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Re: [IP] RE: MiniMed FeedBak

Be advised - delete this if picky details about infusion sets, marketing,
etc. bore you ;-)


Thanks for the feedback. There may also be some "outside pressures" that
encourage MiniMed to take this position. Some thoughts:

1)  The infusion sets are manufactured for MiniMed by another company
(Maersk, in Denmark). MiniMed can only purchase the current offerings from
this company. This same company manufacturers the sets for Disetronic
(Tenders) and ChroniMed / Pureline (Comfort) in the same 2 styles - 1 tube
per cannula, and 1 tube per two cannulas. There may be no provision in MM's
current agreement with Maersk, or they may simply not have enough "pull" to
influence a product change with the supplier. After all, MM was the last of
the three companies to offer this product. In a sense, they are still
playing "catch up" to the volume purchases of the other two companies.

2)  I believe the recommended change times for infusion sets and tubing is
based on guidelines from the CDC (Center for Disease Control). These
guidelines specify a maximum of 48 hours between set changes for metal, 72
hours for "Teflon" or "soft" sets. These are vendor independent and brand
label independent guidelines. I can understand MiniMed's concern about
pumpers changing their sets and tubing at other than the recommended

3)  I'm a bit confused by Jack Joy's comments that "MiniMed wants to
encourage people to change the WHOLE infusion set each time they do a
change, as the older the infusion tubing gets, the more degraded insulin
will have collected in it, possibly contributing to more occlusions". If
that's truly the case, then sell *only* the single tube / single cannula
package (sometimes referred to as "hospital packaging"). A representative
from ChroniMed / Pureline mentioned to me they (Pureline) are aware that
Humalog seems to behave "differently" in the tubing / cannulas than other
insulins. It's possible that MiniMed's stance on this issue is the "safe,
middle of the road" stance, which is laudable. Just conjecture on my part,
but hey, who knows what's being discovered in these design / research labs ?

I can understand that changing the packaging and distribution of the sets
could be difficult for any of the vendors. They would surely have to go
through some added hurdles with the FDA and other regulatory agencies. This
would undoubtedly require additional FDA submissions, as Jack asserted in
his earlier message. If the net result is only a small increase in the
number of infusion sets sold, it probably is not a solid business plan.
Remember, it is a health care "industry" we're dealing with, as much as I'd
like to hope otherwise ;-)

Now, on the other hand, try making some noise - sometimes unexpected things
can happen. I remember the days when MiniMed "refused" to distribute /
approve this type of infusion set for use with their pumps. Enough of us
demonstrated that the sets worked well (often better than the MM sets we
had been using) and they eventually gave in to the pressure when they
realized the market value and safety / performance aspects made good
business sense. We're seeing similar things with Humalog, with varying


At 11:00 tonight, let's all stand in the street and yell "We're fed up and
we're not going to take it anymore". Which ever vendor comes to bail us all
out of the hoosegow should get our business <vbg>

Bob Burnett

mailto:email @ redacted
Insulin-Pumpers website http://www.bizsystems.com/Diabetes/