Concept testing medical devices: Key questions it must answer

concept testing medical devices

The success of new medical devices relies on their ability to provide superior patient outcomes and financial benefits. However, there are many uncertainties and risks associated with introducing new products or product features to the market. In addition to increasingly stringent regulatory requirements, device manufacturers must navigate continuous changes within the industry, including technological advances. Concept testing allows medical device manufacturers to obtain the requisite knowledge to build robust product development and market access strategies to maneuver the risks. 

The importance of concept testing 

Medical products, in particular medical devices, need to meet several patient, physician, and regulatory requirements before being introduced into the market. Concept testing allows companies to identify what those specific requirements are to decide the next course of action – whether to proceed with, revise, or reposition the product. 

An early stage in medical device development, concept testing allows manufacturers to: 

  • assess the viability of the concept, 
  • evaluate the merits and limitations, 
  • prove a concept, or 
  • test a new indication for an existing device. 

This step is critical as it sets the stage for R&D and product development, providing quantitative support and a high degree of statistical confidence. 

At this initial stage, there are several questions that manufacturers need to answer to minimize market risks and support the requirements of R&D and product development teams. Here are some of the questions that a concept test can help answer.

What is the commercial opportunity?

New products are often based on complex technologies that are yet to find a footing in the market. Before taking the leap, it’s essential to define their commercial opportunity, while accounting for drivers and barriers to their use across specific regions of interest.

A concept test allows organizations to determine the forecasted commercial opportunity of the product, based on parameters such as perceived need, revenue potential, and Net Present Value (NPV).

Who are the stakeholders responsible for decision-making?

A concept test should include in-depth qualitative interviews with key opinion leaders to identify relevant stakeholders at all stages of the product decision process.

In addition to influencing product adoption, stakeholders such as physicians, nurses, and purchase managers, offer valuable insights for developing effective target product profiles (TPPs), and identifying pain points and usability issues.

For example, you may realize the need to educate customers on how to use a new feature based on the interviews conducted during the concept testing study. This is a valuable insight for product marketing teams.    

What are the unmet needs that the product can potentially satisfy?

To gain market acceptance, medical devices must address the specific needs of patients and healthcare providers. Testing concepts can help identify those needs, how well they are being met, and if there are any unmet needs, based on qualitative interviews with stakeholders.  

What are the desired features and attributes of the product? 

Concept tests capture the underlying benefits that clinicians and patients are looking for, as well as the favorable features. They reveal which features and benefits of a product are absolute “must-haves” for clinicians and patients. Additionally, it can help provide insight into the most desirable benefits and value drivers that will increase product acceptance.

What is the perceived clinical utility?

Concept tests can reveal the perceived clinical utility of a product’s features by examining the reactions and attitudes of relevant stakeholders. Medical device manufacturers can then assess the perceived value, favorability, impact, and advantages and disadvantages of the product.

By gauging stakeholder perceptions, medical device manufacturers can choose to realign their positioning and take appropriate measures to improve the customer experience or perception.

What is the target product profile (TPP)?

Target product profiles (TPPs) serve as a planning tool for R&D and product development within organizations. Aimed at a particular disease or diseases; TPPs state the intended use, target audience, and desired attributes – including safety, efficacy, and efficiency-related characteristics.  

Concept testing facilitates well-defined TPPs to support effective decision-making, design of clinical research strategies, and communications with regulatory authorities. 

Here’s how a leading medical device manufacturer informed the product launch strategy for its CT and MRI imaging devices through a concept testing study.

How Netscribes can help

Netscribes provides global enterprises with full-service healthcare market research services, including concept testing, commercial strategy development, and market opportunity analysis. Through in-depth concept testing, we develop well-defined TPPs for leading medical device manufacturers. In addition to supporting the development of innovative products, we identify new growth opportunities by using relevant research methodologies. Get in touch with us to learn more.

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