02 · Medical Device Commercialization

Medical device commercialization and market access strategy

When you have a superior product and need a confident path to physician adoption.

We build cost-effective commercialization strategies for double-digit growth.

Surgical team performing a procedure in an operating room

How we help

How does OG Advisors build a medical device commercialization strategy?

Our team includes some of the only advisors in the industry with operating experience on both the technology side and the health system side. We combine seller and buyer perspectives to determine who adopts, why they act, what evidence they need and how the product fits clinical and operational workflows. We identify the commercial route, whether direct sales, partnering or a joint venture, and build commercialization plans with exit potential in three to four years.

Who decides

Every stakeholder needs a different message

Clinical users

Better outcomes and a fit with clinical workflow.

Budget holder

A total-cost-of-care ROI case and a contracting path.

Biomed

Installation, servicing and day-to-day reliability.

Value analysis committee
Patient benefit is almost never enough on its own; any one of these stakeholders can stop adoption.

IT

EHR integration, security and implementation effort.

Revenue cycle

Coding, coverage and reimbursement.

Quality

Outcomes, safety and the evidence behind them.

Launch runway

What has to happen before launch

Workstream
24 months out18126Launch
EHR integration planning and pilotsStarts 18 to 24 months before launch
Launch prioritiesKey opinion leaders, wedge patient segments, the commercialization blueprint
Evidence and materials by audienceTailored to each hospital culture; an internal champion carries the case

Months before launch. EHR integration planning should begin 18 to 24 months out and include dedicated pilots; launch priorities are set 12 to 18 months out.

Evidence

The evidence each hospital needs

Evidence by hospital culture
Hospital culture Evidence that moves it
Early adopters Can act on FDA results or individual case studies.
More conservative systems May need publications, or evidence from key opinion leaders they trust.
Every hospital A message for each value analysis committee stakeholder, and an internal champion who carries the case when you are not in the room.

Five key questions

Five key medical device commercialization questions we solve

The questions we work through with every client facing this problem, answered the way we would answer them on a call.

Who will use your product, who will buy it, who controls the budget and who can stop adoption?

In the complex US healthcare system, patient benefit is almost never enough for adoption. We bring decades of experience inside US hospital systems to tailor a different message for each value analysis committee stakeholder. We think of biomed, IT, revenue cycle and quality not as gatekeepers, but as equal contributors to the procurement decision. So we build total-cost-of-care ROI arguments that strengthen the clinical case and create urgency for change.

How do pricing, reimbursement, procurement and implementation affect one another?

Ready reimbursement, reasonable pricing and superior clinical outcomes may secure a value analysis screening, but installation, integration and implementation determine whether the product advances. We work with your internal teams, including engineering, to make your opportunity a light lift for the customer.

What should our priorities be 12 to 18 months before launch?

Better clinical outcomes alone rarely persuade a health system to change its protocols, as buyers may view the problem you are solving as non-urgent or believe alternatives already exist. As we prepare for launch, we build relationships with the right key opinion leaders, identify the initial wedge patient segments and apply a field-tested commercialization blueprint designed to shorten adoption curves.

What level of evidence do you need to grow the market?

Different hospitals have different cultures. Some are early adopters and can accept FDA results or individual case studies. Others may need publications, or evidence from KOLs they trust. We tailor the evidence and materials to each audience and equip your internal champion to carry the case when you are not in the room.

Have you planned the steps required for EHR integration?

The saying goes that there isn't a deal so good that lawyers can't stop it. In the US healthcare system, there's no product so good that IT can't stop it. EHR integration planning should begin 18 to 24 months before launch and include dedicated pilots. Evidence of a straightforward integration process can be as important as clinical evidence.

Services

Medtech commercialization, clinical adoption and market access strategy services

  • US market entry strategy

    For domestic and international device companies

  • Regulatory pathway assessment

    510(k), De Novo or PMA, and its implications for commercial timing

  • Clinical champion and buyer mapping

    Across hospital stakeholders and care settings

  • Wedge-market prioritization

    Identify the care settings and segments where adoption will be fastest

  • Reimbursement and value-analysis readiness

    Coding, coverage and the economic case for hospital committees

  • GPO and IDN access strategy

    Contracting pathways with group purchasing organizations and integrated delivery networks

  • EMR integration planning

    Address workflow and IT requirements early

  • Strategic partnerships

    Distribution, co-marketing and technology partnerships with established medtech companies

  • Launch planning and leadership

    Commercial launch execution, including fractional or interim Chief Commercial Officer support

More from this work

Aditya Rajagopal
"OGA helped us understand the market better, faster (and cheaper,) than any other consultant."
Aditya Rajagopal · CEO, Esperto Medical

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