top of page

Mergers & Acquisitions:

We have led and participated in numerous M&A transactions in medical device, diagnostic product, clinical and CRO lab service companies in the United States and Europe.

 

 

Advisory Services:

  • Potential acquirers, evaluating strategic options

  • M&A target identification

  • Transaction negotiation

  • Due diligence

  • Integration planning & execution

  • Finding and realizing synergies

  • Cultural integration

Corporate Strategy & Tactical Planning:

Helping you to choose carefully what you will do, and what you should avoid, balanced with thoughtful tactical plans about how you will accomplish your objectives.

 

 

Advisory Services:

  • Develop competitive advantage and barriers to entry

  • Product selection, in/out licensing, collaboration

  • Competitive analysis, market research, customer validation

  • Go to market strategies, positioning, distribution channels

  • Functional plans; clinical, R&D, commercial, operational, IT

Anchor 1

Organization Evaluation & Development:

We build high performance teams that achieve aggressive goals in a wide variety of product and service environments.

 

 

Advisory Services:

  • Organization design

  • Team member assessment, 360 degree feedback

  • Team building, coaching & mentoring

  • Recruiting

  • Team facilitation

Anchor 2

Business Development, Collaboration &

Fund Raising:

We have accelerated results through collaboration and achieving appropriate levels of capitalization to execute plans.

 

 

Advisory Services:

  • Identification of strategic partners

  • Closing collaborative agreements

  • Pharma collaboration for companion diagnostics

  • Financial modeling for cash planning

  • Development of fund raising and diligence materials

  • IPO preparation

  • Introductions to potential investors

Anchor 3

Interim Leadership & Crisis Management:

We provide interim executive leadership in difficult situations.

 

 

Advisory Services:

  • Sudden loss of a key executive

  • Audit failure, product recall, contamination, safety

  • Project recovery

  • Production or service interruptions

  • Key supplier, equipment and facility failures

Anchor 4

Operations Excellence; Metrics & Improvement:

We have deep expertise in medical product manufacturing, lab service operations and performance improvement.

 

 

Advisory Services:

  • Customer centric, voice of the customer metrics and culture

  • On time delivery

  • Lean manufacturing, Kaizen events, VSM, 6S, Six-Sigma

  • Preemptive quality, data utilization, employee engagement

  • Product redesign, process optimization

  • Aggressive cost reduction & margin improvement

  • New product development, transfer, validation, product launch

  • Supply chain development and management

  • Contract manufacturing 

Anchor 5

Project Management & Project Recovery:

Our teams have brought hundreds of products and services through development, transfer, regulatory clearance and market launch.

 

 

Advisory Services:

  • Product specification, design, transfer, capacity development

  • Customer centric transitions

  • Lean manufacturing implementations

  • Information system implementations

  • Facility consolidation or relocation

  • Clean room design and installation

  • Manufacturing automation, robotics, assembly systems

Anchor 6

Regulatory Compliance & Submissions:

We pride ourselves on making Quality Management Systems simple, efficient and compliant.

 

 

Advisory Services:

  • FDA QSR, ISO 9001/13485, & QMS implementation

  • Audits, gap analysis & compliance plans

  • QMS software implementation

  • UL/CSA, CE Mark & OSHA compliance

  • CLIA, CMS, state certifications & CAP accreditation

  • 510(k) & de novo 510(k) device and IVD submissions

  • Customer centric metrics & complaint handling

Anchor 7
bottom of page