One FDA clearance just added 5.5 million patients to the automated insulin delivery market. The diabetes device segment is not a niche anymore.
The reps who figure that out now are going to have options.
THE EDITOR’S NOTE
A few thoughts from the field before we get into it…
It used to be that when I thought about diabetes and diabetic care, I would think about a close family friend who always had to stick herself with a needle to get some blood to check her glucose level. I never really thought there was much to diabetes care past that.
As I moved along in my med device career, I got to see how big this space really is and the complexities that go along with it. This week gave us two reminders of that.
MiniMed completed its spinout from Medtronic and is now operating as an independent company for the first time in 25 years. And Sequel Med Tech received FDA clearance for the twist Automated Insulin Delivery (AID) system for adults with type 2 diabetes. AID, for anyone new to the term, stands for automated insulin delivery: closed-loop systems that combine a continuous glucose monitor with an insulin pump and an algorithm that adjusts dosing automatically in real time. Until very recently, AID systems were approved only for type 1. The twiist clearance changes that, opening the U.S. market to an estimated 5.5 million additional insulin-using patients.
That is not a small number.
What is happening right now in diabetes device is the kind of inflection point that creates careers. The companies scaling into the type 2 market need people who can sell in primary care and endocrinology, understand payer access, and work through DME distribution channels. A lot of those people are going to come from pharma.
This issue is for them. And for anyone else paying attention.
Glad you're here. Let's get into it.
Andy Knapik, Founder
The Modern Med Rep
INDUSTRY INTEL
What's moving in med device this week and why it matters
Five Things Shaping the Industry Right Now
→ MiniMed has completed its spinout from Medtronic and is now operating an independent company.
MiniMed pioneered the insulin pump and was acquired by Medtronic in 2001. After 25 years as a division, it is now back on its own. The spinout gives MiniMed more autonomy to compete directly in a market that has gotten significantly more crowded since Medtronic first brought it in. For anyone in the diabetes device space, a newly independent MiniMed is a meaningful competitive force to watch, and a company likely to be actively building out its commercial team.
→ Sequel Med Tech received FDA clearance for its twiist AID pump for adults with type 2 diabetes.
This is the biggest single expansion of the AID addressable market in the history of the category. The twiist system was already cleared for type 1. Adding type 2 adds an estimated 5.5 million insulin-using adults in the U.S. alone. The commercial implications are significant: different prescribers, different access channels, and a population that has historically been underserved by device-based diabetes management. This clearance will be studied for years as a turning point.
→ Steris has agreed to acquire Xodus Medical for $2.1 billion
Xodus makes patient positioning products used in the operating room, including the Pink Pad cushioning line. This is a substantial deal in what some might consider a mundane segment of the market, which is exactly the point: OR accessories and surgical support products are a durable, high-volume business with strong relationships across surgical facilities. Steris is a major player in sterilization and surgical workflow, and this acquisition deepens its OR footprint considerably.
→ Edwards Lifesciences issued a safety alert for a mitral valve delivery catheter after reports of balloon bursts, including one patient death.
Edwards notified providers to stop using certain delivery catheters for its transcatheter mitral valve replacement system. The FDA reported three incidents, one resulting in death and one in serious injury. Safety alerts in the structural heart space are significant commercial events: they affect case scheduling, require rep involvement in communicating with accounts, and can have immediate territory-level impact. This is an area where your clinical knowledge and communication skills matter in ways that go beyond the normal sales conversation.
→ The FDA is authorizing more medical devices in 2026, but review timelines are getting longer.
Through the first half of 2026, 510(k) clearances are up about 2.5% year over year and premarket approvals are also higher, but average review times have increased across pathways. The FDA is currently rebuilding its staff after significant cuts, and remaining reviewers are carrying heavy workloads. For commercial teams, longer review timelines affect launch planning, capital allocation, and revenue forecasting. Smaller companies feel this most acutely because timing directly affects their capital runway.
MARKET SPOTLIGHT
A deep dive into the segments, companies and technologies shaping the industry
The AID Market: A Commercial Gap
Automated insulin delivery is one of the most commercially dynamic segments in all of medical device right now. To understand why, it helps to understand how the market is structured and what the twiist clearance actually changes.
