Our Proprietary Frameworks

Artificial intelligence is redefining diagnostics, MedTech, and digital health. But without governance, adoption often creates more risk than value. SIGFOC™ provides executives and boards with a structured way to measure AI maturity and strengthen trust with regulators, investors, and patients.

• Establishes a common language for AI governance across executive, technical, and regulatory teams.
• Identifies maturity gaps in oversight, explainability, and lifecycle risk management.
• Equips boards with actionable insights to adopt AI responsibly while accelerating innovation.
   

Outcome: SIGFOC™ replaces uncertainty with clarity, giving leadership confidence to advance AI initiatives responsibly and at scale.

Clinical trials are the proving ground for innovation. Delays, compliance gaps, or lack of diversity can derail even the strongest programs. PTRS™ benchmarks readiness across regulatory, operational, and governance dimensions, helping sponsors and investors spot risks before they become costly.

• Highlights strengths and gaps in governance, data quality, and compliance.
• Incorporates readiness factors tied to modern expectations, including diversity and adaptive design.
• Produces a forward-looking score that boards and investors use to guide oversight and resource allocation.
   

Outcome: PTRS™ enables organizations to enter trials with clarity, reducing costly surprises and improving probability of success.

Global growth requires more than a breakthrough product — it demands regulatory alignment across markets. RRQ™ provides leaders with an executive-level view of how prepared their organization is to scale under evolving U.S. and international standards.

• Maps organizational maturity against key regulatory expectations without drowning leadership in technical detail.
• Provides comparative scoring for investor diligence and board oversight.
• Links regulatory preparedness directly to global market access strategy.
   

Outcome: RRQ™ helps leaders evaluate readiness to expand globally and identify what it will take to get there.

In a leadership role, Ashish guided an oncology diagnostic program through complex global regulatory reviews, including U.S., European, and Asian authorities. By aligning regulatory strategy, AI governance, and clinical validation, the team reduced review timelines significantly across multiple jurisdictions.

Outcome: The product reached patients sooner, secured uninterrupted global access, and enabled the company to strengthen its fundraising position during a critical growth phase.

While leading EU regulatory programs, Ashish designed and executed strategies that achieved first-pass certifications for an entire diagnostics portfolio under evolving regulatory expectations.

Outcome: Protected uninterrupted market access across 20+ countries, reinforcing investor confidence and ensuring the company maintained competitive advantage in a shifting regulatory landscape.

Ashish directed the rollout and remediation of quality systems across North America, Europe, and Asia-Pacific for diagnostics and MedTech operators. These efforts included harmonizing design controls, risk management (ISO 14971), and GxP compliance.

Outcome: The companies achieved inspection readiness, reduced audit exposure, and created a durable foundation for scaling globally.