Integrating Real-World Evidence (RWE) into your Medical Device Commercialization Strategy
Medical device regulators around the world have been emphasizing the uses of Real-World Evidence (RWE) to support safety and effectiveness. Real-world evidence can improve your device’s safety and effectiveness, be leveraged for future regulatory submissions, and can be used to improve your market positioning, clinical claims, and payer acceptance.
When should I start collecting real-world evidence?
If you are a manufacturer developing a medical device commercialization strategy, we highly recommend collecting real world data (RWD) to generate real-world evidence and starting as early as possible. This includes collecting and recording pertinent information on the use of your device during prototype testing, clinical trials, and any other development activities that involve real-world users.
Integrate real-world evidence into your development planning
Planning and generating real-world evidence requires multi-stakeholder engagement and a process to establish what real-world data needs to be collected, how it will be shared, and how it will be used to inform decision-making.
As you develop your plan for generating real-world evidence we recommend considering the following steps:
1- Define the claims you would like to make and determine what kind of real-world data would support these claims. If you are working with a reimbursement consultant / payer you can include them in this process.
2- Develop a strategy to collect real-world data from your customers so it’s of high quality and meets health data privacy requirements.
3- Set up a controlled database / data management system to store and manage the data you collect so it remains traceable, and meets privacy requirements, and can be leveraged to support your claims.
Being systematic and organized will be key.
PASB MedTech Solutions can help you develop a plan to incorporate RWE into your medical device commercialization strategy. Contact us today!