How AID systems work. A full AID system has three components: a continuous glucose monitor (CGM) that reads blood sugar in real time, an insulin pump that delivers doses subcutaneously, and a control algorithm that adjusts insulin delivery automatically based on the CGM data. The closed loop between sensor, pump, and algorithm is what makes these systems fundamentally different from older pump therapy, where the patient still had to manually program doses. AID systems do the math and make micro-adjustments continuously, which leads to better glucose control and less cognitive burden on the patient.
The CGM layer: Abbott and Dexcom. Continuous glucose monitoring is dominated by two companies: Abbott (FreeStyle Libre) and Dexcom (G7 and the newer Stelo for type 2). CGMs are the sensing foundation that AID systems are built on, and which CGM a system integrates with matters clinically and commercially. Abbott and Dexcom both have strong commercial organizations and deep payer relationships, and they compete aggressively on sensor accuracy, wear time, and price.
The pump layer: Insulet, Tandem, and MiniMed. Insulet’s Omnipod is the dominant tubeless patch pump, used by a large share of type 1 patients globally and increasingly by type 2 patients on injectable insulin. Tandem’s t:slim X2 with Control-IQ is a leading traditional tubed pump with a strong clinical evidence base. MiniMed has historically been the market-share leader in insulin pumps by installed base, though its share has been pressured by Insulet and Tandem in recent years. Now independent, MiniMed will be competing under its own flag for the first time in a generation.
The challenger entering type 2: Sequel Med Tech and twist. Sequel Med Tech is a newer entrant that has now done something no AID company has done before at this scale: received FDA clearance specifically for adults with type 2 diabetes using insulin. The type 2 population is vastly larger than type 1, and many of these patients are managed in primary care rather than endocrinology. Reaching them requires a different commercial approach, different payer conversations, and potentially different distribution channels. Sequel has opened a door. The question now is who builds the commercial infrastructure to walk through it first.
The type 2 expansion in one sentence:
Type 1 diabetes affects approximately 2 million Americans. Type 2 affects about 38 million, with roughly 5.5 million using insulin. The addressable market for AID just got exponentially larger, and the commercial playbook for reaching those patients has not been written yet. That is where careers get built.
CAREER OPPORTUNITIES
Where the jobs are, what’s paying, and how to position yourself to get there
What a Career in Diabetes Device Actually Looks Like
Industry Foundation: Diabetes device has a commercial model unlike most of medtech. Understanding the distribution channel before you interview is not optional.
In most medical device segments, the commercial pathway runs through a hospital or surgical center purchasing process. In diabetes device, a significant portion of the business flows through pharmacy benefit and durable medical equipment (DME) suppliers. A patient who needs an insulin pump typically gets it through a DME company, which bills their insurance, manages prior authorization, and handles fulfillment and supply. The device company’s rep is often working to get their product on a DME supplier’s preferred list and to drive prescriber pull-through at the clinical level. This is a different kind of selling than hospital capital or surgical disposables, and candidates who do not understand it before they interview are at a real disadvantage.
The Med Device Career Decoder covers channel models across med device segments including diabetes. Find it at themodernmedrep.com.
Roles in diabetes device fall into a few distinct tracks, and knowing which one you are targeting changes how you prepare.
Territory business manager / sales rep. The core commercial role. You are responsible for driving product adoption across a defined geography, which in diabetes device typically means calling on endocrinologists, certified diabetes educators, and primary care physicians, as well as managing relationships with DME suppliers and in some cases pharmacy contacts. The type 2 expansion means more primary care coverage, which broadens the call pattern significantly.
Clinical diabetes specialist. Similar to the clinical specialist role in surgical robotics, this person is responsible for training and supporting patients and clinical staff on the device. In AID specifically, there is a meaningful onboarding process for new pump users: carb ratios, basal rates, algorithm settings, what to do when the sensor falls off. Clinical specialists carry that relationship, and it tends to be deeply trust-based. Strong candidates often have CDEs, nursing backgrounds, or personal experience with diabetes management.
