Multi-Phased Approach

Northeast Biomedical follows a 5-phase development process that provides structure and a measured approach to each project management program.  From the initial conceptualization through the market launch phase, we apply strategic planning and medical device design expertise to provide a quality final product.  


Our customized solutions help each client navigate through the device development journey with a solid management plan in place, a full understanding of budgetary considerations and a reliable and experienced engineering team ready to transform their device concept into a fully-realized marketable product.

Phase I: Concept Generation and Evaluation

This stage includes investigation and idea generation to define the technology of the product. A complete review of user needs, performance stipulations and initial stage development requirements in conducted.  Structured plans to take each new concept forward are developed, identifying and addressing possible production obstacles.

Phase 2: Design Feasibility

In the second phase, the best option is chosen from the initial research and planning with a focus on design details, engineering analysis, COGS, and capable manufacturing.  This phase concludes with a detailed prototype build and test per engineering protocols of the “frozen” design.  

Phase 3: Design Verification

During Phase 3, the focus shifts to a fully-realized design which can undergo device-specific testing to ensure that client and regulatory agency specifications are met with a high-quality and accurate final product.

Phase 4: Device Validation

Phase 4 is a culmination of all efforts to assure that the design will conform to the user needs and intended use, given expected variations in components, materials, manufacturing processes, and the use environment. We will also determine production feasibility, material costs and production financial considerations.

Phase 5: Device Production

Cost-effective manufacturing is assessed and the best production methods are selected in Phase 5.  Northeast Biomedical looks for creative solutions for production solutions including outsourcing and in-house production as well as blended methods of manufacture.


Taking the Client from Idea to Implementation

Northeast Biomedical can navigate the path to market for clients including individual inventors,  mid-size manufacturers, and large medical supply companies.  We customize our design development programs based on client needs, requirements and budgetary considerations while streamlining the process to eliminate duplication of resources and maximize project management and oversight.


We develop designs with manufacturing in mind.   We can give you guidance regarding the manufacturing process, automation of that process and the regulatory hurdles you may encounter.  Our staff is trained in DFM, DFA and uses DFSS techniques.

Our ability to take on low volume production projects makes us more versatile and makes your investment dollar go farther.  



  • Design for Manufacture

  • Design for Automation

  • Low Volume Production

  • Regulatory Guidance

For a customized solution to your medical device, call Northeast Biomedical for a confidential consultation today!


T: (978) 649-5555


100 Business Park Drive, #5

Tyngsboro, MA 01879

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© 2019 by Northeast Biomedical, Inc.