WHAT WE DO

Gain Consulting Services helps companies - large, small or virtual - get their medical laser/photonics projects going!

OUR Scope

We run down everything technical that is needed to get a laser product or medical photonics project going.  Whether it is figuring out how to get the light to a particular target tissue, or where to find a wet lab to do tissue studies, or how to manage an engineering project on a shoestring, we know the technical, engineering and science side of getting your idea off the ground.

 

SERVICES We PROVIDE

testing services

  • laser and optical radiation safety analyses, testing and reporting (ANSI Z80.36, ISO 15004-2, ANSI Z136.1, IEC 62471, etc.)

interaction of light and biological tissue

  • laser-tissue interaction modeling

  • laser-tissue experimentation (including) femtosecond and picosecond laser tissue proc

  • laboratory experiments, including "wet" lab analyses

  • microscopic tissue analyses

  • design, conduct and reporting of animal studies

design & project management

  • laser, optical and delivery system design

  • prototype development

  • laser and optical component sourcing

  • budget and planning

  • photonics test and measurement services

preparation of peer reviewed publications and scientific presentations

translation services for technical documentation

technical support for US FDA and other medical device regulatory submissions

  • performed in partnership with medical regulatory consulting firm Regulatory Pathways Group

  • preparation of technical documentation for

    • FDA premarket submissions, including 510(k)s, PMAs and IDE studies

    • IRB studies

    • design of pre-clinical studies for laser and photonics devices

intellectual property development

  • invention disclosures

  • technical writing and analysis for patent drafting

fund raising and investment

  • assistance with seed and early stage investor "pitch decks"

  • technical due diligence

recruitment and assembly of personnel for project-based or employment-based teams

expert witness services

SBIR & STTR grant submissions

 

ACCOMPLISHMENTS for our clients* 

 

*non-confidential or published works