The exact product development process for medical devices differs from region to region, with different rulings and standards that need to be met in the EU, USA, UK and in other regions. These precise regulatory requirements are overseen by the relevant regulatory body, such as the Food and Drug Administration (FDA) in the United States and the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK.
Medical device development should be set to meet the requirements of the area the device is to be used in, but there are some general steps in the medical device product development lifecycle that are followed across the board.
These steps include initial concept, product design, protoyping, device testing, design verification and validation, and medical device manufacturing.
Stages of Processing 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:
- Initiation - opportunity and risk analysis
- Formulation - concept and feasibility analysis
- Design and development, including verification and validation to ensure the design output matches the specified design input
- Final validation and product launch preparation
- Product launch and postlaunch assessment
How long does it take to Develop a Medical Device?
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 FDA provide guidelines for the time to gain approval to bring different classes of device to market:
Class 1 Devices
These are the quickest devices to gain FDA approval for and include items such as tongue depressors, oxygen masks and electric toothbrushes. The majority of these non-invasive class 1 devices can be self-registered with the FDA and can be completed in as little as one week.
Class 2 Devices
Class 2 devices have a moderate risk associated with them and include items such as contact lenses, catheters and syringes. 43% of devices fall under this category and need a manufacturer needs to be able to prove device safety and efficacy through substantial comparison to another approved device. The FDA will provide receipt of a submission for approval within 60 days, but the average time to receive clearance is 177 days (nearly six months), with just 19% being cleared within three months. However, the time for clearance can also vary depending on the type of device being submitted. Anaesthesiology devices have the longest average time to approval, at 245 days, while toxicology devices are the shortest with an average of 163 days.
Class 3 Devices
These devices are the most invasive and pose the highest risk to patients. Class three devices account for around 10% of products and include items such as cochlear implants, defibrillators, and implanted prostheses. They also require the most stringent checks during the development process in order to attain approval. The FDA requires adequate scientific evidence to show safety and efficacy of these products. The average time for approval is 243 days after submission, which is just over eight months. This waiting time has been significantly reduced in recent years, as prior to 2010, this wait was an average of 345 days.
How much does it Cost to Develop a Medical Device?
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.
Although it is difficult to put an exact figure on medical device development, research has shown that the total funding costs for a Class 2 medical device is around $30 million, of which development and engineering makes up $2-5 million.
Does a Medical Device need FDA Approval?
All medical devices that are manufactured, repackaged, relabelled or imported for sale in the United States need some level of FDA approval.
The FDA’s ‘Center for Devices and Radiological Health’ are responsible for regulating these products as well as medical and non-medical radiation-emitting electronic products such as lasers, x-ray systems, ultrasound equipment, microwave ovens and even colour televisions.
The required level of regulatory control increases with each class of medical device, from one to three. Most class one devices do not require Premarket Notification 510(k); most class two devices require Premarket Notification 510(k); and most class three devices require Premarket Approval.
In each case, a submission needs to be made to the FDA, increasing in complexity with each class. As a result, the time to gain approval will also increase from days to months.
Medical device development can be a complex process with varying guidelines according to the market you are working in. Therefore, it is best to check the relevant standards and procedures for your region to make sure your product is compliant.
You can find out more by visiting the relevant official website (such as the FDA) and also get some useful information by searching for relevant videos on YouTube.
The development and approval process also differs according to the type of device you are developing.
TWI can assist with many aspects of medical device development, and you can find out more about our medical device consulting services here.
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