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Planning a Medical Device Product Launch: 4 Key Steps to a Successful Process

medical device_product launch - resize2Teams launching a new medical device face four primary challenges: planning, communications, implementation, and follow up. This blog breaks down those challenges, focusing on the planning and communications aspects of a new medical device product launch and offers tips for creating a successful process.

To achieve a successful medical device launch, all disciplines involved with the new device engineering, technical documentation, marketing, sales, distribution channels, and customer support  must work collaboratively to achieve success. This is usually measured by ROI, adoption, market share, customer satisfaction, and/or awareness.

Because medical devices require a pre-market submission by the Food and Drug Administration (FDA) before marketing the device, the actual launch date may be contingent on receiving final regulatory approval. An unpredictable FDA timeline for pre-market approval can have a huge impact on a company's budget, staff, and timelines. This often results in a rush to pull the various phases of the product launch together once approval has been obtained. These areas of uncertainty can be overwhelming for the product launch team. Looking at a medical device product launch as a process rather than as a targeted event can help manage the stress associated with unexpected delays.

4 Ways to Effectively Manage Your Medical Device Product Launch

Below we have outlined four ways to manage the uncertainty that comes with a medical device launch. Use these suggestions to keep your team focused:

1. Determine Your Product Launch Timeline
Take the time to properly assess your regulatory situation and define your strategy for pre-market submission and device launch. If you are introducing a brand new technology or application, you should develop your strategy well before the product is launched sometimes more than a year in advance. One of Launch Team's clients began talking about the promise of their new technology, a research system, 18 months before the product was ready to ship. Two main factors contributed to this decision:
  • Price Point. At close to $250K, prospects would need time to plan the purchase into their budget cycle, and in some cases, seek grant funding.
  • Application Novelty. Because the technology was so new to the target market, the company wanted to publish its pilot test results as they emerged to establish credibility.

For less expensive investments, or more accepted devices, starting launch activities 3-6 months before product availability is appropriate.

2. Develop a Product Launch Plan

Creating a comprehensive product launch plan, which includes a timeline that allows for the unexpected, is the most critical element of a successful product launch. When developing this plan, make sure you include input from all of the disciplines involved in the project. Be sure you establish a communications schedule within the plan that enables all members of the project launch team to have a clear understanding of the timing, scope, and implementation of the product launch process.

3. Create and Follow a Documentation Plan

A customer-focused documentation plan is the most efficient way for Technical Documentation Managers to control documentation costs and contribute to a successful product launch process. A well-designed documentation plan does the following:

  • Enables tasks to be delegated and resources applied appropriately.
  • Shares the customer documentation strategy with engineering, marketing, and implementation teams.
  • Tracks the progress of product development teams and allows for modification if needed.
  • Tracks the development of customer documentation deliverables.

For the documentation plan to be successful, managers need to:

  • Prioritize and schedule only the documentation that actual customers will use.
  • Obtain all product photographs, illustrations, videos, and graphics necessary, making this material available to the documentation and marketing teams.
  • Develop a timeline that ensures all user manuals, installation, and instruction guides are complete and available for distribution prior to the actual launch date.
  • Allow time for translation of the documents if applicable.
  • Develop a deployment strategy so all documentation produced is easily accessible by customers.

4. Create a Customer-Focused Training Plan

The primary purpose of a training plan for a new medical device product launch is to establish a program to train sales, customer service, and support staff on the new product. This ensures they are equipped to help customers evaluate, install, troubleshoot, and maintain the equipment. Secondary purposes of medical device training programs include:

  • Communicate process and support through provided sales tools and collateral
  • Develop a training kit for sales, customer service, and distribution partners to refer to when selling the new product.
  • Schedule training for the distribution channels that will be selling the product.
  • Make sure all service personnel are trained and ready to assist with spare parts and service calls.

Want to learn more about creating an effective documentation program?
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Topics: product launch