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Consulting & Strategic Advisory

Where Medicine, Capital,
and Strategy Converge

Advanced healthcare consulting integrating clinical expertise, financial rigor, innovation strategy, and organizational intelligence — built for organizations that demand more than a generic advisory firm.

Actively Accepting Engagements

Five Domains. One Advisor.

Most consulting firms specialize in one domain. NEG Plus PLLC integrates them all — bridging clinical credibility, financial rigor, strategic precision, organizational intelligence, and policy fluency.

🔬

Clinical Credibility

Board-certified OBGYN with deep women's health and oncology expertise

📊

Financial Rigor

Advanced modeling, valuation, capital structure, and cost analysis

⚙️

Systems Intelligence

Organizational design, relational coordination, performance optimization

🎯

Strategic Precision

Proven frameworks from McKinsey, BCG, and leading business schools

🏛️

Policy Fluency

Healthcare economics, payer strategy, and regulatory navigation

Core Advisory Capabilities

Comprehensive expertise across the full healthcare value chain — from bench to boardroom.

🏥

Clinical Strategy

  • Women's Health & Reproductive Medicine
  • Gynecologic Oncology Strategy
  • Medical Device Innovation
  • Service Line Strategy & Expansion
  • Academic-Clinical Integration
  • Quality & Patient Safety Design
💰

Financial Advisory

  • Financial Statement Analysis
  • Managerial & Cost Accounting
  • DCF, NPV, IRR Modeling
  • Valuation & Capital Structure
  • Break-Even & CVP Analysis
  • WACC & CAPM Applications
🎯

Strategic Management

  • Porter's Five Forces Analysis
  • Blue Ocean Strategy
  • McKinsey 7-S Framework
  • Competitive Positioning
  • Growth & Portfolio Strategy
  • Disruption Theory Applications
👥

Organizational Excellence

  • Leadership Development & Coaching
  • Culture Transformation
  • Relational Coordination Design
  • Team Performance Optimization
  • Executive Leadership Programs
  • Change Management
🧬

Life Sciences & R&D

  • Full-lifecycle drug development advisory
  • Medical device development advisory
  • IND / NDA / BLA / 510(k) / PMA strategy
  • Clinical trial design & oversight
  • Biomarker & companion diagnostic strategy
  • Pipeline prioritization & asset valuation
Drug Development → Device Development →
🤖

Technology & AI

  • AI Governance Frameworks
  • Digital Health Product Strategy
  • Innovation Adoption Roadmaps
  • Health-Tech Commercialization
  • Technology Integration Strategy
  • Data & Analytics Strategy

Drug & Biologic Development Advisory

End-to-end advisory across every phase of pharmaceutical and biologic development — integrating regulatory strategy, clinical expertise, and business rigor from first concept through full lifecycle management.

💊 Pharmaceuticals & Biologics

From Concept to Lifecycle Management

Physician-led advisory integrating deep regulatory knowledge, clinical trial expertise, and commercial strategy across the full IND-to-NDA/BLA continuum — and beyond to LOE defense and indication expansion.

← scroll to view all stages →
1
Concept & Discovery

⚗️ Technical
  • Target identification & validation
  • Mechanism of action research
  • IND feasibility assessment
  • IP freedom-to-operate
📈 Business
  • Business case & market sizing
  • IP & licensing landscape
  • Funding roadmap
  • Asset acquisition strategy
2
Pre-Clinical Development

⚗️ Technical
  • IND-enabling study design
  • In vitro / in vivo protocols
  • Tox, PK/PD, safety pharm
  • CMC early-stage planning
📈 Business
  • Investment thesis & deck
  • Series A/B strategy
  • Partnership evaluation
  • Asset valuation (early-stage)
3
Clinical Development (I–III)

⚗️ Technical
  • Protocol design (Ph I–III)
  • Adaptive trial design
  • Biomarker & CDx strategy
  • Site selection & oversight
📈 Business
  • Clinical budget modeling
  • CRO contracting strategy
  • Milestone & investor planning
  • KOL development program
4
Regulatory Submission

⚗️ Technical
  • IND / NDA / BLA / sNDA strategy
  • Expedited designations (FTD, BT, AA)
  • FDA pre-submission meetings
  • Combination product pathways
📈 Business
  • Regulatory timeline modeling
  • Payer evidence planning
  • HEOR strategy
  • Label & indication strategy
5
Launch

⚗️ Technical
  • Label negotiation & REMS
  • Post-market study commitments
  • Distribution readiness
  • Medical affairs activation
📈 Business
  • Launch sequencing strategy
  • Payer access & contracting
  • GPO / IDN negotiations
  • Commercial team build
6
Commercialization

⚗️ Technical
  • Medical affairs strategy
  • Phase IV & ISS oversight
  • HEOR evidence generation
  • Pharmacovigilance strategy
📈 Business
  • Revenue forecasting models
  • Competitive response strategy
  • Patient access programs
  • Market & geography expansion
7
Lifecycle Management

⚗️ Technical
  • Indication expansion strategy
  • Reformulation & combo therapy
  • Pediatric & rare disease programs
  • Next-gen asset pipeline
📈 Business
  • LOE defense & AG strategy
  • Patent term extension
  • Licensing & divestiture advisory
  • Exclusivity lifecycle planning

Medical Device & Diagnostic Development Advisory

Comprehensive advisory across the full medical device development lifecycle — from concept and design controls through FDA clearance or approval, commercial launch, and post-market surveillance — spanning technical rigor and commercial strategy.

