Invent Healthcare is a series about healthcare to help entrepreneurs navigate the transformation of healthcare and unleash the positive impact of innovation. The series provides tips and tools to starting a business, healthcare regulations, medical research, and answers other questions you may have about entrepreneurship, medicine, and healthcare.

Invent Healthcare is rooted in the belief that innovation in healthcare must be able to retrofit the past while building a bridge to the future. The foundation of health care startup needs to be a commitment to establishing trust with industry and academia working together to improve peoples' lives.

Factors for Benefit Risk Determination in Medical Device Premarket Approval De Novo Classification
1:21:42
Factors for Benefit Risk Determination in Medical Device Premarket Approval De Novo Classification
Webinar: Digital Health Approach by FDA
1:14:43
Webinar: Digital Health Approach by FDA
Webinar: Medical Devices in the Home: Design Considerations and FDA Guidance
41:06
Webinar: Medical Devices in the Home: Design Considerations and FDA Guidance
Regulatory Overview for Developers & Sponsors of Neurological Devices Premarket PMA Approval Part 2
1:02:48
Regulatory Overview for Developers & Sponsors of Neurological Devices Premarket PMA Approval Part 2
Regulatory Overview for Developer & Sponsor of Neurological Device to Starting Human Studies Part 1
1:12:01
Regulatory Overview for Developer & Sponsor of Neurological Device to Starting Human Studies Part 1
Webinar: Medical Devices Cybersecurity in 510(k) Premarket Submissions
1:22:14
Webinar: Medical Devices Cybersecurity in 510(k) Premarket Submissions
Webinar: What is CDRH Regulated Software: An Introduction
38:33
Webinar: What is CDRH Regulated Software: An Introduction
Webinar: Self Monitoring Glucose System for Over-the-Counter OTC Use and Point of Care Use
1:02:37
Webinar: Self Monitoring Glucose System for Over-the-Counter OTC Use and Point of Care Use
Webinar: Introduction to Good Clinical Practice (GCP) for Clinical Trials
28:39
Webinar: Introduction to Good Clinical Practice (GCP) for Clinical Trials
Case Study: FDA Regulatory Responsibilities for Color Additives 510(k) Premarket Notification
1:22:49
Case Study: FDA Regulatory Responsibilities for Color Additives 510(k) Premarket Notification
Case Study: FDA Regulatory Responsibilities for Medical Gown 510(k) Premarket Notification
1:02:33
Case Study: FDA Regulatory Responsibilities for Medical Gown 510(k) Premarket Notification
Introduction to FDA Office of Orphan Product Development and Rare Diseases
18:32
Introduction to FDA Office of Orphan Product Development and Rare Diseases
US FDA Resources for Standards Program and Standards Development Organization (SDO)
14:26
US FDA Resources for Standards Program and Standards Development Organization (SDO)
US FDA Standards Overview
22:18
US FDA Standards Overview
CDRH Standards Recognition Process
9:27
CDRH Standards Recognition Process
Webinar: Principles for Co-development of In-Vitro Companion Diagnostic Device w Therapeutic Product
1:07:27
Webinar: Principles for Co-development of In-Vitro Companion Diagnostic Device w Therapeutic Product
US FDA Medical Device Home Use Initiative
23:50
US FDA Medical Device Home Use Initiative
Webinar: Applying Human Factors and Usability Engineering to Medical Devices
1:27:09
Webinar: Applying Human Factors and Usability Engineering to Medical Devices
Digital Health Software Precertification (PreCert) Pilot Program
1:10:37
Digital Health Software Precertification (PreCert) Pilot Program
General Wellness Policy for Low Risk Devices
58:11
General Wellness Policy for Low Risk Devices
Webinar: Introduction to FDA Unique Device Identification (UDI) Requirements Part II
2:00:07
Webinar: Introduction to FDA Unique Device Identification (UDI) Requirements Part II
Webinar: Premarket Approval Application for Automated External Defibrillator (AED) Overview
28:51
Webinar: Premarket Approval Application for Automated External Defibrillator (AED) Overview
Webinar: Promoting Patient Safety with Home Use Devices
22:00
Webinar: Promoting Patient Safety with Home Use Devices
Webinar: Custom Device Exemption Overview
47:04
Webinar: Custom Device Exemption Overview
Webinar: Management of Cybersecurity for Medical Devices after Approval
1:27:06
Webinar: Management of Cybersecurity for Medical Devices after Approval
Webinar: Introduction to FDA Home Use Medical Device Initiative
12:33
Webinar: Introduction to FDA Home Use Medical Device Initiative
Webinar: Sterility Information in Premarket Notification (510k) Submissions for Medical Device
52:43
Webinar: Sterility Information in Premarket Notification (510k) Submissions for Medical Device
Webinar: FDA Unique Device Identification (UDI) Requirements
1:56:59
Webinar: FDA Unique Device Identification (UDI) Requirements
Webinar: Purchasing Controls and Process Validation for Supply Chain Management
2:00:41
Webinar: Purchasing Controls and Process Validation for Supply Chain Management
Webinar: Quality System Management Controls and Design Controls
2:02:38
Webinar: Quality System Management Controls and Design Controls