Medical Device Manufacturing:
Bag Valve Masks
Social Sustainability in Ethiopia
Andy Bose, Christian Flygenring, Courtney Severson, Samson Payne
Executive Summary
The medical device manufacturing company described in this business plan will produce
a new design of bag valve masks created by University of Wisconsin – Madison engineering
students. Importing medical devices to the country of Ethiopia is expensive and the aim of the
company is to create a socially sustainable solution to the problem, while saving the lives of
individuals who require resuscitation.
We estimated the demand for BVM based on the capacity of the Ethiopian health care
system. Given the 4% birth rate and 10% resuscitation rate and assuming each BVM will be
sanitized every day, the total national demand of BVMs is 14500. In the country of Ethiopia, the
government is the main provider of healthcare. Therefore, it is essential for the company to
participate in the competitive bidding process through the government’s national procurement of
medical devices.
The product is still in the development stages, but the prototype will be completed by
December 2012. The goal of the new design is to reduce the number of parts from eleven to
seven. This will also reduce the number of materials that need to be procured. Our calculations
reflect the fact that all of the materials (capital equipment and raw materials) will need to be
imported to Ethiopia.
The company is expected to reach a 50% market penetration, which translates to a
demand of 587 units each month. The total number of man-hours required for the production of
587 units is 72, which results in costs of approximately $86 USD (per month). Labor needs
could certainly grow over time to be orders of magnitude greater (which would scale with
revenue). As a whole, labor cost is a much smaller factor than COGS and rent when
determining profitability, breakeven, and ROI.
In terms of marketing the product, the product features that should be highlighted
include: simple design, reusability, and low cost. The simple design makes it easy to train health
professionals in device use. In addition, the product can be cleaned using disinfectants already
available at hospitals and clinics. The bag valve mask easily beats its competitors on price.
At this time, the product will be sold business to business. The company should work to
obtain a government contract to sell to the public hospitals. The remaining demand will be for
private hospitals and NGOs. If a public information campaign was created to raise awareness
about the necessity of resuscitation devices, there is a potential to sell the product to consumers.
These consumers might not be able to reach a hospital and would require the device in their
own home.
The product will sell for $10 USD. The cost to produce the product is approximately
$2.31. The calculations assume that the company will sell the product to a distributor/wholesaler
for $8 USD. The distributor will receive a $2 margin. The revenues from this model will be
$54,600 in the first two years. A distributor/wholesaler was considered necessary because the
transportation system in Ethiopia is relatively inefficient.
The capital equipment would allow for the production of other medical devices, which
leads to additional revenue streams and the potential to export. These opportunities should be
explored after the business is launched and successful within the country of Ethiopia.
Company Description
The First Breath Project is a collaboration between Sagean Inc., the University of Wisconsin,
Madison and Addis Ababa University Faculty of Medicine. The purpose of this business plan is
to provide direction for an Ethiopian entrepreneur to create a medical device manufacturing
company, something that is currently missing in the country of Ethiopia. The overall goal of the
project is to develop, manufacture, and sell a Bag Valve Mask (BVM) at a low price within the
country of Ethiopia. The company could expand into other types of medical device
manufacturing or export devices to surrounding countries.
Market Analysis
Medical care in Ethiopia, a nation of 80 million people, is provided by clinics in the countryside
and hospitals in larger towns and cities. The government is the main health care provider in
Ethiopia. According to Corporate Health Foundation Partnerships for Prevention and Care and
Columbia University’s Center for National Health Development Ethiopia, there are about 135
public hospitals, 635 health centers, 5,955 health posts owned by the government, while there
are about 50 private hospitals and 10 NGO hospitals. The limited number of health care facilities,
insufficient supply of medical devices. Lack of skilled manpower and finance and difference
between urban and rural areas make it difficult to provide Ethiopians with adequate access to
health care.
We estimated the demand for the BVM based on the capacity of Ethiopian health care system.
