6 Phases of Medical Device Development

6 Phases of Medical Device DevelopmentAsk any entrepreneur running a conglomerate. He/she will say the world of medical device development and manufacturing involves a lot more than what you think. This is not the forte for several people, because it is all about making a positive impact in everyone’s life. Hence only people who understand the market and consumers in and out can probably thrive in this business. Those seasoned professionals enter the market with a plan and they engineer the plan based on certain parameters that are crucial for success. Even if you skip a single step of this, you’re bound to face the brunt. On the other hand, if employed well, you will make a positive impact in the lives of millions and billions all over the globe. Here are those steps.

Initiating & Analyzing

First and foremost, define the purpose of your device depending upon the demand. For example, the market might require an advanced version of pulse oximeter. You can initiate a process to study how the product you develop will benefit the market. Most importantly, you need to customize it based on the geography. Analyze different responses you might get and see how best you can make it to serve the purpose of different people. Hence in the first phase, you always research and analyze the different possibilities and see what best works for your product.

Formulation & Conceptualization

Now you decided for whom you’re manufacturing a product. You did a financial feasibility study, market study and what is the real demand. Now it is time to develop a concept and how it will be received among the public. For example you design and develop an advanced proxy pulse oximeter and plan to see its effects (both positive and negative) in people of different ages. Then you develop some different versions to see how it works otherwise. Now you will understand the impact of your product on different people. Some even go an extra mile by planning a test on people from different ethnicities.

Design Development & Verification

Probably, all your trial concepts have worked out better and your product is taking shape. Now it is time for real time action. You will build your product all uniformly being the same. You’re all set to do clinical trials. Now as planned you will select a sample of individuals. Some set of senior citizens, some middle aged and so on. You will see the impact it creates on each individual. For example, you will have 5 senior citizens. Not all are going to respond the same way. Likewise, you will test this on other age groups as well. Hence in this stage you see what will manufacture, test and get regulatory approvals.

Regulatory Approvals

The most important aspect for any medical device manufacturer is getting regulatory approvals on time. Infact this will take years and years of time. Also, if you’re launching in a new region, you will have to customize your product based on those specifications. FDA offers several regulations which are to be strictly followed. Some of them include- Establishment Registration & Medical Device Listing, Premarket Notification 510(K), Premarket Approval (PMA), Quality System Regulation and Medical Device Reporting to name a few.

Final Validation & Launch Preparation

Now your manufacturing, regulatory processes and testing is over. You need to do some final validations and be prepared for your launch. This will involve marketing your product to the right audience and at the right place. Most importantly, before each and every product goes out of your factory, you will validate them.

Launch & Assessment

Now the D-Day has come. You launched your product for example let us a million allover the world have shown positive response. Still there are lots of people whom you’re yet to reach and some are giving negative feedbacks. Now you have to assess what are the negative factors in your product. Some might say it is not handy and some will say the battery doesn’t last longer etc. You need to make a note of all and ensure you deliver the best next time.

Technosoft Innovations with an experience of two decades in the field of medical device development offers impeccable solutions to simplify complex processes. Refer to this page to understand how the offerings of Technosoft are unique and how it keeps your ante up in the market. Moreover, understand The Future of Medical Device Designing.

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