Balancing Medical Device Innovation and Clinical Trial Obligations

Balancing Medical Device Innovation and Clinical Trial Obligations

Topics: Medical Devices

Product development is about delivering products to the customer, which contain the features and quality that they are willing to pay for.  Truly new products, which are innovative and provide a product that is substantially different from other products, are important for companies especially if they want to be the market innovator.

To deliver successful products, you need a clear understanding of the problem to be solved from the customer’s perspective and the major customer requirements.  In medical device product development, you also need to define 1) the product claims, 2) the intended use, including the use environment and the targeted user(s), and 3) the indications for use.  These 3 components drive the product classification, submission type, and types of evidence needed to demonstrate the product is safe and efficacious.  Clinical studies, which can be very expensive and lengthy, are the most common method to collect the needed evidence.

Early in product development, engineering/R&D and marketing will define any claims, plus the product’s intended use and indications for use, then work with Regulatory to develop the regulatory strategy.  This strategy will include an estimate of the submission type and evidence needed to support the intended use and indications for use.  Next, the product development organization needs to balance the cost and lengthiness of clinical trials against the value gained from developing and introducing the innovation or new product.

When the regulatory strategy indicates significant studies or a more stringent product submission (e.g., PMA instead of 510k), we occasionally see companies choose to reduce the most innovative features of their product or the features that best address the customer needs so that they can get to market more quickly or to avoid the resource commitment associated with an extensive clinical trial.  With this approach, unfortunately, products are often scaled down substantially to a me-too product that does not meet the desired financial return.

Below are three strategies which can assist in delivering a more innovative product to market quicker, while allowing you to generate the data for the full set of claims.

  • Develop a platform architecture which allows you to start with a limited set of features and add additional features over time, without substantially re-developing the underlying technology. This strategy limits the scope of development and is probably the fastest route to market.  However, this strategy also requires additional design and process verification and validation (V&V), plus submission updates, as each feature is added to the platform.
  • Develop the product with the full set of planned features, but limit the claims, intended use, intended use, user group, etc. This strategy will take longer to complete the design, but enables you to complete design and process V&V up front.  Additional studies (e.g. clinicals) may be required to cover the other claims and to update your submissions.  Limited process V&V may also be needed to address labeling updates for the additional claims.
  • Meet with the FDA or other regulating agency to discuss ways to use animal, simulated use, or smaller clinical studies for early safety and efficacy, along with planned post-market surveillance programs. This strategy allows you to enter the market earlier, but will require significant investment in post-launch follow-up and reporting.

Companies that are transitioning from developing me-too products to more innovative products need to anticipate the additional evidence required to support the product.  When key features are removed, the product often no longer provides sufficient differentiation to change the market.  To get to market sooner, you need to consider how to establish the product is safe and efficacious for its intended use.  Breaking up the product delivery is one way to help you get to market quicker, while you build the evidence for the more innovative product.

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For more information, contact:

Mary Drotar, Partner

Strategy 2 Market, Inc.


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