Product Engineering

Success: starting at the beginning and focusing on the basics.

While a clever product idea and design may be the first step, the path to commercialization of a medical product leads through myriad design control activities including:

  • understanding the voice of the customer and documenting the user needs
  • developing comprehensive product specifications
  • analyzing and managing risk
  • developing meaningful, validated test methods

Medavise engineers have extensive experience in navigating and managing all aspects of the design control process, from initial technology research and assessment, preclinical test development and coordination, failure mode assessment, risk analysis and mitigation as well as overall project management within the typical phase-gate system. We can even help you to assess your own product development system or install a new one as part of an overall ISO 13485 Quality Management System. In addition, our engineers have significant experience and training in process and manufacturing engineering as well as in R&D, assuring your product is developed with a keen eye toward manufacturability.

The Medavise group has a background that includes:

  • Mechanical, electromechanical, chemical and polymer device design
  • Orthopedic, spinal, cardiac, urologic and epidermal-sensor technologies and the conditions they treat
  • Scientific investigations including bench and biomechanical testing, in vitro evaluations and verification and validation (V&V) testing
  • Preparation and presentation of original work for medical device patents, scientific posters, book chapters and podium presentations at scientific and medical conferences
  • Technology discussions and presentations with EU Notified Bodies, FDA staff and FDA panel

Whether you’re developing your technology in-house or with an outside product development group, Medavise can help ensure that your device is ready for successful production transfer and critical evaluation by a US or international regulatory agency.

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The client is a start-up company developing a Class III orthopedic device, and had engaged a contract development group with ISO 13485 certification to design and develop the device.  The client called on Medavise to manage preclinical testing of the device, but otherwise planned to purchase finished devices from the development group for use in clinical trials.  Medavise helped the client to understand that while the development group’s ISO certification clearly showed dedication to a defined process, the client still needed its own quality system to support a CE mark application.

Medavise managed the installation of an ISO-compliant quality system that is soon scheduled for an audit, and is using the system to provide complete design control activities including user needs, product specifications, risk analysis, preclinical testing and phase-gate control.  As a result, the client’s ISO certification process will likely be quicker as it can more easily demonstrate use of the system and compliance to requirements.

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The client is a start-up company developing a Class I device for use in the in-vitro diagnostic (IVD) market.  While initially engaged to assist with business planning, Medavise is also providing the client with quality system installation and performance of design control activities such as defining user needs, preparing product and prototype specifications and developing non-standard test methods for product evaluation.  The in-depth market, competition and technology analysis performed as part of the business planning process has been critical in defining the functional characteristics of the device for the contract group providing product design and development.

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