The medical device development process varies by region, with different rulings and norms that must be complied with in the United States and other markets like the European Union and the United Kingdom. The relevant regulatory body responsible for watching over regulatory requirements in the US is the Food and Drug Administration (FDA). In the UK, it is the Medicines and Healthcare products Regulatory Agency (MHRA). We will be speaking about approval here in the US under FDA regulations for our purposes.
A medical device development program should be tailored to the region's demands where the device will be utilized. However, certain FDA phases in the medical device product development lifecycle need to be followed carefully to gain FDA approval after submission.
The medical device development process requires specific stages to be followed to ensure design controls. These are a methodology to ensure a product is effective and safe for use. They cover the entire product development cycle, from medical device design to clinical trials and risk management to manufacturing.
The FDA has set out five stages for drug and medical device development medical to make them safer and ready for the market. The FDA's quality system regulation (QSR) is defined in 21 CFR Part 820. These five stages form their quality system regulation (QSR) and are described by the FDA as follows.
"The methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use." -FDA
The FDA Development stages are:
It might take several months or even years to complete a new medical device's development and approval process. According to research, a medical device might take three to seven years to get from inception to approval. This may sound like a lengthy period, but it includes the entire device lifecycle, including research, development, and testing.
The FDA's clearance time for these devices is the shortest, and they include things like bandages, face masks, or tongue depressors. They are mainly considered non-invasive class 1 devices. Most of these can be self-registered with the FDA and can be completed in as little as one week.
Class 2 devices have a moderate to high-risk profile. Medical devices under this classification include absorbable sutures, powered wheelchairs, and syringes. 43% of devices fall under this category. This means the manufacturer needs to prove the device is safe and effective compared to another approved device. The FDA will provide notification of receipt for approval within 60 days. However, the typical time to receive clearance is 177 days (nearly six months). The clearance time depends significantly on the type of device being submitted.
The devices that are the most invasive and potentially harmful to patients, devices that sustain life, or are implanted are classified as class III. About 10% of medical devices are classified as class III, including pacemakers, implanted prostheses, and ventilators. They'll go through the most thorough checks throughout the development process to receive approval. The FDA demands substantial scientific proof to demonstrate the safety and effectiveness of these items. The average time it takes to get approval is 243 days after submitting, so around eight months. This doesn't include the time it takes for revisions when a medical device is rejected by the FDA, which happens frequently.
The expenses associated with developing a medical device will vary depending on the item. Clearly, there is a significant difference in complexity between a mouth swab and robotic-assisted surgical devices. These differences will drastically affect the relative development costs.
In more complex class II and III medical devices, deviation from the iterative development, design, and testing stages is not likely. Therefore, cutting costs in the medical device industrial design, safety, usability, testing, and proof of concepts is impossible. However, there may be room for cost savings in medical device manufacturing or medical device packaging in some cases.
There is no hard, fast rule on how much it will cost to bring a medical device to market. However, research shows a Class II medical device takes about $30 million in total, and the development and engineering part of this is about $2-5 million.
Medical device development is incredibly complex. The guidelines vary from market to market and device to device. This is why finding the right partner to develop and manufacture your medical device products is so important. Who you choose will likely play the most crucial role in how fast you get to market and the cost of medical device development.
Speck Design is a leading research, design, and development consultancy, located in Silicon Valley. We take medical devices in any stage of development and improve them for streamlined FDA submission. We have more than 25 years of experience taking medical device ideas, prototypes, or existing products and pushing them past the finish line and through to the market. Our medical device products are both technically sound and focused on the user experience. Our powerful human-centered approach is what sets our company and the medical devices we develop apart. Reach out to us for an in-depth consultation on your medical device. No matter what stage of development you are in, we can help.