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Defining Acceptance Criteria

In the last few posts, we have discussed both the Needs Assessment and the Inventor’s Assessment portions of pre-development planning. The third step in device development is defining the acceptance criteria. These criteria are the conditions that need to be met and the features that need to be included for both the developer and the end-user to accept the design. Not only does this step provide a roadmap to completion, it also sets parameters for everyone working on the design. The ever-present question of “Are we finished yet?” is answered before the project is begun, saving time and funds.

Taking pains to define the boundaries and the requirements of your design will streamline how you approach the entire project. Like the previous two steps, this one can start by asking pointed questions regarding the original idea and what is wanted from the final marketable product.

To begin, ask questions regarding end-user needs:

  • what features are critical for this device to accomplish its main purpose?

  • can the idea be used as a platform technology which can be adapted to other purposes?

  • which central use of this device should be focused on in the first release?

  • are there portions of this design that are superfluous to the integral purpose of your product?

Financial questions can come next:

  • which features need to be included to commercialize this product and set it apart from its competitors?

  • will your product be cost-reductive or cost-neutral? What factors will affect its cost?

  • do the benefits provided by your new device substantiate its proposed price point?

  • is your product differentiated enough from existing technologies to survive in the market?

The final category of questions revolve around commercialization.

  • do you have a strategic timeline for your product?

  • have you mapped out how to maximize return on investment while reducing time to market?

  • have you identified which markets to approach first?

Once you have done your research, it is easier to define what will constitute a completed device and if that device has the possibility of being successful.

How To Tell When and If to Move Forward

While you can determine some of the acceptance criteria, it can be difficult to interpret that information properly to create a successful development process and to strategize a profitable market entrance. Northeast Biomedical work with you to evaluate your acceptance criteria and your path forward.

Our experienced team of development strategists and our specialized engineers have a proven expertise taking products from ideation through to implementation for the medical device industry. From defining questions for single inventors to proving value for funding for venture capitalists, we can help you reach your goals.

Northeast Biomedical offers the following services:

  • Medical Device Design and Prototyping

  • Product Development Strategy

  • Automation Systems and Process Development

  • Contract Manufacturing for Low Volume - High Mix products

  • Manufacturing Support and Tooling Design

Call (978) 649-5555 for your confidential consultation today! Let’s get started!

Check out the prior entries in this series - Needs Assessment and The Inventor’s Assessment.

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