medical device

Medical Device: Commercialization

During commercialization, the product is 1) introduced to the market and 2) monitored for feedback.

Based on the product classification and intended use, the product may need to be registered with or approved by the regulating agencies before commercialization. The outputs from Development, including testing, are often required as part of the submission package.

In addition, launch may be delayed until products have been registered under existing reimbursement codes or new submissions for reimbursement have been approved.

Market Introduction

Before market introduction, the product manager or downstream marketing will determine the overall launch strategy and develop any launch materials. (Note: If the launch materials contain statements that might be considered claims, data must be available to support them.)

Medical devices must have design controls complete and product registrations in place before the product launch. Once those are in place and as defined in the launch plan, the company may introduce the product to market. Limited launch is an acceptable method for product commercialization to learn about marketing materials and market acceptance.

Monitor Market

Just as a project schedule is monitored and adjusted during development, the market introduction needs to be observed and modified. The project team should determine how the market will be monitored, including frequency. Developing thresholds for action and response plans before launch, enables project teams to respond rapidly to feedback from the market.

The response plans should address both positive and negative adjustments to the launch. For example, if the introduction is going much better than planned, how will production be increased to address the new demand? Or if customer feedback cards reveal a negative product perception, how will that be managed?

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