SERVICES

We collaborate with doctors and inventors to assist them with making their ideas a reality.  We are contract partners with multiple companies to assist them with their product development challenges and R&D pipeline.

Complete Product Development Services

 

PINNACLE Design Werks is a full spectrum medical device consultancy that provides timely and cost effective resources to assist inventors, entrepreneurs and med device companies to bring life changing products to market.  The leadership team with over 70 years in med device will guide your project to completion, efficiently and with less trial and error. The Pinnacle team offers a full service medical device R&D organization ranging from early ideation, rapid prototyping, design execution, Verification & Validation services. This includes complete design documentation for creating the Design History File and Design Master Record.  We have certified experts in 3D modeling, in house 3D printing and industrial design expertise.  Our electromechanical systems design capabilities include controllers, hardware/ software and user interface design. We can also provide ongoing sustaining engineering and product line expansion.​

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Key Capabilities

 

  • Ideation – creating, augmenting and converting concepts to something tangible and achievable

  • Proof of concept and feasibility designs

  • Clinician validation and usability

  • Rapid Prototyping – materials selection, component design and fabrication, assembly work and feasibility testing

  • 3D modeling – creating Solidworks models, product renderings and drawings

  • Industrial design

  • In house 3D printing

  • Rapid machining and rapid mold tooling partners

  • Design For Manufacturability – molded parts design, extrusions and assemblies, manufacturing assembly fixtures, test stations

Additional Services

  • ISO 13485 Design Control compliant

  • ISO 60601-1 Electrical safety compliant designs

  • Design History File documentation

  • Risk Management ISO 14971

  • Verification & Validation testing

  • Provisional patent filings

  • Intellectual property landscape assessment and management

  • Class 1 and 2 Regulatory submissions