An idea for a new medical product can arise from a breakthrough in technology (smart phone technology/the cloud, a new biomaterial, nanotechnology, etc.), the identification of a new compound that can interact with a biological process, the ability to manufacture a biological molecule (e.g, peptides, the ability to process human tissue to derive active biological substances (e.g., stem cells) or combining medical devices with biologics or drugs. However, none of these intriguing or exciting breakthroughs will achieve commercial success without a clear connection with an unmet patient or clinical need. These needs can already be in demand by clinicians (a product to monitor patients remotely) and surgeons (an artificial spinal disc that restores motion to the spine). Or the need that may not be appreciated until the technology presents the opportunity (nanotechnology that allows selective uptake of drugs based upon cell type).
These breakthroughs in technology may create new medical products or they may allow existing products to be modified to improve performance, including safety and/or effectiveness. Regulatory bodies dictate the pathway to first human use and ultimately commercial use of these medical products. Insurance reimbursement entities influence the development of products due to reimbursement decisions. Every country has its own pathway, but the medical products indication for use/intended use and its mechanism of action or mode of action play the primary variables in defining the regulatory pathway’s complexity.
What does your company need to define as an intended use or claim regarding performance to make the medical products a commercial success? Do you simply need to state to a potential customer that your surgical instrument ablates tissue, “treats” prostrate cancer or cures prostrate cancer. Clearly the burden of proof increase exponentially from the benign intended use of ablating tissue to curing prostrate cancer. You may be passionate about your medical product but you would be strongly cautioned to carefully strategize the intended use/claims about your product against the “burden of proof” that you will need to demonstrate to a third party like FDA or an EU Competent Authority.
Mechanism of Action is a phrase that is better understood by drug and biologics companies than medical device companies. It is, however, one that all medical product developers need to understand and apply. FDA labeling regulations for drugs require a description of a drug’s MOA (or the developers best understanding of it). FDA now utilizes the phrase Mode of Action (fortunately the same acronym – MOA) and is formally defined in regulation (21 CFR 3). They use MOA and, when it comes to combination products, the Primary MOA to determine whether a medical product will be regulated as a drug/device/biologic. If your product is a combination product, FDA will use the Primary MOA to assign the jurisdictional oversight of your product to CBER/CDRH/CDER by determining if your product acts principally as a drug/device or biologic. Understanding and carefully considering how your product behaves and interacts with the patient will have a profound impact on the “regulatory intensity and oversight” of your product. Also understanding the difference in how your product will be classified in different geographical areas (e.g., US vs EU) may have a significant influence on which market you want to enter first.
Designing a regulatory strategy is important. However, equally important is assuring that during product development and ultimate post market release you maintain the regulatory strategy. RQMIS consultants have carefully crafted strategies and implemented these strategies (including FDA and Notified Body negotiation) throughout the product lifecycle. We have designed and implemented a strategy that moved a company’s product from being regulated as a medical product to a nonregulated (FDA regulations) product (engaging FDA throughout the process). Our consultants have taken an implantable active medical device with an approved PMA and expanded claims of the product that included MOAs that included the product’s ability to influence and affect cellular metabolism to produce endogenous growth factors. Both CDRH and CBER reviewed this major PMA supplement. Finally, our consultants have developed a regulatory strategy to take a novel technology in treating spinal degenerative disc disease by developing and managing clinical studies outside the United States and utilized these results to satisfy phase II clinical safety studies requirements of FDA. By taking advantage of other geographical markets and their regulatory requirements Level I clinical research data was generated and allowed the company to save over 12 months of development time and begin their phase III US studies before the majority of their competitors.
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