Steps In Medical Technology Commercialization

A medical device developer requires a robust medical technology commercialization strategy to enter the market and secure the highest return on investment. For successful commercialization, it is critical to confirm the market size, competitive landscape, projected adoption and risks. Medical device consulting firms use primary and robust secondary data to construct a strong foundation.  

To create a successful medical technology commercialization strategy, the developer requires to understand the current and future market, target market opinions, competition and anticipated developments and risk hurdles. 

Bringing new medical technology to market is a five-step process. Medical technology commercialization requires the developer to understand the FDA requirements and processes, classification, premarket preparation, submission and other factors that affect medical device commercialization.

Device Classification

First of all, the developer has to determine medical device class. Following are the three medical device classes: 

  • Class 1
  • Class 2 
  • Class 3. 

Medical device class is determined on the basis of:

  • Risk level
  • Intended use
  • Indications for use

A class I medical device is the lowest risk device. A class I device requires general controls.

A class II medical device poses moderate risk. In addition to general controls, A class II medical device requires special controls.

A class III medical device is a high-risk device that requires both general controls and pre market approval (PMA). Medical device classification is a critical step that determines the route to successful medical device commercialization.

Premarket submission

Premarket submission depends on device classification. Following are the three types of submission:

  • 510(k) (Premarket Notification)
  • PMA (Premarket Approval)
  • De Novo Classification Request.
  • HDE (Humanitarian Device Exemption)

The accurate premarket submission identification depends on:

  • Class
  • Indication
  • Existing device and technology

A new medical device requires a 510(K) notification. 510(k) (Premarket Notification) applies to most class II and some class 1 devices. The most stringent premarket submission PMA is for most class III devices. It requires information on: 

  • Medical device design 
  • Manufacturing 
  • Scientific evidence to assure effectiveness and safety for preclinical and clinical studies 

The HDE (Humanitarian Device Exemption) applies to medical devices intended for rare diseases. A device qualifies for an HDE when the developer obtains a HUD (Humanitarian Use Device) designation for the device. This can be obtained from the FDA’s OOPD (Office of Orphan Products Development). 

Premarket Submission Preparation 

A premarket submission preparation requires specific information. Depending on the device classification, the following are important considerations: 

  • Design control 
  • Clinical evidence 
  • Nonclinical testing    
  • Labeling 

The developer has to provide clinical and usability data and other details for a high-risk device. 

The FDA Submission 

The medical device developer sends the compiled information to the FDA for review. A traditional 510(k) requires 90 days and PMA requires 180 days. The initial submission also requires an application copy and the associated fee in the case of PMA or 510(k). The FDA determines the application completeness by conducting an administrative review. The agency also requests additional information if required. 

Registration and Device Listing 

This step registers the medical device establishment and lists the device with the agency. The device establishment, registration number assignment or listing does not denote the FDA approval.

For successful medical device commercialization, the developer requires to understand the latest FDA guidelines. Medical device companies rely on medical device consulting firms for the FDA guidelines and regulations. Different types of consulting companies offer different consulting services. Some consulting firms offer services including voice of the customer, market analysis, value analysis, key opinion leader identification, risks analysis, competitive analysis, positioning analysis, financial valuation, exit strategy, business plan and portfolio analysis. Other consulting firms support medical device developers with regulations. 

The American medical device market offers growth opportunities to medical device developers and manufacturers. However, the developer has to choose the right medical device consulting firm to navigate all the requirements and steps in medical technology commercialization.