Payer and access roles. Because so much of the diabetes device business flows through insurance coverage and formulary decisions, companies in this space maintain dedicated market access teams. These roles work to get products covered by commercial and government payers, negotiate with PBMs and DME suppliers, and support prior authorization processes at the clinical level. This is a less visible path but a highly valuable one for people with pharma managed care or payer relations experience.
Where pharma people have a real edge:
If you come from pharmaceutical sales in diabetes, you already know the endocrinology and primary care call points, you understand formulary dynamics, and you are comfortable with the payer conversation. Those are exactly the skills the diabetes device industry needs as it scales into type 2. The main things to learn are the device itself, the DME channel, and the clinical support model. Those are teachable. The relationships and payer fluency you bring are not.
THE MED INSIDER
One thing every med device professional should know this week
The Payer and Access Game in Diabetes Device
If you are going to work in diabetes device, you need to understand how coverage and access work before your first interview. It will come up, and the answer matters more in this segment than almost anywhere else in medtech.
Here is the basic landscape. Most AID systems are covered under the durable medical equipment benefit, which means Medicare Part B and most commercial insurance plans will cover them, but through a different process than a pharmaceutical benefit. The patient typically needs a prescription, a diagnosis code, documentation of their insulin regimen, and in some cases a letter of medical necessity. A DME supplier then handles the billing, which means the device company’s commercial success depends in part on which DME suppliers are equipped and motivated to carry their product.
Prior authorization is a constant. Even with coverage, most payers require prior auth before they will approve a pump for a patient. This creates friction at the point of prescribing that the rep and the clinical team often have to help navigate. Knowing how to support a PA process, which documentation is typically required, and what the common denial reasons are is practical knowledge that separates experienced reps from new ones.
The type 2 expansion complicates this further. Type 2 patients using insulin have historically had less payer support for device-based management than type 1 patients. As AID systems gain clearance for type 2, coverage policy is still catching up. Some payers have not updated their medical policies yet. Some DME suppliers are not yet set up to handle type 2 pump patients at scale. The commercial opportunity is real, but the access infrastructure is still being built. That is both a challenge and an opportunity for the people working in this space right now.
Good interview question:
"How does your company support the prior authorization process for new pump patients, and how has that process changed as you’ve expanded into type 2?"
The answer will tell you how mature their access infrastructure is and what you would actually be walking into day one.
FROM THE FIELD
Your Questions, Answered
This week’s question is one I have been expecting since the twist clearance dropped:
“I have been in pharma sales for six years, calling on endocrinologists and primary care for a diabetes drug. I know this call point cold.
How hard is it to cross over into diabetes device, and what would I need to learn?”
Honestly, you are better positioned than you probably think.
Six years calling on endocrinology and primary care in diabetes is exactly the background that diabetes device companies want right now, especially as the market expands into type 2. You know the physicians. You know how they think about glycemic control. You understand A1C targets and the clinical hierarchy of treatment decisions. That context is genuinely valuable and not easy to acquire from scratch.
What you will need to learn falls into three categories. First, the device itself. Pharma reps are trained on mechanism of action and clinical data. Device reps need to understand how the product works physically, how it is set up and calibrated, what can go wrong and how to fix it, and how to support a patient or clinical team in the room. This is learnable, but it requires hands-on time with the device, not just reading the IFU.
Second, the distribution channel. You are used to a pharmacy-based commercial model. Diabetes device runs significantly through DME suppliers, and understanding how that channel works, how prior authorization flows, and how DME relationships affect your business is a real adjustment. Study it before you interview. Ask whoever you talk to at the company how their DME channel is structured.
Third, the clinical support model. In pharma, your job ends at the prescription. In device, your job often begins there. You may be supporting new starts, training patients, troubleshooting pump settings. That is a different relationship with the customer, and it is one most pharma reps find more rewarding once they are in it. Go in with that mindset and you will hit the ground faster than most.
Have a question? Reply to this email. The best ones make it into the next issue.
QUOTE OF THE WEEK
“In the middle of every difficulty lies opportunity.”
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