Medical Devices
Medical Devices? The medical device development process requires specific stages to be followed to ensure design control so that the product is both effective and safe for use. As a result, this covers the entire product development cycle, from medical device design to clinical trials, and risk management to manufacture.
The FDA, for example, set out five stages for processing medical devices to prepare them for market. These stages form their quality system regulation (QSR), which governs “the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labelling, storage, installation, and servicing of all finished devices intended for human use.”
The FDA stages are:
Medical Devices?
Developing and gaining approval for a new medical device is not a fast process and can take many months or even years depending on the type of device being developed. Studies show that it takes three to seven years to bring a device from concept to approval. This may seem like a long time, but it includes the entire device lifecycle, including research, development and testing.
The exact costs associated with developing a medical device will vary according to what is being developed. There are clear differences in complexity for a tongue depressor and a defibrillator, and this will be reflected in the relative development costs.
Furthermore, it is very difficult to skip any of the iterative development, design and testing stages in order to save costs. A device manufacturer will need to be able to show technology, industrial design, safety, usability, proof of concept, manufacturability, packaging concepts and many other factors before reaching the marketplace.
Here are the key reasons behind the growing interest of businesses like yours in Medical Devices:
- Improved diagnosis and treatment.
- Ability to monitor chronic diseases.
- Enhanced patient and clinician experience.
- Better medical device management.
- Ability to have idea generation through data collection.
Hire the Best Medical Devices developers
When developing a medical device product, you face different challenges. Cutting-edge technology and strict regulations often add an extra level of complexity and can impact the medical device development process.
With expert guidance and top-notch support, you can overcome any obstacle during the medical device development process. Our team of medical device developers at Heftig Digital Services provides you with the insight, infrastructure, and hands-on help you need, in whichever medical device development phase you’re in.
You get all the tools you need to access these resources at any stage of medical device product development – from conceptualization to engineering & design and even small-series production.
At each one, our team helps you make clear definitions and smart choices that protect you from costly mistakes, ensure the desired quality and increase your speed to market.