A medical device launch represents a significant revenue investment and profit opportunity for a company. Launching a new medical device can yield new markets, bring new customers, and increase business with existing customers.
Contiem is well-versed in medical device launches, and we have the technical content expertise you need to be efficient and successful. From documentation to marketing strategy, we share insights on ensuring medical device launch success.
The top four documentation challenges a new medical device launch team faces include planning, communications, implementation, and follow-up. This post focuses on the implementation and follow-up aspects associated with a new medical device launch from a customer support perspective.
Medical Device Launch Implementation & Follow Up
The implementation phase works best if you follow the processes outlined in your documentation plan:
1. Product Adoption Objectives: Set measurable goals for achieving product adoption with customers during and after the launch.
Select someone from your team 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, training, and budget to cover expenditures. Prioritize all critical tasks.
2. Communications Plan: Create a plan that allows everyone associated with the medical device launch to stay informed.
Communication is a critical part of any successful medical device launch. Too little communication causes confusion; too much communication dilutes the overall message. All launch 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 the medical device’s performance in line with market requirements and compliance with all relevant FDA regulations. Complete the medical device documentation development and run a test implementation before the launch. Ask selected distributors to stock the medical device and run a sample promotional campaign. Evaluate test results, and customer feedback then make any necessary adjustments to the launch program.
4. Personnel Training Programs: Conduct training for sales representatives, installers, service technicians, and customer support teams.
It is critical that your company is thoroughly prepared to assist customers at all points of interaction to make your new medical device easily adaptable and efficient for customers. Provide comprehensive training materials, sales guides, user manuals, service manuals, troubleshooting guides, and quick-reference guides to follow up on the training. Hold an internal launch event to build enthusiasm and commitment to the new medical device 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 new medical device. A plan for the sales that follow is just as critical as the initial steps. To ensure you’re prepared, check that spare parts are available and that service personnel is 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 FAQs (Frequently Asked Questions) for customers to reference when needed.
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 FDA Title 21 CFR Part 11. As regulations change and updates are made to the device, revisions should be made to the documentation in order to reflect those changes.