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Launch a Defensible KOL Program for Healthcare Startups in 90 Days
Digital first KOL strategy for healthcare startups and small medical affairs teams. Build an audit ready, scalable program and pilot it in 90 days.
Avoid IRB Delays for US Healthtech Teams With Common Rule Exemptions
Common Rule (§46.104) explained for US healthtech teams. Learn which exemptions apply, when limited IRB review matters, and how to document determinations...
Stop Denials: 4 New U.S. RTM CPT Codes 2026 and EHR Steps
U.S. playbook for billing and healthtech teams: add 98984–98986 and 98979, update EHR edits and workflows, and log live interactions to avoid RTM denials.
48 Hour Account Map to Win IDN Committees in the U.S.
U.S. seller playbook: build a 48 hour account map from public data, identify the loudest pressure point, and win value analysis committees inside IDNs.
U.S. Startups: 7-Item FDA Cybersecurity Checklist for Devices
Convert FDA Section 524B into a submission ready U.S. cybersecurity plan. Use a seven item premarket checklist for device and SaaS startups.
US Health Costs $4.5T: Make Hospital Value Analysis Committees Count
A US governance playbook for hospital value analysis committees: standardize decisions, craft approval-ready submissions, track KPIs, and use fractional...
MDDS and FDA: 6 Steps U.S. Healthtech Teams Use to Avoid 510(k)
U.S. healthtech teams: MDDS and FDA clarity with six compliance steps, a one page intended use memo, and practical actions to avoid 510(k).
U.S. Health IT Teams Need These 6 Steps to Meet ONC Certification
Practical roadmap for U.S. health IT product teams: the six-step ONC certification path, expected timelines and costs, and the operational systems to...
Avoid Months of Delay: De Novo vs 510(k) Strategy for U.S. SaMD Founders
U.S. focused comparison for SaMD and health SaaS founders. Learn when to file 510(k) or De Novo, expected review timelines, evidence needs, and Q-Sub tips.