Based on a study conducted by Corporate Health Foundation Partnerships for Prevention and
Care, a hospital (200 hospitals total) serves approximately population of 200,000 people each, a
health center (650 health centers) serves 30,000, and a health post (5000 health posts) serves
5,000. Given the 4% birth rate and 10% resuscitation rate and assuming each BVM will be
sanitized every day, the total national demand of BVMs is 14500. See the appendix (Calculation
of Market Size) for calculations.
Product Specifications
The product is still in the development stage. The engineering students will have a functional
prototype by the end of the year 2012. The primary motivators behind this new design are
minimizing number individual parts for assembly and the number of material needed to
manufacture the product; both of which are for the purpose of minimizing production cost.
Existing models of BVM’s typically contain 11 components; the engineering teams goal is to
reduce to seven components.
Materials
The following materials were considered (see Appendix for breakdown of materials by part):
● Flexible Materials
○ Silicone rubber
○ SEBS
●
●
Hard Materials
○ Clear PVC
Other
○ Small stainless steel springs
This product should be manufacturable entirely by either a plastic extrusion blow molder or
plastic injection blow molder. We were not able to find information on current availability for
either these pieces to equipment or local sources of the materials needed. Therefore, we are
assuming that all equipment and materials must be imported.
Manufacturing
All manufacturing can be done through an injection blow molder, which can produce and
individual (or batch) component in anywhere between 1.5-15 seconds. At this rate, one injection
molder has the capacity of producing at least 300,000 BVM’s per year. Aside from material and
operating labor cost, the only other costs incurred from manufacturing is electricity. A 17.3kW
Injection molders will consume approximately 300kWh of electricity per month if producing one
component at a time for 587.5 BVMs (50% market penetration) per month, and double that for
100% market penetration. The average cost/kWh in Ethiopia is $0.07, so it will cost
approximately $21 in electricity for manufacturing at 50% market penetration.
A heat sealer will also be used for sealing the assembled BVM’s in shipping packages, but the
electricity cases for this operation are negligible.
Labor
At the estimated demand of 1175 units/mo BVMs in Ethiopia and 50% average market
penetration in the 1st year, we have determined the following schedule for labor (see Appendix
for how figures were calculated:
Man - Hours
Labor/mo
Parts Production
Assembly
Packaging&Shipping
Subtotal
Distribution*
Total*
*If a distributor is not found,
average over year.
Cost in USD (@$1.19/hr)
Cost in USD (@$1.19/hr)*
Man - Hours
587.5 units/mo (50%
Market Penetration)
18
18
36
72
38
110
1175 units/mo (100%
Market Penetration)
36
36
72
144
38
182
85.5
130.63
171
216.13
Notes: The values with astericks (*) represent a model where the company distributes its own
products as opposed to going through a distributor.
The values in the table above do not take into account labor costs for production to meet market
demand greater than what we predicted (which could certainly be greater in actuality), other
products that might be produced by the same facility in the future, and the possibility of
exporting products outside of Ethiopia. With all these factors, labor needs could certainly grow
over time to be orders of magnitude greater (which would scale with revenue). As a whole, labor
cost is a much smaller factor than COGS and rent when determining profitability, breakeven,
and ROI.
Marketing & Sales
The product will sell for $10 USD. The goal is to slowly decrease price (after the initial
investment of machinery has been paid off) until the product is available for $5 USD.
The distinguishing product features are as follows:
○ Simple design, with fewer parts
■ Easy to train health professionals on device use
○ Reusable
■ No need for repeat purchases
■ Can be cleaned using disinfectants already available at hospitals/clinics
○ Low cost (cheaper than the cost of most disposable BVMs)
At this time, the product will be sold business to business. If the company or an NGO created an
educational campaign, the product could also be sold direct to families. Customers who are not
able to reach adequate healthcare facilities could purchase the product and use it as needed.
