Life Science Expertise

Medical Device, Diagnostics, Health IT and Digital Health Services

LBG provides full-service strategic support for companies developing and commercializing healthcare solutions including imaging devices, in-vitro diagnostics (IVDs), drug delivery devices, medical software, health informatics, digital health and wearable devices.  The LBG team has extensive experience in all aspects of device and software development, including design controls, verification and validation processes, design transfer and manufacturing, compliance and regulatory assessments, submission documentation, reimbursement and pricing analyses, and business and commercialization strategies.  LBG has worked with most constituents across the healthcare ecosystem and a wide variety of healthcare solutions focused on population health, infectious diseases, and point-of-care applications.

LBG Medical Device, Diagnostics, Health IT and Digital Health Services Include:

  • Regulatory gap analysis
  • Certify CFR Part 11 and HIPAA compliance
  • Find and secure non-dilutive funding
  • Develop Target Product Profiles
  • Analyze manufacturing procedures, develop models to help optimize processes
  • Design control planning per FDA 21 CFR 820 and ISO13485
  • Design process planning per IEC60601 (for medical device), IEC62304 (for SW as a Medical Device), and ISO14971 (for Hazard and Risk Analysis)
  • Design analytical, clinical and usability studies
  • Develop regulatory strategies and assist with agency communications/submissions
  • Perform market and reimbursement analyses
  • Develop pricing & reimbursement strategies
  • Assist in product positioning
  • Direct BD and sales support
  • Project management