An Overview of the Medical Device Design and Product Development Process

Medical device design is not a new market, but due to lots of entrepreneurial ventures and outsourcing, it has outgrown other major markets. Every hospital, nursing home, or even a house might have some medical appliance that was made by a medical device designer firm.

The two things you must remember before designing a medical device or hiring a medical device designer is- The market value of the product and any intellectual property regulations associated with it. Not valuing these points might land you and your product in deep losses.

What is Medical device design?

Medical device design is the process through which healthcare appliances like machines used at hospitals, software-controlled insulin pumps, an allergic drug vending machine and so on are designed, both internally and externally.

Medical device design confers to all the things which are necessary for a medical device like the software application, hardware (body, wires, screens etc), shape, size, codes and everything you can think of.

Who is a Medical Device Designer?

A Medical Device Designer takes care of all the things necessary to develop a profitable and useful medical device, like mechanically handling and carving the physical aspects of the tool, devising codes and generating software applications for the tool to run on, delving into research, and finding out which products do their customers prefer and lastly taking care of the aesthetics.

The Process for Designing Medical Devices

Let’s get straight to the process, keep in mind this process will just be a general overview that can be understood by a general reader. Different firms might use different processes but the base remains the same.

Here it is:

1. Specification: This is the first step which involves creating lists and mining data for the critical requirements and the aspirational requirements of the medical device. The medical device designer might also look into specific regulations involved while developing and selling the device.

For example, in the US, the FDA approves three classes of medical devices:

a) Class 1: Simple products that carry no risks.

b) Class 2: For complicated products that carry some risks.

c) Class 3: For products with maximum risks and intricate designs.

2) The Concept: This is a rather complicated step. It involves visualization of the design, shape and aesthetics of the product. The medical device designer team might make sketches and storyboards to bring their ideas on paper. You might consider this as the first draft.

3) 3D CAD models: 3D CAD models give a more realistic view of medical device design. They are made after the rough sketches and the complete idea of the design has been confirmed. 3D CAD models are computer generated and give a holistic view of the designer to the medical device designer. 3D CAD models can be printed by 3D printers and can be used for simulations.

4) The Prototype: This is the step when you get to see your product in front of your eyes. The product can be made through different processes depending on the requirements. The general processes are:

. Balloon blowing

. Tipping

. Laser welding

. Injection moulding

. Bonding

. 3D printing

. Film welding

5) Iterations: After the prototype is made, the medical device designers might run several simulations and real-time tests to see if there are any anomalies in the design or can the design be made better.

6) Production: Afte the final prototype has been approved, the product will go for general testing and beta testing. The testing process takes some time and after that, the regular manufacture of the product is done.

Risks associated with Medical Device Design

The medical device designer has to consider many risks before and after designing the product, some of them are:

1) The design process is costly and risky.

2) Whether the product might be successful or not.

3) User-related risks include poor translation of user requirements or unmet user needs/requirements.

4) Internal risks are due to the lack of application of adequate standards to check device performance; poor consideration of the effect of labelling and packaging; or poor communication among device developers, end-users, and marketing.

5) Third party-related sources of risks may include lack of training for end-users; improper or poor assessment of progress by reviewers; and poor planning for regulatory and clinical approvals and tests.

Hope this helps!

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