A Medical Device product launch is a complex process which requires a significant amount of collaboration between all company disciplines. While there are a variety of hurdles that medical device product launch teams must conquer, the primary primary challenges include: developing a great planning structure, having balanced communications, planning an implementation strategy, and follow up infrastructure.
We’ve put together 4 steps to help outline how to achieve a successful medical device product launch.
Depending on where you are in the process of developing your medical device, will ultimately determine your product launch plan and launch date timeliness. These timelines will be strictly dependent upon your pre-market submission and receiving final regulatory approval from the Food and Drug Administration (FDA). Having all of your pre-market approval details appropriately planned out and in line, is critical for your medical device product launch; as an incalculable FDA timeline for market approval, will dramatically impact overall budget requirements, staffing, and team deadlines.
To start, your product launch team should assess your current regulatory environment regarding your device development and submissions. Your team can then use this information to determine a strategy for FDA submissions and launch. The length of time that your med device team wants to give itself is dependent on the type of technology and device price point. These time frames can range anywhere from 3-18+ months depending on the complexity of your application and device.
For example, if you are developing a medical device that has a $225K price point, your potential prospects will more than likely require more time and have higher budgetary approval or grant seeking that will need to take place in order to be able to buy your device. This is when it would be a good idea to have a longer medical device product launch plan.
When dealing with variables such as lower cost, higher device acceptations, and less complexity; traditionally your product launch team could start launch activities 4-6 months prior to device availability and distribution.
When creating a comprehensive product launch plan, you want to give your project launch team enough time to look at everything from a full 360 ° angle. One of the most crucial components to this process is developing a timeline that provides a buffer and allows your team to prepare for the unexpected to happen. Make sure that all the company’s disciplines are present, engaged and always providing input to ensure that you are limiting mistakes and have everyone’s best interest for success. Your project leader will need to develop a road map or communications schedule so that each team member can effectively understand the entire project timeline, scope of work and full implementation of the medical device product launch schedule.
Your medical device product launch documentation plan is a critical part to this entire process and is a tool that will enhance your team’s productivity, while limiting documentation cost. Your team’s Technical Documentation Managers will need to be able to do the following with this plan:
The purpose of a customer-focused training plan is to both develop and establish a program that should be effectively used to train everyone on the new product. This includes: sales teams, customer service representatives and field service staff, so that they have the necessary tools to set them up for success.
This plan and documentation should be tailored to anyone that will be speaking on the behalf of the device itself. This should include anyone who will be providing training, product demos, customer support, and or service to ensure that they have a deep understanding of the product that is coming to market.
You can create the most detailed product launch plan in the world, but in order to be successful, all company disciplines must learn to come together and work in unison. From engineering and technical documentation, to marketing, sales, distribution partners and customer support; each team member of the med device product launch team plays a crucial role. In the end, the success of your medical device product launch will be measured in a variety of different ways including: your return on investment (ROI), customer adoption, market share acquired, market response, and customer satisfaction and/or overall awareness built. The more collaboration between your team members, the higher chances of success for your medical device product launch.