Compare competing medical devices
The regulatory affairs department in a company interfaces with the health authorities, such as the FDA, to get their product approved for public use. To market a medical device in the US, the company’s regulatory department submits a premarket submission, or 510(k), to the FDA. Note that the process to market a drug is different. The type of submission depends on the class of the device and whether there are similar devices already approved.
During the submission process, the regulatory affairs department works with multiple departments, such as business development and preclinical and clinical departments, to make regulatory and business strategy decisions on what is the best path to take to get their company’s product approved in a cost and time-effective manner.
One regulatory and business strategy is to identify the competing devices and determine what enhancements were made to the devices that are still within the safety and efficacy boundaries of already approved devices by submitting a 510(k). Companies can improve the device, for example, in terms of cost or effectiveness, and still get 510(k) approval if these changes do not affect safety or efficacy. This may allow the device to compete better for a larger market share in a particular device space.
There are are several advantages to this method:
Premarket Process for a Medical Device
Although there are many possible paths, for the purposes of this simulation, here is one of the paths that a regulatory affairs department might take to prepare a premarket submission of a medical device:
Medical devices can be divided into three classes:
Four different premarket submission pathways:
Prepare a summary of information on equivalent devices from other companies.
Your company is interested in marketing embolization coils, which are used to block the flow of blood in faulty blood vessels (more info here). Your company has embolization coils already on the market, and wants to know what types of changes they can potentially make that would still allow them to use the 510 (k) pre-submission pathway. They want to know what competitors with similar devices are doing, and what changes they made to the legally marketed device to which they are drawing equivalence (predicate device).
You are an entry level regulatory affairs associate in a medical device company supporting the regulatory affairs department. One of your responsibilities is to gather market data to help the department shape regulatory and business strategy.
|Task 1: Identify embolization coils already on the market and gather relevant data on each device
Use the FDA website to read about the product, and gather information from internet searches, such as the company’s website.
Make a powerpoint with information about the devices to present to the business development and regulatory affairs monthly meeting. Include the following:
For this task:
Needed in this career:
A professional in the field of regulatory affairs may also perform these activities:
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Simulation author: Linda Lee, PhD
Simulation vetted by professionals in the Bay Area