Four Industry Leaders Reveal How Human Factors, Real-World Evidence, and In-Silico Testing Create Unbeatable Competitive Moats When Used Together

FOR IMMEDIATE RELEASE

September 17, 2025 — While many MedTech startups struggle with traditional development approaches that burn through capital and delay market entry, a select group of companies is leveraging three often-overlooked evidence engines to accelerate approvals and create sustainable competitive advantages. This Thursday, an expert panel will reveal exactly how these methodologies work together to transform device development timelines. 

Register Now: https://bit.ly/4pusbqY

The complimentary webinar, "Closing the Blind Spots: Building Devices for the Real World," brings together leading practitioners from ClariMed, 3Aware, Dassault Systèmes, and Canon Medical to demonstrate integrated approaches that most companies either ignore completely or implement in isolation.

The Competitive Intelligence Gap

According to FDA data, 36% of medical device recalls stem from design-related issues, while industry research shows a 6-month average delay between regulatory approval and reimbursement decisions. Meanwhile, companies implementing advanced computational modeling are reaching market two years earlier and saving millions in development costs through reduced clinical trial requirements.

"By the time a device reaches design lock, most usability-related decisions are frozen in place," explained Kelley Kendle, CEO of ClariMed. "If those decisions don't reflect real user needs, fixing them later can delay market entry by months or years. 

Early integration of human factors with real-world evidence collection and computational modeling creates development processes that eliminate costly surprises."

The Three Evidence Engines Transforming Development

The webinar will explore how human factors engineering, real-world evidence collection, and in-silico testing create exponential benefits when integrated strategically:

Human Factors Engineering moves beyond regulatory compliance to become a competitive differentiator. Companies implementing comprehensive usability engineering see reduced post-market issues and accelerated regulatory pathways through evidence-based design decisions.

Real-World Evidence transforms post-market data collection from reactive surveillance into proactive competitive intelligence. Early RWE strategies support label expansions, reduce clinical trial costs, and provide payers with the effectiveness data required for coverage decisions.

In-Silico Testing enables virtual validation of device performance across thousands of patient scenarios before physical prototypes are built. Advanced computational modeling reduces development cycles while providing regulators with robust safety and efficacy evidence.

"When we leverage real-world evidence early in development, we uncover patterns and risks that aren't visible in controlled environments," noted Amelia Hufford, PhD, Co-Founder at 3Aware. 

"That insight shapes design decisions, guides usability testing, and builds stronger regulatory submissions while avoiding costly rework later."

FDA Recognition and Regulatory Pathway

All three evidence approaches have established regulatory pathways with active FDA support. The agency maintains nearly 200 scientists supporting computational modeling in device reviews, issued comprehensive guidance for real-world evidence in 2017, and requires human factors validation for most Class II and III devices.

Steven M. Levine, PhD, from Dassault Systèmes, emphasized the maturation of computational approaches: "In-silico methods allow us to test and refine device performance in virtual environments before prototypes are built. This approach identifies issues early, reduces development costs, and creates more robust designs through comprehensive scenario testing."

Strategic Implementation for Competitive Advantage

The panel will address practical implementation strategies for startups and established companies looking to integrate these evidence engines effectively. Rather than treating each methodology as a separate requirement, leading companies are discovering how strategic integration creates compound benefits.

"Regulatory affairs combines art and science," observed Jay Vaishnav, PhD, Director of Regulatory Affairs at Canon Medical. "The science involves building and testing solid technology; the art lies in strategic decision-making and creative problem-solving. When supported by strong evidence from multiple sources, regulatory strategy becomes a driver of innovation and competitive positioning."

Industry Transformation Implications

The integration of these evidence engines represents a fundamental shift in how medical devices are developed, tested, and brought to market. Companies that master these approaches early are positioning themselves for sustained competitive advantages in an increasingly complex regulatory environment.

For MedTech startups facing pressure to reduce development costs while accelerating time-to-market, these methodologies offer proven pathways to achieve both objectives simultaneously.

Webinar Details

Event: “Closing the Blind Spots: Building Devices for the Real World”
Date: Thursday, September 18, 2025*
Time: 10:00-11:00 AM Eastern Time (4:00-5:00 PM Central European Time)
Format: Live online panel discussion
Cost: Complimentary registration
Registration Link: https://bit.ly/4pusbqY
*Recording: Available to all registrants

Expert Panelists

• Kelley Kendle, CEO & Chairman, ClariMed - Leading authority on human factors and usability engineering for medical devices
• Amelia Hufford, PhD, Co-Founder & SVP Clinical and Regulatory Science Operations, 3Aware - Specialist in real-world evidence applications and post-market data strategies
• Steven M. Levine, PhD, Senior Director Virtual Human Modeling & Executive Director Living Heart Project, Dassault Systèmes - Expert in computational modeling and in-silico testing methodologies
• Jay Vaishnav, PhD, Director Regulatory Affairs, Canon Medical - Authority on regulatory strategy and evidence integration for device approvals

The session will include case studies demonstrating quantified benefits, practical implementation roadmaps, and discussion addressing common implementation challenges.

Registration Link: https://bit.ly/4pusbqY