Over the past three years, head of Research and Development (R&D) for the Insulin Delivery Closed Loop group, Carolyn Schmitz, has helped bring engineering solutions to insulin delivery products, paving the pathway toward an artificial pancreas. Passionate about helping the diabetes community, Carolyn and her team are committed to delivering diabetes technology that improves outcomes while reducing the weight of diabetes management.
Q. Describe your role here at Medtronic
A. I am the head of R&D for the Insulin Delivery Closed Loop business unit, and am responsible for the engineering behind our insulin delivery products. Working closely with my team and peers who lead continuous glucose monitoring R&D and artificial pancreas algorithm R&D, we create and bring high technology products to the market as quickly as possible.
Q. Can you tell us a little bit about your background?
A. My background and passion is in biomedical engineering. Starting my career in blood bank diagnostics, I worked in the industry for seven years before moving into consumer electronics, helping bring cell phones and smart phones to the market. I was drawn to be on the leading edge of software, but was sad to leave the medical industry. When I joined Medtronic in 2010, I was delighted to move back into the medical field and am so pleased to be working in this industry again.
Q. What was the attraction to the medical device industry?
A. I have always been interested in medicine, and I really like how customer-focused Medtronic Diabetes is. Working in the medical device industry does not necessarily mean working directly with the people who use your devices. However, in this space, I am able to work directly for and with our customers. I am really proud when I see people using and having their lives changed by our devices, and that is very important to me in terms of enjoying my hard work.
Q. What is your favorite part of your job?
A. Engineers by their nature are problem solvers, so I really enjoy looking at the presented opportunities and working with a team of fabulous engineers to generate new ideas and solutions. For me, it is finding ways to get innovative product into our pipeline, and out into the market and into our customer’s hands more quickly. It is about product realization – we have an idea and we want to make it something real.
Q. How do you and your team get that connection with the customer in order to ensure what you’re developing has their wants and needs in mind?
A. Understanding and identifying our customer’s wants and needs is our first priority. The people that work here are very passionate and committed to helping people with diabetes. I love the customer forums that Medtronic Diabetes hosts here, where we bring in customers to talk with the entire organization. This gives us a very broad view of their likes and dislikes, and what is working for them and what’s not. They are always very candid on how we could do better and I really like that. We also visit our physicians in their clinics to identify their biggest need in caring for their patients with diabetes. In addition, our market research teams conduct various studies and focus groups with our customers and potential customers to identify which product features are missing, or should be improved, and then collaborate with us in R&D to incorporate features into the development of new products.
Q. What was your involvement in the development of the MiniMed 530G with Enlite system?
A. My team and I partnered with our clinical team to support the clinical studies that were necessary for product approval. We are currently partnering with them on the pediatric clinical study, helping generate the data necessary to back a future submission to the FDA to ask for a product indication for children under the age of 16. We are also partnering with our clinical team on the MiniMed 530G with Enlite post approval studies, which are highly collaborative with the FDA in terms of the structure. In these studies, we help ensure our clinical teams have the necessary study environment and devices in order to conduct the breadth of circumstances they want to study.
Q. What are you and your team working on next? What are you working on next?
A. The next advancement we’ve been working on is predictive low glucose management. Instead of shutting off insulin delivery at a specific threshold, predictive low glucose management technology predicts 30 minutes in advance of that threshold. Our goal is to help people with diabetes obtain better glucose control. We’re also working on integrating this technology into our new pump platform, which will look different than the pump we sell today and will include a few more consumer-friendly features that our customers have told us they’re looking for. Future steps beyond that include technology that would automatically deliver an amount of insulin based on the sensor glucose reading.
Q. What are some of the challenges and opportunities your team faces?
A. The challenge in creating an Artificial Pancreas is taking the independent pieces of technology (algorithm, sensing technology, and delivery mechanism), and combining them to create an integrated system that delivers intelligently, and functions as a pancreas to keep the individual in a steady state of glycemic range. In addition to this complexity, the system needs to be user friendly. Challenges are opportunities, so they complement each other well. Medtronic Diabetes has an important role to play in the diabetes therapy field. As the industry leader, we have an obligation to tackle the hard problems and help bring solutions a reality.
Q. What keeps you motived to work in the field of helping people with diabetes?
A. The people. The chance to work in a company and field where I am able to see the impact my work has on other people’s lives is what motivates, drives, and rewards me. I come to work every day, not because I love my work or because I work with brilliant people, but because at the end of the day, I am working on something that really matters to a lot of people with diabetes and helps them. My daughter has a friend who uses our pump, and seeing her excitement about how our products have helped her is so cool and rewarding. That’s what it’s all about.
IMPORTANT SAFETY INFORMATION
Medtronic Diabetes insulin infusion pumps, continuous glucose monitoring systems and associated components are limited to sale by or on the order of a physician and should only be used under the direction of a healthcare professional familiar with the risks associated with the use of these systems. MiniMed 530G with Enlite is intended for the delivery of insulin and continuous glucose monitoring for the management of diabetes mellitus by persons 16 years of age or older who require insulin.
Pump therapy is not recommended for people who are unwilling or unable to perform a minimum of four blood glucose tests per day. Insulin pumps use rapid-acting insulin. If your insulin delivery is interrupted for any reason, you must be prepared to replace the missed insulin immediately.
The information provided by CGM systems is intended to supplement, not replace, blood glucose information obtained using a home glucose meter. A confirmatory fingerstick is required prior to making adjustments to diabetes therapy. MiniMed 530G with Enlite is not intended to be used directly for preventing or treating hypoglycemia but to suspend insulin delivery when the user is unable to respond to the Threshold Suspend alarm and take measures to prevent or treat hypoglycemia themselves.
Please visit www.medtronicdiabetes.com/importantsafetyinformation for more details.
Tags: artificial pancreas
, closed loop system
, diabetes management
, diabetes technology
, insulin pump
, MiniMed 530G
, product development