Outsourcing in Clinical Trials: Medical Devices USA 2026

Hear fresh insight on regulatory changes and hottest technologies impacting MedTech trials

2 - 3

June

2026
  • Minneapolis Marriott West, Minneapolis, Minnesota, USA
  • Complimentary
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Why attend?

The meeting place for healthcare pioneers and innovators

➤ Stay Ahead of Regulations – Get the latest updates on FDA, EU MDR, and AI-driven clinical trial compliance

➤ Explore AI & Digital Innovation – Discover how AI, real-world data, and decentralized trials are transforming medical device development

➤ Learn from Industry Experts – Hear from top leaders at Medtronic, Abbott, Boston Scientific, and more

➤ Solve Key Challenges – Address cybersecurity risks, funding constraints, and ethical concerns in AI-powered trials

➤ Unmatched Networking – Connect with peers, sponsors, vendors, and regulators shaping the future of clinical trials

120+

Attendees

15+

Exhibitors

15+

Speakers

120+

Attendees

15+

Exhibitors

15+

Speakers

Agenda

  • 2 Jun 2026
  • 3 Jun 2026
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8 AM

Registration and refreshments

8:50 AM

Chairperson’s opening remarks

9 AM

Preparing clinical teams for QMSR enforcement in 2026

  • Translating QMSR expectations into clinical evidence and documentation
  • Strengthening vendor oversight records without slowing delivery
  • Connecting trial execution to inspection readiness and CAPA linkages

9:30 AM

Designing clinical evidence early: a smarter path to medical device success

  • The importance of starting clinical design data planning very early—even before product design is finalized—to save time, avoid rework, and reduce budget waste
  • How early visibility and alignment across product management/marketing, R&D, and clinical/regulatory prevents misalignment and ensures the design supports meaningful evidence generation.
  • A practical shift toward design-linked evidence decisions, focusing on the data that will matter later for claims, regulatory expectations, and real-world adoption

Speakers

Hatice Bilgic Lim
Director Clinical Innovation, Philips

10 AM

Morning Refreshments & Networking

10:30 AM

Designing lean protocols while protecting endpoint credibility

  • Reducing site burden without weakening interpretability
  • Stress-testing endpoints against missingness and real-world workflow
  • Preventing avoidable amendments through feasibility discipline

Speakers

Pamela Wolfe
Director of Clinical and Regulatory Affairs, Agitated

11 AM

Session reserved for event sponsor

11:30 AM

Implementing decentralised elements without creating integrity and safety gaps

Selecting which activities can move remote without compromising control

Governing telehealth, home visits, and local HCP models

Tightening delegation, training, and deviation handling

Speakers

Terry Noel
Senior Clinical Research Specialist, Medtronic

12 PM

Lunch

1 PM

PANEL DISCUSSION Running hybrid trials by aligning sponsors, sites, and vendors on accountability

  • Mapping responsibility lines across oversight, safety escalation, and data flow
  • Comparing models for home nursing and local provider involvement.
  • Defining minimum viable controls that prevent preventable findings

1:30 PM

Session reserved for event sponsor

2 PM

Improving participation by modernising eligibility and enrolment practices

  • Revising eligibility to support access without increasing risk
  • Using site strategy and engagement to improve retention
  • Documenting rationale so improvements remain defensible

Speakers

Matthew Uhles
Chief Operating Officer, Clayton Sleep Institute

2:30 PM

Session reserved for event sponsor

3 PM

Afternoon Networking & Refreshments

3:30 PM

FIRESIDE CHAT Proving digital workflow value by simplifying consent and participant experience

  • Reducing friction in consent and re-consent while protecting comprehension
  • Designing participant communications that improve retention
  • Auditing usability and documentation to avoid avoidable noncompliance

Speakers

Serhii Zatsarynin
Chief Executive Officer, Ovulio

4 PM

Session reserved for event sponsor

4:30 PM

PANEL DISCUSSION Cutting through AI noise by sharing real clinical operations use cases and controls

  • Comparing validated use cases across feasibility, monitoring, and documentation
  • Defining guardrails for privacy, bias, and human oversight
  • Identifying where AI adoption increases risk more than it reduces work

Speakers

Adam P. Carvel
Vice President, Data Management & Analytics, Fairview

5 PM

Chairman’s Closing Remarks & Drinks Reception

8:15 AM

Registration and refreshments

9 AM

WORKSHOP QMSR six months on — implementing change in clinical study plans, submissions and compliance strategies

