BME100 f2017:Group3 W1030 L2

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Name: Blake McCal
Name: Michael Finocchiaro
Name: Chris Zakanycz
Name: Nick Faas
Name: Jonathan Planten


Device Image and Description

Description: Our product is a phone case that can also act as an inhaler for asthma patients. This case was based off of a design that we found off of grab cad, but the addition of the actual inhaler mechanism were of our own design. Our mechanism has a button on the top that releases the metered dose of medicine, much like a regular inhaler design. We have included a retractable end piece that allows the patient to inhale the medicine. The design has a removable back so that the consumer can add their own medicine cartridges. The product will be made out of stainless steal and has a relatively easy design so it shouldn't be costly to mass produce.

Technical and Clinical Feasibility

Technical Feasibility

What are the technologies needed?
a). plastic milling machine
b). Metal mill for external housing, welding may be needed depending on how we decide to attach the bottom plane to the arc shaped upper housing.
c). plastic injection molding for pieces related to the button and trigger system
d). stainless steel, aluminum welding machine for canister containing the medicine

What are the challenges?
a). We are concerned that a flat, ellipse shaped canister will expand around the areas with smaller slope. Cylindrical canisters don’t have this issue since the pressure is equalized in 360*, reducing the chance of unwanted expansion of the walls.
b). Metered dosing issues. We are unsure about how to incorporate a metered dosing function into a flat ellipse shaped canister

What could go wrong?
a). We may be unable to create the canister in the desired shape. We want a canister that can fit inside a sleek, arced housing attached to the back of the phone case. Typical inhaler designs involve cylindrical shaped canisters, so we will need to spend time in R&D testing innovative canister designs
b). If the metered dosing feature fails, people will be unable to administer medicine to themselves. This is obviously an extreme concern since this sort of failure could lead to cardiac arrest or death.

Clinical Feasibility

Given the technical feasibility, would it work in the clinic?
a). Based on the technical feasibility, the product should work in a clinical setting because the manufacturing plan is logical.

What are clinical risks?
a). The metered dose could fail
b). The trigger button could get jammed
c). Explosion due to build up of pressure in canister

Have similar products been in a clinical trial?
a). No current model to compare to

Technical Feasibility Score: 3
Clinical Feasibility Score: 1

Market Analysis

Value Creation
a). Our product delivers peace of mind as well as functionality for asthma affected individuals. Many children carry a smart phone all day, yet don’t have access to their inhaler when they need it. If customers had a backup, emergency inhaler attached to their phones they would rarely be caught without their medicine.

Manufacturing Cost
a). Phone case: $3k for a mold, plus $0.10 - $0.50 per unit for materials
b). Canister housing: finished dimensions 0.5” x 2.4” x 4.0” (H x W x L).
-Aluminum housing: 6061 Aluminum flat bar; 0.5” x 3” x 4” = $2.53 (metals depot)
-Stainless steel housing: 304 Stainless Steel Flat; 0.5” x 3” x 4” = $6.24 (metals depot)
c). Canister containing the medicine 0.5” OD x 4” = $0.41 (aluminum), $0.80 (stainless)
d). Miscellaneous hardware:
-Activation button: 0.5” x 0.5” x 1.0” piece of metal (aluminum or stainless)
-Safety mechanism: 0.25” x 0.25” x 1.0” piece of metal
-Retractable mouthpiece: 0.5” x 0.5” x 1.0” piece of metal
-Metal track to hold canister in place: 0.3” x 2.5” x 4” piece of metal
Total metal required for misc hardware: 3.56 cu. in Since this is a variable cost, we estimate it as $2 (aluminum), $6 (stainless steel)

Cost of phone case + aluminum housing + hardware = $5.44 per unit (max)
Cost of phone case + stainless steel housing + hardware = $13.54 per unit (max)

Sales Price
(6061 Aluminum) $27.20
(304 Stainless steel) $67.70

Market Size
Aluminum Case: ($27.20)x(0.05)x(25,000,000)= $34,000,000.00
Stainless Steel Case: ($67.70)x(0.05)x(25,000,000)= $84,625,000.00
Total Market Size= $118,625,000.00

Fundability Discussion

Customer Validation:1
Market Size:1
IP Position:2
Technical Feasibility:3
Regulatory Pathway:1
Clinical Feasibility:1

Total Score:18

This product should be funded because it offers a level of convenience that hasn't been seen by other inhaler designs. We have virtually no competition because there is not a phone case similar to our product. Since the fundability score is 18 the inhaler phone case is fairly fundable. This case also has a fairly simple design so when it comes to mass production the product should be easy to make and cost effective. It will be made out of stainless steal so it will be not only a durable inhaler, but phone case as well. The case also has a removable back so the customer will be more willing to buy the product knowing that they can replace empty cartridges.