USHSG planning guide · October 29, 2026
Build a market and buyer brief.
A useful brief identifies the decision your team needs to make and the evidence needed to make it. Start with one intended use, one care setting and a defined initial geography.
- Define the use: product, intended user, care setting and permitted claims for the stage of development.
- Map the decision: clinical user, internal sponsor, purchasing authority, budget owner and implementation team.
- List the evidence: existing studies, workflow information, economic assumptions and unresolved questions. Keep facts and assumptions separate.
- Identify the barriers: procurement, payment, training, integration and operating responsibilities requiring further review.
- Specify the next decision: prioritize a segment, commission research, develop a channel plan or prepare a focused commercial test.
Working deliverable: a concise buyer brief, priority-account map and evidence-gap log. This is a planning framework, not a validated market-size estimate or a payer determination.
Explore market and buyer assessmentUSHSG planning guide · October 29, 2026
Prepare an RFP response for review.
- Confirm the current solicitation, amendments, deadline and submission instructions.
- Map every requirement to a response, supporting evidence, owner and reviewer.
- Identify missing product documentation, commercial inputs, certifications and approvals early.
- Use client-approved claims and pricing. Keep qualifications and limitations visible.
- Complete a final review and obtain the authorized party’s approval before submission.
Working deliverable: a requirements matrix, draft response package and submission-readiness checklist. The client and qualified reviewers confirm eligibility, legal terms and submission authority. Response support does not guarantee an award.
Explore RFP developmentUSHSG planning guide · October 29, 2026
Define the distribution and supply chain brief.
- Identify the product category, regulatory stage, intended market and territories.
- Assign the manufacturer, seller-of-record, importing, quality, inventory and fulfillment responsibilities that apply.
- Document storage, handling, training, support and service requirements for partner review.
- Compare potential partners by relevant qualifications, capacity, geography and operating fit.
- Agree onboarding evidence, escalation owners, commercial terms and performance reporting before work begins.
Working deliverable: a partner requirements brief and responsibility matrix. Required authorizations and operating contracts must be verified for the product and jurisdiction.
Explore distribution servicesPrimary references
Check the source behind the decision.
FDA device regulation
Start with the FDA’s overview of device regulatory requirements and follow the applicable product-specific pathway.
FDA regulatory overviewClinical evidence
Use PubMed to locate biomedical literature. Evaluate the original study, population, methods and limitations before applying a finding.
Search PubMedMedicare coverage
Use the CMS database to locate national and local Medicare coverage documents. Confirm the relevant policy, jurisdiction and effective dates with a qualified reviewer.
CMS Medicare Coverage DatabaseFederal opportunities
Search current federal procurement notices. Review each solicitation’s requirements and amendments with the responsible contracting team.
SAM.gov Contract OpportunitiesReferences checked October 29, 2026. External sources can change. These original planning guides are not research studies, medical advice, legal opinions, regulatory submissions or reimbursement determinations. No government affiliation or endorsement is implied.