Pivotal Development

Phase 2

We help you build the commercial foundation your pivotal results will rely on. Reimbursement, pricing, and stakeholder strategy need to be in place before your data reads out, not after.

Phase overview

Pivotal Development is the phase where you commit to the definitive technical, regulatory, and clinical work required to support a regulatory submission. For devices on a PMA pathway, this typically means an IDE-approved pivotal trial with formal endpoints. For devices on a 510(k) or De Novo pathway, it means intensive pre-submission preparation, bench testing, biocompatibility, substantial equivalence documentation, and design validation. From a commercial perspective, this is where health economics work begins, payer strategy takes shape, and brand architecture should be largely locked before data readout or submission.

Reimbursement

Coding, coverage, and payment strategy developed ahead of data readout.

Health Economics

Budget impact, cost, and economic value models that payers and health systems will evaluate.

Pricing

Pricing set and tested against the market, grounded in real cost of goods.

Medical Affairs

KOL relationships formalized into advisory and investigator roles, with publications planned around pivotal results.

Business Model Strategy

Forecast and business model updated as clinical and regulatory timelines firm up.

Brand Strategy

Brand architecture and value-based positioning locked before readout or submission.

NEXT PHASE

Regulatory Submission

With pivotal work complete and the commercial strategy positioned, the filing goes in and launch preparation begins.

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