Advice and best practices for writing SOPs, training for product launch, outsourcing technical documentation, and more.

7 Quick Steps for Successful Medical Device Product Launch

steps to med device launchA medical device product launch represents a major revenue investment and profit opportunity for a company. Successful product launches can yield new markets, bring new customers, as well as increase business with existing customers.

As well-versed experts in product launch, Novatek and Launch Team combined their expertise to bring you a collection of resources for medical product launch. From product documentation to marketing strategy, we're sharing insights on how to ensure medical device launch success.

We've previously discussed the top four documentation challenges faced by a new medical device product launch team, including planning, communications, implementation, and follow up. This blog focuses on the implementation and follow up aspects associated with a new medical device product launch from a customer support perspective.

Medical Device Product Launch Implementation & Follow Up

The implementation phase works best if you follow the processes outlined in your documentation plan:

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1. Product Adoption Objectives: Set measurable goals for achieving product adoption with customers during and after the product launch.

From your technical documentation and marketing teams, select a member who can effectively help coordinate all customer awareness, adoption, and support activities associated with the launch. Prepare a comprehensive launch plan that includes all marketing communications, product documentation, and training, as well as a budget to cover expenditures. Prioritize all critical tasks.

2. Communications Plan: Create a plan that allows everyone associated with the product launch to stay informed.

Communication is a critical part of any successful medical device product launch; too little communication causes confusion; too much communication dilutes the overall message. Communications should be well planned, developed early in the process, and shared with team members regularly.

3. Customer Documentation: Produce essential documentation to meet regulations and support customer needs.

Make sure the launch team has evaluated product performance in line with market requirements and compliance with all relevant FDA regulations. Complete the development of product documentation and run a test implementation before the launch. Ask selected distributors to stock the product and run a sample promotional campaign. Evaluate test results and feedback, and make any necessary adjustments to the medical device product launch program.

4. Personnel Training Programs: Conduct training for sales representatives, installers, service technicians, and customer support teams.

To make your new product easily adoptable and efficient for customers, it's critical that your company is thoroughly prepared to assist customers at all points of interaction. Provide comprehensive medical device training and sales guides, service manuals, troubleshooting guides, and quick-reference guides to follow up the training. Hold an internal product launch event to build enthusiasm and commitment to the new product within the company.

5. Launch Timeline and Scope: Brief the distribution network on the project timing and details.

It's important to hold training programs for your extended network of medical device dealers and distributors. Supply any promotional materials and support documentation that reinforces the benefits of the new medical device.

6. Support Infrastructure: Confirm that necessary support is in place and that spare parts are available.

The launch doesn't end once you announce your product, a plan for the sales that follow is just as critical as the initial steps of a medical device product launch. To ensure you’re prepared, check that spare parts are available and service personnel are trained and available for installation and maintenance. Verify that a help desk is in place to handle support requests and queries during the initial launch phase. Continue monitoring incoming calls and questions and consider publishing Frequently Asked Questions for customers to utilize.

7. Technical Documentation Monitoring: Set up a revision program for producing and delivering updates to documentation when necessary.

Make sure all electronic customer documentation for your new medical device is monitored and managed in compliance with the FDA’s Title 21 CFR Part 11. As regulations change and updates are made to the device, revisions should be made to technical documentation in order to reflect those changes.


Make sure you haven't missed any of the important steps in your medical device product launch. 
Download our free Product Launch Checklist for New Medical Devices


Topics: product launch, medical device launch