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Insights
Perspectives on governance, litigation support, transactions, and decision-making informed by experience in regulated medical technology.
Governance & Judgment
Why Independence Matters More Than Experience Alone
Independence allows judgment to remain unanchored from outcomes, incentives, or legacy decisions. In governance and advisory contexts, this often matters more than raw experience, particularly when decisions involve uncertainty, regulatory risk, or long-term consequences.
The Importance of a Clear Scope
Clearly defined scope, entry, and exit points are not administrative details, they are core governance mechanisms. Poorly scoped engagements often blur accountability and dilute decision quality.
Litigation & Dispute Contexts
Technical Clarity Precedes Legal Strategy
In complex product disputes, technical understanding often lags legal framing. Clarifying how a device is designed, used, and regulated is frequently a prerequisite to meaningful legal strategy.
Process Documentation Is Often the Dispute
Many disputes hinge less on product failure than on how decisions were documented. Operating agreements, design controls, CAPA records, and risk assessments often become central facts.
Transactions & Strategic Decision-Making
Diligence Is About Risk, Not Just Valuation
Transaction diligence in regulated environments is less about financial modeling and more about identifying where risk resides, technically, operationally, and organizationally.
Strategic Alternatives Create Their Own Constraints
Once a strategic alternatives process begins, optionality narrows quickly. Governance discipline matters most before paths are publicly or internally constrained.
Product, Risk & Regulation
Regulatory Feedback Is a Design Input
Regulatory interactions often reshape products more than markets do. Treating regulatory feedback as a design constraint, rather than an obstacle, improves outcomes.
Remediation Requires Leadership, Not Just Compliance
Effective remediation during regulatory scrutiny requires cross-functional leadership and prioritization, not simply procedural compliance.
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