Medical Design Briefs - November 2024 - 24

MUST-SEE SESSIONS
Product Development 101
Many entrepreneurial medical professionals have great ideas
for a new product, but what does the path to market look like? We
have all heard of design controls, verification and validation, and
regulatory approval, but what does this all mean? This session will
focus on the classic path through a stage/gate process from concept
through V&V to regulatory approval and finally design transfer
to manufacturing. Chad Herremans, VP Quality and Operations
at Meddux Development Corporation, will discuss when the
proper time is to implement design controls and what that means.
He will discuss the necessary milestones/end points to move into
the next phase of the process. He will also address lessons learned
that resulted in either good or bad outcomes from a failure to
gain regulatory approval to spiraling costs and an inability to exist
the V&V phase. Finally, he will introduce V&V strategies and use
case studies as supporting examples of good and bad strategies.
Strategies and Techniques to Translate from Medical
Device Research into Product Development
In this practical session, Timothy Looney, President & CEO
at Northeast Biomedical, Inc., will discuss the nuances of transitioning
medical technologies from research into product development
and manufacturing. He will explore the challenges
of recognizing the right time to move forward, taking into account
the risks associated with premature advancement. Moving
too quickly can lead to wasted time and resources, necessitating
additional funds, research, and time to market.
This session will shed light on the real-world challenges faced
by management teams, who are often compelled to make decisions
before the technology is ready to meet stakeholder expectations.
We'll address the balance between satisfying upper
management and stakeholders and the associated risks.
Throughout the session, Looney will delve into practical techniques
for identifying and assessing areas of risk, enabling informed
decisions on the progression of medical technology. We'll
also discuss the implementation of pragmatic plans and processes
to mitigate these risks, aiming for a smoother path to market while
improving patient outcomes. The session will be a down-to-earth
exploration of the decision-making process in medical technology
development, gaining insights into optimizing the path from development
to market in today's dynamic landscape.
Regulatory Strategy for AI-Enabled Medical Software
Manufacturers
In this session, Balazs Bozsik, Technical Director - Medical
Audit at SGS North America Inc., will provide an overview of
current and foreseeable regulatory controls for AI-enabled
medical software for the major markets (EU+UK, MDSAP
countries) and outlines considerations for manufacturers to
prepare their QMS and product technical documentation to
improve the chances of a successful regulatory submission for
new and changed AI-enabled software products.
GenAI Security Challenges and Solutions in Medical
Devices
Investment in artificial intelligence (AI) and machine learning
(ML) is skyrocketing, with the global AI market valued at $196.63
billion in 2023 and projected to grow at a CAGR of 36.6 percent
from 2024 to 2030. The U.S. leads with $62.5 billion in private
investment, followed by China and the EU. AI's impact spans industries,
with the manufacturing sector expected to gain $3.78
trillion by 2035. Significant growth is also anticipated in AI applications
like self-driving vehicles and AI-driven customer service.
Healthcare AI/ML systems are particularly vulnerable, with
healthcare ransomware attacks costing, on average, $11 million
per incident and posing. Healthcare ransomware attacks cost, on
average, $11 million per incident and pose risks to patient safety.
In this session, Rajesh Kanungo, CEO at Tala Secure, Inc.,
will outline these problems and proposes mitigations, including
robust security measures, continuous monitoring, strong
data validation practices, and GenAI-driven auto-remediation
solutions to ensure the reliability and integrity of AI/ML systems.
Addressing these risks is crucial for leveraging AI's full
potential while protecting against threats and safety concerns.
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Medical Design Briefs, November 2024
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Medical Design Briefs - November 2024

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