Medical Device Product Launch: 4 Critical Planning Steps

Four top challenges faced by a new medical device product launch team include planning, communications, implementation, and follow-up.

To achieve a successful medical device launch, all disciplines involved with the new device (engineering, technical documentation, marketing, sales, distribution partners, and customer support) must work collaboratively. Product launch success is usually measured by return on investment, adoption, market share, customer satisfaction, and/or awareness.

Many medical device companies are moving towards a more digital and customer-centric approach going to market. Customers have gotten used to omnichannel options for all steps in the sales, purchase, and service lifecycles, and medical devices are no exception. 

Since medical devices require a pre-market submission to the Food and Drug Administration (FDA) before marketing the device, the actual launch date may be contingent on receiving final regulatory approval. To enhance the transparency of operation and decision-making processes, the FDA implemented the Transparency Initiative. With an unpredictable FDA timeline for pre-market approval, the potential to impact a company’s budget, staff, and project timelines often results in a scramble to pull the various phases of the market launch together once approved. Looking at the product launch as a process rather than as a targeted event will help manage the stressors associated with unexpected delays.

1. Determine your Product Launch Timeline

Take the time to assess your regulatory situation and define your strategy for submission and launch. When introducing a brand-new technology or application, you’ll want to develop your strategy well before the product launch–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.
 
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2. Create a Product Launch Plan

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

Plan for an omnichannel and personalized customer experience for each journey phase. Ensure the switch is seamless - whether they are getting pricing from your website, talking to a live customer service rep, or accessing self-service training. This takes careful planning, training, digital tools, and good data to implement. 

3. Create and Follow a Documentation Plan

Using a customer-focused documentation plan efficiently allows Technical Documentation Managers to control costs and contribute to a successful product launch process, designed to:

  • Enable tasks to be delegated and resources applied appropriately.
  • Share the customer documentation execution strategy with engineering, marketing, and implementation teams.
  • Track the progress of product development and modify the documentation plan accordingly.
  • Track the development of customer documentation deliverables.
As part of the documentation plan, managers need to:
  • Schedule only documentation content that an actual customer will use.
  • Map a customer's journey and create content and tools for each portion of the journey. 
  • Obtain all product photographs, illustrations, videos, and graphics necessary for the literature produced for the new product and make 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 product launch is to establish a program to train sales, customer service, and service staff on the new product so they are equipped to help customers evaluate, install, troubleshoot, and maintain the equipment. Secondary purposes include:

  • Provide sales tools and collateral and document process and support.
  • 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 sell the product.
  • Train all service personnel to assist with spare parts and service calls.
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