Do you have an innovative idea for a new medical device? Here are four critical steps you will need to take to bring your concept to market:

1) Properly Classify the Medical Device

Before bringing a medical device to market in the U.S., it must be appropriately classified according to FDA guidelines. Depending on the potential health risk your device poses, it will fall into one of three categories:

  • Class I presents the lowest risk, with minimal potential for harm. (e.g., bandages, bedpans, stethoscopes)
  • Class II presents a higher risk than Class I devices. (e.g., catheters, pregnancy test kits, absorbable sutures)
  • Class III presents the highest risk and includes implantable devices. (e.g., pacemakers, ventilators, defibrillators)

The medical device design control process requires many layers of documentation that demonstrate the safety and efficacy of your product. Figuring out which category applies to your device—and ensuring the technology complies with FDA regulatory requirements—can be daunting. It may be useful to engage the services of a proven team of multidisciplinary experts to help you navigate the classification process.

 2) Select and Prepare the Premarket Submission 

Next, you must identify the appropriate submission type, which is listed in the product classification. While there are multiple submission options, savvy entrepreneurs often qualify for 510(k), which is typically the shortest pathway to FDA clearance because the proving grounds are based on a predicate device. If the sponsor demonstrates the new device is “substantially equivalent” to an existing product, it can enter the U.S. market without a clinical trial or additional evidence of consumer safety.

3) Send the Premarket Submission to the FDA 

After preparing the appropriate premarket submission, you need to send it to the FDA for review. Medical device user fees are usually associated with these submissions, but if your operation qualifies as a “small business,” those fees may be substantially reduced. 

4) Ensure Compliance with Regulatory Controls 

It is also important to comply with regulatory controls for medical devices. These risk-based requirements help the FDA to ensure products are reasonably safe and effective for consumer use. All three classes of medical devices are subject to these controls, and the FDA requires that all device facilities:

  • Register their establishments, listing the medical devices they market with the FDA 
  • Manufacture devices using Good Manufacturing Practices
  • Label devices in accordance with labeling regulations
  • Ensure the device cannot be adulterated or misbranded

At times, devices may be exempt from one of the general controls. In such cases, the exemption will be stated in the classification regulation for the device.

Expertise Is Key to Medical Device Product Design

Once you’ve successfully classified your medical device, you’ll need a design plan. It’s crucial to design and develop medical devices without busting your budget or compromising quality. Yet it is not easy to achieve a viable proof of concept that checks off every box. Many innovators have brilliant concepts in mind, but no idea how to execute their ideas. 

Remember, your design isn’t complete until it can be manufactured efficiently, repeatedly, and meets top quality standards and regulations. It’s useful to partner with medical device design experts equipped with the necessary experience and resources to make your vision a marketable reality. 

Know How To Market a Medical Device?

Even the most ideal, FDA-compliant medical device will languish at the gate unless you market it effectively. There is a delicate balance to attracting your target audience while remaining in regulatory compliance. Effective market research will help you identify your consumer base and the pain points your device is designed to solve. You must clearly understand these challenges and demonstrate how your product is an improvement over any previous iterations. For example, many cardiologists complain that the adhesive on wearable heart monitors does not stick for long enough. Can your product solve this problem so doctors can get an effective reading? To successfully launch your product, you should consider hiring marketing experts to help you formulate and optimize your communications strategy; this is especially important if you don’t already have someone on your team who has marketing experience and skills. 

You may feel strongly that your medical device will solve a multitude of problems—from improving the quality of life of people suffering from debilitating conditions to enhancing the overall health care experience. Keep in mind, you’re not always marketing to the end-user. In many cases a hospital administrator or clinic manager is the first to consider your product, so you must highlight the value-add potential of your solution for these and other key decision-makers.

We live in an increasingly digital world where most people do their research online. If you don’t leverage an advanced digital marketing toolset—including search engine optimization and sophisticated web design and development—you could miss out on a variety of prime marketing leads.

Is Your Medical Device Plan Robust Enough for Today’s Market?

Pathway NPI can help with medical device design, engineering, regulatory issues, and manufacturing. If you’re eager to leave the corporate red tape behind and carve out the path of least resistance to launch your medical device, contact Pathway NPI today