Experienced, Strategic Consulting

Osiris specializes in strategic multifunctional support of medical device companies for fundraising, device iteration, surgical/interventional procedures (animal/human cadaver/bench), regulatory interactions, data analysis & interpretation, as well as the design and execution of KOL/PI/sales force training, feedback, usability, & marketing studies.

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About

Mike Bravo, SRS

Founder & President

Medical device leader with a proven track record over 20+ years of assisting companies with their multifunctional development and commercialization needs as well as over 15,000 hours of surgical and interventional procedural experience in animal, human cadaveric, and bench models.  A very collaborative member of core teams represented by R&D, regulatory, clinical, quality and biostatistical experts.  Develops and implements efficient plans for successful global regulatory clearance as well as sales force and end user training for market adoption.  Subject Matter Expert for US and OUS industry presentations and panels.  Co-author on multiple publications, abstracts, and posters.

Services

What are our services for you

Our services include product development and R&D support, surgical and interventional expertise, regulatory interactions, and comprehensive commercialization strategies. 

Product Development/R&D Support

  • Evaluation and vetting of medical devices from pre-prototype (physiologic theory or back-of the-napkin stage) through GLP
  • Data generation strategies for go/no-go decisions and fundraising
  • Multifunctional/multidisciplinary strategy development and execution (R&D, regulatory, clinical, quality perspectives)

Surgical and Interventional Support

  • Over 15,000 hours of procedural experience in animal, human, cadaveric, and bench models
  • Study implants, interative tableside/benchside feedback, and usability studies
  • Interventional therapies (coronary, neuro, and peripheral vascular)

Regulatory Interactions

  • Guidance document interpretation and application
  • Pre-sub response review, strategy, and presentation
  • Submission strategy
  • Regulatory body deficiency/response strategy and presentation

Commercialization

Development and execution of informational, training, and publication-driven lab studies/sessions for:

  • Engineers
  • End Users
  • Principal Investigators (PIs)
  • Key Opinion Leaders (KOLs)
  • Sales Teams
  • Marketing Teams

Data Review

  • Current/existing preclinical study data interpretation
  • Gap analysis
  • Report writing

Overall Support

  • Program leadership/management
  • CRO navigation
  • Study director assistance
Testimotial

What They Say About Healme Clinic?

Working with Osiris has been a game-changer for MedTech Innovations. Mike Bravo and his team provided us with invaluable strategic insights, and their surgical support has been exceptional. Thanks to Osiris, we've achieved milestones we never thought possible.

Jane Smith

Osiris has been an indispensable partner in our medical device research. Their deep expertise in product development and regulatory affairs has streamlined our projects. We've seen a significant improvement in our study outcomes and efficiency.

Dr. Richard Lawson Lead Researcher at LifeTech Labs

Lisa and her team at Osiris have been instrumental in navigating the complex world of medical device regulations. Their meticulous approach to submission strategies and regulatory interactions has been a game-changer for BioHealth Solutions. We couldn't have asked for better support.

Lisa Carter Regulatory Affairs Manager at BioHealth Solutions