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I Want to Make a Medical Device. Now What?

Updated: Feb 17, 2019


Everyone needs a place to start. Great products are the result of shrewd planning and a structured development process. That planning is key is obvious. How to begin that planning, often is not.

Throughout my career, I have managed to surround myself with product development engineers. My work with the product development team at Northeast Biomedical has made it clear that a definite pattern emerges at the beginning stages of most medical device development projects. Whether these engineers work for start-up companies with three employees or for multi-billion-dollar, multinational firms, they often share the same basic concerns.


Engineers, as a group, tend to approach things systematically, breaking a problem down into its core parts and synthesizing logical solutions. This same approach can be applied to the question of “where to start” by breaking down the first few steps of a project into three distinct initial steps: crafting a needs assessment, performing an inventor assessment and defining acceptance criteria. Let’s examine the first stage of inquiry, the needs assessment.


Crafting a Needs Assessment


Developing an accurate and relevant analysis of the gap between the currently available technologies and the customer need often necessitates asking difficult questions. The lines of inquiry you pursue become integral to the success of the project. Start with the basics, such as:

  • Is there a true need? What problem does the idea solve for the user?

  • Is there a fundamental problem affecting the quality of life for a given population?

  • Is there significant data available in the form of early prototypes, research, or even napkin sketches? Are there other ways to try and capture the idea to support this need?

  • How much work has already been completed on this idea?

These questions are a good start, but there are many more aspects to consider and many more questions to ask. To move forward with the process, use the data gathered through your needs assessment research to plot a course to market for your product.


Using Your Needs Assessment to Identify a Path Forward


Asking questions is important. Asking significant and strategic questions is vital. It can be overwhelming sorting through which pieces of information are crucial in the decision to move forward.


Northeast Biomedical has years of experience in mapping out an efficient and strategic needs assessment analysis. Our team of mechanical, electrical, materials scientists, and biomedical engineers has over 140 years of collective experience in research and development, medical device, and contract manufacturing. We will meet with you, navigate through this initial process, and help you identify the path forward for your medical device.


Northeast Biomedical offers the following services:

We offer the following services:

Call (978) 649-5555 for your confidential

consultation today! Let’s get started! Look for our next post on Performing an Inventor Assessment available on our blog in February.

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