Competitors
The Ethiopian Food, Medicine, and Health Care Control Industry found 92 wholesalers and 114
importers of medical devices. These companies are able to provide BVMs. Wholesalers and
importers buy devices from the manufacturer and increase the selling price in order to receive
high margins. In this case, the company will manufacture and sell the he product. There is no
need to increase the price above the $10 selling price.
The majority of products imported to Ethiopia come from China, India, the European Union, and
the Middle East. Companies that manufacture medical devices and export to Ethiopia represent
a potential threat if they can beat the BVM on price. No import laws exist, but medicines and
medical devices must be registered with the Drug Administration and Control Authority of
Ethiopia. This is the largest barrier to entering the market.
In Ethiopia, public hospitals use national contracts for procurement of goods and services. The
bidding process would be used for procurement of Bag Valve Masks. This company would likely
win the bid from the Ethiopian government for two main reasons: the product is created within
the country and has the lowest cost.
Financial Projections
The financial projections section is broken up into three parts: initial investment, short-term
revenue, and long-term revenue.
Initial Investment
Capital equipment: The capital equipment required includes an injection molder,
customized molds, and a heat sealer. The cost of the injection molder is approximately
$15,000. The customized molds are approximately $1,000 for each part, with design
costs of approximately $1,000. The heat sealer is $300.
Materials required: See the appendix for the materials needed.
Labor: See Labor section above.
Short Term Revenue
Cost per device: Assuming the BVM is produced entirely of SEBS, clear PVC, and a
spring, and an estimated 30% material use is lost in production, we have estimated the
cost per unit to be $2.31 (42.04 ETB). See Appendix for details. SEBS was chosen in
place of silicone rubber due to significantly lower material costs.
Sales: We predict an average market penetration of 50% (587.5 units/mo) over the
course of the first 2 years of production. Because of the relatively low production volume,
sale price will likely need to be on the higher end of our target ($10/unit), and distribution
margins may be on the order of $2. At these operating points, we anticipate an average
annual of $56,400/year for the first 2 years.
Long Term Revenue
BVM Sales In Ethiopia: We estimate that over time, market penetration will reach 80%,
allowing for negation of a lower distributor margin ($1.50), and that sale price may need
to decrease (to $9/unit) in order to remain competitive. At these adjustments, revenue
would increase to $84,600/year.
Other device manufacturing: An injection molder has the capacity to produce almost
and soft or hard plastic device, medical or otherwise. They also have a high output rate
(as high as an impression every 1.5 seconds). Because of this, facilities set up to
produce BVMs could produce a plethora of other devices.
Exporting
The Bag Valve Mask can be exported to other countries. The surrounding countries of
Sudan, South Sudan, Kenya, Uganda, Somolia, Djibouti, and Eritrea should be
considered first. The potential revenues from selling in these countries are difficult to
determine. A variety of factors must be considered, including: import/export laws,
distribution/transportation, and market size.
In order to export the product, a trading license must be obtained from the Ethiopian
Ministry of Trade and Industry. See their website for more information:
http://www.ethiopia.gov.et/English/MOTI/Services/Pages/PrincipalRegistration.aspx
The projections for this area should be obtained after successful implementation within
Ethiopia. If the projections for potential revenue and expense are made at this point, the
numbers will be inaccurate. The goal is to translate this company to other countries after
5 years, so estimates for revenues and expenses should be made after the initial project
is successful.
Conclusion
The manufacturing of bag valve masks in Ethiopia is financially viable. The company provides a
social sustainability solution to the current problem of lack of availability to low cost bag valve
masks. See the Appendix for further calculations and graphs showing multi-variable
relationships. In addition, the excel sheet provided will allow the changing of assumptions and
show the differences in revenue and expenses.
Appendix
Ethiopian Health Care System
Population per facility
Hospital by type
Calculation of Market Size
Birth rate: 0.04, resuscitation rate: 1/10,
Number of resuscitation needed per facility per month:
200 hospitals, 650 health centers, 6000 health posts.
population served per facility: 200,000, 30,000, 4000 respectively.
