Balancing innovation and Medical Device Regulation

Innovation is the soul behind every new medical device idea. But often regulatory becomes a hurdle in the path of medical device innovation. Complying with regulations and keeping innovation intact is an uphill task.

Especially as a fresh start-up, when you are entering completely new territory, it’s difficult to understand how to balance innovation and Medical Device Regulation.

Here we outline some key pointers you can opt for to keep innovation and regulations balanced.

Patent Landscaping

You know that your design, idea, and technology are unique but to ensure legal ownership of the product idea, patent landscaping is a crucial part.

Market Analysis

Market analysis involves checking the competitors for their idea, design, and technology efficiency. Properly analyzing similar products can help you get an idea of what is working in the market. Once we know what is working and what is not working you get an idea of what will fit the FDA bracket as per the regulatory guidelines

Outsourcing to Contract Manufacturer

Contract Manufacturers hold years of experience that you can leverage for your product. Outsourcing your product, you get expertise and regulatory assistance to fast-track your product to the market. Contract Manufacturers work closely with the clients on multiple ranges of products, outsourcing your manufacturing brings you their experience, vendor network, and extensive capabilities. Also, they can also help you upgrade an existing product in terms of design, technology, and so on. The research and design can add to your idea.

The manufacturing certifications of the Manufacturer like FDA, MDSAP, ISO: 13485 are also of immense importance. The product should be manufactured in FDA-compliant manufacturing to ensure a quality product that is easily approved in the global markets.

Developing an adaptable project

The product you develop should be easily adaptable to changing times. Every time you cannot develop the product from scratch. You need to make the technology adaptable so that you can upgrade it with time and it shouldn’t require too much effort to get it approved in the market. When a slight improvement is made every time in the product you just need to upgrade the technology and get the 510k approval. The 510k approval process is comparatively shorter and less complex as compared to the PMA (Pre-Market-Approval) process.