The World's Leading Event for Medical Device Software Design and Development
13-15 September, 2022
|Crowne Plaza Frankfurt - Congress Hotel
Conference Day One
8:30 am - 9:00 am
REGISTRATION & REFRESHMENTS
9:00 am - 9:10 am
PHARMA IQ WELCOME
9:10 am - 9:50 am
OPENING PANEL DISCUSSION: EVALUATING THE RAPID GROWTH AND DEVELOPMENT OF THE MEDICAL DEVICES INDUSTRY
John Mulcahy -
VP Product,
S3ConnectedHealth
Patrick Alff - Founder, Ezthera
Harsh Jain - Product Quality Engineering Manager, Align Technology
Bringing together a panel of knowledgeable voices, with an overview of the digital health and medical technology sector, this opening session will consider how the COVID-19 pandemic has accelerated interest in the opportunities that digital health technologies and Medical Device Software offers and how this is being reflected in the industry:
- How has the COVID-19 pandemic accelerated the development and adoption of Medical Device Software to diagnose, treat and manage patients?
- Understanding the developing start-up landscape and the emergence of new health technologies
- What is the impact on existing Medical Device manufacturers?
- How should the industry respond to meet the demand and maximise the opportunity of this moment in time?
- What are some of the potential challenges and how might these be overcome?
9:50 am - 10:30 am
HEALING WITH DATA! OPPORTUNITIES AND BOUNDARIES FOR DIGITAL HEATH: EXPLORING THE GERMAN MARKET
Professor Dominik Böhler -
Professor for Management in Digital Health,
Deggendorf Institute of Technology
Professor Dominik Böhler
Professor for Management in Digital HealthDeggendorf Institute of Technology
10:30 am - 10:45 am
INTERACTIVE SPEED NETWORKING
A highlight of previous Pharma IQ events and now back at SDMD 2022! It’s been two years since we were able to meet in person, so this is your opportunity to get out from behind the computer screen, meet your peers and share best practices. You will have 2 minute conversations to enable you to introduce yourself to your peers, add to your contact pool and begin the discussions that will continue over the next two days. Participants are invited to share
- Who you are
- The scope of your job role
- What you plan to achieve from attending SDMD 2022
- Your #1 challenge
10:45 am - 11:30 am
NETWORKING BREAK & MORNING REFRESHMENTS
11:30 am - 12:10 pm
UTILISING THE THREAT MODELING APPROACH AS A CYBERSECURITY RISK ASSESSMENT METHODOLOGY
Alessandro Vitiello -
Head of Software Development,
D.med Software
12:10 pm - 1:10 pm
INTERACTIVE DISCUSSION GROUPS:
This quick-fire format will enable delegates to take a deep-dive into a variety of topics that address the challenges, whilst engaging in
collaborative, problem-solving focused discussions with their peers. At the end of the roundtable session, each of the moderators will provide a brief summary of the different discussions that have taken place at their tables.
Each discussion session will last for twenty minutes, with a five-minute break to rotate to the next discussion group of your choosing. Delegates will get the opportunity to take part in two twenty-minute discussion groups. At the end of the whole session, the moderators from each of the roundtables
will each deliver a five-minute feedback summary of all the discussions that took place at their table.
12:10 pm - 1:10 pm
ROUNDTABLE 1: ADVANCING ADOPTION OF DIGITAL THERAPEUTICS
John Mulcahy -
VP Product,
S3ConnectedHealth
12:10 pm - 1:10 pm
ROUNDTABLE 2: COMMON CHALLENGES WITH DESIGN CONTROLS WHEN DEVELOPING MEDICAL DEVICE SOFTWARE
Patrick Alff -
Founder,
Ezthera
1:10 pm - 2:15 pm
NETWORKING LUNCH
2:15 pm - 2:55 pm
MOVING BEYOND THE HYPE: UNDERSTANDING THE REALITIES OF AI ADOPTION AND THE CHALLENGES OF THE REGULATORY AND STANDARDS LANDSCAPE
Pat Baird -
Regulatory Head of Global Software Standards,
Philips
Pat has a wealth of experience in the Medical Device Software industry and represents Philips on many committees and industry groups globally designed to advance standards, including those in typically under-represented areas. Hugely influential, Pat is renowned by many as the ‘go-to’ person on the adoption of AI standards.
- Discussing the current adoption of AI within the Medical Device Software industry and the challenges that manufacturers are facing
- Evaluating the wide-range of standards and guidelines worldwide that are governing AI adoption and how to manage compliance efficiently
- Uncovering the opportunities that AI offers in the deployment of innovative devices to meet previously unmet medical needs in diverse settings
2:55 pm - 3:35 pm
APPLYING A RISK MANAGEMENT STRATEGY TO CYBERSECURITY THROUGHOUT THE PRODUCT DEVELOPMENT LIFECYCLE
Harsh Jain -
Product Quality Engineering Manager,
Align Technology
Verily Life Sciences is at the convergence of healthcare, data science and technology, with its key focus on building integrated solutions to improve human health.
- Understanding the importance of end-to-end risk management when considering cybersecurity
- Outlining the critical success factors for the integration of risk mitigation techniques
- Sharing examples of how existing cybersecurity mitigations have been integrated into the product lifecycle development and where there is room for further development
3:35 pm - 4:10 pm
AFTERNOON NETWORKING BREAK
4:10 pm - 4:50 pm
UNDERSTANDING HOW TO BALANCE CYBERSECURITY AND CLINICAL EXCELLENCE TO MAINTAIN DEVICE PERFORMANCE
Celestina Bianco -
Quality Assurance and Regulation Affair Director,
Werfen
Werfen is a worldwide leader in specialised diagnostics for Hemostasis, Acute Care Diagnostics and Autoimmunity. Through their OEM business, they research, develop and manufacture customised assays and biomaterials.
· Applying QA/RA to ensure cybersecurity
· Understanding how cybersecurity standards are applied globally and working with your notified bodies effectively
· Building in contingency plans to managed necessary upgrades whilst managing the costs of doing so
4:50 pm - 5:00 pm
CHAIR’S SUMMARY OF DAY ONE
5:00 pm - 6:30 pm
CLOSE OF DAY ONE & DRINKS RECEPTION
In-person events offer the opportunity to relax and socialise with your peers and colleagues, which helps to build deeper connections and consolidate your take-aways from the conference sessions. Once the formal conference day has concluded, this is your chance to engage with your fellow conference attendees and continue the conversations started during the day. Enjoy!
