Consulting

Watershed’s technical experts have significant core competencies learned through decades of orthopedic and life science successes. Let our team help you succeed.

Product Development

Watershed has assembled top-notch talent with extensive histories of developing and commercializing medical device systems.  Our goals are focused on helping companies and individuals commercialize their product as quickly and efficiently as possible. 

Our team members’ products have generated over of $2 Billion (USD) in commercial sales with nearly 100 USA and non-USA issued patents.  The team’s cross-functional skillset continues to expanded their product realization successes.

Product Development Phases

Phase 0:

Exploration / Feasibility

  • Feasibility or evaluation of new product/application
  • Initiate project and formally commit additional resources

Phase 1:

Project Planning and Concept Development

  • Design and Development Planning
  • Develop User Needs and translate into measurable Design Inputs

Phase 2:

Device Development

  • Prototypes and Process Development
  • Preliminary Verifications / Validations
  • Design Outputs

Phase 3:

Verification

  • Verifications of Design Inputs

Phase 4:

Validation

  • Validations of User Needs

Phase 5:

Regulatory and Design Transfer

  • Regulatory Submissions
  • Compile Device Master Record
  • Design Transfer to Production

Phase 6:

Commercialization / Post Market

  • Post Market Surveillance
  • Design Changes / Sustaining Engineering
  • Line Extensions
  • Product line decommission

"Working with Watershed on the daily basis has really accelerated our product development process. Having an instant extension of our R&D department has allowed us to focus on new product development instead of trying to find and interview multiple candidates for weeks or months. Watershed engineers are vastly experienced in our field and can complete projects quickly and efficiently covering all aspects of medical device R&D. "

Spine Company
CTO/Co-Founder

Quality Assurance / Quality Compliance

Based on extensive industry experience, Watershed works with clients through a variety of engagements to provide customizable programs that help elevate quality in the design and manufacturing processes that meet or exceed governing body standards. These engagements range from consulting and training to on-site embedding to FDA/ISO remediation solutions. Our goal is to provide our clients with robust design, manufacturing and quality management systems that are implemented and maintained in an efficient way.  Example projects include:

  • Manufacturing and Quality Management System Implementation
  • Product and Process Development
  • Quality Auditing
  • Process Development/Improvements
  • Verification and Validation
  • Corrective and Preventive Action
  • Statistical Techniques

"When I started in this role, I was very new to auditing.  Jim was able to not only train me, but he gave me the tools I needed to excel as an auditor."

Medtech company
Lead Auditor

Regulatory

Not only do our Design History Files dovetail effectively into regulatory filings but our teams’ history of writing, reviewing, and submitting regulatory documents make us the perfect team properly stage your technology for  commercialization.   We specialize in:

  • Pre-submissions
  • 510(k) filings
  • GUDID registrations

"I was impressed by Watershed's level of professionalism with our surgeons and their deep understanding of the full development cycle and regulatory filings necessary to commercialize our products."

Biomedical Tech Company
VP of Operations

Reach Out To Us

Contact us, make a request, or get more information on select services today!

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1815 Aston Ave.
Suite 106
Carlsbad, CA 92008

4754 Shavano Oak, Suite 101
San Antonio, TX 78249