(200,000 * 0.04 *0.1)/365= 2.19 resuscitations/day per facility => At least 3 BVM’s
needed/facility
(30,000* 0.04* 0.1)/365= 0.32 resuscitations/day per facility => At least 2 BVM’s needed/facility
(5,000*0.04*0.1)/365 = 0.05 resuscitations/day per facility => At least 2 BVM’s needed/facility
Each each health facility will likely want more than the bare minimum to account for days with
abnormally high demand. Each facility will likely want at least 2 BVM’s in case one breaks.
Therefore, we added 1 to each result above:
(3 + 1)*200+(1 + 1)*650+(1 + 1)*6000= 14500 BVM’s needed in the Ethiopian Market.
Unfortunately, we could not obtain any data on the lifespan of each BVM. We are currently
assuming that each BVM will need to be replaced every year. Therefore, the the Ethiopian
demand for BVM’s should be at least 14500 units/yr.
Materials By Part
Component
Material
Bag
Latex free thermal plastic rubber, capital
SEBS
Mask
Alpha PVC 300695,
Silicone Rubber,
Spring
Stainless Steel
Neck, 02 port, threaded neck piece,
Stopper neck
PVC, K Resin,
One way valve/rubber stopper
Polysulfone,
Silicone rubber
Cost of Production per BVM
Materials Cost
Per spring ($)
Rubber per kg ($)
Rubber per unit (kg)
PVC per kg ($)
PVC per unit (kg)
SEBS per kg ($)
SEBS per unit (kg)
Packaging per unit ($)
Material Lost in Production
(fraction)
Total cost/unit
($/kg)
0.1
8.3
0.1379
2.2046
0.0815
3.4
0
0.018
0.3
2.308
Potential Travel Costs
Estimated One-Way Travel Distance & Time
of major Highways
Major Roads
Distance km
1200
800
900
980
1000
700
1000
740
Total
14640
Time hr
16
10
12
13
13
9.5
14.5
9.5
195
Gas Cost ($/gal)
Mileage (MPG)
Mileage (kmPG)
Gas Cost ($)
8.33
10
16.0934
7577.715088
per trip
% Time at site
Distribution Time (hrs)
0.15
224.25
number of trips/year
Cost per month
Timer per month
2
1262.952515
37.375
<<Round Trip
Graphs
The following are a series of graphs that show how breakeven is affected by several variables.
This can be very useful information, because all of our predictions can only serve as a best
guess of what the actual operating points are for the business model.
Additionally, if multiple variables differ from our predicted operation points, then the proportional
change caused by each one individually can be multiplied together to get a new estimate of
breakeven. The error in this value tends to be proportional to the amount of deviation, and the
number of variables that deviate, from our predicted operating points, but so long as the actual
operating point is within the range that is plotted on the graph for the given variable, then the
actual breakeven tends to be accurate to within +/- 50% of the calculated result, and is often
accurate to within +/- 10%. This is still accurate enough to determine viability.
Ex. (using Model with a distributor):
Actual Material Waste: 20% => Breakeven changes from 21mo to 17mo
=> 17/21 = 0.81
Actual Rent: $1500/month => Breakeven changes from 21mo to 15mo
=> 15/21 = 0.7
Original Breakeven was 21 months => It is now 21*0.81*0.7 = 12.1 months
For each graph, breakeven was also plotted for 3 scenerios:
● Model using a distributor
● Model where the business does its own distribution
● Model where the business does its own distribution, and has to initially purchase a
$10,000 truck to transport the products
For each graph, all other variables are held constant, and one is changed. The other variables
are fixed at the following values.
Base Operating Points
● Two full trips per year (w/o Dist.), see Potential Travel Costs
● $2 Distribution Margin (w/ Dist.)
● 587.5 units/mo (50% Market Penetration)
● $2000/mo Rent
● Sale Price $10
● $1.19/hr wage
● 30% Material Waste
● $10000 Truck (w/o Dist. + Truck)
This graph works the same as the previous graphs (see example at the beginning of Graphs),
only they are now all plotted on the same graph (ONLY for the model that uses a distributor). To
get all of the variables on the same graph, each curve was scaled by its base operating point.