🩺 Medical Devices & Diagnostics

From Concept to Post-Market Lifecycle

Physician-led advisory on design controls, regulatory pathway strategy, QMS architecture, and go-to-market execution — integrating FDA regulatory expertise with commercial and business strategy across capital equipment, consumables, SaMD, combination products, and diagnostics.

← scroll to view all stages →
1
Concept & Feasibility

🔧 Technical
  • Clinical needs analysis
  • Design inputs & outputs
  • Regulatory pathway assessment
  • Risk management initiation (ISO 14971)
📈 Business
  • Market validation & TAM analysis
  • Business model design (cap vs. consumable)
  • IP strategy & provisional patent
  • Investor pitch & funding strategy
2
Design & Development

🔧 Technical
  • Design controls (21 CFR 820)
  • Design history file (DHF)
  • Risk management & DFMEA
  • Design review facilitation
📈 Business
  • Development budget modeling
  • Supply chain & mfg partner strategy
  • IP prosecution strategy
  • Series A/B fundraising support
3
Testing & Validation

🔧 Technical
  • V&V protocol design
  • Biocompatibility (ISO 10993)
  • Human factors / usability (IEC 62366)
  • SaMD validation strategy
📈 Business
  • Clinical evidence roadmap
  • Payer evidence requirements
  • Milestone investor updates
  • Testing vendor strategy & CRO selection
4
Regulatory Pathway

🔧 Technical
  • 510(k) / PMA / De Novo strategy
  • IDE & Q-Sub / Pre-Sub meetings
  • CE Mark (MDR) & international strategy
  • Combination product (21 CFR Part 3)
📈 Business
  • Regulatory timeline & cost modeling
  • Reimbursement pathway (CPT / APC)
  • HEOR & payer access planning
  • Investor regulatory milestone framing
5
Manufacturing & QMS

🔧 Technical
  • QMS design & ISO 13485 alignment
  • Process validation (IQ / OQ / PQ)
  • Supplier qualification strategy
  • DHR / DMR architecture
📈 Business
  • Unit economics & COGS optimization
  • Contract mfg evaluation (CMO)
  • Quality cost modeling
  • Scale-up readiness assessment
6
Market Launch

🔧 Technical
  • Post-market surveillance plan
  • Clinical training program design
  • MDR / MAUDE reporting setup
  • Medical affairs activation
📈 Business
  • Channel strategy (direct / distributor / GPO)
  • Pricing & contracting strategy
  • Sales force design & launch sequencing
  • KOL & clinical champion program
7
Post-Market Lifecycle

🔧 Technical
  • PMCF / PMSR design & execution
  • MDR / MAUDE compliance & trending
  • Next-gen device development initiation
  • SUD & reprocessing policy strategy
📈 Business
  • Revenue lifecycle & competitive defense
  • Next-gen asset business case
  • Licensing, partnership & divestiture
  • Portfolio rationalization strategy
🔗
Combination Products & Cross-Track Complexity

Drug-device combination products, companion diagnostics, drug delivery systems, and Software as a Medical Device (SaMD) require integrated expertise across both tracks. NEG Plus PLLC advises on 21 CFR Part 3 combination product classification, FDA Office of Combination Products (OCP) interactions, and the unified regulatory, technical, and commercial strategy these programs demand.

Strategic Frameworks & Tools

Proven analytical frameworks from leading consulting firms and business schools — applied with healthcare-specific judgment and clinical context.

Porter's Five Forces
McKinsey 7-S
Blue Ocean Strategy
OAS Framework
SWOT / PESTLE
Disruption Theory
BCG Growth Matrix
CAPM & WACC
DCF Valuation
CVP & Break-Even
Relational Coordination
Activity-Based Costing
Balanced Scorecard
Lean Healthcare
Design Thinking
Scenario Planning
NPV / IRR Modeling
Ansoff Growth Matrix

Ideal Client Sectors

Organizations at the forefront of healthcare innovation, transformation, and value creation.

🧪 Biotech & MedTech

Early-stage to commercial companies developing breakthrough therapeutics, devices, and diagnostics — with women's health expertise at the table.

🏛️ Academic Medical Centers

Institutions integrating research, education, and clinical excellence — navigating growth, governance, and strategic positioning.

🏥 Health Systems

Organizations undergoing transformation, service line expansion, or repositioning in an increasingly competitive market.

💼 Private Equity & Venture Capital

Investment firms building and evaluating healthcare portfolios — with clinical credibility at the diligence table.

