Where We Engage

LBS supports organizations across a range of operating environments:

Growth & Emerging MedTech Companies

• Transition from development to commercialization
• Clinical, regulatory, and manufacturing scale-up
• Preparation for capital raises, partnerships, or exit

Established & Corporate MedTech Organizations

• Operational optimization and cost structure improvement
• Manufacturing transfer, site expansion, and global footprint strategy
• P&L performance improvement and margin expansion
• Integration of new technologies into existing platforms and workflows

Private Equity & Investment Groups

• Independent operational diligence and risk assessment
• Pre- and post-investment value creation planning
• Interim operating leadership to support management teams
• Execution of transformation initiatives aligned to investment thesis

Core Value Creation Areas

Operational Transformation & Manufacturing Scale

• End-to-end manufacturing optimization (pilot → commercial scale)
• Process validation, yield improvement, and throughput acceleration
• Cost reduction initiatives and standard cost structure development
• Global manufacturing strategy, site transfer, and capacity expansion

Regulatory, Quality & Risk Alignment

• FDA and EU MDR pathway execution and remediation
• Quality system maturity (ISO 13485, design controls, CAPA)
• Risk management and compliance alignment to reduce enterprise exposure
• Inspection readiness and regulatory credibility

Clinical, Commercial & Health System Integration

• Alignment of product design with clinical workflow and adoption
• Clinical strategy, trial design input, and evidence generation
• Integration into hospital systems, cath labs, and specialty care pathways
• Market access, reimbursement strategy, and KOL engagement

Financial Performance & Value Creation

• Gross margin expansion and cost of goods optimization
• P&L improvement through operational discipline and process control
• KPI development and performance management cadence
• Positioning for IPO, acquisition, or strategic partnership

Growth & Emerging MedTech Companies

LBS works with early and mid-stage medical device companies transitioning from development to clinical validation and commercialization.

At this stage, success depends on aligning technology, clinical strategy, regulatory pathways, and operational execution—while maintaining capital efficiency and investor confidence.

How LBS Supports

• Transition from R&D to clinical and early commercial operations
• Design transfer and manufacturing scale-up
• Development of ISO 13485-compliant quality systems
• Regulatory pathway execution (FDA, EU MDR)
• Clinical strategy support, including trial design and endpoint alignment
• Early commercial readiness, including KOL engagement and site activation strategy

Outcome

LBS helps emerging companies establish the operational discipline, regulatory credibility, and commercial readiness required to support capital raises, partnerships, and sustainable growth.

Corporate & Strategic MedTech Organizations

LBS supports established medical device companies seeking to improve operational performance, scale manufacturing, or integrate new technologies into existing platforms.

These engagements often focus on P&L improvement, cost structure optimization, and execution of strategic initiatives across global operations.

How LBS Supports

• Operational optimization and cost reduction initiatives
• Gross margin expansion through proven process control and yield improvement
• Manufacturing transfer, site expansion, and global footprint strategy
• Validation and integration of new products or technologies into existing operations and workflows
• Quality system enhancement and regulatory alignment across global markets
• Cross-functional alignment between engineering, operations, regulatory, and commercial teams

Outcome

LBS enables organizations to improve efficiency, scalability, and financial performance, while strengthening operational infrastructure to support long-term growth.

Private Equity & Investment Groups

LBS partners with private equity, growth equity, and strategic investors to provide independent operational diligence and post-investment value creation support.

Engagements are grounded in an operator’s perspective, translating technical, regulatory, and operational complexity into clear risk assessment and actionable execution plans.

How LBS Supports

Pre-Investment

• Independent assessment of:
  • Operational scalability
  • Manufacturing readiness
  • Regulatory and quality system risk
  • Clinical and commercial viability
• Identification of key value drivers and execution risks

Post-Investment

• Development of value creation plans aligned to investment thesis
• Interim or fractional operating leadership to support management teams
• Execution of operational transformation initiatives
• Ongoing performance monitoring and KPI development

Outcome

LBS helps investors de-risk investments, accelerate performance, and drive measurable value creation across portfolio companies.

Boards & Executive Leadership

LBS serves as a trusted advisor to CEOs, boards, and advisory boards—providing insight and guidance across the full lifecycle of medical device development and commercialization.

Advisory Focus Areas

• Clinical and regulatory strategy
• Product-market alignment and adoption pathways
• Integration into healthcare systems and clinical workflows
• Commercialization strategy and market access
• Organizational readiness and scaling strategy

Outcome

LBS supports leadership teams in making informed, execution-focused decisions that align innovation with real-world clinical, operational, and financial outcomes.