(Ex. 1.6 for Distribution Margin means 1.6*base value($2) = $3.2).
For example, we used $2000/mo for rent (red line), which is 1.000 on the horizontal axis
($2000/base value of $2000 = 1.000). So if rent was actually $2400/mo, it would appear on the
graph as $2400/$2000 = 1.200. In this case, breakeven increased from about 1.75 years (@
1.000) to 2.5 years (@1.200).
In this situation you might ask, “How should I adjust price to reduce breakeven back to where it
was: ~1.75 years?” The change in rent increased breakeven by a factor of 2.5/1.75 = 1.43. So
the change in price needs to reduce breakeven by a factor of 1/1.43 = 0.7. At a price of 1.000
(1.000*base price of $10), breakeven was ~1.75. So 0.7*1.75 ~ 1.25. The Price curve (light
blue) yields a breakeven of 1.25 at about 1.15. Therefore, setting the price to 1.15*$10 = $11.50
will bring the breakeven down to its original value.
(change in breakeven cause by factor 1)*(change in breakeven caused by factor 2) = (change in
breakeven)
So in the previous example, 1.43 (@rent = 1.200) * 0.7 (@Price =1.15) = 1 (no change in
breakeven);
and actual rent = 1.2*$2000 = $2400, and actual price = 1.15*$10 = $11.50.
If many factors are different from our target values, then the change in breakeven can be
calculated by the same means:
(proportional change 1)*(proportional change 2)*(proportional change 3)*... = (proportional
change in breakeven)
The greater the deviation from our model, and the greater number of variables that deviate from
our model, the greater the error in the calculation of % change in breakeven. However, it would
still be accurate to +/- 50%, so if the resultant calculation seems reasonable, then this should be
a good business venture.
Revenues, Expenses, & Breakeven Points
Cost with distribution
Yearly Quantities
Prod Labor/mo
Assembly&Packaging&shipping
Distribution Time
Labor Cost/mo
Prod. kWh/mo
Other kWh/mo
Total Energy Cost
17.95139
53.85417
0
85.2691
296.4427
181.44
33.45179
hrs
hrs
hrs
$
215.4166667
646.25
0
1023.229167
3557.3125
2177.28
401.421475
Materials
Springs (per spring)
Rubber(per kg)
Rubber per unit (kg)
PVC (per kg)
PVC per unit (kg)
SEBS (per kg)
SEBS per unit (kg)
Packaging (per unit)
%Material Lost in Production
Total cost/unit
0.1 $
8.3
0.1379
2.204622
0.0815
3.4
0
0.018
0.3 :0.3
2.307595 $
1.2
99.6
1944.39
26.45546388
0
40.8
0
Retail Price ($)
Distributor Margin ($)
% market penetration
Units demanded/mo
Units produced/mo
Revenue/mo
10
2
0.5
1175
587.5
4700
10: prescribed by Tiff
:2
:0.5
1000: prescribed by Tiff
120
14100
56400
Fixed Cost
Rent ($/mo)
Distribution Cost (sort of fixed) ($/mo)
Profits
COGS/month
Profits/month
1355.712
1225.567 $
Breakeven
Mold cost
extrusion molder cost
Injection molder cost
Truck
heat sealer cost
Packaging (100k units)
SEBS (1 ton)
PVC (1 ton)
Silicone Rubber (1 met Ton)
Springs (15000 units)
Shipping costs
Breakeven months
Breakeven years
$10,000
0
15000
0
300
1800
3400
2000
7000
1500
$0
20.64
1.720292
2000 :2000
0
<-- need to add initial supplys cost
