Introduction: Arena International held its 3rd US “Outsourcing in Clinical Trials: Medical Devices & Diagnostics” conference on June 23rd and 24th 2015 at the Minneapolis Marriot Southwest Hotel in Minneapolis, Minnesota. Set in one of the largest clusters of Medical Device companies in the nation, this two day conference brought together members of the global Medical Device industry and experts in the field of clinical trials management to discuss trends in clinical trials outsourcing and best practices to guide success in an increasingly competitive environment.

The feedback from conference attendees was outstanding, as all of the presenters provided practical, actionable advice derived from years of personal experience.

In 2015 as in past years, several common themes were found across many of the presentations including; realistic and clear goal setting, clear definition of CRO roles and responsibility and regular meetings/reports to permit monitoring of study progress by all parties. In a word, COMMUNCIATION was identified as key to CRO relationship and outsourced clinical trial success.

Day One Highlights:

The conference began with a presentation by Linda Nelson, VP Clinical Research at Respicardia. Linda’s presentation was titled ‘Selecting a CRO for international medical device clinical trials, based on best practice ideas for consistent, reliable and effective clinical trial results. Key takeaways from Linda’s talk included the importance of a strong relationship with your CRO, agreeing on expectations early, and tracking performance relative to those expectations with meaningful metrics. Using her personal experiences as a foundation, Linda shared tremendous advice and lessons learned that resonated with with members of the audience.

Anastasia Becker, Director of Clinical Trials for Boston Scientific provided a case study based talk titled ‘Exploring the benefits of moving to fully outsourced model of a clinical trial’. Anastasia beganwith an overview of a functional outsourcing model she has used successfully in the past, while highlighting potential differences between the approachthat large and smaller companies might find effective. Anastasia closed with practical advice based on her own experience as well as adaptions to the fully outsourced model she discussed to be considered in the future.

PrithulBom, Director, Medical Device Development at Theorem Clinical Research engaged the audience with a highly interactive presentation on ‘Mobile Medical Applications: From clinical investigation and regulatory clearance/approval to reimbursement’. Prithul was joined on the podium by her colleague Dr. Elizabeth Brooks from Decision-Driver Analytics. Prithul shared her own deep knowledge of the rapidly evolving mobile health regulatory and reimbursement landscape, incorporating all relevant FDA guidance documents and applicable international standards. The presentation provided practical strategies targeted to mobile application developers who want to engage successfully with theFDA, while simultaneously building effective reimbursement pathways.

Randall Sanagria, Director of Clinical Affairs at GE Healthcare echoed earlier speakers in his presentation by emphasizing the importance of communication between a company and its CROs, along with clear documentation of shared expectations and outcomes to be achieved.

Dr. Elizabeth Brooks, President of Decision-Driver Analytics returned to the podium to share insights on how using value analysis in early product developing can facilitate go/no-go decision, product and feature set prioritization which can in turn influence clinical study design, site selection and ultimately product adoption and reimbursement.

These key lessons were emphasized in presentations by Jeff Mifek (Sr. Director of Clinical at St. Jude Medical, Deborah Schmalz, Sr. Director of Regulatory and Clinical at MedPace Medical and others.

Day Two Highlights:

Steve McQuillan, VP Regulatory & Clinical Operations for Spinal Modulation, returned in 2015 on the heels of the company’s acquisition by St. Jude Medical, and updated the audience on the detailed model that he created at Spinal Modulation that successfully guided CRO selection for the company’s pivotal clinical trials.

Steve shared the company’s fully populated CRO matrix detailing the company’s own internal capabilities as well as those of the candidate CROs. A retrospective look at the CRO selected, their performance and contributions to the company’s successful trials was provided. Steve noted that, in the end, several CROs were used for various aspects of the trial. He likewise made clear that the information collected would now serve as valuable input to future trials. He thanks the CRO partners for their work and support in achieving Spinal Modulation’s clinical and business objectives

PramoteHochareon, CEO and founder of NIrva Medical LLC gave a lively and empassioned presentation on the topic of clinical study design from the perspective of a medical device start-up. Key take-aways included the importance of capitalizing on pre-clinical data to design efficient clinical trials; the need for patience and guidance on the part of CROs when dealing with start-ups and the importance of CRO selection in attracting start-up funding.

The final speaker of the day was Melissa Martinson, President of Technomics who shared her experience working with companies to incorporate economic data collection into their clinical trials design.

Wrapping Up:

The conference ended with a series of roundtable discussions by attendees on optimization of outsourcing models for medical device trials; selecting the right combination of on-site and remote monitoring of off-shore medical device trials and; Assessing the regulatory requirements in the US and internationally to ensure compliant and cost-effective clinical trial design, execution and reporting.

The co-chairs, summarized the key take-aways and thanked all of the presenters for their contributions to the conference. They then thanked the organizers at Arena International and all of the Conference sponsors who made the event possible. Kathryn Essery from Arena International formally closed the session with an invitation to attendees to participate in Arena’s future medical device clinicaloutsourcing conferences.