The World's Leading Event for Medical Device Software Design and Development
13-15 September, 2022
|Crowne Plaza Frankfurt - Congress Hotel
Conference Day Two
8:30 am - 9:00 am
REGISTRATION & REFRESHMENTS
9:00 am - 9:05 am
CHAIRPERSON’S DAY TWO OPENING COMMENTS
9:05 am - 9:45 am
TACKLING THE CHALLENGE OF IMPLEMENTING ARTIFICIAL INTELLIGENCE INTO EXISTING SYSTEMS
Taig Mac Carthy -
COO & Co-Founder,
Legit.Health
9:45 am - 10:25 am
EVALUATING THE SOFTWARE DEVELOPMENT METHODOLOGIES THAT ENABLE YOU TO BALANCE SPEED, EFFICIENCY, COMPLIANCE AND CLINICAL PERFORMANCE
Patrick Alff -
Founder,
Ezthera
Ezthera offers a range of specialised CTO-led services focused on state-of-the-art digital health technologies, with a focus on Digital Theraputics and Software as a Medical Device and bringing together R&D, software engineering, clinical teams, regulatory and quality management.
- Understanding the need to industrialise software development and engineering to effectively bring your medical software to the market
- Discussing the methodologies to speed up achieving compliance with standards including ISO13485 and IC62304
- Building development models that successfully integrate clinical input at an early stage to better define algorithms from the beginning of the process
10:25 am - 11:00 am
NETWORKING & MORNING REFRESHMENTS
11:00 am - 12:20 pm
UTILISING PROCESS MINING TO DRIVE CONTINUOUS IMPROVEMENT FOR SOFTWARE DEVELOPMENT
Jan Van Moll -
Advanced Development Global Lead for Quality & Regulatory,
Philips
Muthuvelan (Muthu) Varadharajulu - Senior Manager & Master Black Belt, Quality & Regulatory – Magnetic Resonance Imaging, Phillips
Jan has worked at Phillips for over eleven years, and he is currently responsible for leading the transformation of the Quality & Regulatory functions towards enhanced, leaner, innovative, and analytical approaches to product quality. Phillips has a long history in the healthcare industry and today has over 450 products and services.
- Exploring the gaps that the typical approaches to customer feedback and complaints create
- Adopting a process mining methodology to utilise feedback on both soft and hard reliability issues and drive continuous improvement of your medical device software
- Ensuring that there are mechanisms in place to complete the feedback loop between QA/RA and software development
Muthuvelan (Muthu) Varadharajulu
Senior Manager & Master Black Belt, Quality & Regulatory – Magnetic Resonance ImagingPhillips
12:20 pm - 1:20 pm
NETWORKING LUNCH
1:20 pm - 2:00 pm
EXPLORING THE DEVELOPMENT JOURNEY OF A NEW REMOTE PATIENT MONITORING APP: FROM UNMET NEED TO THERAPEUTIC BENEFIT
Marek Vosecký -
Innovator & Founder,
CF Hero
CF Hero is an innovative app that has been developed to promote better health outcomes for teenage Cystic Fibrosis patients. CF Hero are on the journey to demonstrate the therapy adherence and clinical outcomes when their app is utilised. This presentation will explore the personal reasons for establishing CF Hero and the clinical need that the product aims to fulfil, whilst discussing the development of the app and plans for future development.
· Outlining the goals of the CF Hero app and the medical need that it aims to meet
· Discussing the development process and working with clinicians and HCPs
· Considering the user experience and how this influences the use of the product
· Evaluating the potential steps to validate CF Hero as a medical device
