Finding the chase and cutting to it

Actually that’s a little unfair, I have been considering this for a while but the resolution harden at 1:04am this morning.

In 2002, I bought my first insulin pump and it was nearly perfect.  Unfortunately, its design based around an insulin pen cartridge is not a profitable one for any manufacturer, so I now cannot buy a replacement for it.

One of the reasons I bought it was that it was based on a pump design I had come up with in 1993 (albeit that was based on a 1.5ml pen cartridge rather than a 3ml one).  The consequence was that was much cheaper to run as there were fewer consumables to buy each month.

Yeah, that may have been the other consideration as I was self-funding.

OK, where is this going, cut to the chase?

This is my design for the perfect insulin pump and why it won’t be made by an existing manufacturer

Consumables or single use components

• standard Insulin pen cartridge (lasting approx 5 days) – there are four of these, ranging in size and fixing mechanism
  The insulins in use are Humalog (lispro) and Novarapid (aspart).
  These are all 100iu/ml so dosing programmes are identical but the cartridge bay may be different.
• Adapter one for each cartridge use, specific to the cartridge type in use

Not supplied by the company

• The infusion set: Cannulas and Tubes
• 1xAA battery replaced as required

Tubes come interfaced, typically, with a common luer adapter.  So the users can source these anywhere.

Because of this, there is no guaranteed recurring revenue.  This makes it highly unlikely this type of pump can make money for a manufacturer.

The pump itself

Operating features

1. Four basal rates each defining a 30 minute period in the day and up to 0.005 units.
2. Four button all on front
3. Either B&W LCD or paper white screen
4. 2 bolus types, each with records showing insulin on board and the potential to take blood glucose readings.  If taking a longer bolus the user should be able to perform a fast one on top
   1. one fast bolus
   2. one “pizza” bolus
5. Past weeks records visible on screen
6. Programmable by computer – infra red connection only accessible if the pump is off
   This can set the unusual things like priming amounts, blood sugar levels for insulin on board calculations, insulin duration, insulin type.
   The programme should be available for the cheap computers like the machines defined here: http://www.zdnet.com/pictures/ten-raspberry-pi-2-alternatives/2/ .
   The pump comes with this kit for no added cost.
7. Records received locally on the diabetics computer – infra red connection only accessible if the pump is off
8. Simple limited screw face plates for batteries and the insulin adapter
9. No wireless control (for security)
10. Boluses can be performed underclothing, so vibrating bolus and alarms.
11. Two modes:
    1. running (allowing boluses and basals to be delivered)
    2. ceased: (allowing computer connections, priming and withdrawing the cartridge)
12. When the battery runs out, it remembers where the cartridge is so the user doesn’t have to reprime
13. Alarms are loud and vibrate the pump
    Including:
    1. empty cartridge (limit set by user)
    2. empty battery
    3. automatic off (set by user)
    4. occlusion
    5. mechanical error
    6. electronic error
14. Warnings are either soft or silent but do vibrate the pump
    including:
    1. low cartridge
    2. low battery
    3. pump not set up to run
    4. cartridge/adapter alert
    5. temporary basal rate cancelled
    6. temporary basal rate completed
    7. bolus cancelled
15. Checks are made regularly (when insulin delivery is made, either for basal or bolus amounts) on whether the pump is functioning
16. A light for the screen to allow use in the dark (cinema or bedroom for example)
17. A pre-set limit for hands free priming but also a stop function to allow the user to change tubing lengths easily.
    Priming the cannula can be achieved in run mode with a fixed bolus.
18. No promise on more than IPX 7 although the insulin components and pump electronics should be protected as much as possible.

These are based on my experiences of what works best and more buttons (especially on the side and top) do not help.

I want a flat bottom, so the pump can be easily stood up up while trying to establish the infra red connection to the computer (again, this is for sanity).

The user interface on the pump is driven by four raised buttons in either running or stop mode:

• Menu button: for scrolling through the menus
• Select button: for selecting a menu to drill into or signal a choice has been made
• Up arrow: for increasing choice through the menu or while setting a value
• Down arrow: for decreasing choice through the menu or setting a value

The buttons need to be on one face of the pump and raised so they can be differentiated under clothing or for a blind user.  A differentiated t configuration works well and you can make it obvious from the pump shape which button set is which.

Menus should be navigable in both directions from any point in the menu (rotating menus).

That’s pretty specific

Along with the cartridge design, these are things that make life easier for the pump user.  Most of these have come from my beloved DTron pump although the paradigms are pretty common throughout the pump world.

Security wise, NFC and blue tooth extra are all complexities you very rarely need, even as a woman who wears the occasion evening dress.  I tend to locate the pump in a garter belt – hides it well and you can programme boluses under the table, remember the vibrations which allow me to “feel” the dose even if heavy rock is happening all around you.  You check the record by going to the log if you are not 100% sure.

But this also allows use on a conference call without having to explain away the beeps.

I’m a grown up – many of the features I see in newer pumps are not that useful – like remote bolusing.  If you are an adult looking after a toddler or first few years of primary school diabetic or a disabled older person, this is important to you.  By the time the diabetic gets to their second decade of age, they will be wanting that control themselves not having their parents do it for them.

I like to wear my pump outside my clothes, so a belt clip that can be repositioned so that I can read the screen easily is a must.  On a belt, the pump is situated so I can read it!  See above about remote control.

Cloud based records are the only ones available on my current pump and that is great so long as you are on grid.  There is no ability to programme the four basals anywhere but on the device.  That is really painful.

Sounds great – so why won’t someone sell this?

There is a limited amount of revenue creation here and pump manufacturers are, after all, trying to make money.

The only revenue generation is on the cartridge adapters, approx. 4/5 are used a month.  You cannot fund an organisation with that.

Then there’s medical approval and testing.  The pump would need to be sold for a significant mark up to cover those costs.

It would need to be a non-profit organisation.  How could I find funding for that?

As my friend Phil Ashby stated, could you go open source pump and let people build their own using 3D printers?