Krista Woodley
Founder - Craig Alan Consulting
Krista Woodley is a Digital Health and Medical Technology executive with over twenty years in the healthcare technology arena, focusing on driving digital and technology transformation initiatives for global pharma, biotechnology and medical device companies.
Most recently, Krista served as Vice President, Quality Assurance at Hillrom where she played an integral role in advancing Hillrom’s Connected Care Strategy, which included the company’s transformation to a highly integrated medical technology company, which leveraged digital solutions to enable earlier diagnosis and treatment, accelerated patient recovery, and simplified clinical communication and collaboration. She was responsible for oversight of Hillrom’s Global R&D and Sustaining Engineering product portfolio, which included both hardware and software-based products across three global business units; Patient Support Systems (smart beds, patient monitoring and lifts), Global Surgical Solutions (positioning, operating room workflow, surgical access, and digital connectivity) and Front Line Care (screening devices and diagnostic tools). She also was responsible for Hillrom’s Supplier Quality organization where she implemented supplier-based design principles to significantly reduce R&D lead times and improve overall product quality and performance.
Prior to joining Hillrom, Krista worked for Johnson and Johnson, where she established and led the company’s Digital Quality function. In this capacity she partnered with R&D, Commercial, Operations and Technology accelerate J&J’s digital capabilities such as AI/ML, digital manufacturing, robotics, and standalone digital health applications (SaMD) to improve health outcomes and optimize J&J’s drug discovery, development and commercial capabilities. Krista led several digital transformation programs within J&J’s Pharma, Medical Device and Consumer segments. This included establishing Janssen’s (J&J Pharma) Digital Health function for SaMD products, which included developing and implementing Janssen’s Legal Manufacturing Entity (LME), establishing the QMS for digital products and implementing the Digital Health Center of Excellence (CoE). In addition, she led the effort to oversee the development of Ethicon’s (J&J Medical Device) “Digital Health Enabling Platform” which hosted J&J’s digital surgery components (surgical robots, gateways, cloud infrastructure and front-end surgeon portals) which included advanced analytics to deliver powerful insights to improve the patient experience (pre, intra and post op). Finally, she co-led J&J’s participation in the FDA Precertification Pilot for Digital Health, responsible for reshaping the regulatory paradigm for SaMD products.
Before joining Johnson and Johnson, Krista worked for Biogen where she was the head of the company’s Digital Quality and Risk Management function. In this role, she was responsible for quality oversight of Biogen’s Technology solutions, including establishing Biogen’s Digital Quality Organization. She was continually recognized for delivering innovative and efficient quality practices which enabled streamlined delivery to business partners and customers, while ensuring that Biogen’s technology programs met regulatory compliance expectations.
Krista Woodley is a Digital Health and Medical Technology executive with over twenty years in the healthcare technology arena, focusing on driving digital and technology transformation initiatives for global pharma, biotechnology and medical device companies.
Most recently, Krista served as Vice President, Quality Assurance at Hillrom where she played an integral role in advancing Hillrom’s Connected Care Strategy, which included the company’s transformation to a highly integrated medical technology company. This included launching digital solutions to enable earlier diagnosis and treatment, accelerated patient recovery, and simplified clinical communication and collaboration.
Prior to joining Hillrom, Krista worked for Johnson and Johnson, where she established and led the company’s Digital Quality function. In this capacity she accelerated J&J’s digital capabilities such as AI/ML, digital manufacturing, robotics, and standalone digital health applications (SaMD) to improve health outcomes and optimize J&J’s drug discovery, development and commercial capabilities. In addition, she co-led J&J’s participation in the FDA Precertification Pilot for Digital Health, responsible for reshaping the regulatory paradigm for SaMD products.
Before joining Johnson and Johnson, Krista worked for Biogen where she headed the company’s Digital Quality and Risk Management function. In this role, she was responsible for quality oversight of Biogen’s Technology solutions, including establishing Biogen’s Digital Quality Organization. She was continually recognized for delivering innovative and efficient quality practices which enabled streamlined delivery to business partners and customers, while ensuring that Biogen’s technology programs met regulatory compliance expectations.