Market Access Insights

Many medical devices

struggle in the U.S.

not because the technology lacks merit,

but because market access

is misunderstood.

In real hospital environments,

adoption is shaped

by more than “interest.” 

It is influenced by workflow, economics, operational burden, stakeholder alignment, and trust in execution. 

Market access is rarely a single decision

—it is a sequence of approvals, behaviors, and sustained usage patterns

that must align over time.

For manufacturers

entering the U.S. for the first time,

this can feel opaque.

For established manufacturers,

it can feel slower

and more complex than expected.

Either way, the underlying dynamics

are the same:

successful commercialization

depends on how well

the path to routine use

is designed and supported.

 Below are a few misconceptions

that regularly create friction

for both domestic

and international manufacturers:

• Access is not the same as adoption. A product can be “in the building” without becoming routine.
   
• Clinical enthusiasm is rarely enough. Hospital systems still require operational fit and economic clarity.
   
• Workflow matters as much as features. If a device adds steps, staff burden, or uncertainty, usage can stall.
   
• Multiple stakeholders influence outcomes. Surgeons matter—but so do OR staff, supply chain, value analysis, and administration.
   
• Execution affects confidence. Responsiveness, follow-through, and reliability shape whether teams trust a product long-term.
   
• Early missteps linger. Confusion, inconsistent messaging, or weak support can slow momentum for months.

 Hospitals and health systems

typically evaluate technology

through a practical lens:

1) Clinical workflow fit
How the product fits

into real OR and clinical routines

—before, during, and after a case.

2) Economic impact and justification
How the product affects

total cost and value—not just unit price.

3) Operational burden and reliability
Whether adoption increases complexity

for staff, and whether

support is dependable.

4) Stakeholder alignment
Whether key voices agree

on when the device should be used,

how it should be used,

and why it matters.

5) Trust and execution
Whether the

manufacturer and commercial partner

demonstrate consistency, responsiveness, and professionalism over time.

When these elements align,

adoption becomes smoother

and more sustainable. 

When they do not,

usage can remain limited

—even if early interest is strong.

 Commercialization and distribution

are often treated as the same thing.

They are not.

Commercialization is

how a product

enters and grows within a market

—how it earns evaluation, earns adoption,

and becomes routine.

Distribution is

the reliable execution layer that supports adoption once demand exists

—fulfillment, documentation alignment,

and operational consistency.

Both are important.

But they must be approached

in the right sequence, with

a clear understanding

of what hospitals actually require

to move from interest to routine use.

Manufacturers often benefit

from external market access support

when:

• Entering the U.S. market for the first time (international expansion)
• Preparing for hospital adoption beyond early pilots
• Expanding beyond a small set of early users into routine usage
• Needing stronger OR access and stakeholder alignment
• Repositioning a technology that has stalled despite clinical interest
• Seeking a practical commercialization plan that matches real hospital dynamics
   

For international manufacturers,

this can also include guidance

around U.S. commercial expectations,

stakeholder mapping,

and how adoption decisions are made

in U.S. systems.

 Peerless Medical approaches

U.S. market access

with a focus on realism, preparation,

and trust.

Our perspective is informed

by decades spent

working inside

U.S. hospitals and operating rooms, supporting technologies

across multiple clinical categories.

We believe successful adoption is built

—not rushed.

The goal is not “a launch.”

The goal is reliable evaluation,

sustainable usage, and

the operational confidence

that keeps a product moving forward.