  • Assessing the impact of the February 2026 transition from QSR to QMSR on submissions and oversight
  • Putting knowledge into practice: updating Clinical Study Plans, budgets and regulatory strategies
  • Interactive discussion and Q&A

Workshop Overview:
Six months after the transition from QSR to QMSR incorporating ISO 13485, this practical workshop will examine how medical device teams are applying the new requirements in real-world clinical programs. Participants will explore the regulatory elements shaping clinical trial oversight and practice translating QMSR expectations into submissions and Clinical Study Plans, gaining practical insight into navigating both in-flight and future studies within the evolving global regulatory framework.

Speakers

Rebecca Stepan
Director Quality Systems & Regulatory Compliance, Medtronic

9:45 AM

Session reserved for event sponsor

10:15 AM

Session reserved for Amanda Maltzen

Speakers

Amanda Maltzen
Director of Clinical Affairs, Sonex Health

10:45 AM

Morning Refreshments & Networking

11:15 AM

Session reserved for event sponsor

11:45 AM

Building cybersecurity evidence into clinical and lifecycle planning for connected devices

  • Translating cybersecurity expectations into clinical risk and user impact
  • Planning evidence for resilience claims and update pathways
  • Preparing submission-ready documentation and traceability

Speakers

Vikrant Joshi
Director, Quality & Regulatory Compliance, iRhythm Technologies

12:15 PM

Generating credible clinical evidence with limited budgets

  • Prioritising evidence that meaningfully advances regulatory and clinical credibility
  • Leveraging publications, partnerships and existing data without inflating costs
  • Practical tips and insights on structuring FDA interactions and study design to maximise impact with constrained resources

 

Speakers

Liv Williamsen
Chief Operating Officer, Phenomix Sciences

12:45 PM

Networking Lunch

1:45 PM

PANEL DISCUSSION Breaking the silos: how early clinical–regulatory–commercial alignment drives impact

  • Identifying where misalignment between clinical, regulatory, and commercial teams most commonly breaks down and delays submissions or launches
  • Understanding which decisions need cross-functional alignment from day one to ensure evidence supports both approval and adoption
  • Sharing leadership-level lessons on how to structure collaboration early to avoid costly rework later in development

Speakers

Christine Horton
Chief Executive Officer, Visura Technologies
Liv Williamsen
Chief Operating Officer, Phenomix Sciences

2:15 PM

Using updated FDA RWE guidance by building fit for purpose data strategies

  • Choosing when RWD can credibly support device regulatory questions
  • Establishing data quality, provenance, and governance requirements
  • Designing hybrid evidence packages combining trials and RWE

2:45 PM

Afternoon Refreshments, Networking & Prize Draw

3:15 PM

PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

During the roundtable discussion session, the conference hall will be divided into three ‘zones’. Delegates can choose which zone they would like to join. Each zone will be led by a table moderator and will focus on a different challenge within the medical devices industry. After 30 minutes, delegates will have the opportunity to swap and choose a different table, and each roundtable will run twice.

ROUNDTABLE 1
Hybrid and decentralised execution playbooks aligned to FDA’s decentralised elements guidance

ROUNDTABLE 2
Cybersecurity evidence expectations for connected devices

ROUNDTABLE 3
Improving participation through eligibility and enrolment practices reflecting FDA’s December 2025 guidance

ROUNDTABLE 4
Continuous post-market evidence expectations influenced by MDCG 2025-10

 

4:15 PM

Close of Conference

Speakers

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Serhii Zatsarynin
Chief Executive Officer, Ovulio

Session Details:

FIRESIDE CHAT Proving digital workflow value by simplifying consent and participant experience

2026-06-02, 3:30 PM

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Next speaker
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Christine Horton
Chief Executive Officer, Visura Technologies

Session Details:

PANEL DISCUSSION Breaking the silos: how early clinical–regulatory–commercial alignment drives impact

2026-06-03, 1:45 PM

View In Agenda
Next speaker
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Terry Noel
Senior Clinical Research Specialist, Medtronic

Session Details:

Implementing decentralised elements without creating integrity and safety gaps

2026-06-02, 11:30 AM

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Next speaker
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Pamela Wolfe
Director of Clinical and Regulatory Affairs, Agitated

Session Details:

