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Manufacturers of medical electronics have their work cut out for them. These products have to pass approval by the Food and Drug Administration (FDA) in addition to getting the nod from more typical entities such as Underwriters Laboratories (UL) and Conformité Européenne (CE, also known as European Conformity). Most medical device developers will admit that achieving FDA approval can be a big hurdle on the way to new product introduction (NPI).
The need to gain FDA approval may seem daunting. Approvals differ depending on so many different variables: classification, new technology or incremental improvement on existing products, and so much more. Michael Lynch, quality manager at Libra Industries in Mentor, Ohio, offered a brief explanation of FDA device classifications.
“Everything is risk-based. The FDA uses three main regulatory classes to group medical devices: Class I, Class II, and Class III. Class I devices require the lowest level of regulatory control because they present the lowest level of risk in the form of a low probability of causing injury if they don’t work properly. Class I devices are not used to sustain life,” said Lynch.
“Class II devices require a higher level of assurance that they will perform without causing harm to the patient than Class I,” he continued. “If a Class II device fails, there is a low risk of causing serious injury to the patient. Blood pressure monitoring equipment is a typical example of a Class II device. Though, because patients and staff may be depending upon these devices for feedback, Class II devices are designed and constructed to a high level of assurance that the device will work properly. Class III includes critical care and life support. A malfunction in a Class III device can cause serious injury or death.”
Based on the class of the product different pathways, objective evidence and requirements may be necessary. For example, one often-mentioned FDA clearance is Section 510(k) of the Food, Drug, and Cosmetic Act. According to the FDA code of federal regulation, Section 510(k) “requires device manufacturers… to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as premarket notification—also called PMN, or simply 510(k). The premarket notification allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories.” The 510(k) process could be considered one of the more well-known approval processes for medical products.
But there are other paths that a design team could follow to complete FDA approval successfully, all of which are worth exploring. We’ll look at examples from two new companies: 2C Tech and Project Vive.
Project Vive is a Pennsylvania-based bootstrapped startup creating the VozBox, an affordable, portable, durable communication device for people who have lost the ability to speak. 2C Tech’s (Irvine, California) product —although not strictly electronic—delivers an electrical stimulus to the patient’s retina. Both products enhance a patient’s sensory control in various ways and take different paths through the FDA approval process.
Strict R&D at 2C Tech
2C Tech has been developing a quantum dot (QD) technology that helps patients with degenerative retinal disease to see. The quantum dots are semiconductor crystalline structures a few nanometers in size. These quantum dots are injected into the retina where they absorb light and create an electric signal that the retina will recognize as a single wavelength. In essence, the patient achieves increased clarity in their monochromatic vision.
Jim Taylor, 2C Tech CEO, observed, “Most medical devices progress by ‘evolutionary steps’ rather than whole new concepts. If the innovators decided they had a way to make a better implantable defibrillator, for example, then a lot of the groundwork and pathway have already been pioneered; the task then is to innovate while leveraging that prior experience.” The 2C Tech technology may be extremely passive in its function, but it is injected into the patient’s tissues, making FDA classification of the technology trickier. Classification can have a dramatic impact on the development cycle for a medical product.
To read the full version of this article which originally appeared in the November 2018 issue of PCB007 Magazine, click here.
