Design Practices Track
Moderator: Kobi Blank, CTO, Agada Medical
Yoel Ezra
CEO & Founder
EfA-Engineering for All
11:20 - 11:40
Design Practices: System Approach and Inhouse/Outsourcing Balance - Lessons Learned
​Design Practices: A Systems Approach – From military technology to medical devices, explores system and business trade-offs, in-house vs. outsourcing decisions, and key lessons learned to drive innovation and execution in complex, high-risk industries.
BIO:
Yoel Ezra, with over 30 years of experience in executive roles within high-end defense technologies and Class III medical devices, founded EFA-Engineering for All with a vision to make healthcare accessible everywhere
11:40 - 12:00
Kobi Blank
CTO
Agada Medical
Review and share insights on project management and product development, with a focus on enhancing team dynamics by understanding and improving human behavior among all stakeholders, including developers, customers, suppliers, and other project participants
BIO:
Kobi Blank, CTO of Agada Medical, brings 24 years of expertise in multidisciplinary medical device R&D and engineering. He is leading the development of a groundbreaking AI tool for spine surgery planning. The technology uses automatic segmentation, dynamic simulations, and ML & AI tools for predicting surgery outcomes. As the founder of Blank Innovations, an R&D service company, Kobi has led the development of a diverse range of products, including active implants, stimulators, delivery systems, and imaging technologies. He is the author of issued patents and pending patent applications. Kobi holds a B.Sc. in Mechanical Engineering from Tel Aviv University and an MSM from NYU, with additional training in anatomy and physiology.
Jose (Yossi) Chvaicer
SME on Process Validation and Quantitative Methods
Gsap
12:00 - 12:20
The Benefits Of Test Method Validation On The Production Floor
Test Method Validation (TMV) is a critical process in the Medical Device industry, ensuring valid results when testing and inspections are performed under work instructions. It plays a crucial role in the design phase of a product as well as later on maintaining the quality of products, safeguarding patient safety while complying with regulatory requirements. Some industries refer to it as Gage R&R. This presentation reveals how TMV is carried on, sources of hidden measurement errors at a real-life case study, the advantages of having a reliable data collection and why you should care about validating the measurement system
BIO:
Jose (Yossi) Chvaicer is an expert in Process Validation and Quantitative Methods for the Medical Device Industry. Yossi holds a M.Sc. Industrial Engineer degree, GB Six-Sigma and B.Sc. Mechanical Engineer. As a SME Senior Project Manager in GSAP, Yossi has extensive Engineering, Managing and Validation practices at the Medical Device and Pharmaceutical industries, including worldwide FAT's, IQ's, OQ's and PQ's, Process Validation and Management also at the Chemical, Biotechnology, FoodTec and Software Industry. Most recently Yossi has received a certificate of Biomedical Data Analyst. His achievements are based on several projects in Israel, Canada, Ireland, and the USA.
Dr. Emmanuel Loeb
Certified Veterinary Pathologist, CEO and Founder
Patho-Logica
12:20 - 12:40
Advanced Laser-Based Technology for the Preparation of Biological Tissues and Materials in Plastic Embedded Sections for a Histopathological Evaluation
Plastic embedding was originally designed for bone histology, to avoid the decalcification process and later it was adjusted to solid and implanted medical device research.
The analysis of the interaction of invasive medical device with the surrounding tissues in animal models is crucial for safety and efficacy evaluation of the invasive device. Patho-Logica is presenting a novel Laser based technology for these plastic embedded samples that result in a high histological images compared to the classical ground sections and permit an accurate histopathological evaluation of the device within the surrounding tissue. We will describe the technical process of the laser microtome and provide some comparative images of this novel technique compared to the classical method.
BIO:
Dr. Emmanuel (Mano) Loeb is a graduate of The School of Veterinary Medicine, Utrecht University, The Netherlands, and a qualified expert (IL Diploma) veterinary pathologist with published papers. He has 20 years of experience in experimental pathology. He participates in annual professional meetings such as the ESVP and follows The Society of Toxicologic Pathology (STP) recommendations. He has established new methods such as “modified free floating sections” for immunofluorescence staining, and has developed translational tools from pathological hallmarks to histological endpoints. Dr. Loeb is also teaching pathology at the Veterinary school of Koret (Hebrew University).
Aviad Yedgar
General Manager Israel
S4 Medical
12:40 - 13:00
S4 Medical – Lessons Learned in Transferring and Scaling a New Medical Device for Production
An insightful presentation focusing on the principles and methodologies of design practice and transfer to production of medical device using partnership with turn-key suppliers. Aviad Yedger will share practical examples and best practices that drive innovation and efficiency in a lean, fast track, transfer to production of new medical devices.
BIO:
Aviad Yedgar is the General Manager S4 Medical of the Israeli site, in charge of development, engineering and production, with extensive experience in the design and development of innovative medical devices. His expertise lies in bridging cutting-edge design practices with quality, engineering and production aspects.
