Medical Device Design Process

In our last article, we gave an overview about the medical device development steps. In this one, we will focus more on medical device design regulations, and compliance.

Medical Device Design Regulations & Compliance

By now you surely know that your medical device has to meet certain regulatory requirements and standards in order to enter the market. Medical devices standards such as the International Electrotechnical Commission (IEC) or The International Organization for Standardization (ISO) enable medical device manufacturers, designers, laboratories and all other service providers for the development of medical devices, such as HDE , to test, evaluate and maintain their medical devices and equipment according to certain standards of quality and use.

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Flexible Medical Device Design

Design engineers are incorporating new materials into the medical devices market. For example, Original Equipment Manufacturers (OEMs) are replacing fabricated metals, glass, and other structural materials with precision-molded plastics. 


First of all, for its flexibility. 

If you manufacture disposable medical devices, or even certain reusable devices, many critical components must bend and flex to be used on or near a patient’s body. Examples of flexible components and devices include tubing, intravenous and drug infusion sets, catheters, oxygen and anesthesia masks, and hemodialysis equipment. For such components, the substrates must be malleable, elastic, and often resistant to torsion.

What is the Medical Device Design Process

When designing a new medical device, everything from appropriate material, cost, performance properties, aesthetics, human factors to regulatory compliance and biocompatibility must be considered. Ensuring that all aspects are considered can be a challenge, which can lead to a standstill at the concept and design stage if product performance fails to meet specifications. Medical device manufacturers must stay on top of the newest trends and materials available, as well as their benefits and limitations.

How the Medical Design Process Starts?

It’s starts with bench testing the prototypes designed by your engineers in order to optimize the design and check for biocompatibility, extractables and leachables, flexibility and overall strength of your medical device product. 

The job of your company’s regulatory advisor is to search the regulators’ database and provide you with a guide to help you determine whether or not your product can be regulated as a medical device. The intended use and how your medical device works will guide the design and eventually will determine the approval pathway.

As illustrated in the beginning of this article, both the scientific and regulatory processes are intertwined throughout the product life cycle. There is an opportunity to create links with both the FDA and the manufacturers so that parts of the life cycle are not at risk of being viewed in isolation. For example, it is not uncommon for an application to be assessed before it is placed on the market without taking into account real world users’ experiences with similar products.

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What is Design Control ?

Design Control is a holistic approach and does not end with transferring the design to the production phase once the design is complete. It also affects the manufacturing processes according to changes in the design phase or even post-production feedback.

Developing a product that is useful to the user is an ongoing process, and therefore product improvement takes into account revolutionary changes due to usage patterns as well as analyzing failed products.

What is Taken Into Account When Doing Design Control?

User Needs

The requirements are defined considering the market needs and the device is designed to meet those needs. After a series of development steps, the medical device design is finalized and handed over to production for manufacture. Feedback is required at every step of this process.

Draft Entry

This is an iterative process. 

When an organization decides to address a specific need, it evaluates how well (or not well) the medical device design is accepted with its target audience based on their needs. At this point, the iterative process of converting requirements into a medical device design begins.

Medical Design Process

These design users inputs are turned into design outputs by turning these requirements into high-level specifications of the medical device.

Medical Device Design Performance Verification

The verification process confirms whether the specifications meet the requirements or not. The output becomes the input for revising the requirements, and this process continues until the design output matches the design input.

Medical Device Manufacturing

Once the final design is complete, it is sent to the manufacturing facility for mass production. The Design Control Regulation requires a Design History File (DHF) that illustrates the links and relationships between all design controls and helps track all changes throughout the product development process.

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