Medical Device Seminar 2019 at Exponent Shanghai Office
May 23, 2019
9:30 AM - 5:00 PM
Exponent will be hosting a Medical Device Seminar on May 23, 2019 from 9:30 am to 5:00 pm CST in our Shanghai office located at No. 1387 Zhangdong Road, Suite #101, Building 1, Shanghai, China. This seminar will explore both the proactive and reactive challenges involved in product development, manufacturing, reliability test and failure analysis. Topics to be discussed include:

  • Tips and Traps in Medical Device Product Development - Presented by Jeffrey P. Rouleau, Ph.D., Senior Manager
  • Lessons from Medical Electronics Manufacturing - Presented by Jason O. Clevenger, Ph.D., Principal Scientist
  • Imaging Modalities in Product Development - Presented by Joshua White, Ph.D., Manager
  • Medical Device Reliability Analysis and the Use of Computational Modeling - Presented by Paul L. Briant, Ph.D., P.E., Principal Engineer

Tips and Traps in Medical Device Product Development Medical devices have the potential to restore health and extend life, but they also have the potential to cause harm. For this reason, medical devices are evaluated for safety and effectiveness before broad market release. This presentation will explore examples of both proactive and reactive challenges that can be addressed with scientific and engineering analysis. Examples will include medical device recalls, litigation, and proactive efforts to improve product performance. Both traditional and novel analytical tools will be highlighted for both root cause analysis and continuous improvement activities.

医疗器械既可以帮助恢复健康延续生命,又有很大的医疗风险。正因为如此,医疗器械在推向市场之前都会经过全面的安全性有效性评估。在此次讲座中,我们将以一些实例来向大家介绍Exponent 在医疗器械召回,法律诉讼,提高产品功效等领域从事的前摄性和应对性的工作。同时也将对传统的和新兴的分析技术和工具进行介绍。这些技术在我们应对失效进行溯源的分析和持续提高产品性能过程中发挥了重大作用。


Lessons from Medical Electronics Manufacturing Medical device manufacturing takes place in a highly regulated environment where supply chains, particularly for embedded electronics, are becoming increasingly diversified and outsourced. In this talk, we will examine some key lessons learned regarding the impact of seemingly minor process changes involving cleanliness and/or component substitution on the final quality attributes of medical device electronics. In addition, we will discuss the usefulness and limitations of analytical techniques commonly used in the industry to determine cleanliness levels in devices, as well as the appropriate use of tools such as accelerated aging to predict component lifetime in the context of substitution.

电子器件是医疗器械制造的关键一环。在这个讲座中,我们将为大家揭秘一些看起来细微的工艺改动(洁净程度,元件替换等)是怎样影响医疗器械电子模块的质量的。我们将涵盖确定器械洁净等级的分析技术和预测产品寿命的工具方法。


Imaging Modalities in Product Development X-ray, CT, and MRI scanning are each powerful imaging techniques. They can be used to non-destructively evaluate internal and external features of devices, as well as to evaluate how the device interacts with the body under different loading scenarios. This talk will describe some of the basics of each imaging modality and how they can be applied during medical device product development to optimize design, perform failure analysis, and ensure safety to patients.

X光,CT 和核磁共振扫描作为行之有效的获得图像的技术,被广泛应用到对医疗产品特性和产品/人体交互反应的非破坏性的评估中。这个讲座将着重介绍在医疗器械的设计,失效分析和安全可靠性分析中各种拍照模式的原理和应用。


Medical Device Reliability Analysis and the Use of Computational Modeling Analyzing the reliability of any medical device is critical for evaluating device safety and effectiveness. Medical device reliability analysis frequently involves a combination of experimental testing and computational analysis. The computational modeling is frequently used to justify loading conditions used in experimental testing, quantify margins between component strength and expected loads (i.e. safety factors), compare different designs, and understand issues observed in testing. Combined with the laboratory bench testing and potential clinical studies, this reliability analysis is an important component of regulatory submission.

医疗器械的可靠性分析对于医疗产品的安全和有效至关重要。可靠性分析通常采用实验方法和模拟计算相结合的方式。计算机模拟能够和实验中的载荷施加情况相互验证,而且还能够计算设计载荷和元件强度的余量,横向比较不同的设计等。计算模拟与实验测试和临床研究相辅相成,共同成为产品合规申请的重要组成部分。

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