Guides & reference sources

Start with a better commercial question.

Practical USHSG planning guides and primary reference sources for healthcare innovators. Use them to define the work, identify evidence gaps and prepare a useful project brief.

Three engagement paths. Project-specific people and responsibilities.
Written engagement · Named owners · Approved permissions
  1. OnboardAgree the workspace and delivery channel.
  2. DeliverProduce and review the scoped work.
  3. AcceptDocument evidence, decisions and next actions.

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.

  1. Define the use: product, intended user, care setting and permitted claims for the stage of development.
  2. Map the decision: clinical user, internal sponsor, purchasing authority, budget owner and implementation team.
  3. List the evidence: existing studies, workflow information, economic assumptions and unresolved questions. Keep facts and assumptions separate.
  4. Identify the barriers: procurement, payment, training, integration and operating responsibilities requiring further review.
  5. 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 assessment

USHSG planning guide · October 29, 2026

Prepare an RFP response for review.

  1. Confirm the current solicitation, amendments, deadline and submission instructions.
  2. Map every requirement to a response, supporting evidence, owner and reviewer.
  3. Identify missing product documentation, commercial inputs, certifications and approvals early.
  4. Use client-approved claims and pricing. Keep qualifications and limitations visible.
  5. 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 development

USHSG planning guide · October 29, 2026

Define the distribution and supply chain brief.

  1. Identify the product category, regulatory stage, intended market and territories.
  2. Assign the manufacturer, seller-of-record, importing, quality, inventory and fulfillment responsibilities that apply.
  3. Document storage, handling, training, support and service requirements for partner review.
  4. Compare potential partners by relevant qualifications, capacity, geography and operating fit.
  5. 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 services

Primary 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 overview

Clinical evidence

Use PubMed to locate biomedical literature. Evaluate the original study, population, methods and limitations before applying a finding.

Search PubMed

Medicare 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 Database

Federal opportunities

Search current federal procurement notices. Review each solicitation’s requirements and amendments with the responsible contracting team.

SAM.gov Contract Opportunities

References 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.