Design Guidelines & Design Questions

Rough Product Requirements Document for a mechanical spark generator that could be manufactured and sent to third world countries. (This document contains more questions than answers)

Mechanical

No exact max size requirements have been set, though the lighter and smaller it is, the more likely it will be with the person who is bitten.
Max L x W x H: TBD
Min L x W x H: TBD

Max weight: TBD
Min weight: TBD
Cable length, max - min:
Cable length is probably 1.5 feet and is standard spark plug wire. The cable would ideally wrap up on the side of the unit.

Cable wire gauge:
Standard spark plug wire guage.

Max torque required:
RPM guide: ~20 revolutions/sec
Packaging - carried bare, or in a carrying pouch?

Packaging would probably be in a cheap carrying pouch, though where we could get something like that is TBD.

Integrated cable spool?
Dis-similar cable contacts? (i.e., polarity?)
If polarity, then must rotor have ratchet?

We don't know yet if direction of rotation makes a difference.
Ideally there will be some sort of crank & charge mechanism by which it can be ‘wound up’ and waiting to be discharged. A repeatable burst of sparks could be generated every time.

Environmental

Storage:
Max Temp -
Min Temp -
Operation:
Whatever the Max temp and humidity of Africa or the south American rainforests would be our guide. If there are bearing surfaces must be of a material that won't corrode. The cheapest probe would be a tinned tip of the sparkplug wire that a probe has been molded around.

Max Temp -
Min Temp -
Permissible internal humidity:
Tinned cable? Stranded?
Mildew resistance:

Serviceability

There isn't much that could be serviced on this unit. The cable could be replaced if it was pulled out but it is epoxied into the ignition and wouldn't be easy to replace. If the unit was to get dropped, it could get out of alignment but that could be adjusted pretty easily.

Open the case?
Cable replacement:
Cable contact replacement:

Electrical:

Voltage: 20Kv – 25Kv range. Waveform - squarish with a pulse width of at least lms. The signal should as closely replicate the characteristics of the Zappers manufactured by Wade which had so much success.

Current: max - min:
Voltage: max - min:
Waveform - specific waveform desired?

Documentation:

A simple, wordless (Pictographs) 1-2-3 instructions would embossed. We would also have a separate sheet with more details and languages.

  • Separate instruction sheet?
  • Instructions embossed on case?
  • How many languages?

I'm not sure how many languages.

Pictographs?

Regulatory Requirements:

Any FDA requirements?
Must any foreign requirements be met for medical devices?
Our product would be used in 3rd world so no FDA requirements. I'm not sure about any foreign requirements be met for medical devices.

Production Volume:

Anticipated number of units per year, years 1 - 5 at initial
We have no idea of the volumes though 50 a year would be a starting point.

Price point

Clinical:

Do there need to be different models for different areas with different
types of snakes? I could imagine a scenario where small snakes with shallow penetration require a different treatment than larger snakes with deeper penetration, or possibly that different types of venom respond to different types of treatment.

Our desire would be to create one model for the worst case snake bites. You can't over shock a venom site so we wouldn't be worried about the less venomous snakes.

Risks:

Competition

I could imagine that the largest markets would be outside the US. Have you considered obtaining foreign patents? Even so, it appears that the devices might be easily-replicable by locals - not a bad thing for expanding patient care, but problematic for insuring that you recoup your investment. There are ways to minimize that but the risk of competition should be kept in mind.

The concept of our design should be reproducable by locals. They are the ones who need it most.
Our largest market would be the 3rd world. We are not interested in pursuing foreign patents.

Liability

In the US, medical device mfrs have to worry about lawsuits. Because this device delivers emergency medical care, this will need to be discussed.

When used in the US, this device can only be used under the premise that it is first aid that is given on the way to a hospital. Because it isn't FDA approve, we won't advertise that this will cure a snake bite.

Customers

Strongly-related to potential volume. Given the need to use the device within 10 - 15 minutes, devices will need to be no further away than that from potential victims. If the cost were low enough, I could imagine the devices being present in every village clinic, on every work crew that goes out to work in the jungle, every church office, etc. The question is how to target such a diverse customer base to get the word out to them. Be benefit of developing high volumes, of course, is to significantly reduce production costs.

Aggregation

(I'll call it this for now because a better term escapes me). Would it make sense for this item to be aggregated with other "kits" that are already used in those areas? Could it be sold to mfrs of first-aid kits for inclusion in those kits? Could it be sold through industry-specific suppliers in those areas, such as shops who sell supplies for the logging industry, farming equipment, etc?

We would also like to see the devices being present in every village clinic, on every work crew that goes out to work in the jungle. Ron has been discussing this Zapper for the last 25 years in churches around the US. If we get a product that is cheap enough, we already have a lot of people interested in it.