The ORS is the leading research society supporting engineers, orthopaedic surgeons, biologists, veterinarians, and clinicians in pursuit of a world without musculoskeletal limitations.

The ORS Innovation Network serves as a hub for orthopaedic clinical translation and the commercialization process of early-stage ideas to provide a home for innovation within the field of orthopaedics.

Saturday, February 5

Sunday, February 6

8:00 AM – 9:00 AM

Program Leads:

Chelsea Bahney, PhD and Michael Archdeacon, MD (OTA)

Identifying novel solutions to unmet clinical needs requires cross-disciplinary expertise and creative brainstorming find targeted and feasible approaches to previously unsolved clinical problems. This Session includes a presentation from an industry leader to explain the power and process of effective brainstorming followed by 3-4 short presentations by surgeons describing an unmet clinical need in their field of expertise. Attendees will then be divided according to their background into small groups and participate in guided brainstorming of solutions that could address one of the unmet clinical needs. The session will conclude with a report-out and discussion of the brainstorming results.

Speakers:

Successful Innovator Case Presentation
Michael Archdeacon, MD

When Damage is Not Isolated: The Challenges in Polytrauma
Todd McKinley, MD

Beyond the Bone: Unmet needs in Soft Tissue Management following Trauma
Joseph Hsu, MD

How Understanding Molecular Mechanisms in Fracture Repair can Lead to Novel Therapeutic
Philipp Leucht, MD

Training in Effective Brainstorming
Chelsea Bahney, PhD

Understanding Clinically Meaningful Benefit Versus Statistical Significance in Outcomes

10:45 AM – 11:45 AM

Program Leads:

Ahmad Faizan, PhD, Jennifer Woodell-May, PhD

Much work in contemporary translational orthopaedic research is centered on utilizing pre-clinical methods to differentiate performance between therapies (drugs; devices; etc) and placebo, with the hope that this differentiation translates to a difference in clinical outcomes.  Much clinical research similarly aims to differentiate clinical metrics (radiography; PROMs, etc) using statistical methods. However, the relationship (or lack thereof) between a statistically motivated conclusion from data and a true difference on patient care is not well understood. The goal of this program is to highlight ways to increase the clinical impact of pre-clinical and clinical research methodologies.

Speakers:

Defining Clinically Meaningful Benefit
Chris Swearington, PhD

Defining clinically meaningful benefit for pre-market clinical studies for the FDA
Glenn Stiegman, MS
Senior Vice President, Clinical and Regulatory Affairs
MCRA, LLC

On the Way to Your Success – Let’s Talk Quality

3:30 PM – 4:30 PM

Program Leads: Yifei Dai, PhD, Bob Hastings, PE

The session inspires a quality mindset and provides essential knowledge on the quality management and activities for a successful translation of research outcome to a clinical product. The speakers share their wisdom and experiences regarding how good quality system/practice can address patient safety, manufactures cost reduction, and product development efficiency

Speakers:

Quality System, Workflow, and Considerations for Orthopedic Implants
Weimin Yue, PhD, PMP, CSSBB, CSQE, CQE, CQA, RAC
Senior Manager, Quality Engineering, Operations, Exactech Inc.

Quality System, Workflow, and Considerations for Electronic Systems and Software as Medical Devices
Eric Moore, BS MBA
Design Quality Engineering Manager, Therapy Planning Solutions, Philips HealthCare

Quality System, Workflow, and Considerations for Orthopedic Biologic Products
Tracy TreDenick-Fricke, BA
Head of Regulatory and Quality, BioTechLogic

Monday, February 7

Business Innovation Competition (BIC)

12:00 PM – 1:30 PM

Program Leads:

Suzanne Tabbaa, PhD, Farshid Guilak, PhD and Chelsea Bahney, PhD

The purpose of the ORS Business Innovation Competition (BIC) program is to provide the resources and opportunity for clinicians and researchers of all levels in the field of musculoskeletal research to participate in a business plan competition to validate the market potential of their technology and develop a commercialization plan through expert mentorship and feedback to assist in translating their ideas from bench to market.

The actual pitch event will be held during 2022 ORS Annual Meeting. The BIC will include two sessions (podium and poster session). The top 3 finalists will have the opportunity to pitch their companies during an oral presentation session (10 min presentation and 10 min Q&A/Feedback).  The session will include a panel of expert judges who will score their oral presentations based on an established ORS BIC scoring system.

The top 10 semi-finalists will compete during a poster session. Expert judges will score their 1-min elevator pitch and poster content based on ORS BIC scoring system. In addition to the pitch event competition, the ORS Innovation Network Group will host a networking event to provide an opportunity for participants and ORS members to network with experienced academics, clinical partners, and leading industry judges and supporters.

Meet the Competitors:

GPN Therapeutics, Inc.
After participating in the National Science Foundation i-Corps Ohio program, NEOvations Bench-to-Bedside entrepreneurship Program at NEOMED and Fast Forward Medical Innovation (FFMI) Program at the University to Toledo. Dr. Safadi, with encouragement from NEOMED, formed GPN Therapeutics, Inc. (GPN) to serve as a commercialization vehicle for this exciting new Autologous Bone Biologic agent and Extraction Device (SACCAVI) for spinal fusion.

Apex Orthopedic Technologies
A start-up orthopaedic device company that produces a new surgical device called the “rib construct”, which utilizes rib fixation for the treatment of early onset spinal deformity.  The rib construct concept was conceived when Dr. Gross (member of our research team) was faced with managing a child with VATER syndrome and a rapidly progressive kyphoscoliotic deformity and concurrent osteoporosis.

PythonFix
Current surgical repair of rotator cuff tears relies on millennia old technology: sutures grasping tendon. Due to stress concentrations at two grasping points the sutures cut through tendon leading to failure of the repair. PythonFix combines a unique mechanical fixation approach with sustained local delivery of biologics. The device consists of a porous base secured at the attachment site and teeth that rise above to grasp tendon. PythonFix fundamentally changes the repair paradigm by distributing load transfer across the entire repair footprint. Initially, we will target the repair of massive rotator cuff tears, which show up to 94% failure rates.

Learn more about the Business Innovation Competition (BIC).

Nuts and Bolts of Funding and Running a Startup as a PI

3:15 PM – 4:15 PM

Program Leads:

Ata Kiapour, PhD, MMSc, Lara Silverman, PhD

Over the past decade, there has been a growing interest in translating novel inventions and discoveries into a product or service that addresses unmet clinical needs in patients with musculoskeletal disorders. While licensing the technology to an existing company is one option, starting a brand-new company focused on the novel idea is another option. It may seem alluring to start a company, but there are significant hurdles and obstacles that must be faced. In this session, established Principal Investigators who have started companies based on their research will share their triumphs, challenges and tips for starting your own company. Also, they will describe how to balance their academic pursuits with their corporate ones.

Speakers:

Bradley T. Estes, PhD
President and Chief Operating Officer
Cytex Therapeutics, Inc.

Suzanne Maher, PhD
Associate Scientist
Hospital for Special Surgery
Co-Founder of AGelity BioMechanics

Martha M. Murray, MD
Orthopaedic Surgeon in Chief, Boston Children’s Hospital
Professor of Orthopedic Surgery, Harvard Medical School
Founder of Miach Orthopaedics