Determine the Regulatory Pathway & Reimbursement Route
Posted by Melda Research on May 17th, 2019
IX. Determine the regulatory pathway and reimbursement route
The regulation of medical drugs and biodevices is carried out to ensure safety and efficacy while offering rapid movement of innovative concepts through the investigative as well as the regulatory procedures as rapidly as possible. In the United States, the Federal Food and Drug Administration (FDA) undertakes this central process, while in the European Union it is a role carried out by regional and centralized regulatory bodies. The approval of biodevices in both the US and the EU follows the steps shown in the figure 7 below, in which it entails the assigning of the medical devices into three primary regulatory classes namely Class 1 (low risk), class II (moderate risk) and class III (high risk).
This medical device on its own poses low-risk to injury or harm or any other safety issue to agent or user; hence will be considered a Class 1 medical device. This means that it will be subject to the FDA’s general controls, in addition to the other regulatory constraints described above in Section V. The rough path to market, based on FDA guidelines, is shown below in Figure 8. This pathway is much faster than if the device were to be subject to 510(k) review, which averages 95 days. With general controls, as long as the device meets all the requirements, the time to market once those are completed should be relatively quick.
This path has been chosen, as stated above because the device will be very low-risk. The device itself, based on our preliminary design concepts, is not any more danger to the user than the bottles that consumers generally imagine when thinking of pill containers. As such, there is no reason to subject any of our proposed designs to any regulatory constraints beyond the general controls.
Once the device can be sent to market, several things must happen for the new device to generate revenue. Reimbursement is a crucial area in the development and dissemination of drugs and medical devices. In the US, if no reimbursement pathway is implemented by either the Center for Medicare and Medicaid Services (CMS), a concept for a device will hardly be adopted regardless of how brilliant the device is. It entails covering the device under an umbrella reimbursement code as well as performing reimbursement studies with true endpoints that demonstrate that the device provides benefits over the existing practice that include saving time during the procedure and also minimizing repeat operations (Kucklick, Theodore R., 426). The next phase after carrying out the reimbursement studies, with precisely successful endpoints, an application for a reimbursement code to acquire coverage and a payment level is done, which is to be used by the customer to get reimbursed for the device.
According to Wolpaw, Jonathan, and Elizabeth Winter Wolpaw (344) the three main conditions that should be met for a biodevice firm to survive on insurance reimbursement for its product are that a code for the procedure or medical device must be created, a coverage decision must be made and payment for the device must be adequate to justify sales and manufacture.
Bottle Manufacturers → Pharmaceutical Industries → Sales Representatives, Pharmacies → Customer
Kucklick, Theodore R., ed. The medical device R&D handbook. CRC Press, 2012. Pp. 426
Van Norman, Gail A. "Drugs and devices: comparison of European and US approval processes." JACC: Basic to Translational Science 1.5 (2016): 399-412.
Wolpaw, Jonathan, and Elizabeth Winter Wolpaw, eds. Brain-computer interfaces: principles and practice. OUP USA, 2012. Pp. 344
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