10 Reasons to Attend the 16th Annual Device Research & Regulatory Conference

Angie Rock


Kathi Durdon


Early in her medical device research career, Kathi Durdon, MA, CCRP, discovered a gaping hole in the professional conference offerings: most were geared toward pharmaceuticals, not devices – so she created one.

“My initial incentive for starting an annual device conference was because I needed help. I wanted to connect with subject matter experts, get new updates, and share resources. I knew it would be helpful for others, too,” said Kathi. As a member-driven organization, SOCRA enthusiastically supported Kathi’s vision, and the Annual Device Research & Regulatory Conference was born.

“Thanks to SOCRA’s support, I could create a different kind of conference – one where attendees would come every year to discuss and learn about an evolving array of topics. I also wanted a full complement of speakers who are experts in different areas – not just one or two areas,” Kathi recalled.

With Kathi at the helm, the first Device Research & Regulatory Conference was held in 2007, and sixteen years later, it’s still the medical device research “go to” conference. The conference started as a two-day program and then the faculty added a half-day Device Basics workshop thanks to past co-chair, Donna Headlee, RN, BSN, CCRP, who developed and still presents at the program today.

As we gear up for the 16th year, the Device Research & Regulatory Conference is still going strong. And as Kathi prepares to turn over the reins to Angie Rock, MBA, CCRP in 2024, the two gathered to commemorate Kathi’s tenure, to discuss the importance of the program, and to discuss future plans for the conference.

“This conference is Kathi’s brainchild. I’m honored to be a part of this phenomenal program – it is the premier conference for medical device professionals and one of the first that is entirely clinically oriented,” said Angie.

In this post, we’ll outline Kathi and Angie’s top ten reasons to attend this annual conference and why it’s important for device newbies and experts alike.

Top 10 Reasons to attend the annual Device Research & Regulatory Conference in 2023

1. It was created by device professionals for device professionals

As a device professional, Kathi designed the Device Research & Regulatory Conference to provide industry professionals with the tools, knowledge, information, and connections to succeed in their careers. Attendees should expect content and discussions that are offered on a range of relevant topics, including regulatory compliance, innovation and device development, and requirements for clinical investigations.

2. You will learn how to navigate the regulatory landscape

Angie pointed out that medical device research is drastically different from pharmaceutical research, in part, due to the complexity of regulatory pathways in bringing devices to market in the U.S. With so many intricacies and gray areas in the regulatory landscape, Angie believes that it’s critical to learn how to navigate the varying pathways. “I know that when I started, I had very little knowledge regarding the regulatory issues and opportunities, and this conference helped to provide a framework for navigating them,” said Angie.

3. Fantastic keynote speakers on hot topics

In keeping with Kathi’s vision for dynamic keynote and conference speakers discussing hot topics, this year’s speaker schedule is brimming with notable industry leaders and must-see presentations, including:

· Device Regulations & Classifications –

Angie Rock, MBA, CCRP, Director, Clinical Operations, BIOTRONIK, Inc., and Kathi Durdon, MA, CCRP, Executive Director, CNY Biotech Accelerator

· Overview of Premarket Submissions

Donna Headlee, RN, BSN, CCRP

· Devices, Decentralized Research, and Quality by Design – 3 Pillars to Success

Brian Barnes, MA, Senior Director, Product Development, Medidata Solutions

· FDA’s Digital Health Centers of Excellence Program (DHCoE) Overview of Resources

Glenda Guest, CCRA, RQAP-GCP, ACRP-MDP, FACRP, President, Assured of Quality Consulting & Training

· Career Planning: Acquiring Competencies & Champions

Erika Stevens, MA, FACRP, Principal Consultant, Recherche Transformation Rapide, Faculty Lecturer, Rutgers University

· GDPR and Other Regulatory Frameworks

Carl Carpenter, CEO, Arrakis Consulting

· Breakthrough Devices Program and Safer Technologies Program (STEP)

Donna Headlee, RN, BSN, CCRP

· The Ethics and Regulation of Medical Device Innovation

Quincy J. Byrdsong, EdD, CIP, CCRP, Vice Provost for Health Affairs, Lipscomb University

· Increasing Female and Minority Enrollment in Clinical Studies

Karlene Cox, BS, CCRP, CRA Manager, BIOTRONIK

· Imagining Failures to Identify Blind Spots in Device Research

David Staley, MA, Associate Director, Advarra’s Institutional Research Center of Excellence

· What to Know About the Proposed Rule to Harmonize the FDA Regulations on Human Subjects Research with the Common Rule

David Peloquin, JD, Partner, Ropes & Gray, LLP

· Updates to the FDA Inspectional Guidance Documents

Brandy Chittester, MS, Executive Vice President and Chief Strategy Officer, M&B Sciences, Inc.

· The Challenges of Subject Enrollment and Retention in a Longitudinal Study

Scott L. Wehage, MS, CCRP, Director, Clinical and Rural Health, St. Lawrence Health

4. Discover industry trends and how to put them into practice

This conference provides a unique opportunity to discover the latest medical device research trends and offers expert predictions for the industry’s future. Kathi and Angie hope that attendees will walk away with a greater understanding of industry trends and practical ways to incorporate them into their daily practice.

