Stages Involved in Designing of A Medical Device

medical devices
Are you someone planning to launch a medical device? or Someone who is intrigued by the medical device development process and wants to know how they are designed? 

Then this article is for you!

To begin, here are a few reasons as to why a fresh medical device product development happens-

  • To make the lives of medical practitioners easy by assisting them in saving other lives.
  • To help those suffering from any particular ailment or disease.
  • To deliver a device that is capable of positively affecting thousands of lives.

Whatever the reason, there are innumerable benign consequences on the lives of a myriad of people when a new medical device comes into the market. 

Now, there’s a bad bit and a good bit-

So what’s the bad part?

Devices concerning the medical area are not straightforward to launch. Launching these devices comes with many stringent regulations that need to be followed. 

And what’s the good part?

There are experts and professionals well versed in the medical device development process, having the ability to tackle the most stringent norms. Their help with the medical product design can make developing a new medical device ‘a cakewalk.’  

These experts can guide you through launching your product into the desired market while staying within the regulations. The essential part is that if you are finished with your research, and found a market. Consulting the medical product design experts would ensure no hefty expenses and a perfect product following the norms.

The medical device development process is divided by experts into a few stages, requiring a certain amount of planning, collaborations, and documentation to become triumphant.


Stages Involved In Medical Device Development


STAGE I: Conceptualization and Analyzing Risks

The foremost step required for a successful medical device development is documenting and planning the medical device development process. Conceptualizing all vital elements and analyzing the risks to move to the next stage is crucial. 


  • Whether the device is to be utilized directly by the patients
  • The operational environment of the medical device
  • Manufacturing methods to fabricate the device
  • Device’s operational environment

All are to be taken care of during this initial stage of medical product design

Besides reviewing the regulations and guidelines, analyzing the risks that could hamper the process is another important facet of this process. 


STAGE II: Formulating and Investigating Feasibility

This stage of formulating the idea ‘into action,’ by assessing the feasibility, is crucial. Past stage 1, it would determine your idea’s fate. 

To start, seek patients and clinicians and begin with collecting feedback. Moreover, performing an in-depth analysis of the competitor’s product will help kick off your medical design prototype

Documenting the process and performing a more formal risk analysis will answer if the concept is feasible to be manufactured for practical implications or not. 


STAGE III: Verifying and validating existing Designs

This stage requires optimizing the final design to satisfy the regulatory norms and guidelines. With the device taking its final shape, it had to be exposed to the compulsions of norms in this stage. To withstand these, mark the criteria you are looking for as benchmarks. 

Design Trace Matrix is one such way to ensure that you’ve not lost track of the consumer needs. 

Moving forward, decide on the below questions in this stage to avoid any setbacks later-

  • How would you deal with the customer’s requirements?
  • What mode should be used for testing and verifying? 
  • What engineering processes do you need? 
  • Is there anything that can be outsourced?
  • How to test the device for quality assurance?

Moreover, a detailed risk analysis again can prove to be fruitful. Look out for all possible failures that could occur due to a bad design, poor component quality, and manufacturing processes. Finding these would curtail any impending failures. 

Additionally, knowing and following the country’s regulatory norms you are about to sell in, is critical. Also, look out for any external approvals required to be successful in the medical device product development process.


STAGE IV: Testing, Final Validation, and Approval

Beware! If you are thinking of marketing the product at this stage, learning the marketing jargon beforehand could save you from the twists and turns later. Remember, any claim should be backed by evidence.

  • Now, if you have reached this phase of medical device product development
  • Consider gathering all the documented data and statistics in one place. Evidence of the tests passed should also be documented.
  • If a few products are fabricated successfully, lookout for ways to replicate for large-scale production?
  • Consider performing all shipping trials and the final phase of mandatory testing.
  • Compile all the documents, results, pieces of evidence in the report for the authority to review and approve the device.


STAGE V: Launching the Product and Post-assessment

Congratulations! For coming this far with your medical device product development process and being so close to making the device accessible to the consumers.  At this decisive and end stage, keeping the below points in mind would help-

  • Perform a last and final check of your documentation
  • Take care of every possible loophole that could harm the progress.
  • Plan your post-market strategies to deal with the consumer feedback and queries effectively.

After the launch, taking regular feedback from consumers would help to work on the stone left unturned or even help decide if there’s a need to recall the device? 


To Conclude,

Medical devices can transform the lives of thousands, millions, or the whole of mankind. With the incessant evolution of technology and scope for improvement, there’s always a need for a better medical device. 

In this article, we have discussed the medical device development process in detail. Though, pondering over the points, developing a medical product design could appear to be an easy task. But that’s only the tip of the iceberg. With the intricacies and stringent norms in developing a medical device, this process could be cumbersome. Thus, to successfully develop a medical device, consulting the specialists could be advantageous. Their competency in working with the development of the medical tools would catapult your project to newer heights!.

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