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Do You Have What It Takes to Bring a Medical Device to Market?

The journey from idea to completed project has to be charted carefully and the planning must be detailed and thorough.  This journey, however, does not have to be arduous or time-intensive. With the assistance of an experienced strategic management team, this process can be smooth and efficient.

As we discussed in our last post, the initial planning of each new medical device design project can be divided into three distinct initial steps: crafting a needs assessment, performing an inventor assessment and defining acceptance criteria. Today, we will be looking more closely at an Inventor Assessment.


The Basics of the Inventor Assessment

Where a Needs Assessment looks closely at the gap between current technology and customer needs, the Inventor’s Assessment evaluates existing resources such as technical capabilities, personnel expertise, and financial considerations.  This second step focuses on the “how” of the planning process. Below are examples of the base lines of inquiry that need to be considered to fully identify any significant gaps between existing and required resources.

Questions of Technical Capability

Can you create a sketch or 3D CAD model of the design?Can you create the necessary circuits or sensors for the design?What is the minimum number of prototypes required to move it to market launch?Do you have the equipment necessary to build the prototypes?Do you have suitable resources and equipment to test your product?

Questions of Personnel Expertise

Can you create a business plan for your product?Are there gaps between your and/or your team’s skill set and your development requirements?Do you have project management expertise?Are you equipped to deal with regulatory and quality system requirements?

Questions of Financial Considerations

Do you know how to determine the costs of each development phase?Do you have the financial resources to complete the regulatory testing?Are you going to build a manufacturing line or outsource the production?How many units will you need to produce and to inventory for a market launch?

Together the answers to these types of questions will provide you with a clear picture of how your development team should be structured.  


Move Forward with Northeast Biomedical

The experienced team at Northeast Biomedical acts to augment rather than duplicate your existing resources.  With our focus on versatile and scalable solutions, NEB can assist with your next development project from the beginning with advanced strategic planning.  We can also jump in at particular phases of your design process where you have identified a gap between your in-house resources and your requirements to move your project forward through production to launch.  Our internal experts can also assist with creating a development plan that takes into account future manufacturing and automation needs throughout the process, reducing delays and maximizing limited budgets.

We have produced prototypes for the solo inventor, provided contract manufacturing for small start-ups and built specialized analytical equipment for larger companies. Our team has over 140 years in combined engineering and strategic project management experience to bring your product from ideation through to market release.

Our services include:

  • Concept Generation

  • Product Development Strategy

  • Medical Device Design and Prototyping

  • Manufacturing Support and Tooling Design

  • Automation Systems and Process Development

Let Northeast Biomedical chart a profitable and efficient course for your next design project.

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100 Business Park Dr #5, Tyngsborough, MA 01879, USA

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