Market Clearance

Boyd Biomedical, Inc.

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Commercial Phases

We integrate with every phase of your commercialization journey.

Engage us when you need us, from Foundation through Growth.

Learn More

Foundation

Assess the market and define the business model, investor strategy, and brand positioning that set your direction.

Clinical Evidence

Build an evidence strategy and engage the KOLs and clinical stakeholders whose support you need.

Pivotal Development

Build the reimbursement, health economics, and pricing strategy needed to capitalize on pivotal results.

Regulatory Submission

Finalize coding, coverage, and payment strategy while your submission is under review.

Market Clearance

Lead payer engagement, finalize pricing and contracting, and prepare your team for market entry.

Commercial Launch

Execute your go-to-market plan with launch readiness, clinician education, and sales enablement.

Growth

Drive sustained adoption through real-world evidence, payer coverage expansion, and portfolio strategy.
Disciplines

We build the path from innovation to adoption.

Our disciplines span commercial strategy, market access, evidence and insights, and go-to-market programs.

Learn More

Commercial Strategy

Choose the right market, define a differentiated position, and confirm the opportunity justifies the investment.

Market Access

Build the path to payment and purchase, from coding and coverage to contracts.

Evidence & Insights

Ground commercial decisions in what clinicians, payers, and buyers need to see.

Go-to-Market

Turn strategy into launch plans and marketing programs that drive adoption.
Our Work

Home
Services

Design by Boyd

Build by Boyd

Launch by Boyd
Knowledge Center

Articles

Reports

Videos

Case Studies

Newsletter
Careers
Newsroom

Commercial Phases

We integrate with every phase of your commercialization journey.

Engage us when you need us, from Foundation through Growth.

Learn More

Foundation

Assess the market and define the business model, investor strategy, and brand positioning that set your direction.

Clinical Evidence

Build an evidence strategy and engage the KOLs and clinical stakeholders whose support you need.

Pivotal Development

Build the reimbursement, health economics, and pricing strategy needed to capitalize on pivotal results.

Regulatory Submission

Finalize coding, coverage, and payment strategy while your submission is under review.

Market Clearance

Lead payer engagement, finalize pricing and contracting, and prepare your team for market entry.

Commercial Launch

Execute your go-to-market plan with launch readiness, clinician education, and sales enablement.

Growth

Drive sustained adoption through real-world evidence, payer coverage expansion, and portfolio strategy.
Disciplines

We build the path from innovation to adoption.

Our disciplines span commercial strategy, market access, evidence and insights, and go-to-market programs.

Learn More

Commercial Strategy

Choose the right market, define a differentiated position, and confirm the opportunity justifies the investment.

Market Access

Build the path to payment and purchase, from coding and coverage to contracts.

Evidence & Insights

Ground commercial decisions in what clinicians, payers, and buyers need to see.

Go-to-Market

Turn strategy into launch plans and marketing programs that drive adoption.
Our Work

Phase 4

We help you turn authorization into readiness. Clearance opens the market, but reimbursement, pricing, and a prepared commercial team determine whether your device gains traction.

Please fill out the form below and someone from our team will contact you shortly.

Home / Services / Launch by Boyd / Commercial Phases / Market Clearance

Phase overview

Market Clearance begins when the FDA grants clearance or approval and you are authorized to market your device. The regulatory decision opens the door to commercial activity but doesn’t guarantee commercial success. Reimbursement, pricing and contracting, sales enablement, and channel readiness all need to be in place before clearance can turn into revenue. This is the phase where the work done during review is finalized and activated.

What happens in this phase

Each phase draws on a different combination of our disciplines and sub-disciplines. These are the ones that turn regulatory authorization into commercial readiness.

Reimbursement

Payer engagement led to secure coverage and a clear economic pathway before the first order.

Pricing

Pricing finalized and contracting approach defined for target accounts.

Health System Access

Value analysis committee, IDN, and GPO strategies activated for priority accounts.

Launch Planning

Launch readiness confirmed, with your internal team and channel partners prepared for coordinated market entry.

Marketing Programs

Sales enablement tools, objection handling, and evidence summaries delivered to the field team.

Brand Strategy

Positioning and messaging aligned to the cleared indication and claims.

What you walk away with

You leave Market Clearance with payer engagement underway, pricing and contracting finalized, and health system strategies active for priority accounts. Your internal team and channel partners are prepared for a coordinated market entry, your field team is equipped with sales enablement tools, and your positioning reflects exactly what the clearance permits.

Why this phase matters

Clearance is often mistaken for the finish line. It authorizes commercial activity, but it doesn’t mean clinicians will change practice, payers will cover the device, or accounts will buy it. Companies that treat clearance as a starting point, with reimbursement resolved and the field team prepared, move faster from authorization to adoption.

NEXT PHASE

Commercial Launch

With reimbursement in motion and the team prepared, the program moves into launch, where the device enters the market and traction begins.

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