Proven Pathways from Idea to Adoption.

Challenge:

A surgical technology startup developing an intelligent intraoperative visualization platform struggled to identify its true clinical user, workflow barriers, and purchase decision drivers. The team lacked structured insight from Sterile Processing Directors, perioperative leaders, and surgeons. Early product direction was based on assumptions not validated clinical needs.

Approach:

Synera Advisory designed and executed a 

two-silo clinical insight program.

1. Sterile Processing and Perioperative Director Track addressing:

• workflow mapping
• instrument handling needs
• safety and training requirements
• integration barriers
• reprocessing and compatibility considerations

2. Surgeon and ASC Owner Track

• clinical usability and feature prioritization
• visualization pain points
• efficiency and OR time considerations
• ideal integration with existing tools
• metrics needed to justify ROI

Each group received a structured questionnaire and aa 60 minute moderated insight session ( FMV-compliant). Synera also designed:

• legal and regulatory components and contracts
• FMV compensation models
• Advisory board goverance frameworks

Deliverables:

• 32 page insights report
• integrated cross-silo workflow diagram
• validated ICP 
• early baseline value proposition
• Advisory Board selection recommendations ( 12 KOLS )

Impact:

• Company shifted away from low value features and prioritized surgeon led workflow pain points.
• SPD / Periop insights identified two major adoption barriers that would have stalled hopsital purchase
• Development roadmap was updated within 30 days based on Synera insights.
• Company requested Synera's ongoing support for advisory formation and market entry strategy

Challenge:

A neuro-focused medical device startup needed rapid recruitment and screening of PM&R, SCI, and Pain Management specialists for early clinical discovery. They required:

• Clinical validation
• Customer discovery interviews
• Workflow mapping
• FMV-based advisory selection
• and full project management / clinical informatics insights

However, their internal operations were not structured to manage clinical engagement, documentation, or compliance.

Approach:

Synera Advisory deployed a full clinical engagement program:

• Recruited and screened 12 qualified Subject Matter Experts
• Moderated all clinical discovery interviews
• Structured insights around safety, workflow, ideal use-cases, and patient selection
• Provided project management, scheduling, and session documentation
• Advised on FMV compensation, fair contracting, and compliance
• Flagged risk areas in product claims and documentation gaps

Deliverables:

• Contracted clinical discovery program
• Advisory screening deck
• 20+ pages of clinical insights
• Risk analysis memorandum
• Documentation summary for legal counsel

Impact:

• Client obtained foundational clinical feedback for early design
• Identified major regulatory and documentation deficiencies
• Advisors protected from exposure due to inaccurate public claims
• Synera's work informed the startup's revised clinical strategy and risk posture.

Challenge:

A fast-moving AI automation company sought to enter regulated healthcare markets (orthopedics, radiology, ASC operations). They lacked:

• Clinical workflow insight
• FDA pathway clarity for potential SaMD functionality
• AL governance for bias, reliability, and PHI handling
• FMV-compliant clinical advisory structure
• Early-stage product-market fit validation

Approach:

Synera Advisory provided a cross-functional commercialization and clinical safety program:

1.Clinical Workflow Mapping

Across multiple specialties (orthopedic surgeons, spine, ASC directors) Synera captured:

• Current-state workflows
• Bottlenecks
• Automation opportunities
• Safety concerns
• Documentation burdens

2. AI Governance and Regulatory Planning

Synera outlined:

• SaMD potential pathways ( Class II 510(k) vs. non-device AI tools )
• PHI / HIPAA and data minimization requirements
• Bias mitigation and explainability expectations
• Guardrails for agentic AI in clinical settings

3.ICP and Market Strategy

Using clinician feedback and market analysis, Synera developed:

• Ideal Customer Profile
• Priority beachhead segements
• Advisory board composition strategy
• FMV compensation and engagement framework

Deliverables:

• 24 page commercialization roadmap
• AI governance and compliance playbook
• HIPAA / GDPR data strategy outline
• KOL advisory structure ( physicians + administrators)
• Value proposition refinement tied to clinical ROI

Impact:

• Company pivoted product messaging to align with regulatory-safe language
• Identified 3 highest-value clinical use cases
• Established a compliant framework for future physician engagement
• Built clinical credibiity and reduced regulatory risk profile