FDA Approval or Market Approval?

Eunice K. Lin, EK Lin Consulting



Securing FDA approval is a critical step in selling and promoting a medical device in the US market.   This important process demonstrates to both the government agency and the market that a medical device is safe and effective for use.   Because of the complexity in the submission process, coupled with cost and the length of time involved in preparing and waiting for approval, companies make securing FDA approval their most important priority, and put put all hands on deck to focus on getting their product approved as quickly as possible.


And there is nothing worse than to wake up the day after a company receives FDA approval to find out that the product cannot sell.  What just went wrong?


Obtaining FDA approval is an important part of a company’s product launch strategy, but it should go hand in hand with understanding market’s approval.  The FDA approval focuses on a product’s safety, effectiveness and quality.  It answers the questions of: What potential risk or hazard has been identified associated with using the product? Does the product work as the company indicates?  And can the company consistently produce the same product quality?  Market approval, on the other hand, ensures that people will choose your product over other alternatives, such as the existing method or a competitor’s offering.  For example, if a device is unable to integrate its data to an existing IT system, its value may be dramatically reduced, even with great gain from the product’s efficiency.


What then, can a company do to ensure that it understands the market acceptance of a product before going to market, or more specifically, before FDA approval?  Here are a few tips to consider.


1. Build market acceptance testing protocol into your clinical trial design.  Develop a list of questions to ascertain how user would accept your product over alternatives.  Some examples are economic benefits, ease of data integration, and workflow.


2. Demonstrate the use of your product to both opinion leaders and your target market – whether at trade shows (with proper labeling) or speaking at conferences.  Go beyond the scientific merits and technological marvels of the product, which tend to be the primary focus during the early stage of product launch.  Speak also about how the product would be used, the skills required to administer or operate it, and the time and efforts involved.  You will receive invaluable feedback on their acceptability.


3. Collaborate with research scientists for a feasibility study to evaluate the product’s performance and usability.  Before launching into a lengthy, costly and laborious clinical trial, conduct a mini study to determine how the product would be accepted by the end users.  This study can  validate the product’s readiness for both the clinical trials and the market.


4. Conduct testing in the oversea market.  Testing the product in the overseas market can give company quick feedback on a product’s design and usability.  Care should be taken in choosing the right overseas market to ensure that they share similar concerns as the US users.


Validating market acceptance of your medical device as early as possible will serve companies well in multiple ways.  It provides feedback to developers and manufacturers early enough to minimize the cost of redesign or resubmission; it helps shorten the time to market; and it gives the marketing team the information it needs to design the right marketing strategy to achieve the end goal of selling the product on target.



Eunice Lin is a strategic marketing consultant for medical devices.  She helps companies to develop strategies for successful product development and product launch, including securing FDA approval and marketing acceptance.


Eunice can be reached at eunice@eklinconsulting.com or (847) 701-4126

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