Designing lean protocols while protecting endpoint credibility

2026-06-02, 10:30 AM

View In Agenda
Next speaker
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Vikrant Joshi
Director, Quality & Regulatory Compliance, iRhythm Technologies

Session Details:

Building cybersecurity evidence into clinical and lifecycle planning for connected devices

2026-06-03, 11:45 AM

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Next speaker
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Hatice Bilgic Lim
Director Clinical Innovation, Philips

Dr. Hatice Bilgic Lim is a leader in medical device clinical development and regulatory writing with over 25 years of experience in research, strategy, and communication. She has held senior positions at leading MedTech companies, including Medtronic, Becton Dickinson, and Philips, where she led cross-functional teams in creating high-impact clinical and regulatory strategies that facilitated global product approvals. Her expertise lies in developing and executing effective clinical trials for innovative technologies that enhance access to care across diverse global markets.

In addition to her industry experience, Dr. Bilgic Lim has a background in academia and nonprofit leadership, emphasizing the advancement of healthcare through research, communication, and training. She is the founder of Academy HBL, where she mentors students and professionals in scientific communication and career development, and she serves as a board member for various academic nonprofits.

At the OCT Medical Devices USA 2025 conference, Dr. Bilgic Lim will lead a roundtable discussion titled "Strategic Leadership in MedTech Clinical Development: Creating Agile, High-Impact Trial Strategies." This session will draw on her hands-on experience in designing streamlined, globally aligned clinical programs that not only meet regulatory milestones but also accelerate innovation.

Session Details:

Designing clinical evidence early: a smarter path to medical device success

2026-06-02, 9:30 AM

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Next speaker
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Rebecca Stepan
Director Quality Systems & Regulatory Compliance, Medtronic

Session Details:

WORKSHOP QMSR six months on — implementing change in clinical study plans, submissions and compliance strategies

2026-06-03, 9:00 AM

View In Agenda
Next speaker
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Amanda Maltzen
Director of Clinical Affairs, Sonex Health

Session Details:

Session reserved for Amanda Maltzen

2026-06-03, 10:15 AM

View In Agenda
Next speaker
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Kevin Hagelin
Senior Clinical Data Manager, Sonex Health
Next speaker
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Liv Williamsen
Chief Operating Officer, Phenomix Sciences

Session Details:

PANEL DISCUSSION Breaking the silos: how early clinical–regulatory–commercial alignment drives impact

2026-06-03, 1:45 PM

Session Details:

Generating credible clinical evidence with limited budgets

2026-06-03, 12:15 PM

View In Agenda
Next speaker
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Bonnie Handke
Senior Vice President, Patient Access, Reimbursement and Healthcare Economics, CVRx
Next speaker
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Matthew Uhles
Chief Operating Officer, Clayton Sleep Institute

Session Details:

Improving participation by modernising eligibility and enrolment practices

2026-06-02, 2:00 PM

View In Agenda
Next speaker
Back
Adam P. Carvel
Vice President, Data Management & Analytics, Fairview

Session Details:

PANEL DISCUSSION Cutting through AI noise by sharing real clinical operations use cases and controls

2026-06-02, 4:30 PM

View In Agenda
Next speaker

Advisory Board

Select a member to learn more

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Dr Alison McMorn
Head of Clinical Strategy and Development, LifeArc

Dr. McMorn is an experienced clinical development researcher with over 25 years of industry experience and has a strong focus in CNS and paediatric drug development. She has worked for both Pharmaceutical Companies and Contract Research Organisations including holding positions at SAR Monitoring Services Ltd, Mundipharma International Ltd and Shire Development Inc. Starting her career at SAR as a Clinical Research Associate (CRA) she subsequently moved to Mundipharma where she was responsible for initiating the first paediatric clinical research program for the company. At Shire Dr. McMorn led, planned and managed global paediatric and adult clinical development programs for a wide variety of indications including psychiatry, pain, gastrointestinal and hepatology across all phases of development (Phase 0 to Phase 4). In addition she was responsible for harmonizing Clinical Trial Administrator (CTA) working practices across all regions for the company. In 2015 Dr. McMorn joined AMO Pharma Ltd, a virtual pharmaceutical company focused predominantly on paediatric neurodevelopmental rare diseases, as VP of Clinical Development. She holds an undergraduate degree in Pharmacology and a PhD in Psychology from the University of Leeds, UK.

