Editor’s Note: If you have ever watched a cleared product sit unanswered in a hospital inbox, this one is for you. The team named below is current as of October 2026.
The clearance finally came through. Your device is legal to sell in the United States. So you start contacting hospitals, and almost nobody replies. The few who do reply ask questions nobody prepared you for. Which group purchasing organisation are you on contract with? Has the product been through a value analysis committee? Which billing code does a hospital use when it uses your device? Every one of those questions points at a part of the US healthcare system that has nothing to do with how good your product is.
If that is where you are, the product isn't the problem. US medical device market entry is a structural challenge, and the companies that move fastest treat it like one from the start. Genesis MedTech, a division of Genesis Business Humanity, was built to take them through it.
Here is what is going on. Clearance tells a hospital that a device is legal to sell. It doesn't tell the hospital to buy it. Between clearance and a first contract sit gatekeepers who decide on more than product quality.
The first is the group purchasing organisation, or GPO, which negotiates supply contracts for many hospitals at once. A study published in JAMA Health Forum in September 2026 found that just three of them, Vizient, HealthTrust and Premier, were the primary GPO for more than 80% of US hospitals in 2024. Inside the hospital, a value analysis committee of clinical and administrative staff weighs each new product's cost against its clinical, patient and process outcomes. Integrated delivery networks, which are groups of hospitals and clinics run as one health system, add their own financial, operational and clinical criteria on top. The GPO and the health system are separate processes that call for separate relationships, and a contract with one doesn't open the door at the other.
Reimbursement is the next gate, because a hospital can only use what it can be paid for. Clearance doesn't make a device billable. Hospitals are paid through a coding framework, and if no suitable CPT or HCPCS code exists, the application for a new CPT code can take up to 24 months. US health systems also expect domestic accountability at every point in the supply chain, so distribution, billing, a legal entity and in-market representation are prerequisites too. Handled one at a time, each of these adds its own delay.
Genesis MedTech closes those gaps as a co-ordinated market entry programme for medical device, health-tech and software companies. It doesn't hand over a report and step back. The Genesis MedTech team builds, sells and delivers alongside your company until your product is moving.
How the programme works
The programme starts with an honest evaluation of your product's US fit across regulatory pathway, reimbursement positioning and competitive landscape. Target health systems and GPOs come next, chosen from direct institutional knowledge rather than secondary research, followed by a sequenced strategy and the commercial build itself: GPO contracting, IDN engagement, value analysis navigation and enterprise sales. The reimbursement case is built alongside the regulatory submission, so no months are lost waiting.
What makes it work is the people. Dan Romano spent nearly 30 years in healthcare, including more than 20 years with Arjo/Getinge Group and Zimmer Biomet, and founded HSUS in 2016 to help companies accelerate US market adoption. Don Webster, a former Regional VP at Vizient, builds the GPO and IDN relationships that open procurement. Geoff Rohrer, a former VP of Sales at two top-25 medical device companies, leads enterprise sales execution. Jon Berger, a middle market investment banker, connects companies to capital. And a medical advisory board of six practising physicians and clinical leaders, including Dr. Joseph Pergolizzi, helps shape how each product is positioned for clinical adoption and health system credibility.
What stage can companies come in?
Genesis MedTech suits a company with a validated product, early clinical evidence and a genuine commitment to a durable US commercial presence. It holds particular relevance for Israeli and international companies, given Genesis's direct connections to global innovation ecosystems, and it is open to any company that meets those criteria. To talk through your US market entry, write to the Genesis team at amiel@genesisbh.net or ranny@genesisbh.net, or visit www.genesisbh.net.
This article is for general information only and does not constitute investment, tax or legal advice. Past performance is not a guarantee of future results. Please consult your own professional advisors before making investment decisions.