5 Key Steps to Medical Device Commercialization

Medical Device Commercialization


Bringing medical devices to the market requires a full understanding of the process to result in successful commercialization. From a device’s classification to premarket preparation and ever-changing FDA regulations, there are requirements that need to be understood and followed with an effective medical device commercialization strategy.  

Medical device developers need to understand the current and anticipated future markets to plan to address market needs. Developers require confirmation of market size, risk analysis, clinical treatment trends and competitive landscape. Data collected can further be used to design a business plan as a strong roadmap to success. The services of a medical device commercialization consulting firm can help manufacturers. 

A strategy, developed by experienced and skilled professionals, delivers the probability of success and chances of achieving the highest return on investment for innovation. 

A medical device commercialization strategy by experts includes a multi-step process that needs to follow FDA guidelines and regulations. Below are suggested steps:

Classifying a Medical Device

There are three classifications of medical devices, based on patient risk, the intended use and indications for use.  All medical devices require general control of the FDA for manufacturing and sale.   

  • Class I medical devices pose the lowest risk to patients.  An example would be a stethoscope or bandaids 
  • Class II devices have moderate risks and may have some special controls.  An example of a Class II device would be x-ray machines, powered wheelchairs, infusion pumps, surgical drapes, surgical needles, and suture material, and acupuncture needles.
  • Class III includes high-risk devices that have special controls and premarket approval. Class III medical devices sustain or support life, are implanted, or present potential risk of illness or injury. Examples of Class 3 medical devices include cardiac pacemakers, breast implants, high-frequency ventilators, fetal blood sampling monitors or implanted prosthetics.

Classification of devices helps determine the regulatory requirements to bring them into the market. 

Identifying Appropriate Premarket Submission

The step of identifying correct premarket submission depends on a device’s classification. There are multiple types of submission, and the most common among them are 510(k) premarket notification, and PMA application. Apart from that, there is FDA’s De Novo Evaluation designation for Class I and Class II devices.  FDA issues clearance for Class 1 and Class II devices when they are able to be sold.

Most of the medical devices from Class III need premarket approval. Before beginning the process of marketing these devices, manufacturers require FDA approval for them.    

Preparing Premarket Submission

Once a premarket submission has been identified, the next step in the medical device commercialization process is to prepare the submission. In this phase, several key components are considered, such as design controls, clinical evidence, nonclinical testing, device labeling, and others. 

Class III or the devices with higher risks need to be added with more detailed information than other classes. 

Approaching FDA for Review

After compiling the required information, the device to be launched reaches the fourth step where an application is sent to the FDA for review. The approval process for Class II devices may take between 90 to 180 days, depending on a device and its classification. 

Why Hire a Medical Device Commercialization Consultant

From classifying a device to listing it, there are several processes related to successful commercialization that should be followed by meeting the FDA guidelines. 

A medical device commercialization consulting firm develops a strategy as a framework to achieve the highest return on investment. From the market size and clinical trends, target market applications, competitive landscape and risk analysis are handled by a consultant to construct a blueprint for a strong foundation with a medical device. In short, a consulting firm offers cost-effective information that serves as the base of a potential medical device, which is going to enter the market soon. 

Ultimate Objective

A medical device commercialization strategy prepares a company for future challenges and hurdles that need to be overcome to achieve the highest return for innovation. 

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