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Behtash Bahador
Senior Director, Community Engagement & Partnerships, CISCRP

Behtash Bahador is the Senior Director of Community Engagement & Partnerships at the non-profit organization CISCRP, and holds a Master of Science in Health Communication from the Tufts University School of Medicine. Since 2014, he has collaborated with a range of stakeholder groups to establish and implement patient- and public-centric initiatives across the life-cycle of drug and treatment development. This has included supporting the development of regulatory and cross-disciplinary best practice guidelines, operationalizing key elements of evidence-based public health programing into research engagement activities, and always keeping the needs of patients, participants and the public at the forefront of his work.

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Kathleen Cohen
Vice President, Clinical Development, Marinus Pharmaceuticals

Kathleen Frenia Cohen is Vice President and Head of Clinical Development Operations at Marinus Pharmaceuticals.  Prior to joining Marinus, she spent 20+ years at PRA Health Sciences in a variety of project management and operational oversite roles. Kathleen graduated from the University of the Science in Philadelphia with a PharmD and completed a post-doctoral fellowship in Pharmacoeconomics and Outcomes Research from Rutgers College of Pharmacy. Kathleen resides in Media, PA.

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Aditya Kotta
VP Business Development, Novotech

Aditya Kotta is the VP of Business Development for Novotech. He has been with the company since 2018. He has 14 years of experience in the clinical trial industry, working in both Clinical Operations and Business Development. He holds degrees in Biomedical Engineering from Johns Hopkins University and Medical Science from Boston University.

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Martin Rodriguez
Consumer Safety & Evidence Global Quality & Excellence Head, Opella

Senior executive Leader in Life Science (Biochemist) and Lean/Six Sigma Green-belt certified, with more than 20 year of experience in clinical operations, Operational Excellence (i.e., operational strategy, performance management, process optimization, risk management, Quality-by-Design and team performance), clinical quality, and Service Providers / Outsourcing management.

I developed, reengineered, automated, and optimized business processes with a risk-based and approach to produce high quality outputs and to ensure regulatory compliance. I led the development, implementation and monitoring of different operational and quality strategies and models including Outsourcing as well as new/ innovative clinical capabilities to fulfill consumers/ patients needs .

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Rosalie Filling
Vice President, Senior Global Head R&D Operations, Endo Pharmaceuticals

In her over 25 years of experience, Rosalie “Rosie” Filling has transformed R&D operations in every company she has worked for, developing clear-cut strategies to help advance clinical trials with high-quality operational execution and scientific excellence.

 

Rosie is the Vice President, Senior Global Head R&D Operations Endo International plc. She is part of the global R&D leadership team and is charged with the coordination and implementation of clinical development strategies for the company’s research and development. She provides strategic direction and oversight of the R&D Operations team, which includes clinical operations, data management, biostatistics, medical writing, clinical supplies, trial master file/inspection readiness and business operations. This integrated team handles the execution of all aspects related to Endo’s clinical trials. Endo has active research and development programs in men’s health, orthopedics, and endocrinology. Beyond these therapeutic areas, the company also has focused development in the areas of sterile injectables and complex generic products.

 

Rosie’s main focus at all times is on the end users—the patients. Bringing new and, at times, life-saving medications to patients drives Rosie’s sense of purpose.

 

Rosie joined Endo from Lupin Pharmaceuticals in Blue Bell, PA where she was Senior Director, Head of Clinical Operations, and built the clinical operations organization to support the US and Global R&D Organization. Prior to Lupin, Rosie spent nearly five years at Teva in Frazer, PA where she was the US site head of Clinical Operations and was responsible for the successful delivery of Inhalation, Women’s Health, and Cardiovascular clinical trials. Earlier in her career, Rosie held various roles at Eisai, MGI Pharma and PPD.

 

Rosie earned her B.S. in Biology with a minor in Chemistry from the University of Pittsburgh.

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Edwin van Vulpen
Executive Director and Head of Clinical Business Development Euro-Asia
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Venue

Marrott Minneapolis

Minneapolis Marriott West 9960 Wayzata Boulevard Minneapolis, Minnesota, USA, 55426

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  • Speak with key decision makers as part of our intimate, interactive roundtable style workshop sessions with over 8 hours allowed for networking

Event reach

  • 150+ attendees each year
  • 80% attendees C-suite level

 

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To enquire about speaking opportunities for the conference, please contact:

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