Digital Healthcare Track
Moderator: Moshe Klaiman, CEO, Matrix Medika
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- The Way You Never Looked at it
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.
Yael Meitar Ray
Senior Solutions Architect
12:20 - 12:40
The Life Cycle of a Winning Medical 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.
Yael Meitar Ray is a Senior Solutions Architect at Matrix and Matrix Healthcare.
Yael leads processes planning and executing solutions-based projects, leading professional teams working to enable the best solution for Matrix's Customers, with a specific focus on finance and healthcare industries, and In the last almost-2-years(!) had the privilege to lead and assist with COVID-19 related projects.
In the last 20+ years Yael had different roles including Department Manager - leading professional teams, CEO and Co-Founder a computer-solutions company and for the last 10 years as a Senior Solution Architect at Matrix.
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.
A 20+ year veteran of enterprise IT technologies, Frankel has a vast expertise in a range of categories.
From relational, object and document databases, thru interoperability platforms and microservices, dealing with healthcare protocols and formats, and building analytics and machine learning projects - he has deep knowledge and valuable insights in these domains.
Frankel works daily with independent software vendors building enterprise solutions, as well as startups innovating breakthrough technologies, in addition to working closely with large organizations (healthcare providers and others), to help them address their critical challenges.
Prior to his current role as Senior Sales Engineer at InterSystems, Frankel was an instructor for several courses including learning Operating Systems and programming.
Tani (Netanel) Frankel
Senior Sales Engineer
14:20 - 14:40
Navigating Key Legal Issues to Establish a Successful Digital Health Business in the EU and UK
Entering new markets is a hazard map of legal issues to negotiate. This is a whirlwind tour of the major points to be mindful of when setting up your successful digital health business selling across Europe
Adrian immerses himself in his client’s technology, product roadmap and patent/IP strategy. He is involved in the negotiation and drafting of technology licence agreements and other contracts with a heavy IP element, such as R&D collaborations, joint ventures, grant funding agreements and other commercial arrangements. He also advises on the EC and UK competition law aspects of these agreements, and issues relating to technical standardisation, essential IPR and patent pooling.
14:40 - 15:00
Success Stories in Medical Device Innovation
MEDX Xelerator is a leading medical device incubator partnered with Boston Scientific, MEDX Ventures Group, Consensus Business Group (CBG) and Sheba Medical Center. MEDX leverages the healthcare expertise and industry experience of its team with the industry leading insights of its partners to nurture its portfolio companies into successful medical ventures for the benefit of patients and health care professionals. MEDX’s first cohort of portfolio companies achieved remarkable results:
CAPS Medical completed $3.5 million series A round for selective cancer treatment technology. The round will enable CAPS Medical to perform its first clinical trial and assist the company in further developing its portfolio for treatments of solid tumors.
EndoWays LTD, developer of the first Disposable Robot for the Cathlab, was acquired by Ascendum. The deal will provide EndoWays with access to the vast experience and network of the Ascendum team, helping accelerate its clinical and commercial development, especially in China.
Append Medical successfully completes first ever transcatheter implant-free Left Atrial Appendage (LAA) exclusion procedures. Append closed a $7.4 million Series A to help with its first clinical trial.
In this lecture CEO, Shai Policker, brings their stories.
In the last 20 years, Shai Policker has been leading development, clinical validation and commercialization of innovative medical devices for various indications such as heart failure (Impulse Dynamics), metabolic (MetaCure) and GI diseases (EndoStim). Shai holds an Electrical Engineering degree from the Technion, Israel Institute of technology and an MBA from Columbia University. He is an inventor of 40 issued patents.
15:00 - 15:20
The Secret Sauce of Internal Innovation in Healthcare
How do you lead innovation inside organizations that are designed for efficiency? How do you manage the risk and uncertainty when you are expected to bring results in a predictable and repeatable way? And how does the ecosystem fit in to this picture anyway? The answers to these questions and many more – in this talk about the power of internal innovation.
Shachaf is married to Naama and father to Amit and Karni - his biggest achievement so far.
Shachaf is also an Innovation professional with more than a decade of experience in designing innovative organizations, working in companies such as Amdocs and Bank Hapoalim, as well as working as an innovation consultant for many other firms.
Today Shachaf is leading the internal innovation unit at Clalit Health Services, which is the biggest provider of health services in Israel.
Director of Internal Innovation
15:20 - 15:40
Digital Healthcare Product Story – from A to FDA
Omer Maman is a Marketing and Product Executive with experience at big corporations as-well-as innovative start-ups.
At Nonagon, Omer has established the foundations of product characterization, marketing strategy, GTM all from scratch.
Prior to Nonagon, Omer served as director of products and head of laser hair removal BU at Lumenis where he held direct responsibility for the products and strategic marketing management, KOL relationships, global portfolio positioning, go-to-market strategy, R&D plans, launches, PR and more.
Previously, Omer also served as a director of product and engineering at Motorika Medical and had engineering and project management roles at ReWalk Robotics.
Omer holds a BSc. in industrial engineering from the Technion and an EMBA from Haifa University.
VP Marketing & Products