Memorandum

Medtronic begins limited launch of MiniMed Pro-set with BD’s FlowSmart; same price as mio set and available in Luer Lock – October 3, 2016

Executive Highlights

  • On Friday, Medtronic began the limited launch of the long-awaited MiniMed Pro-set with BD’s FlowSmart technology. The set is posted in Medtronic’s online store, with a 10-ct box running $162, the same price as Medtronic’s all-in-one mio set. The initial launch will gather feedback from at least 1,000 users over at least three months. We expect a full launch in early 2017.
  • As expected, the set is available for both Medtronic and non-Medtronic (Luer Lock) pumpers (Animas, Tandem, Roche). It requires a prescription for purchase, and users must make an online store account before checking out (no “guest” option). The set is available in both 24’’ and 42’’ tubing lengths, with all featuring 6 mm catheters. We ordered a box of sets with a credit card in just a few minutes.
  • How quickly will patients from Medtronic and other pumps get on this set once it fully launches? How much better will the MiniMed Pro-set be in real life use? Will patients notice a glycemic control, variability, insertion pain, or quality of life differences relative to current sets? Will other pump companies see a revenue impact from this launch? We’ll let you know ASAP!

On Friday, Medtronic began the limited launch of the long-awaited MiniMed Pro-set with BD’s FlowSmart technology (dual-ported catheter), right on par with previous plans for an initial launch in the US and France in September (BD 2Q16, AADE). The set is posted in Medtronic’s online store, with a 10-ct box running $162, the same price as Medtronic’s all-in-one mio set, and a very slight premium to the $139 10-ct Quick-set box. The 0% to 16% premium is excellent to see for what appears to be a much-improved product (plus, we assume those with insurance won’t see a major out-of-pocket difference, if any at all).

As expected when the exclusive partnership was announced last June, the set is available for both Medtronic and non-Medtronic (Luer Lock) pumpers (Animas, Tandem, Roche). The MiniMed Pro-set requires a prescription for purchase, and users must make an online store account before checking out (no “guest” option). The set is available in both 24’’ and 42’’ tubing lengths, with all featuring 6 mm catheters, unsurprising given BD’s research on skin thickness and the dangers of intramuscular infusion with longer 9 mm catheters.

There is a single web-page on Medtronic Diabetes’ site that tells customers to call the company for more details on the set, but there is no link to the online store page for purchase. This is presumably strategic to control the initial launch, and following feedback from at least 1,000 patients in the US and France over at least three months, we assume the full rollout and marketing will occur early next year (BD’s “early FY17”).

We found it fairly easy to place an order in the online store for a Luer Lock version of the set, though did find it hard to add our insurance plan (we kept getting an error message). In signing up for a Medtronic Diabetes store account, we noticed that the company will collect some information about non-Medtronic pumpers, including a pump’s serial number – see below.

It will be interesting to see how quickly patients from Medtronic and other pump companies get on this innovative set once it fully launches. How much better will the MiniMed Pro-set be in real life use? Will patients notice a glycemic control, variability, insertion pain, or other quality of life differences relative to current sets? To what degree will other pump companies see a revenue or margin impact from this launch? 

  • Medtronic is not marketing the set heavily yet (see the single web page here and the store page below), presumably because it’s in a quiet initial launch mode. Interestingly, there is no mention of BD’s strong research on how FlowSmart’s dual-ported catheter reduces silent occlusions (published in DT&T earlier this year). The set’s branding is very clean (see picture below) and we’re glad to see BD’s FlowSmart mentioned prominently in the online store description, even if it’s more minor on the actual product packaging. 

  • In signing up for a Medtronic Diabetes store account, we noticed that the company may collect some key information about non-Medtronic pumpers, including a pump’s serial number. The registration process immediately recognizes when someone is not a Medtronic pumper and gives the option of entering pump brand and pump serial number. Fortunately this is optional and a user can still add the MiniMed Pro-set to the cart without entering it. Still, it is positioned as “optimizing” the shopping experience, and we wonder if Medtronic may be able to track when these pumps go out of warranty or if this is future information that the company will look to collect. 

  • It is unclear how significantly the launch of the MiniMed Pro-set will impact other insulin pump companies. As planned, the set will be made available for both Medtronic and non-Medtronic pumpers, and Medtronic controls distribution in both cases while BD handles the manufacturing. Patients at other pump companies who want the set will either: (i) become Medtronic customers to access it; or (ii) go through a distributor, who would in turn buy it from Medtronic. As planned, the innovative set will become available for Tandem, Roche, and Animas pumpers, through Medtronic, making the news likely less than positive from a healthy pump ecosystem perspective. The margin implications are clearly negative for the smaller players, though we’re not sure how quickly patients will move to the new set or how soon it will be possible to copy this set. Leading up to this, innovation in sets had been slow and we do think faster movement will now be seen.
  • Exclusive distribution of this set is a definite competitive advantage for Medtronic, particularly as the MiniMed 670G comes to market in Spring 2017; see our coverage of last week’s unexpected FDA approval
  • As a reminder, BD’s new set revolves around a new catheter with “FlowSmart technology,” which allows insulin to flow out of two places: the bottom (like current infusion sets) and the side (a new innovation). The set also has a slew of new form factor improvements: a less painful, 30 gauge insertion needle, making this the smallest infusion set insertion needle on the market (roughly similar to a pen needle in size); a multi-position connector that allows patients to connect the tubing to the on-body set in eight different positions (e.g., no need to line it up); a sliding shield that covers the insertion needle and contains it after insertion, helping to prevent accidental needlesticks (also great for those who are needlephobic); options for both manual insertion and insertion with the Quick-Set inserter; and both 24 and 42 inch tubing lengths. It is only offered in 6 mm catheter size, reflecting BD’s research on skin thickness. 

  • BD and Medtronic completed a study of the new MiniMed Pro FlowSmart infusion set in 75 type 1 patients in February. The trial assessed insertion pain and wear comfort vs. patients’ existing sets. No results have been posted, and since glycemic control is not an outcome, we assume this could drive marketing if outcomes are positive (e.g., less pain than other sets or X% of patients prefer MiniMed Pro to other sets). See our BD F2Q16 report for more details on the study.
  • A Diabetes Technology & Therapeutics paper published in March shows reduced silent occlusions with the BD FlowSmart versus the Medtronic Quick-set infusion set in two separate studies. In study 1 (n=25), a pilot study, fewer silent occlusions were seen with FlowSmart versus Quick-set for both manual and mechanical insertions, yielding occlusion risk reduction in the mid-70% range. In study 2 (n=60), a more rigorous experiment, occlusions occurred in three of 117 FlowSmart sets and 12 of 118 Quick-Set sets, a risk reduction of 75%. This technology clearly works, and should hopefully prevent some unexplained hyperglycemia. We wonder if it will work similar or even better in real-world use than in these controlled studies. We were surprised not to see more references to this work online. 

-- by Adam Brown and Kelly Close