5. Connect and network with other device professionals

One of Kathi’s primary goals when creating this program was to offer an opportunity to connect and collaborate. So, expect plenty of opportunities to network with fellow medical device professionals at this 2-1/2 day conference. If you want to make the most of your experience, check out these helpful tips for networking at scientific conferences.

6. Share your knowledge and get advice

The Device Research & Regulatory Conference allows ample opportunity to share knowledge through interactive presentations and Q&A sessions. “If we didn’t hit on a topic an attendee is interested in, we invite them to share that topic with the group so that we can work together to solve a problem, find resources, or offer suggestions,” said Kathi. Angie added, “I love working with teams and mentoring individuals, and the device conference is a great platform for sharing education and experience with people seeking advice.”

7. Discover career development opportunities

This conference offers plenty of educational sessions and opportunities to connect and network with “movers and shakers” in the medical device industry, making it an excellent forum to also explore career development opportunities. Whether you’re looking to upskill, discover new opportunities, or find a mentor, the Device Research & Regulatory Conference has it all. You will also earn CME, CNE and SOCRA continuing education credit hours by attending the conference and the optional Device Basics preconference workshop.

8. It’s a valuable resource for startups and for those new to device research

With Kathi’s background and experience in helping medical device startups navigate the process of bringing safe and effective devices to market, she passionately encourages device innovators to attend this conference. “I love my job because I get to work with students, faculty members, and small company representatives with ideas for new devices in responses to unmet needs,” she said. “Some of the proposed technologies blow my mind! However, it can be a daunting task when you’re unsure which development path is potentially the most effective, especially on a limited budget. That’s where I and the incredible resources at this conference come in. We’re here to help big ideas succeed because innovation is essential for economic development.”

9. There will be something for everyone

The Device Research & Regulatory Conference is geared for attendees with a range of roles and responsibilities, including:

· Clinical Research Professionals (e.g., Clinical Investigators, Clinical Research Associates, Clinical Research Coordinators, Program Managers, etc.)

· Government, University/Academic, Industry, and Support Organization Representatives

· Quality, Regulatory, Research and Development, Engineering, and Human Factors professionals

· Medical Device Designers/Developers

· Medical Device Startup Companies

· Medical Device Vendors and Service Providers

· Contract Research Organization (CRO) specialists

· All others interested in learning more about medical device research and the medical device development regulatory process

Angie Rock noted that the conference is great for new and experienced research professionals alike, “Everyone will leave the conference with new information and additions to their professional network.” and “Our audience’s backgrounds are an even mix of site-oriented and sponsor-related professionals, giving attendees many opportunities to talk to other researchers about their “pain points,” and how they can work together for a better outcome.

10. Help advance the release of new device technologies

Finally, the Device Research & Regulatory Conference offers a place to learn and connect as we work toward a universal goal: to release safe and effective medical technologies to the market. “What motivates me every day is to help drive development so that clinicians are more efficient in their diagnoses and treatments and patients can experience improved outcomes,” said Angie. “This conference allows you to connect with a diverse group of people to help you to address and satisfy the high level of compliance requirements and scientific rigor that will ensure the safety of all research participants, as we work toward releasing safe and effective devices.

To learn more about the 16th Annual Device Research & Regulatory Conference or register for this premier conference for medical device professionals visit the links above or email us at office@socra.org.

Medicare Coverage Analysis – A Billing Compliance Perspectives

Sachit Verma, MD, MBA, FAPCR

Medicare Coverage Analysis (MCA) is a uniform methodology of analyzing the items and services provided in a clinical research study, i.e., a comprehensive review of protocol documents that helps identify the appropriate payor (sponsor or third-party) for each study service, assessment of the protocol driven items and procedures that can be billed to either insurance, as routine cost, or as costs billable to the study sponsors.

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Leveraging eSource as a Study Manager for Remote Monitoring 

By:  Takoda Roland, CTM, CCRA, Associate Director of Clinical Operations, Sitero


I have long been a proponent of the potential of eSource and its advantages in clinical trials.  From my experience as a CRA (Clinical Research Associate) I first wrote about eSource in Nov 2018 SOCRA and Jan 2019 ACRP which enabled me to see that clinical research was only just scratching the surface on leveraging eSource to fundamentally change the way we are monitoring clinical trials.  At the time I did not expect to be find myself in a position to make a meaningful shift towards remote monitoring.  Several years later while working as a CTM (Clinical Team Manager) COVID forced CROs (Contract Research Organizations) to rethink their monitoring paradigm.  Drawing from both my own and my team’s experience with eSource, our study was able to successfully implement a remote monitoring process to mitigate the issues of running a clinical trial during a pandemic.  Even as someone who had long advocated for remote monitoring using eSource, I found myself astounded at the success our team achieved.   