🚀 Healthcare Startups

Growth-stage companies commercializing digital health, diagnostics, therapeutics, or health services — accelerating market entry.

🏢 Executive Leadership

C-suites, physician leaders, and boards navigating high-stakes strategic decisions and organizational transformation.

Flexible Structures

Engagements designed around your organization's specific needs — from rapid-cycle diagnostics to long-term advisory relationships.

1

Strategic Diagnostic

Rapid assessment of positioning, competitive landscape, and strategic opportunities. Delivered in 2–4 weeks.

2

Financial Deep-Dive

Comprehensive analysis of financial performance, cost structure, capital optimization, and investment modeling.

3

Board-Level Advisory

Ongoing strategic counsel for executive leadership and governance teams on a retainer or project basis.

4

Innovation Roadmap

End-to-end commercialization planning from concept through regulatory clearance and market launch.

5

Executive Coaching

Intensive leadership development for physician executives navigating high-stakes decisions and organizational influence.

6

Transformation Advisory

System-wide organizational redesign for health systems navigating strategic pivots, mergers, or restructuring.

7

Portfolio & Pipeline Strategy

Capital allocation, asset prioritization, and risk-adjusted pipeline optimization for biotech and PE portfolios.

8

Expert Witness & Litigation Support

Clinical, financial, and strategic expert analysis for medico-legal matters in women's health and healthcare management.

9

Speaking & Education

Keynotes, grand rounds, faculty development, and executive education on strategy, innovation, and physician leadership.

Your Lead Advisor

Dr. Jimmy Belotte

Dr. Jimmy Belotte

MD, MBA · Board-Certified OBGYN
Consulting Lead
Founder, NEG Plus PLLC
OBGYN & Women's Health Lead
Full Profile →

Dr. Jimmy Belotte is a board-certified obstetrician-gynecologist and the founder and managing principal of New England Gynecology Plus PLLC. He combines deep clinical expertise in women's health, gynecologic oncology, and minimally invasive surgery with advanced business training — including an MBA with concentrations in healthcare management, corporate finance, and strategic management.

Dr. Belotte's consulting practice sits at the intersection of medicine, capital markets, and organizational systems — serving health systems, biotech companies, academic medical centers, private equity investors, and executive leadership teams. He brings a rare dual fluency: the clinical judgment of a practicing physician and the analytical sophistication of a trained strategist and financial modeler.

His advisory work encompasses clinical strategy, financial valuation, innovation and regulatory advisory, organizational transformation, and board-level counsel — with a particular emphasis on women's health, oncology, and the intersection of technology and healthcare delivery.

Women's Health Strategy Gynecologic Oncology Drug Development Advisory Medical Device Development IND / NDA / BLA Strategy 510(k) / PMA / De Novo Clinical Trial Strategy FDA / CMS Regulatory Financial Modeling Private Equity Advisory Organizational Design Biotech / MedTech Executive Coaching Keynote Speaking Grand Rounds & CME

Keynotes, Grand Rounds & Executive Programs

Dr. Jimmy Belotte is an experienced speaker at the intersection of clinical medicine, healthcare strategy, and business leadership — delivering programs that challenge thinking, build capacity, and inspire action across academic medicine and industry.

Dr. Jimmy Belotte

Dr. Jimmy Belotte

MD, MBA · Board-Certified OBGYN
🎤 Keynote Speaker
🏥 Grand Rounds
🎓 Executive Education
⚖️ Panel & Moderator
🏛️ Policy & Board Briefings
Book Dr. Belotte →

Featured Speaking Topics

Healthcare Strategy & Competitive Positioning Women's Health & Gynecologic Oncology Physician Leadership & Executive Transition Financial Literacy for Clinicians Drug & Medical Device Development Health Equity & Disparities in Women's Health AI & Digital Health in Clinical Practice Organizational Transformation in Healthcare Life Sciences Commercialization & Market Entry Investor & Board Perspectives on Healthcare Innovation

Engagement Formats

🎤
Keynote Address

Healthcare conferences, medical society meetings, and industry summits — 30 to 60 minutes

🏥
Grand Rounds

Academic medical centers, residency programs, and department seminars on clinical and strategic topics

🎓
Executive Education

C-suite workshops, leadership development programs, and MBA/MPH guest faculty sessions

⚖️
Panel & Moderation

Health policy forums, biotech investor panels, and innovation symposia — as panelist or moderator

🏛️
Board & Leadership Briefings

Strategic briefings for boards of directors, governance committees, and executive leadership teams

📚
Medical Education

Medical school curricula, resident didactics, and continuing medical education (CME) programs

Dr. Belotte tailors every program to the audience — blending evidence-based clinical insights with rigorous strategic analysis. Engagements are available in-person, hybrid, or virtually. Contact us to discuss availability, honoraria, and program customization.

Ready to Transform Strategy
into Execution?

Let's discuss how NEG Plus PLLC's consulting practice can accelerate your organization's most critical strategic objectives.