The US is the world’s biggest market for MedTech devices. It represents over 45 per cent of worldwide MedTech revenue as of 20251 while Consulting firm EY says the global MedTech industry topped US$584 billion in 20252.
This is the market often referred to as the ‘holy grail’ for New Zealand MedTech innovators heading for commercialisation. But there are some things innovators need to know, which is where Andy Maloy comes in.
Maloy is a seasoned executive with 35 years of diverse, challenging experience in healthcare and life science industries. His resume includes our own Alimetry, Verustat, Transform Vitas, and Integron.
We asked Maloy six key questions about getting into the US market. His responses include valuable input from Harry Misselbrook who was lead sales for Alimetry when Andy Maloy was GM Americas Alimetry.
1. What aspects of the US healthcare system might surprise international/NZ companies?
The New Zealand healthcare market is largely funded by the government and a universal healthcare system whereas the US healthcare market is funded through employers’ healthcare insurance companies who have all the power to dictate what types of products, procedures and diagnostics they will pay for. Success means getting your device approved under the Current Procedural Terminology (CPT) reimbursement code. You will need a strong strategy to ensure that your CPT code is valued to the level that makes your product viable. Then, you need to get the insurance coverage.
You also need to understand that the US healthcare market has lots of different segments: private clinics vs ambulatory surgery centre (ASC) vs outpatient clinics vs inpatient clinics vs full-service hospitals. All of these have different ways of billing and coding. and require different sales strategies.
2. How would you advise a New Zealand MedTech company wanting to enter the US and the first steps they should take?
There are two key things you need to know.
Firstly, you need to understand US healthcare regulations (FDA registration, compliance, certifications).
Secondly, the US healthcare market is a decentralised reimbursement system linked to the government (Medicaid and Medicare reimbursement) and the payers (insurance companies). Success means you must have a reimbursement strategy and plan. That strategy must include the ultimate goal of getting their products listed on the CPT codes for coverage and payments which means you will need clinical data or proof of efficacy to progress. Then, you will need payer access and approval.
3. Having achieved those two steps, what should they do next?
Find people experienced in reimbursement in your area of MedTech. Don't go with any consultant with reimbursement experience; you'll easily pay a lot of money for generic advice.
Create a detailed strategy with contingencies and a timeline, and use them to determine when you'll need to start a commercial launch.
Build a strong operations foundation in the USA.
Develop strong commercial relationships with medical distributors, importers and future third-party logistics organisations.
Understand that med device sales reps in the US command large salaries and commission packages compared to New Zealand. You get what you pay for.
These will all contribute to long-term success.
4. What role do key opinion leaders play in gaining traction? How important are relationships and networks in getting early traction?
Key opinion leaders (KOLs)are critical to commercial success. They can influence reimbursement approval, and they play a dominate role in development of clinical guidelines. Multiple KOLs (researchers and product users) are required to receive widespread approval for reimbursement in the US healthcare market.
Find KOLs who do research and are well respected in societies on the conference scene.
Find KOLs who will use your products ever yday and advocate for your products to other clinicians.
5. What is a typical sales cycle for medtech in the US? What is procurement like?
That is a tough question to answer. For a startup new to the US market, even with funding, it can take 3-10 years to gain full reimbursement. But before you run you must crawl and that needs a hospital or ASC to complete a value analysis. Normally, that’s a committee that review new products. It’s essential you find the right hospitals to pitch to with a clinical champion. Then you need Value Analysis Committee (VAC) approval. It’s like you’ll need to provide an evaluation or pilot first, with clinical results. Each hospital can take 6-18 months to complete this work.
6. What is the best way to gain traction?
You’ve taken into considerations all of the advice above? Now, you must building credibility, stay focused and resist expanding before creating momentum in your specific segment. Getting KOLs early in the process with clinical data will allow for investors and US hospital interest.
There is an excellent checklist of actions on the New Zealand Trade and Enterprise website for innovators targeting the US market.
[1] https://www.lifesciencemarketresearch.com/insights/us-medtech-market-growth-the-numbers-behind-the-trends#:~:text=U.S.%20Medtech%20Market%20Resilience%20Amidst,trajectory%20for%20U.S.%20medtech%20companies.
[2] https://www.ey.com/en_us/newsroom/2025/09/ey-releases-pulse-of-the-medtech-report-2025
