Hardware Podcasts

The Tools that Make Clinical Investigations

Global Medical Device Podcast · 13 May 2023 · 37m · Episode 318

What this episode covers

Jon Bergsteinsson, founder of SMART-TRIAL by Greenlight Guru, discusses the critical role of Electronic Data Capture (EDC) systems in medical device clinical investigations. He argues that while ISO 14155 provides process standards, it does not guarantee data quality, which is instead determined by how data is formatted and collected using digital tools rather than paper or Excel. Bergsteinson highlights that purpose-built EDC platforms reduce the high costs of manual data entry, transcription errors, and audit preparation, ultimately providing a better return on investment than legacy methods. He emphasizes that leadership often lacks understanding of clinical operations and needs education on why digital-first approaches are essential for compliance and efficiency.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Greenlight Guru
Products
SMART-TRIAL
Tools
Excel, SolidWorks
Also
ISO 14155

Related episodes from other shows

Other shows on the same ground, closest first.

  • Being an Engineer · 37m

    S1E12 Simplifying Quality Management | Jon Speer

    Jon Speer, founder of Greenlight Guru, explains how his frustration with managing medical device quality via Excel spreadsheets led to the creation of a dedicated QMS software platform. He details the transition from chemical engineering to medical device systems, highlighting the specific pain points of manual data merging and the high validation burden for electronic records. The episode covers Greenlight Guru’s development, its focus on design controls and traceability matrices, and the regulatory challenges of FDA submissions and ISO 13485 certification for startups.

    Quality & yieldStarting a product company
    8 chapters

  • The Manufacturing Executive · 35m

    It’s Time for a Digital Transformation of Analog Data Entry

    Greg Bohling, Vice President of Sales and Customer Success at Alpha Software, explains how manufacturers can digitize manual, paper-based processes using no-code mobile apps like Alpha Transform. He details the risks of analog data entry, including errors and delayed decision-making, and highlights specific use cases such as first-piece inspection and quality audits in injection molding facilities. Bohling describes how digitizing these workflows improves data trust, accountability, and operational efficiency while helping companies attract younger workers who prefer modern, tech-enabled environments.

    Quality & yieldManufacturing partners & offshoring
    7 chapters

  • The Manufacturing Executive · 38m

    Quality Management in a Changing Manufacturing Environment w/ Naveen Poonian

    Naveen Poonian, President and CEO of iBase-T, discusses the critical state of quality management in aerospace and defense manufacturing, citing Boeing and Starliner delays as examples of risks when speed compromises quality. He argues that manual, paper-based processes and disconnected data systems lead to massive rework costs and quality escapes, urging a shift to digital ecosystems that enforce process control. Poonian highlights the urgent need to capture retiring workforce tribal knowledge into software to prevent quality loss and enable hyper-automation. He outlines iBase-T’s consultative approach to implementing MES and MRO solutions, emphasizing cloud-native agility, IT/OT integration, and phased adoption strategies to ensure user buy-in and successful digital transformation.

    Quality & yieldManufacturing partners & offshoring
    6 chapters

  • Let's Combinate · 35m

    205 - Why Less Than 20% of Companies Have Started Quality 4.0

    Larry Mager, Founder of MGMT-CTRL, explains why fewer than 20% of companies have started Quality 4.0 despite 63% believing it will transform operations. He introduces his Quantum Quality Management (QQM) framework, a five-phase roadmap that prioritizes people, process, and technology to move beyond compliance. Mager argues that legacy Electronic Quality Management Systems (EQMS) fail because they are pre-programmed, whereas modern solutions use 'digital twins' to model workflows and ensure digital continuity. He emphasizes that successful implementation requires a strategic roadmap, cultural change, and management control rather than just installing software.

    Quality & yieldFactory operations & automation
    6 chapters

  • Let's Combinate · 45m

    123 - Uncovering HUGE Quality Issues, Inspection Readiness in 2024, Data Integrity, AlCOA+/PIC/S and Critical Thinking in Quality Management with Peter Baker

    Peter Baker, President of Live Oak Quality Assurance and former FDA Drug Investigator, discusses his career uncovering data integrity breaches in overseas manufacturing facilities. He explains that 99% of data integrity issues stem from poor process design and 'right environment' failures rather than human error, urging companies to shift from compliance-focused checklists to quality-driven critical thinking. Baker highlights specific field failures, such as the manipulation of product quality by blending failed batches with passing ones, and emphasizes the importance of honest reporting of unknown discrepancies to ensure patient safety.

    Quality & yieldCertification & compliance
    9 chapters

The summary, chapters and topics are generated from the episode’s audio by this directory, not written by Global Medical Device Podcast. The episode itself belongs to its publisher.