Every medical device development journey starts with Ideation and Conceptualization; Here is beginner's process for the same.
December 18, 2017
It takes an efforts to market the healthcare device that intersects with customer needs.
A healthcare devices solution requires starting with powerful product definition out of the end user's requirement. It takes team-wide efforts, sense of sticking to product requirements gathered from need identification, concurrently justifying risks and adhering to the best quality.
As with other industries, Medical devices invention begins with identifying and analyzing the marketplace, the area and the requirement of that can be unmet or untapped or there's a better way to deal with those needs.
These demands could be something which provides a solution like a new or improved means of easy and powerful care delivery alternatives for tracking health, devices or technology to provide better administration that encourages wellness and a life.
These user needs are either Vitamins or Pain Killers.
Let's understand "Vitamins and Pain Killers" in this context.
It’s apparent that the device will deliver a solution for a specific health problem. but what if a solution providers find a way to aid convenience in a day-to-day lifestyle or situation.
Yes, for a solution to be marketed, it's not necessary to address the particular problem but also it could be an improved way to achieve something.
For an example
A device such as Activity tracker tracks calories burned, walking distance or sleeping behavior. Many such devices are available in the market which does not target any health problem but delivers insights for better health of tomorrow or delivers insights to take your health next level. Similar devices help you go proactive. Similar application can be termed as Vitamins, on other hand a device addressing to problem such as insulin injector can be termed as Pain Killer.
Here is the process for the product ideation/conceptualization:
The very first thing a team needs to do is identify an unmet demand which can be converted into a medical device or healthcare offering & solution.
Proper identification is crucial and success depends on below factors:
1. The need gap between target market needs and perceived need by developer
2. A product scope extracted from the market needs analysis
Medical device scope definition is about defining a design and minimum expected performance aligned to extracted needs.
Once product definition, scope, and functionalities frozen, the developer needs to consider where your Medical Devices solution falls into FDA defined devices classification.
FDA classification is classified on the basis of associated risk with device usage. It is also advised to look for any existing IPs on an idea which might force not to use the technology by law.
A product discovery phase demands a well-versed development team. This could be a challenge if team is not well experienced. The team needs to have subject matter experts in below areas:
Engineering plus design
Human factors engineering
Scientific and Clinical knowledge of the industry
Quality assurance practices
Intellectual property rights and laws
Once you got product scope and team ready, further step is to transit the idea into a discovery phase. In this phase activities such as primary design, prototype development, PoCs, and redesign efforts from V&V process are carried out.
Once you done with the product discovery phase, you can proceed for FDA approval and then commercialization.
But before going to commercialization, you must adress below stages of product development process:
Addressing Regulation and Compliance need
Design control regulations
Testing – Verification and Validation
Risk management procedures
You can check out a Guide for Medical Device Design and Development for more information.