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Research and Development at Medtronic: Driving Toward a Closed Loop System

By Dr. Francine Kaufman

Chief Medical Officer

Posted:  5/3/2011 12:00 AM

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Almost two years ago, I left my three-decade long position in academic medicine to come to Medtronic to be part of the effort to develop an artificial pancreas, a fundamental goal for all of us in diabetes research. With all of the work currently underway, Medtronic is committed to bringing innovation and advancement to diabetes therapy.

We have made significant progress on our ultimate goal to provide patients with a fully-implanted, fully-automated pump – a true artificial pancreas. Our work in this area represents the reason I came to Medtronic and why our entire group is committed to helping people with diabetes live a better life.As we work toward that goal, we are also focused on what we can do today and in the near future to improve the overall health and quality of life of people with diabetes. We are making significant advances in our pump and sensor technology, refining the algorithms that direct our devices to do what we design them to do, and updating our offerings to be more adaptable in today’s constantly changing technology environment.

I tell you this because it’s important to understand the breadth and depth of our work when you consider what Medtronic is doing for people with diabetes. We noted with great interest the recent story in Diabetes Health about our implantable insulin pump and the online discussion that followed.  We read first-hand the stories of people who have gone to great lengths to avail themselves of our implantable insulin pump.

As you know, the implantable insulin pump is not approved by the FDA in the United States. It has been made available outside the U.S., most notably in France.

The comments that followed the posted story covered a number of areas, mostly advocating for its broader use and questioning why we have not brought it to the market in the U.S. One thing that we would like to point out is that the implantable pump is not a closed loop system. The people in Europe who use this product still need to test their blood sugar multiple times per day, count carbs and calculate and administer bolus dosages using the pump's external remote.

In addition, included in those comments were a number of insinuations that we are somehow withholding this device from patients. That is completely untrue.

The reasons why the implantable pump is not available in the U.S. are as follows:

• There are many technical, scientific, clinical, regulatory and healthcare system hurdles. We regularly manage through these, but in some instances, and the implantable insulin pump is one, we need to consider not only our device, but the insulin that is provided through that device. Having one component approved is challenging, having two components is doubly so.

• The implantable pump – in its present form – is difficult to adopt. It is a complex device that requires meticulous attention and care. Refilling and readjusting it is a challenge. We’re working to make the pump smaller and easier to adopt.

• A particular type of concentrated insulin must be used in the implantable pump to provide the best opportunity for an efficacious and safe treatment for the patient. That formulation is still being developed and refined, and the original formulation is no longer available.

• Our research and development budget is robust, but has limits. We work on the innovative advances we believe we can bring to the market quickest so that we can have a more significant impact on the care of people with diabetes.

Developing the next generation of implantable pumps will take significant time and resources. We know there are many innovations that we can bring to people sooner to reduce the burden of diabetes management and improve outcomes. As supported by the roadmap developed by the JDRF, it is within our grasp to have pumps/sensors/algorithms that determine how to deliver insulin automatically, and that can start making big differences in the lives of people with diabetes now and in the years to come. That is where Medtronic is placing the bulk of its resources and efforts, while at the same time it continues to invest in the implantable pump program.

Of course, we are pleased to hear stories from people who report success with our devices. We remain committed to supporting the patients who currently benefit from the implantable pump.  However, no device is right for everyone. That’s why we create a portfolio of devices that will suit the broad spectrum of people with diabetes.

We remain committed to listening and engaging with the diabetes community. You are a passionate, informed and motivated group of people who have brought about great change in how this disease is treated and we have no doubt you will continue your tireless advocacy. Your words and deeds motivate us everyday to develop innovative treatments which help improve the lives of diabetics everywhere.

I’ve seen a lot of positive changes in diabetes technology in the 32 years I’ve been practicing medicine. It’s exciting to see how far we’ve come. But, knowing how much talent and resources are currently dedicated to developing an artificial pancreas, it’s even more exciting to think about what technology patients might have in the near future.
 

Comments

Brent

Posted on Wed May 04 14:01:53 GMT 2011

I have to say I'm pretty disappointed in this response, though not at all surprised. There is no mention of the distinct advantages of intra-peritoneal delivery of insulin, and what Medtronic might be doing to further this as a product design goal. She notes that it would take years of development to update the implantable pump, but makes no mention of the ten years since the development of the last version. And finally tries to pin the blame on the FDA, while there have been no updates (and in fact the product has been cancelled) for the countries that have allowed the implantable pump (i.e. the EU).

We should all loudly protest this type of pat response to our questions.

Brent

Florence Weems

Posted on Wed May 04 19:04:00 GMT 2011

I would like to volunteer for the implantable pump program when it is approved for testing in the United States.

John

Posted on Wed May 04 19:05:00 GMT 2011

What you fail to mention are the key differences between the implantable pump and the external. Most notably, insulin delivery (sub-q is physiologically abnormal and dangerous), and the costs of the external pump are exorbitant and keeps getting worse and once consumer based healthcare is adopted by more and more companies we (diabetics) will be faced with ridiculously high premiums, no doubt influenced by rising costs in durable medical equipment. Obtaining an insulin pump will truly become opportunity cost for many! All of your reasons why the tech has slowed are not insurmountable, just get the right people and resources working on it. We live in an age where technology is constantly shrinking so I don't buy it. It sounds like the insulin analog has been managed for 20 years so where are the metrics.

Amanda Sheldon

Posted on Wed May 04 19:06:00 GMT 2011

@John Of course, no technology available today is perfect. And while there are many, many studies demonstrating the safety and effectiveness of sub-q insulin delivery, no therapy is without its risks. As Dr. Kaufman touched on in this entry, intra-peritoneal delivery of insulin isn't perfect either. That's why so many people are working to advance the science, trying to make diabetes management better and easier.

@Brent We did not mean this to come across as a "pat response." We are trying to provide perspective for the trade-offs that we face as we bring products to market.

Pat Wolfarth

Posted on Tue Mar 20 14:08:39 GMT 2012

I want to let you know I have been a long standing diabetic using the sensors. I have been a diabetic so long the I have been recently having problems with pocketing insulin. The implantable pump would be my dream to make things less complicated. I have hypoglycemia unawareness this would be wonderful I would try it with out a doubt. Thank you for all the hard work you do.

Donna Cook

Posted on Wed Sep 18 16:50:43 GMT 2013

I am new to diabetic research, so consider me semi-knowledgeable about all of this. Has there been any research on pancrras implants? I am so curious about all the possibilities.

Karrie

Posted on Thu Sep 19 15:12:43 GMT 2013

Interesting question Donna! This is definitely not my area of expertise, but perhaps someone on your healthcare team could point you toward some information on research in this area?

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