2018 MedTech Conference
MDIC will be attending the 2018 MedTech conference in Philadelphia, PA this year.
Visit our booth #650, near the CEOs Unplugged Stage.
Exhibit Hall hours:
- Sept. 25 9:00 am – 7:00 pm
- Sept. 26 8:00 am – 12:30 pm
Interested in meeting with us to discuss membership while attending the conference? Send an email to firstname.lastname@example.org and we’ll set up a time to speak.
FDA and Industry Outside the Regulatory Box
The medical technology industry continues to evolve at a rapid pace. New technologies such as digital health and 3-D printing, taken with FDA’s growing focus on firms’ quality culture, require new regulatory approaches. In response, FDA has launched a set of innovative programs that break from conventional medical device review and oversight. These programs offer the promise of streamlined approaches that promote the introduction, improvement, and distribution of devices from manufacturers that know and show strong quality practices. This session will highlight these FDA programs and consider how they might progress from pilots to permanent initiatives, and how FDA will develop new approaches to support innovation and good quality practice.
- Stephanie Christopher, Program Director, CfQ & SPI, Medical Device Innovation Consortium (MDIC) (Speaker)
- Diane Johnson, Johnson & Johnson (Speaker)
- Bakul Patel, Associate Director for Digital Health, FDA (Speaker)
- Francisco Vicenty Program Manager, Case for Quality, USFDA/CDRH/Office of Compliance (Speaker)
View the complete list of panelists here.
Advances in Leveraging Real-World Evidence (RWE) through NESTcc Test-Cases
NESTcc is working to accelerate the development and translation of new and safe health technologies, leveraging Real World Evidence (RWE), and innovative research. Guided by this mission, NESTcc launched its test-case initiative in 2018 to answer industry questions, test the capabilities of its Data Network, and identify where NESTcc can reduce transaction costs. To achieve these goals, NESTcc has matched test-case projects to its initial set of 11 Network Collaborators committed to advancing the use of high-quality Real-World Data (RWD) from various sources, including electronic health records (EHRs), pharmacies, public and private claims, registries, and patient-generated data. Responding to questions submitted by industry partners, Network Collaborators will determine their ability to capture data needed to support a range of studies and analysis.
- Jeff Shuren, Director, FDA, CDRH, U.S. (Speaker)
- Rachael Fleurence, Executive Director, National Evaluation System for Health Technology Coordinating Center (Moderator)