Design is a funny word. Some people think design means how it looks. But of course, if you dig deeper, it’s really how it works.- Steve Jobs

As the quote goes, when designing a product such as a medical device, you might ponder on some intriguing questions:

• Does my product function in a way users want it to?
• Is my product solving a medical need?
• Is it optimal for the desired target population?

These questions would be easy to answer if while designing your medical device, you had followed a methodical approach by taking into account medical need, target user and user’s need that the product intends to address. One needs to delve deeper to identify!

Sometimes customer needs can be lost while translating information across different domains of a company. Hence, at all times one must have a clear idea of the following:

  1. Medical Need

Medical need is a requirement that calls for medical attention to facilitate diagnosis, treatment or prevention of an underlying condition. These needs can be identified by acquiring a comprehensive and logical feedback from target users such as doctors, surgeons, experts, health care professionals and patients.

  1. Target User

A target user is the intended user of a product. Target users can be a specific patient population, surgeons, experts or even laypersons and can be identified via market research.

  1. User Need

User needs to point out the requirements of people so as to meet particular use or set of uses. Typically, user needs can be identified by conducting a market survey, obtaining user feedback, and determining the target environment in which a medical device is used.

Once the above criteria have been clearly defined for a device, you would want to base your Design Inputs off the User Needs. Design Input means the physical and performance requirements of a device that are used as a basis for device design. Whereas, Design Output refers to the results of a design effort at each design phase and at the end of the total design effort. Based on the Design Inputs, the Design Outputs can be subsequently obtained.

In order to ensure that the Design Outputs meet the inputs, verification activities (such as the following) should be conducted:

• Worst case analysis of assembly
• Package integrity tests
• Biocompatibility testing of materials
• Bioburden testing of products to be sterilized

Once the verification activities are complete, a final working prototype is created that is subjected to validation activities such as:

• Analysis and inspection methods
• Compilation of relevant scientific literature
• Usability or human factors study
• Clinical investigations or clinical trials

These ensure that the final product can indeed function as per the intended performance and meets all predefined user needs. At every stage, design reviews are conducted to provide a systematic assessment of design results, feedback to designers on existing or emerging problems, assess project progress, and provide confirmation that the project is ready to move on to the next stage of development.

Emphasis on customer needs and meeting applicable regulatory requirements have enabled companies launch successful medical devices into the market. Let’s look at some products that are hitting this mark!

• Medtronic’s Deep Brain Stimulation (DBS) Therapy for treating Parkinson’s disease.

This therapy addresses the medical and user need and is only dedicated for people with Parkinson’s (target users).

• NanostimTM  Leadless Pacemaker by St. Jude Medical is small enough to fit inside the right ventricle due to its compact design. This device addresses the medical and user need and is only directed to people with cardiac complications.

PC : ST. Jude Medical

• The Tablo by Outset has a simple touchscreen user interface that is designed to carry out dialysis by layman users in home at the click of a few buttons. This device addresses the medical and layman user needs and is only directed to people undergoing dialysis.

Good design is making something intelligible and memorable. Great design is making something memorable and meaningful. – Dieter Rams

Design memorable and meaningful products by utilizing methodical approach!

PC : Monolithic Dome Institute

Elexes Team

Elexes medical consulting is one of the leading regulatory & compliance consultant for several industries: Medical device, Pharmaceuticals, Cosmetics, Food, and Biologics.

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