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Insulin Pump Manufacturers Idea Proposal (MDT, PODD, TNDM)

Insulin Pump Manufacturers Idea Proposal (MDT, PODD, TNDM)

Will the recall of Medtronic’s MiniMed 600 result in patient declines for the company and gains for Tandem and Insulet?

Report Available: March 26, 2020


Blueshift’s ongoing research found MDT experiencing another insulin pump recall. The U.S. Food and Drug Administration (FDA) has identified the issue as a Class I recall, the most serious type. This comes on the heels of a June 2019 recall. In the meantime, TNDM and PODD have published more positive data on their insulin pumps, experienced FDA approvals for enhanced technology, and partnered with other diabetes care providers, all of which may result in share gains for these two companies, especially when combined with the news of MDT’s recall.



  1. Insulin pumps and their components are complicated devices. They have the highest overall number of malfunctions, injuries, and death reports in the FDA database. In the last decade, MDT has faced 20 manufacturer recalls and about 100 lawsuits alleging pump malfunctions. So, it is not a surprise that MDT is facing yet another recall for some of its pumps. This is a Class 1 recall due to 26,421 complaints in which the device malfunctioned, and the firm is aware of 2,175 injuries and 1 death. This latest recall was announced in November 2019 for insulin dosing errors, and it followed a recall notice issued in June 2019 for cybersecurity issues. These back-to-back serious recalls raises the possibility that patients and physicians may be wary of MDT and willing to consider migrating to competing insulin pumps.
  2. TNDM has also experienced some recalls of its own. In January 2014, a Class 1 recall was issued because of leaking insulin cartridges and in April 2018 a Class 2 recall was issues for 55 t:slim G4 Insulin Pumps with faulty fuel gauges. However, TNDM has been riding a recent wave of success:
  • 2020 – TNDM began the U.S. commercial launch of its t:slim X2 insulin pump with Control-IQ advanced hybrid closed-loop technology.
  • 2019 – FDA approves t:slim X2 insulin pump and Control-IQ advanced hybrid closed-loop technology to control Type 1 diabetes.
  • 2019 – Health Canada approves TNDM’s t:slim X2 insulin pump with Basal-IQ technology.
  • 2019 – ABT and TNDM partner to develop and commercialize integrated diabetes solutions.
  • June 2019 – TNDM reports positive results from two studies, including the Protocol 3 (DCLP3) of the National Institutes of Health (NIH)-funded International Diabetes Closed Loop (iDCL) trial and interim data from the Freelife Kid AP study.

TNDM’s Control-IQ Technology

The t:slim X2 insulin pump with Control-IQ technology is designed to help increase time in range (70-180 mg/dL)*

using Dexcom G6 CGM values to predict glucose levels 30 minutes ahead and adjust insulin delivery accordingly.


  1. PODD experienced its own Class 1 recall in July 2015 for defective insulin pods. Lately the  company has experienced the following positive developments:
    • 2020 – DXCM and PODD announce a commercialization agreement to combine current and future DXCM CGM system with PODD’s Omnipod Horizon System.
    • 2020 – ABT and PODD partner to integrate ABT’s CGM technology with PODD’s Omnipod Horizon System.
    • 2019 – PODD secures FDA approval for use of NVO’s Fiasp insulin with the Omnipod insulin management platform.
    • 2019 – The FDA approved PODD’s Omnipod Dash as an alternate controller enabled infusion pump, or ACE pump, allowing it to be a part of an interoperable automated insulin delivery system.


  1. Blueshift’s past TNDM reports on October 23, 2019 and June 19, 2019 were both  extremely positive. Sources said TNDM’s growth trend would not be disrupted over the next six to 12 months. Sources did not anticipate any major competitive product introductions or enhancements in the short term that would derail the company’s market-leading position. In the October report, sources said PODD’s OmniPod Horizon—a hybrid closed-loop insulin delivery system—when approved and commercialized, could provide significant competition for TNDM. In the June report, sources said MDT was losing share because the 670G is complex, inaccurate, and generates too many alarms.


Will MiniMed prescribers and patients remain loyal to MDT in light of another serious product recall? Will the MDT recall create additional opportunity for TNDM, PODD and other insulin pump manufacturers? Which insulin pump manufacturers are gaining/losing market share? Is there any new insulin pump or CGM technology on the horizon that will disrupt the market? To answer these and other questions, Blueshift will gather data and issue a market research report from independent sources in the following areas: Diabetes centers, Nurse educators, Endocrinologists, Competitors, and Distributors.  


Companies: Dexcom Inc. (DXCM), Tandem Diabetes Care Inc. (TNDM), Abbott Laboratories (ABT), Insulet Corp. (PODD), Medtronic plc (MDT), Eli Lilly and Co. (LLY), Nemaura Medical Inc. (NMRD), Senseonics Holdings Inc. (SENS), MicroPort Scientific Corp. (MCRPF), Novo Nordisk A/S (NVO), Sanofi (SNY), Valeritas Holdings Inc. (VLRX)


Research Begins: March 9, 2020



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