To get FDA approval for your medical device, you’ll need to go through the following five steps.

When the FDA moves to a more conservative posture, it is generally a good thing for those companies that already have approved drugs or devices on the market – fewer new approvals means less competition for them and may encourage start-ups to sell out instead of trying their luck in the market as competitors.

A Premarket Approval (PMA) application is a scientific, regulatory documentation to FDA to demonstrate the safety and effectiveness of the Class III device. There are administrative elements of a PMA application, but good science and scientific writing is a key to the approval of PMA application.

1. Know Your Device’s Classification. Medical devices fall into three classes:
2. Develop a Prototype.
3. Submit Your Applications (If Applicable)
4. Wait for FDA Review and Approval.
5. Maintain FDA Compliance.

Bringing Medical Devices to Market in the U.S.

1. Classify your device. The first step is to determine the type of device you’re bringing to market.
2. Identify the correct premarket submission.
3. Prepare the premarket submission.
4. Submit to the FDA.
5. Establish registration and device listing.

7 ways to break into medical device sales

1. Marketing internship. If you are currently enrolled in a Bachelor’s degree program, consider our Marketing internships.
2. Sales Operations Rotational Program.
3. Associate-level roles.
4. Leadership skills.
5. Sales experience in any industry.
6. Proven sales success.
7. Build relationships.

6 Keys to Selling Medical Devices & Medical Supplies

1. Effectively Demonstrate Complex Products.
2. Stay Engaged, From Beginning to End.
3. Personalize the Buyer’s Journey.
4. Stay Updated on the Medtech Industry.
5. Educate Yourself & The Stakeholders.
6. Focus on Their Patients.
7. 7 Tips for a Successful Product Launch.

Below are some secrets to marketing for medical devices effectively:

1. Be laser focused on your most important buyers.
2. Define the purchasing process of ideal buyers.
3. Take advantage of blogs and premium content.
4. Keep up-to-date on your industry to maintain an edge.
5. Implement SEO techniques.
6. Nurture the leads you create.