Taking a me-too product to market is easy and comparatively less hectic as you just have to find a substantial equivalent (510k) to start selling. On the other hand, a new innovation led product requires much higher investment for clinical trials, documentation and regulatory approvals. But, does it imply that you have to compromise on innovation to fast-track your product to market? Obviously, no!

It is important to keep the innovation in Medical Device Manufacturing alive to remain relevant with the changing dynamics of the Medical Device industry. For a successful medical device design & development process, here we empower you with some cheat codes to fast-track your product to market without compromising the innovation & quality.

How the Regulatory strategy contributes to bringing down the product’s value?

Adding Innovation in terms of design, functionality, or any other aspect of a Medical Device means entering the complete regulatory cycle process again. Medical Device Companies do not want to invest in long clinical studies to avoid unnecessary financial resource investment. Often, they reduce the innovation factor to fit the regulatory checklist but that eventually ends up in a Me-too product with unsatisfactory returns.

What can Medical Device Design & Development companies do to keep innovation alive without compromising the Go-To-Market of the product?

Here we list out several strategies that we as seasoned Medical Device Manufacturer can adapt to fast pace your medical device product to market.

Developing a platform architecture

Instead of changing the core technology or adding too many features at once, you can add features one by one. Although this would require a validation and verification process, it will surely save you the extra hassle to apply for a clinical trial. Keeping the core technology same, you can just add or modify the side features of the device.

Limit the user group, intended impact, claims

Add new features and develop the design as per the plan, but limit the user group, intended impact, claims, and so on. The process may take more than necessary time to complete, alongside the V&V process. Adopting this approach, you can easily reduce the clinical trials needed to update submissions. Labeling updates may also be necessary to address the changes done.

Consulting FDA for small simulated clinical studies

In case your device isn’t a highly invasive product, FDA might agree to take the results of a small animal-based simulated study that can be used as evidence.

Adopting a flexible Design Control Approach

While entering the design control phase, developers often struggle with defining everything at once. Teams experience a long debate over what needs to be highlighted first and what can be ignored. Spending too much time at this level can make things tricky. The regulators expect major claims to be supported by evidence and customer’s need to be identified. Not everything is needed in the first place, other requirements might evolve as the product is developed.


Developers in the medical device domain need to understand that cutting on innovation to fit the regulatory bracket isn’t worth going for. When the key features are compromised the product will never make the impact that gives you higher ROI. Exploring ways to find out substantial evidence for newly added features is the right way to improve the Go-To-Market of the products. Fragmenting the product delivery is one of the primary ways to collect evidence and fast pace Go-To-Market of the device.

Partner with Johari Digital Healthcare Ltd. to get maximum returns on investment. As a 40+ years Medical Device Manufacturers we help you fast-track your product to market without compromising the quality and innovation.



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