion Leaders, especially due to the overall cost.  Temperature monitoring and controls were important to the Key Opinion Leaders especially while in transport and while in refrigerators.  Key Opinion Leaders believed that with temperature control and remote monitoring they could better prevent freezing and over-heating.
  • 68. 68 Critical Success Factors - Features Key Opinion Leader Feedback  A majority of the interviewed Key Opinion Leaders felt that the SmartFridge needed multiple compartments with segmented temperature controls; this would be a key differentiator from current vaccine storage models.  Three sizes would be ideal: One big storage unit, intermediate unit, and a small unit.
  • 69. 69 Critical Success Factors - Features Notable Features and Benefits:  Alarm system – must be known if a vaccine/drug becomes too hot or too cold  The alarms may either be audible or visual  There is a need for manual or automatic defrost technology  Manual defrost is the preferred method  Easy to read display panels that can be manipulated  It would be preferred if product is cooled from the top down
  • 70. 70 Critical Success Factors - Features SmartFridge Example:  RFID Software that locates vaccines.  Internal cameras that link with visual panels or smartphones – see inside without opening the refrigerator.  Capacity data and information  Cooling controls and protocol
  • 71. 71 Critical Success Factors - Benefits Key Benefits Sought by the SmartFridge/Transport Container:  Easy of tracking supply usage  Reduce Manual process  Reduction of stock-outs  Measurable return on investment  Accuracy in billing  Standardize inventory  Mistake reduction  Efficient workflow
  • 72. 72 Critical Success Factors - Financial Financial Component:  Key Opinion Leaders were skeptical of the potential revenues and cost savings component of the SmartFridge and Transport Container.  It was most commonly noted that revenues can come from the manufacturers and not the market. Manufacturers should compensate users for the units so that it would make financial sense and be embraced by the market.  In pediatric offices, cost savings must be clearly shown. “I do not want to spend money on something that cannot show a return on investment.”  In order to be successful in the pediatric market, Key Opinion Leaders stated that a reduction in wastage should be at least 25%.
  • 73. 73 Critical Success Factors – Supply Chain Inventory Control  The inventory control component was viewed by Key Opinion Leaders as particularly important. “I think the big issue is the whole inventory control management within cold chain. If inventory control could be added to a “SmartFridge,” that would make it extremely attractive. Everything from reimbursement to patient coding, I could go on and on. Add to that any type of tag/barcode, that would be a very effective solution that I would really like to see.”
  • 74. 74 Critical Success Factors – Supply Chain In the Supply Chain:  It is critically important that the SmartFridge and Transport Container easily assimilate into the existing supply chain. This was echoed with the introduction of new vaccines.  “Manufacturers should consider vaccine quantity impact packaging before designing vaccines and introducing them into unfamiliar areas with limited resources.”  Within the supply chain, transport containers and cooling systems must be reliable. The current “solutions” are not very good according to the Key Opinion Leaders interviewed.  “Cold storage must be reliable and transportable. Think of all the places that vaccines are shipped where it can be damaged, exposed to light, or with great temperature fluctuations.”
  • 75. 75 Critical Success Factors – Supply Chain & Partnership Automation and Supply Chain:  “An ideal solution would have a digital management system that automated the re- ordering system and also handle reimbursement. If we could eliminate paperwork and simplify everything for doctors and nurses, in combination with a reduction in wastage, this may be worth the investment.”  Several Key Opinion Leaders responded similarly and stated that there may be an opportunity for the SmartFridge to be similar to a Automation System that is provided by McKesson or CareFusion.
  • 77. 77 Potential SmartFridge Designs Futuristic Biopolymer Fridge Four times smaller than a conventional refrigerator, the ultra slim Bio Robot is a biopolymer based fridge without doors, drawers, or even a motor. Each item you put in the fridge is stored in its own biopolymer vacuum bubble at its own optimal temperature by bio robots. Designed by Russian industrial design student Yuriy Dmitriev, the fridge can be hung vertically, horizontally, and even on the ceiling.
  • 78. 78 Potential SmartFridge Designs Smart Fridge Concept Smart Fridge is a concept that turns your fridge into a trust-worthy cooking companion. The fridge can track the ingredients available inside it, make a menu list of all that can be prepared with the available ingredients, and give a step-by-step instruction of the dish being prepared. The Smart Fridge also tells you when you are running low on a particular ingredient. The concept was conceived by Ashley Legg, while the visual impressions of the gadget were done by Yanko Designs.
  • 79. 79 Potential SmartFridge Designs IceCloud Fridge IceCloud Fridge by Fanni Csernátony is a futuristic makeover of Nigeria’s zeer pot for the year 2050 when space, energy and water will be our most precious treasures. The fridge uses evaporating water to keep things cool naturally. The hanging structure makes it perfect choice for houses with limited space.
