ORS Innovation Network

Organizers: Jeff Bischoff, PhD and Robert Hastings, PE, ORS Industry Engagement Committee 

Much contemporary translational research entails collaboration between different sectors – academic investigators, industry researchers, clinicians.  When the translational research involves new technologies, navigating through the intellectual property interests of the constituent parties can be daunting, and in some cases disruptive to the advancement of the research into the clinic.  The goal of this session is to engage a panel of legal representatives and investigators who will provide basic knowledge and practical strategies for pro-actively addressing IP within translational research programs.

• What is considered IP?
• What is the IP of an academic investigator, and what is the property of the institution?
• How is IP properly assigned if it is the outcome of a research collaboration?
• How is ownership of IP impacted by federal or private funding streams?
• How should consideration of IP impact strategies for securing research funding?

Organizers: Vishal Deshmukh, PhD and Yifei Dai, PhD, ORS Industry Engagement Committee

This workshop aims to prepare emerging/next generation investigators with fundamentals and forward-looking views regarding conducting high quality orthopedic related clinical research. Attendees will learn the design and conduct of clinical trials under Good Clinical Practice (GCP), associated scientific and regulatory principles, trial and site management, as well as statistical analysis of the trial data. Latest game-changing features of modern clinical trials, enabled by the advancements in digital technology, Artificial intelligence (AI), and machine learning (ML) will be discussed regarding future advancing of the clinical trials.

The faculties also will share their expert experiences and insights on conducting clinical trials under various roles (trial designer, regulatory body, study operator/manager, collaborator, and data scientist) and perspectives (clinical leadership vs researchers, surgeon vs academia vs industry).

This workshop provides ORS investigators the needed fundamentals and exciting novel research skills to further advance the ORS goal of developing musculoskeletal discovery and research to improve health.

Organizers: Lara Silverman, PhD, Suzanne Tabbaa, PhD, and Scott Bruder, MD, PhD, ORS Industry Engagement Committee

This session is the sixth in a series, continuing an open discussion with the FDA which was started at the Industry Connect session in 2016 (Orlando) and has continued annually since then.  The series is focused on presentations and discussion of timely regulatory topics relevant to orthopaedic product development. The session this year will cover existing regulations around Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), compliance, and provide insights into upcoming FDA changes around these regulations. Presenters include expert regulatory consultants and the FDA.

Organizer: Lara Silverman, PhD, ORS Industry Engagement Committee

You’ve successfully identified a promising new orthopedic product or treatment. How do you manufacture it so that it can be actually tested in human patients? In this session, we will review the basics of how to make your product suitable for human use. Speakers will outline the key considerations and processes for fabricating medical devices and manufacturing biologics/cell therapies for early stage clinical use. Topics will include the use of Contract Manufacturing Organizations (CMOs), adherence to appropriate regulatory standards, and common pitfalls to avoid when engaging in early-stage manufacturing for human clinical use.

Organizers: Commercialization & Innovation Group 

Moderators: Nicholas Pachuda, Pure Medtech Advisors; Chelsea Bahney, PhD;  Zach Working, MD

Identifying meaningful unmet need is one of the most critical steps to in validating that your ideas have market potential. For healthcare innovation that requires understanding the clinical need, target patient population/procedure, the regulatory pathway, market competitors, and possibly even reimbursement potential. In this session we host a discussion with a surgeon-entrepreneur, strategic marketing business expert and kickstart-style investor to understand how they successfully uncover, evaluate and prioritize the unmet needs that ultimately create actionable insights for companies.

Featured Speakers:

• Danny P. Goel, MD. CEO-Founder at Precision OS Technology
• David Anshen. Senior Consultant at Market Edge
• Neil Littman. CEO-Founder at BIOVERGE