Digital Healthcare Track
11:20 - 11:40
Who Will Be the Next Unicorn in the Healthcare Industry?
Many healthcare startups today are eager to succeed and to become the industry’s next unicorn. What path do they take to success? What challenges are they facing and how do they overcome them? And why do we have so many fintech and cyber Unicorns but so little (none?) medical/digital healthcare?
With his extensive experience and knowledge in the healthcare software industry, Moshe Klaiman, CEO of Matrix Medika, will discuss the development, regulatory and other challenges that companies encounter on their way to FDA/CE approval and on US/EU markets. He will demonstrate how your company can maximize safety and confidence throughout the journey, including how to design and develop secure, innovative solutions, ensure rock-solid cybersecurity and privacy in compliance with HIPAA/GDPR standards, successfully manage FDA/CE submissions and deployment and support when meeting the markets and real customers.
With over 20 years of experience in development, management and R&D in the healthcare industry, Moshe founded Medika (now part of Matrix) to deliver high-end projects, systems, and domain expertise to cutting-edge medical device and digital healthcare companies. Under Moshe’s leadership, Medika has made a name for itself by taking on the regulation, cybersecurity, and development challenges unique to the industry.
11:40 - 12:00
Artificial Intelligence in the EU – A Regulatory and Legal Perspective
While AI can help improve patient care and the development and operations of products and services across the health care space, at the same time, this technology raises a variety of unprecedented regulatory and legal questions. In this session, we’ll discuss whether or not new legal strategies are required to harness opportunities or mitigate risks associated with AI. We'll also touch on the policy changes at the EU that would need to happen to lay a solid groundwork for this technology to develop while continuing to impose reasonable controls to appropriately balance the risks that come with the technology. Attendees will leave this session with a practical toolkit to help navigate some of the key legal issues associated with AI in the EU.
Fabien Roy advices clients on European Union (EU) and national regulatory matters involving medical devices and pharmaceutical laws and guidelines. Fabien focuses particularly on guiding clients through the regulatory and technical regulatory requirements applicable to the CE marking of medical devices. He assists clients in addressing a range of complex issues during clinical investigation procedures, conformity assessments, registration procedures, and post-market activities. He is also a qualified lead auditor for ISO 13485 quality management systems.
Dr. Ella Sheiman
RA/QA Project Manager
12:00 - 12:20
Digital Health - Innovative Technologies Under the Regulatory Requirements of Medical Devices
Digital health, or digital healthcare, is a broad, multidisciplinary concept that includes concepts from an intersection between technology and healthcare. Digital health applies digital transformation to the healthcare field, incorporating software, hardware and services. While software-based medical devices products are currently controlled via medical device regulation, they differ significantly from traditional medical devices requiring a more streamlined and efficient regulatory oversight.
In this short session we will present interesting innovative digital health technologies cases and follow their path to the marketing authorization through the current regulatory landscape for Digital Health in Europe and US. Based on those case studies we will also address the importance of establishing regulatory strategy in early stages as part of the business plan.
Dr. Sheiman is a Doctor of Veterinary Medicine with an experience in Medical Devices regulation and QA of more than 10 years. Her experience covers establishment and maintenance of Quality Management Systems and around the globe regulatory submissions for a wide range of device, ranging from devices with minimal regulatory requirements to complicated monitoring devices with profound regulatory requirements. Today her main point of interest and expertise is the Digital Health field.
Head of Digital Services
12:20 - 12:40
The Life Cycle of a Winning Medical Device Solution
Developing a medical device or SaMD solution is not like any other application development.
The life cycle from the idea to a working platform goes through unique proceeds. Aspect related to regulatory, customer behavior and app development can dramatically influence the approach to such solutions.
Going through the right process will enable fast go to market, compliance and ability to grow and change.
Rami Gur manages the digital services at Matrix and Matrix Health.
Rami leads the digital strategic team at Matrix and leads teams focusing on customer experience, marketing and development all in an agile approach.
In the last 20 years Rami had deferent roles including CTO and CEO of startups, Techno- Business leader of the technology division at Matrix and vast experience in the Health arena from the major health organization to homecare startups and more.
12:40 - 13:00
Painful Engagement - 5 Steps to Creating Engaging Digital Experiences Even If It Hurts
In our talk, we will present best practices that we at Zemingo use in order to translate product requirements and functionalities into an engaging digital flow - a series of screens that drive users, patients, or doctors successfully through medical and wellbeing processes. We will share the experience, knowledge, and insights we've accumulated while designing & developing award-winning digital products like Theranica's Nerivio, Voiceitt, Tempdrop, and more.
Robert is the CEO of Zemingo, an Israel\NY-based Digital Product Agency that specializes in creating digital products & services for corporates & tech companies. Robert's expertise is in building digital processes and products that drive digital transformation for organizations with a focus on business success. Robert has over 15 years of experience in the tech industry and held senior business and engineering positions in various organizations. Robert holds a Master's degree in Economics from Bar-Ilan University and B.Sc in Computer and Software Engineering from the Technion.
13:00 - 14:00 : Lunch, Exhibit Viewing
14:00 - 14:20
Your Solution is on FHIR®
(FHIR is the Future of Interoperability and Application Development in Healthcare)
HL7 FHIR® (Fast Healthcare Interoperability Resources) closes the gap between the explosion of healthcare data and our ability to make that data accessible, computable, and usable to improve outcomes.
FHIR allows us to access exactly the information needed to improve decisions and outcomes across the health and care continuum.
In this lecture we will discuss this new emerging standard at a high-level, and review how InterSystems could help you in your journey adopting this standard.
Tani (Netanel) Frankel
Senior Sales Engineer