  • 80. 80 Potential SmartFridge Designs Neff Portable Fridge To reduce the energy consumption for cooling, German designer Stefan Ulrich has decided to harvest the leftover energy from the kitchen to power the fridge through an innovative combination of new materials. Dubbed as Neff, the portable fridge can either be mounted on the wall or placed on the table.
  • 81. 81 Potential SmartFridge Designs Electrolux Flatshare Fridge The Lego-like fridge design is Stefan Buchberger’s solution to the food conflict between roommates who share one fridge. The Flatshare fridge consists of up to four stackable modules on top of a base station which allows each roommate to have his or her own secure and secluded refrigerator space. Each module can be further customized with add-ons like bottle openers or a whiteboard.
  • 82. 82 Potential SmartFridge Designs Celsius Stackable Modular Refrigerator Designed by Angeline Meloche, Celsius is a conceptual stackable fridge with individual rooms for different items such as vegetables or beverage, meats or fishes. You can purchase the basic one-shelf version and expand the refrigerator by stacking one to each other. It features controls 5 temperature settings which can be controlled by a touch sensitive front panel.
  • 83. 83 Potential SmartFridge Designs Koolie Shopping Cart Fridge Koolie is a space-saving fridge design which doubles as a shopping cart or a picnic basket. The fridge features a built-in RFID field that detects all the new food items placed inside and charges a predefined credit or debit card automatically when you leave the store through cashier gates.
  • 84. 84 Potential SmartFridge Designs Window Fridge It’s not uncommon for us to open the fridge door and waste several minutes thinking about what you want to get. To help you save time and energy, the Window fridge comes with a transparent door which helps you make a decision before opening the door. It also comes in a long tube design that makes it a snap to turn on the inside.
  • 85. Key Takeaways and Recommendations
  • 86. 86 Key Takeaways Key Takeaways for the SmartFridge and Transport Container  There is a clear need for improvement in the cold chain.  SmartFridge would be of great value on a global basis.  The Transport Container seems to have more applicability in developing countries.  The SmartFridge/Transport Container must be easily assimilated into the overall vaccine supply chain.  Several key features must be included.
  • 87. 87 Recommendations Recommendation I - WHO  It is imperative that the Vaccine SmartFridge and Transport Container meet the World Health Organizations Performance, Quality, and Safety Standards sheet.  Meeting these standards is extremely important when selling/leasing devices internationally and specifically to UNICEF.
  • 88. 88 Recommendations Recommendation II – More Research is Needed Ø Harrison Hayes recommends to conduct additional research to specifically examine SmartFridge and Transport Container size. This is especially true in developing countries. Ø Harrison Hayes recommends technologies outside of the Peltier Element be explored. There was an overwhelming negative reaction to this type of technology.
  • 89. 89 Recommendations Recommendation III – Features to be Included  There are several features that must be included.  Remote temperature monitors  Visual and Audio Alarms (temperature related)  RFID System  Different temperature zones
  • 90. 90 Recommendations Recommendation IV – Find a Partner Ø It was extremely important to Key Opinion Leaders that the SmartFridge and Transport Container be automated. Ø A specialized, automation partner would be of great benefit in developing this type of system. Ø Potential partners may be McKesson (Robot-Rx technology) or CareFusion with Pyxis technology. Ø “Mini-Bar” may also be a viable partner, but would not be as respected as a McKesson or CareFusion.
  • 91. 91 Recommendations Recommendation V – Proof of Technology Ø Proof of concept must show that it will reduce vaccine wastage by an absolute minimum of 25%. Ø 25% appears to be the threshold for market viability on a global basis. Ø The dollar amount of this will vary depending on the vaccine. Ø Proof of technology must also show that it will save time for nurses and physicians.
  • 92. 92 Recommendations Recommendation VI – Entering the Market Ø Harrison Hayes would recommend a “phased” approach to entering the market. Ø In the United States the pediatric space is the initial target audience and appear to serve as the “early adopters.” Ø Dermatology offices represent a secondary market. Ø Assuming the cold chain solution reduces cost and wastage, a national roll-out to pharmacies and general practitioners would be advised. Ø Company should develop a Leasing Option for domestic customers. Ø Globally, a partnership with PATH and UNICEF must be created in regard to the cold chain solution.
  • 94. 94 About Harrison Hayes Harrison Hayes is a strategic consulting firm to the life, chemical, and material science industries. Specific areas of expertise reside in our unique and proprietary research methodologies that support strategic and tactical decision making processes for our clients.