Medical device development requires that specific stages must be followed for design control, quality assurance and patient safety. As COVID-19 has shifted the medical and business landscapes, we have seen an influx of interest in developing medical devices. Compared to bringing a consumer product to the market, bringing a medical device to market is layered with regulations and additional product testing.
As 3D Innovations President, Collin Kobayashi states, “The development of medical devices is a lot longer than most other product types, so you will need to make sure that you have enough capital, patience, and determination for the long haul in order to see it through the end.”
The FDA Stages of Medical Device Development
The U.S. Food & Drug Administration has a five stage medical device development process that products must go through in order to obtain approval.
- Step 1: Device Discovery and Concept
- Step 2: Preclinical Research—Prototype
- Step 3: Pathway to Approval
- Step 4: FDA Review
- Step 5: FDA Post-Market Safety Monitoring
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, labeling, storage, installation, and servicing of all finished devices intended for human use”.
What is the time frame for developing a medical device?
While the answer to this hinges on the type of product you are bringing to market, it is generally understood that developing a medical device and gaining the necessary approvals takes time and is not a quick process.
“The FDA categorizes medical devices into one of three classes – Class I, II, or III – based on their risks and the regulatory controls necessary to provide a reasonable assurance of safety and effectiveness. Class I devices generally pose the lowest risk to the patient and/or user and Class III devices pose the highest risk.” Products in Class I can go to market at a much quicker rate than those in Class III.
“Medical related products, regardless of the classification typically do require additional testing to ensure that it complies with certain industry specific ratings, FDA requirements, as well as meets the quality specifications.” – Collin Kobayashi, President of 3D Innovations
Certain medical devices will require additional testing such as clinical trials or other user testing along with particular certifications on materials being used, sterilization methods, packaging, and quality specifications. Additional FDA certifications such as Premarket approval (PMA), De Novo pathway, Pre Submission, and 510k submission will be required in order to bring your medical device to market.
What will it cost to develop a medical device?
This depends on your specific product; however, your budget should include both medical device development along with any additional attorney fees for intellectual property and additional regulatory filings.
3D Innovations Medical Device Case Studies
KN95 Mask Filter Development
In response to the COVID-19 pandemic, we worked with InsightPPE LLC on their KN95 Mask Filter Insert. It was developed and manufactured using KN95 material and was designed to fit with fabric masks containing pockets. The KN95 filter material is identical to the material used in KN95 masks which contains 4 layers of electrocharged filtration material for additional barrier protection against airborne virus and bacteria particles. Factory material was tested at 99% efficiency at 0.1 micron. Fits with most pocketed fabric masks.
Marine Biopsy Sampling Device
We worked with Pelagic Research Group, LLC on a biopsy sampling device. This minimally invasive method collects biological tissue samples from specific marine species. This biopsy dart can be mounted on a tethered pole, harpoon, lance, spear, arrow, or other striking device using a standard M8 thread. The device is capable of collecting 1.5cm3 of tissue sample.
Medical device development can be a complex process, however with the right team in place you can successfully bring your device to market. If you still have questions about developing a medical device, please send us an email at email@example.com.
3D Innovations is a Product Development Company – from the 3D Design to a fully functional 3D Prototype & Product.