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Propose a Design of a Novel Medical Device
Kishan Koradiya
Kishan Koradiya
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Propose a Design of a Novel Medical Device

Use CAD and industrial best practices to design a simple medical device of your choice.

Register today
Apply now
Wednesdays
 at
8:00
A.M.
 ET /
5:00
A.M.
PT
8 weeks, 2-3 hours per week
Intermediate
No experience required
No experience required
Some experience required
Degree and experience required

Description

Every year, there are thousands of new medical devices created to improve the lives of patients across the globe. The demand for competent engineers is on the rise, and it's crucial that they follow the best practices for developing effective and safe products. In this Build Project, you'll wear the hat of a Product Design Engineer and propose a simple device that solves a health problem of your choice (or propose a modification to an already existing device to improve any of its functions). Under the supervision of an experienced Build Fellow, you'll learn how to follow the industry guidelines for designing medical devices. You'll define User Needs, create Product Specifications, and finally prepare a 3D CAD model of your solution. All this will happen in an environment that simulates the operations of a real product development team.

Session timeline

  • Applications open
    June 24, 2024
  • Application deadline
    July 21, 2024
  • Project start date
    Week of July 8, 2024
    Week of
    August 5, 2024
  • Project end date
    Week of

What you will learn

  • Explore the medical device industry in the USA, the role of regulatory authorities like the FDA and the importance of designs that are safe and effective.
  • Get hands-on experience writing concise and effective User Needs and Product Specifications that act as a compass for your design.
  • Develop your ability to conceptualize and refine designs using CAD software and learn to optimize them for manufacturability and presentation.  
  • Learn the skills of asking good questions, sharing ideas, and interacting with others in a professional setting to evolve and document your design correctly.
Build Projects are 8-week experiences that operate on a rolling basis. Selected participants engage in weekly live workshops with a Build Fellow and 2-15 other students.

Project workshops

1
Introductions
2
FDA Device Classification and Regulatory Controls
3
FDA Design Controls and Design History File
4
User Needs Scoping and Detailing
5
Product Specifications Scoping and Detailing
6
Conceptualize CAD
7
Refine CAD
8
Presentations

Prerequisites

  • Basic knowledge of engineering principles: Hooke’s Law, free body diagrams, stress-strain diagram, key steps of the manufacturing processes etc.  
  • Experience using parametric modeling CAD software: you should be familiar with fundamental concepts of engineering drawing (planes, projections, views) and be able to create solids such as housings/enclosures/simple objects in CAD. This would mean that you should be able to create these objects using your imagination/self-generated sketches or other reference objects.  
  • Problem-solving skills and ability to find answers even if you have not directly been taught them. Don’t worry if you don’t know anything about medical devices, the Build Fellow will provide necessary guidance on what resources to use and will also provide lectures/group discussion opportunities/1:1 meeting for additional help.
  • Before the project starts, you'll need to have access to the CAD software of your choice. Our recommendation is to use SolidWorks or Autodesk Fusion 360 (.edu emails get free access) or OnShape (free online 3D CAD program). You'll need to get the selected CAD installed on your computer. If you choose to use OnShape, then it can be accessed via a web browser without the need to download anything.

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About the expert
Kishan Koradiya
Visit
Kishan
's Linkedin

Kishan is a Mechanical Engineering Fellow at Open Avenues where he works with students leading projects in medical device design.

Kishan is a Product Design Engineer at NIRSense Inc where he works on developing next-gen wearable sensor systems to measure cerebral and somatic oxygenation.

Kishan has over 3 years of experience in medical device product design and development, having previously worked on multiple FDA Class II devices.

He holds a master's degree in mechanical engineering.

He likes to explore the outdoors.

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Kishan Koradiya
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