Continue reading Leveraging eSource as a Study Manager for Remote Monitoring 

SOCRA 2022 Year in Review & What to Expect in 2023

As 2022 draws to a close, we’re proud to recognize the year’s activities, accomplishments, and progress as we prepare to welcome the New Year ahead. We invite you to join us in reflecting on 2022 and looking ahead to what you can expect in 2023.

Continue reading SOCRA 2022 Year in Review & What to Expect in 2023

31st SOCRA Annual Conference Wrap-Up

We proudly hosted the 31st Annual Conference from September 14-17, 2022, gathering our global clinical research community virtually in an engaging learning and networking environment. This year’s event was brimming with more experts, content, networking and learning opportunities as part of our commitment to offer new ways to learn, grow, and connect with other clinical research professionals.

We were thrilled with this year’s attendance and energy as we shared ideas to promote safe, efficient, and high-quality clinical research. We also hosted award presentations recognizing our members’ steadfast dedication to advancing this ever-evolving field.

In case you missed this year’s conference, we’ve summarized the event in this wrap-up post featuring conference highlights, themes, and special recognition award winners.  Also, as a benefit to our broader clinical research community, plenary session recordings from this conference (and past conferences) are available on our website here.

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Leadership and Line Management in Clinical Research

Anatoly Gorkun
Senior Manager, Global Clinical Management, PPD
Hugh Devine
Senior Director, Global Clinical Management, PPD

Abstract: Line management is generic, utilizing the same approaches throughout all industries; line management brings together company needs and its workforce to deliver company objectives. This article provides an overview of line management styles and line-management-through-leadership approaches in the clinical research environment. The line management cycle – team building, support, motivation, and development—is described. Real-life examples illustrate how line management can support clinical research deliverables.

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Clinical Research Nursing Conference– Understanding the role that nurses play in Clinical Research and Empowering them to become leaders in the field

Jennifer Goldfarb, MSN, RN, CCRP

We here at SOCRA are very excited for the relaunch of the Clinical Research Nursing Conference which will be offered virtually this November. The course faculty includes very experienced clinical research nursing professionals who will be bringing a wealth of knowledge and experience to the conference attendees. Take a look below for our Course Chair’s personal perspectives on Clinical Research Nursing – how she became a nurse, then clinical research professional and why she’s not only excited for this course, but also where the field is headed. As you’ll see below – this is an exciting time. This conference presents the opportunity to highlight the role that nurses play in Clinical Research, to celebrate this role, and to empower them to become leaders in the field.

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An Inspiring Interview with SOCRA’s 2022 Recipient of the President’s Special Recognition Award for Distinguished Service: Nancy Wintering, MSW, LCSW, CCRP

From September 14 to September 17, 2022, our global clinical research community will gather virtually for SOCRA’s 31st Annual Conference to enjoy an engaging learning and networking experience to promote safe, efficient, and high-quality clinical research.

At the event, we will honor this year’s President’s Award recipient Nancy Wintering, MSW, LCSW, CCRP, for outstanding service and dedication to SOCRA’s mission. Nancy is the Assistant Director of Research for the Marcus Institute of Integrative Health at Thomas Jefferson University. Nancy has served SOCRA in many ways, including as a past board member, SOCRA Source Journal author, Annual Conference speaker and session chair, workshop and conference organizer and speaker, and poster presenter.

We caught up with Nancy to discuss her thoughts on clinical research, SOCRA, the future, and much more. Read on for interesting insights and perspectives in this inspiring interview.

Continue reading An Inspiring Interview with SOCRA’s 2022 Recipient of the President’s Special Recognition Award for Distinguished Service: Nancy Wintering, MSW, LCSW, CCRP

Cultivating an Effective Research Team Through Application of Team Science Principles

Shirley L.T. Helm, MS, CCRP Senior Administrator for Network Capacity & Workforce Strategies

C. Kenneth & Dianne Wright Center for Clinical and Translational Research

Virginia Commonwealth University

Abstract: The practice of team science allows clinical research professionals to draw from theory-driven principles to build an effective and efficient research team. Inherent in these principles are recognizing team member differences and welcoming diversity in an effort to integrate knowledge to solve complex problems. This article describes the basics of team science and how it can be applied to creating a highly-productive research team across the study continuum, including research administrators, budget developers, investigators, and research coordinators. The development of mutual trust, a shared vision, and open communication are crucial elements of a successful research team and research project. A case study illustrates the team science approach.

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Clinical Trials Day 2022: Insights from SOCRA Nominee Aryn Knight

Aryn Knight, CCRP

Administrative Director

Texas Heart Institute

Houston, Texas

On May 20, the world will honor clinical research professionals in an annual celebration of Clinical Trials Day (CTD). This internationally recognized event raises awareness of clinical trials and the many career opportunities in this wonderfully rewarding field, and it is our honor to kick off the 2022 celebration. In keeping with tradition, we’ve invited SOCRA members to nominate each other for their outstanding work and contributions to public health, medical advancement, and improved health outcomes.

In this article, we’re sharing the insights and perspectives of Aryn Knight, Administrative Director for the Center for Clinical Research at Texas Heart Institute. We are recognizing Aryn for her positive contributions to clinical research education and advocacy.

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