Reg. Affairs: Performing a Competitive Analysis

Background

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:

• Cost – marketing a device as “substantially equivalent” exempts the device for having to undergo costly clinical trials demonstrating safety and efficacy of the device. In addition, the cost of 510 (k) submission is lower than a PMA submission. (more info here)
• Time – time between pre-market submission to FDA approval is shorter for a 510(k) than for PMA.
• Regulatory maintenance – devices approved through PMA requires an annual report to the FDA, and an associated fee for submitting that report; there is no annual report required for 510 (k).

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:

1. Classify the medical device.
2. Choose the correct premarket submission pathway.
3. Prepare the appropriate information for the your premarket submission to the FDA.
4. Send your premarket submission to the FDA and interact with FDA staff during review.
5. Complete the establishment registration and device listing.

Medical devices can be divided into three classes:

Four different premarket submission pathways:

• 510(k) (premarket notification) – “A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA [premarket approval]”.
• PMA (premarket approval) – company must demonstrate safety and effectiveness of device
• De Novo (Evaluation of Automatic Class III Designation)
• HDE (Humanitarian Device Exemption)

The Exercise

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.

1. Using the embolization coils device code (KRD), search the releasable 510 (k) database.
2. Search the internet for similar devices. Note that companies may also seek approval for their medical devices in other countries.

Use the FDA website to read about the product, and gather information from internet searches, such as the company’s website.

The Deliverable

Make a powerpoint with information about the devices to present to the business development and regulatory affairs monthly meeting. Include the following:

1. 510 (k) approval number
2. Device Name
3. Date of FDA submission
4. Date of FDA decision (clearance date)
5. Indications
6. Device modifications
7. (Optional) approval in other countries

Resources

• A guide from the FDA on how to study and market your device.

Skills

For this task:

• Analytical and critical thinking
• Technical writing skills
• Scientific background
• Attention to detail and accuracy

Needed in this career:

• Oral and written communication
• Organizational and documentation skills
• Interpersonal skills
• Strategic thinking
• Strong scientific background
• Creative and flexible thinking

Additional Responsibilities

A professional in the field of regulatory affairs may also perform these activities:

• Project management
• Business development
• Communicate regulatory and development issues to team members
• Strategic planning of clinical development programs
• Regulatory submissions
• Communicate with health authorities
• Regulatory compliance