13:00 - 14:00 : Lunch, Exhibition Visit
14:00 - 14:20
User Experience in Medical Devices: Combining Smart Design with Regulatory Requirements
Regulatory requirements for the usability of medical devices, driven by constantly evolving guidance documents, provide critical safety nets aimed to ensure the development of devices that are safe and effective for use. Understanding and incorporating the methods outlined by these requirements early in the product design process is essential for any successful medical device development process.
This talk will explore how embedding regulatory requirements into every stage of the product / user interface design and correctly applying the human factors engineering process, ensures compliance, reduces risks, and aligns with changing standards. Drawing from extensive industry experience, I will highlight how proactively aligning design strategies with these requirements can streamline and support the development of devices that meet both user and regulatory demands.
BIO:
Gal is a Senior Usability Researcher with Cognit, and a leading member of Cognit's usability team. Gal conducts and supervises the design and execution of complex user research and usability studies for medical devices and provides strategic input for usability regulatory processes across a wide array of projects. Leveraging her strong multidisciplinary background and an in-depth knowledge of human factors methodology, Gal helps create safer and more effective user interfaces for the end user.
Gal holds an M.A. in cognitive science with computational emphasis and a Ph.D. in cognitive psychology and neuroscience, specializing in the neural and behavioral mechanisms underlying decision-making, both from Ben Gurion University.
Gal Nir-Cohen, PhD
Senior Usability Researcher
Cognit
14:20 - 14:40
Software Development Lifecycle in Medical Device
Haim Eliyahu
CEO and Validation & Quality Assurance Expert
HCE Med
Compliance with standards like IEC 62304, FDA guidelines, and EU MDR is a complex but essential task. In this brief 20-minute session, I will highlight the critical aspects of the software development lifecycle (SDLC) tailored for medical device companies.
The lecture will focus on the challenges companies face in meeting regulatory requirements and how leveraging expert guidance can streamline the process.
BIO:
With over a decade of experience in the medical device and pharmaceutical industries, Haim specializes in end-to-end product lifecycle management, ensuring compliance with international standards such as FDA, EU MDR, and ISO 13485. Haim`s expertise spans process validation, software and cmputerized system validation (IEC 62304), clean room qualification and test method validation, including projects for FDA and CE-marked devices. As a leader in quality and validation consulting, Haim delivered public lectures and training on medical device software validation and process validation, including at past MDI conferences. His work emphasizes bridging technical excellence with regulatory compliance to support innovative healthcare solutions.
14:40 - 15:00
Envisioning the Future: Integrating Mass Production Insights During the Prototyping Stage
Shlomi Even
COO
DielTech
Envisioning the Future: Integrating Mass Production Insights During the Prototyping Stage" explores the importance of incorporating mass production considerations early in the product development process. This presentation highlights how integrating insights from manufacturing at the prototyping stage can lead to more efficient, cost-effective, and scalable products. By aligning prototype designs with mass production capabilities from the outset, companies can reduce production challenges, minimize costs, and streamline the path to market success.
BIO:
Shlomi Even – Industrial and Management Engineer
For the past six years, I have been guiding dozens of startups at various stages in the Adhere to Skin and Adhere to Device application fields, from design to solution.
An expert in Scale-Up, I specialize in transitioning initial production to large-scale industrial manufacturing for global companies.
I lead teams and processes with a true passion for the field!
15:00 - 15:20
Everything You Wanted to Know About Cost Reduction Overseas
Eng. On Golan
Founder & CEO
4MODEL
BIO:
The 4MODEL company was established in 2012 by the engineer On Golan (specialist in mechanical engineering with rich experience in the field of production)
Our company was founded out of a need to optimize production processes, unify various technologies and production methods in one factory, thus saving our customers money and valuable production time.
15:20 - 15:40
Use of Real-Time AI in Robotic Surgery
Erez Lampert
CEO
PathKeeper Surgical
Artificial intelligence (AI) has been progressively transforming various sectors of healthcare, notably in diagnostics such as radiology and pathology. However, its integration into the operating room has been limited. PathKeeper Surgical is among the pioneers in applying AI directly during surgical procedures, enhancing precision and outcomes in real-time
BIO:
Erez Lampert is a distinguished expert in 3D medical imaging with over two decades of experience leading R&D projects in the healthcare and aerospace industries. He notably spearheaded the development of the iTero Element Intraoral Scanner, a leading 3D dental scanner globally.
Erez holds a B.Sc and M.Sc in Electrical Engineering, specializing in AI, a B.A in Mathematics, and an MBA, all with honors from top Israeli universities. He has also published several patents in the field of 3D cameras for medical applications.
In 2018, Erez founded PathKeeper Surgical, an Israeli-based startup company that has developed a cutting-edge 3D optical spine navigation system. This system is based on an IR Laser 3D camera supported by AI software, enabling a radiation-free, real-time anatomical tracking spine navigation solution.