Below are the top three questions we hear in the first phase of a new product lifecycle: Planning. Since the purpose of a product launch is to build sales momentum, planning the product launch is critical to sales success.
FAQs for Planning a Medical Device Product Launch
1. What is a realistic timeframe for launching a new product?While external benchmarks are appealing, only one thing is consistent among all the product launches we've seen: the new product launch process is a marathon.
Medical device companies must plan time for research, design, prototyping, testing, multiple redesign and retesting cycles, possible clinical trials, FDA submission preparation (which can take upwards of 180 days), verification and validation, marketing review and redesign, and regulatory review. Therefore, product launch timeframes vary depending on the type of product, classification, and complexity.
Novatek often recommends researching similar classified medical devices for benchmarks or reaching out to peers for anecdotal evidence. LinkedIn discussions can provide some of the fastest and most beneficial feedback.
2. When should we start the technical documentation so it is ready to launch with the product?
Depending on the type, technical documents may be produced to meet the FDA's minimum requirements in the Code of Federal Regulations. Novatek's technical writers consider 3 main types of technical documentation:
- Design controls and the Design History File (DHF)
- Labeling and Instructions for Use (IFUs)
- Quality management system (QMS) documentation
As soon as senior management makes the research effort a formal project with budgeting details, the DHF technical writing efforts should begin. These efforts will continue throughout product design and development to document that the product was developed according to the approved design plan and the FDA's design control requirements.
We recommend planning the development of labeling and Instructions for Use in the design plan for the device. By doing this, insights from the technical writers about user safety and ease of use can be factored into the product design. This increases overall usability and reduces the number of design iterations in the future.
If your company doesn't have the in-house talent or experience to write the IFUs, learn about Novatek's IFU Template. Our technical writing team can help you stay on budget with the do-it-yourself template.
QMS documentation must accurately define your procedures for developing the medical device and describe how your processes interact. To maintain an organized development process, it's best to document QMS procedures when a new activity is being defined. Documenting early can help ensure compliance and efficiency.
3. How much of the customer IFUs can we begin writing while the product is in development without having to revise the manual?
Customer documentation, including Instructions for Use, should start with an audience analysis and task analysis to ensure the information collected will meet the needs of the user. We recommend starting these activities after research and prototype.
After necessary procedures are identified in the task analysis and put into a content outline, documentation is most productive when the functions of the product are stable. Novatek's technical writers often adopt a "waterfall" approach, documenting procedures in groups as components are developed or software functions are established. Developing a thorough task analysis makes it easy to identify which procedures support the same components or functions and can be grouped together for writing efforts.
To learn more about making each product launch phase a success…