Innovation is helping to improve patient care, increase standards and lower mortality rates across the globe.
Developing an exciting idea into a realistic product can, therefore, be rewarding, as the forward-thinking item could help to temporarily or permanently improve the quality of life for many patients each day.
If you have a different biodiagnostic product idea or an innovative device you believe could improve healthcare, read the following advice on how to make a medical product a reality.
Aim to Solve a Problem
Every good idea should start its life by finding a solution to a problem in healthcare. For example, Raleigh Adhesive Coatings Ltd is dedicated to breaking down the complexities of a process, with their technical team aiming to identify a biodiagnostic product’s required coating.
As a result, it could lead to the production of a brand-new medical product, such as a new medical-grade tape, wound dressing, or specialist label, which will effectively resolve a specific healthcare issue.
Perform Market Research
It is imperative to embark on market research before producing a product or device. The correct analysis will help you to identify if there are equivalent or better options available on the market. It could also help you to identify your price point and target customer while refining a sales strategy.
Every market will also have its own regulations and challenges to overcome, which you need to be aware of before you venture into a specific healthcare field. Consider the risks of a medical device or product, as well as your customers’ requirements.
To gain an in-depth knowledge of the market, you should perform:
- Competitor analysis
- Focus groups
File for Intellectual Property and a Patent
If you are developing a medical product or device that no individual or company has ever produced, you must protect your idea by filing for intellectual property and patenting your unique design.
While intellectual property will increase the market value of a product, a patent can ultimately prevent others from mimicking, manufacturing, selling or importing your medical product without your prior permission.
Understand a Product’s Regulatory Requirements
Every forward-thinking medical product or device company must understand the regulatory requirements for the country or region they are targeting. For example, the United States requirements can differ to European healthcare regulations, but there is often a similar overlap.
Submit Your Product to the FDA
If your goal is to sell a medical product in the US, your company will need to classify a device into either a Class I (low risk), Class II (moderate risk) or Class III (highest risk) category.
You’ll also need to prepare the premarket submission, detailing information such as:
- Design controls
- Nonclinical testing
- Clinical evidence
Once you’ve compiled the information, you must submit it to the FDA to review, as well as any associated fees. Once received, the FDA will conduct an administrative review to identify if your submission is sufficient, which can commonly take between 90 to 180 days. However, the time-length will be determined by the device class and your premarket submission.