Digital-Therapeutic Governance Board Adviser

The mandate

The company is extending a regulated digital therapeutic from a narrow studied population into adjacent pathways, languages and reimbursement models. Product teams want faster iteration, clinicians question whether engagement improvements represent therapeutic benefit, and commercial partners request configurable journeys that may change intended use. The board’s standing question is how to govern product evolution so released claims, software behaviour and post-market evidence remain aligned.

The adviser will review monthly evidence and change dossiers, hold pre-committee sessions with the clinical, quality and product owners, attend four Stockholm meetings and observe one delivery site. The cadence will challenge claim-to-feature traceability, algorithm and content changes, subgroup performance, human escalation, adverse-event capture, real-world evidence and commercial configuration boundaries. Written advice will identify what may proceed, what requires stronger evidence and what belongs before formal client decision-makers.

The appointment lasts ten months through two major release and surveillance cycles. Any renewal must be approved explicitly by the committee after management demonstrates an embedded classification route for therapeutic, behavioural, technical and commercial changes. The board expects the advisory need to diminish as internal challenge matures; the term will not roll forward simply because regulatory or product uncertainty persists.

No line authority attaches to this role, and the adviser accepts no executive responsibility for clinical claims, patient safety, regulatory submissions, quality release, software deployment or commercial commitments. Those accountabilities remain with designated officers and clinicians. The adviser may request evidence and record dissent but cannot operate as an informal approver whose opinion displaces the company’s regulated decision process.

The appointee must disclose work, research funding, equity or governance relationships involving therapeutic developers, providers, payers, clinical-research organisations and relevant technology suppliers. Conflicting product reviews require recusal; confidential evidence may not support publications or other clients. The adviser will neither recommend vendors for consideration nor accept contingent compensation tied to clearance, reimbursement or commercial launch.

Why the board wants this voice

Management’s existing forums are strong within individual disciplines but struggle when a seemingly modest experience change also affects clinical mechanism, intended use and real-world surveillance. Directors receive dense evidence without a coherent account of which assumptions have changed. An independent digital-therapeutic product operator can connect those domains, challenge optimism around engagement metrics and help the board ask proportionate questions without becoming a second quality system.

What you will own

• Challenge traceability among intended use, therapeutic mechanism, clinical claims, product features, algorithms and patient communications.
• Examine whether pathway, language and partner configurations remain within studied bounds or create a materially different intervention.
• Test change classifications for content, model, interface and workflow releases against evidence, safety and post-market implications.
• Review subgroup outcomes, disengagement, escalation behaviour and missingness that aggregate engagement or efficacy measures may conceal.
• Assess whether real-world evidence plans can detect therapeutic drift, inequitable performance and operational sources of apparent benefit.
• Give the committee concise options, uncertainty statements, dissent and evidence thresholds before consequential product decisions.
• Leave a board challenge map linking change types to required clinical, quality, privacy, safety and commercial consideration.

Candidate qualifications

• Has held product, clinical technology or quality governance responsibility for a regulated digital therapeutic or software medical device.
• Can distinguish engagement, adherence, surrogate response and clinically meaningful benefit without dismissing legitimate product learning.
• Understands change-control consequences across algorithms, therapeutic content, intended use, localisation and partner-configured workflows.
• Has challenged subgroup performance and real-world evidence where missing data or operational selection created misleading aggregate outcomes.
• Works credibly with clinicians, quality leaders, regulators, software teams, privacy officers, payers and commercially accountable executives.
• Has advised a board while preserving the formal accountability of medical, quality and regulatory officers under difficult release pressure.

Non-negotiables

• Can attend all four Stockholm committee sessions and the designated clinical-site observation during the appointment.
• Will make complete disclosures covering digital-health investments, research ties, provider work and supplier or payer relationships.
• Brings regulated digital-product governance experience; wellness application, generic software or clinical research experience alone is insufficient.
• Will record unresolved dissent and refuse success-linked compensation connected to regulatory, reimbursement or launch outcomes.

1. 49 words maximum. Which product change looked cosmetic but altered a therapeutic claim or intended-use boundary?
2. 49 words maximum. How would you challenge strong engagement data that lacks convincing evidence of clinical benefit?
3. 49 words maximum. What conflict would require your recusal from a digital-therapeutic board discussion?