All products are different, but those in the MedTech industry, in particular, come with some unique challenges and associated costs. Regardless of the size of your company, from startup to large corporation, ensuring efficient time-to-market in this competitive and highly regulated industry can be difficult.
In response, we decided to follow our recent supply chain blog series with one focused exclusively on MedTech. For the next several months, through the contributions of industry experts within the PRG group, we will be exploring this unique market and how you can drive success for your MedTech product. Some areas of focus we will explore include:
1. Understanding the market for your product
◦ Market assessment and go-to-market strategy
◦ Creating your competitive advantage
2. Getting funded
◦ Making the business case
◦ Creating a funding strategy
3. Product development
◦ Product requirements and strategy
◦ Creating and executing the product plan
◦ Electrical and Mechanical design considerations
◦ Verification and Validation (V&V)
◦ Design controls and outputs
4. Regulatory strategy
◦ Regulatory landscape and strategy
◦ Submissions pathway
◦ Navigating communications with the FDA
5. Quality management systems
◦ Importance of QMS
◦ QMS through the stages of product development
6. Manufacturing and distribution
◦ Developing a strategy
◦ Selecting a manufacturer
◦ Setting up the factory
We are excited to take you through this blog series and share insights with you.
As a firm committed to accelerating your MedTech products to market, while meeting quality and regulatory requirements, we offer multiple solutions to help you succeed. These services and capabilities include access to a group of trusted hands-on professionals with expertise commercializing products for a broad spectrum of medical applications, such as monitoring equipment, medical robotics, surgical devices, imaging and wearable devices.
Working with you, we can help you meet aggressive development schedules, set up the right supply chain for your product, provide guidance around adhering to regulatory requirements, and optimize processes to meet cost and production goals.
To learn more please contact us today.