FOB
:20000
FOB
FOB
FOB
FOB
FOB
FOB
FOB
<4k * number of heavy items
$41,000
Cost with distribution, company owns a truck:
Prod Labor/mo
Assembly&Packaging&shipping
Average Distribution Time
Labor Cost/mo
Prod. kWh/mo
Other kWh/mo
Total Energy Cost
17.95139
53.85417
37.375
129.6519
296.4427
181.44
33.45179
Materials
Springs (per spring)
Rubber(per kg)
Rubber per unit (kg)
PVC (per kg)
PVC per unit (kg)
SEBS (per kg)
SEBS per unit (kg)
Packaging (per unit)
Material Usage Factor (per unit)
Total cost/unit
0.1 $
8.3
0.1379
2.204622
0.0815
3.4
0
0.018
0.3 :0.3
2.307595 $
Retail Price ($)
Distributor Margin ($)
% market penetration
Units demanded/mo
Units produced/mo
Revenue/mo
Fixed Cost
Rent ($/mo)
Distribution Cost (sort of fixed) ($/mo)
Profits
COGS/month
Profits/month
Breakeven
Mold cost
extrusion molder cost
Injection molder cost
Truck
heat sealer cost
Packaging (100k units)
SEBS (1 ton)
PVC (1 ton)
Silicone Rubber (1 met Ton)
Springs (15000 units)
Shipping costs
Breakeven months
Breakeven years
10
0
0.5
1175
587.5
5875
hrs
hrs
hrs
$
Yearly Quantities
215.4166667
646.25
448.5
1555.822917
3557.3125
2177.28
401.421475
10: prescribed by Tiff
:2
:.5
1000: prescribed by Tiff
1.2
99.6
1944.39
26.45546388
0
40.8
0
120
14100
70500
2000 :2000
1262.953
1355.712
1093.232 $
$10,000
0
15000
10000
300
1800
3400
2000
7000
1500
$0
32.29
2.690798
<-- need to add initial supplys cost
FOB
:20000
FOB
FOB
FOB
FOB
FOB
FOB
FOB
$51,000
<4k * number of heavy items
Cost without distribution (selling to a wholesaler):
Prod Labor/mo
Assembly&Packaging&shipping
Average Distribution Time
Labor Cost/mo
Prod. kWh/mo
Other kWh/mo
Total Energy Cost
17.95139
53.85417
37.375
129.6519
296.4427
181.44
33.45179
Materials
Springs (per spring)
Rubber(per kg)
Rubber per unit (kg)
PVC (per kg)
PVC per unit (kg)
SEBS (per kg)
SEBS per unit (kg)
Packaging (per unit)
Material Usage Factor (per unit)
Total cost/unit
0.1 $
8.3
0.1379
2.204622
0.0815
3.4
0
0.018
0.3 :0.3
2.307595 $
Retail Price ($)
Distributor Margin ($)
% market penetration
Units demanded/mo
Units produced/mo
Revenue/mo
Fixed Cost
Rent ($/mo)
Distribution Cost (sort of fixed) ($/mo)
Profits
COGS/month
Profits/month
Breakeven
Mold cost
extrusion molder cost
Injection molder cost
Truck
heat sealer cost
Packaging (100k units)
SEBS (1 ton)
PVC (1 ton)
Silicone Rubber (1 met Ton)
Springs (15000 units)
Shipping costs
Breakeven months
Breakeven years
10
0
0.5
1175
587.5
5875
hrs
hrs
hrs
$
Yearly Quantities
215.4166667
646.25
448.5
1555.822917
3557.3125
2177.28
401.421475
1.2
99.6
1944.39
26.45546388
0
40.8
0
10: prescribed by Tiff
120
:2
:0.5
1000: prescribed by Tiff 14100
70500
2000 :2000
1262.953
1355.712
1093.232 $
$10,000
0
15000
10000
300
1800
3400
2000
7000
1500
$0
23.14
1.928533
<-- need to add initial supplys cost
FOB
:20000
FOB
<-- Might need, not factored into ROI, since existing vehicle may be possible
FOB
FOB
FOB
FOB
FOB
FOB
$41,000
<4k * number of heavy items
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