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2013 Three-in-Five Competition

Wednesday AM Plenary Session, April 10, 7:15-8:45
Meridian Ballrooms 2-4, The Commons Hotel


2013 Three-in-Five Winner Richard Hendrick"Design of an Endonasal Graft Placement Tool for Repair of Skull Base Defects"

Presented by Richard Hendrick, Vanderbilt University

Endonasal skull base surgery has proven to be a safe, effective, and significantly less invasive surgical approach when compared to open, highly invasive techniques. Nevertheless, one initial difficulty with this minimally invasive approach has been postoperative leakage of cerebrospinal fluid (CSF). While the incidence of postoperative CSF leaks are low (<1%), the potential consequences are severe and include meningitis, brain abscess, neurologic deficits, brain hemorrhage, and death.


2013 Three-in-Five Winner Shayne Kondor"On Demand Additive Manufacturing of a Basic Surgical Kit"

Presented by Shayne Kondor, Naval Postgraduate Dental School

Treatment of battlefield trauma presents a unique set of challenges, among which is the logistical challenge of providing sterile surgical instruments to surgeons. Transport and supply constraints limit the quantity and variety of surgical instruments available in the field and sterilization equipment is often not available to support the instruments on hand. Furthermore, it is difficult to predict and supply the exact type and quantity of instruments needed by a surgeon in the field.

New manufacturing technology offers a compelling solution to overcome the logistical challenge. Durable, biocompatible plastic resins can be formed into any shape using commercially available additive manufacturing devices. This technology is already having an impact on healthcare with the production of custom shaped prostheses and implants. A 2009 SBIR/STTR grant solicitation from the National Institutes of Health, suggested that additive manufacturing technologies could be employed for on demand production of medical instruments in remote sites. This concept was recently explored by the Defense Advanced Research Projects Agency (DARPA) as a 90 day technology evaluation project by the Third Quarter 2012 DARPA Service Chiefs Fellowship Program. The DARPA Fellows assembled a team from the Naval Postgraduate Dental School (Bethesda, MD), US Army Edgewood Chemical Biological Center, (Aberdeen Proving Grounds, MD), and Stratasys (Eden Prairie, MN) to conduct a rapid demonstration of additive manufacturing of surgical instruments in a field hospital setting. The goal of the demonstration was to show that on demand, remote site fabrication of a variety of sterile surgical instruments is a real possibility with the current technology.

Over a period of less than three months the team developed and demonstrated the ability to produce sterile surgical instruments in a field setting using a material extrusion 3D printer. The instruments were printed in a modified ABS plastic resin, extruded in layers to form the instrument shapes. High processing temperatures of the ABS resin produced sterile parts, directly out of the printer. Rapid trials and iterations of the instrument designs resulted in a functional surgical kit which could be printed in a single build on the 3D printer. At the conclusion of the project, the 3D printer and surgical instrument kit were demonstrated in a mock field surgery. A team of military surgeons used the printed instruments to perform a laparotomy procedure on a model wearing a "Cut Suit" training simulator (Strategic Operations, San Diego, CA).


2013 Three-in-Five Winner Carlos Pardo-Martin"Minimally Invasive Device for Rapid Urethrovesical Anastomosis"

Presented by Carlos Pardo-Martin, Harvard University
(pictured Qian Wan, Vanderbuilt University accepting on behalf of Carlos Pardo-Martin)

Radical prostatectomy is a common treatment for patients with prostate cancer. The current surgical technique for radical prostatectomies requires dividing the urethra from the bladder in order to aid the removal of the prostate. At the end of a prostatectomy, the urethra is reconnected to the bladder in a procedure known as urethrovesical anastomosis (UVA) involving suturing the urethra to the bladder with bio-absorbable sutures. This procedure is commonly done first by reconstructing the posterior aspect of the rhabdosphincter, using this reconstruction to bring together the bladder and the urethral stump and lastly performing a running suture to avoid multiple knot tying. UVA is the most challenging and time consuming of the radical prostatectomy procedure due to the constrained surgical field, the proximity of the external urethral sphincter, and the complexity of suturing on very small tubular structures. These have limited the surgical time for the UVA for an experienced surgeon to 15 min.

Most current suturing or stapling devices on the market are not designed for UVA and, therefore, lack crucial features necessary for performing the procedure, for example placing the urethra and bladder neck in contact to insert the sutures. One of the challenges in creating a device to automatically perform UVA is that no non-absorbable structures can remain in the urethra or bladder as interaction with urea in the urine can result in stone formation and further complications.


Panel Judges:

Ben Arcand, Chief Medical Innovations Engineer, Kablooe Design
Dr. Ben Arcand is an engineer and product  innovator in the medical devices field. Recently named one of Minnesota's top inventors by Twin Cities Business Magazine, Ben has contributed to dozens of patent applications in his years with Boston Scientific, the UMN's Innovation Fellows Program and AMS. Currently, Ben is Chief Medical Innovations Engineer at Kablooe Design. In his spare time, Ben volunteers as a Judge Advisor for MN Regional FIRST Robotics Competitions, Sr. Design Advisor for UMN's BME program and an instructor at local maker space The Mill.

Tom Hektner, Independant Consultant
Hektner led medical device company incubators, backed by New Enterprise Associates (NEA) that created six NewCos in markets including stroke, vascular disease, soft and hard tissue repair and glaucoma. These NewCos have attracted > $350M in capital investment. Part of the Founders Group for Scimed Cardiology, financed by a $3M R&D limited partnership where the angioplasty business grew to > $300M which was acquired by BSC for ~ $1B.

Michael Hoey, Founder/CTO, NxThera, Inc.
Michael is a former academic researcher, now an entrepreneur. He previously taught or did research in the departments of Physiology, Urologic Surgery, the Institute of Technology and the Carlson School of Management at the University of Minnesota. He also taught in the Biological Sciences at Hamline University. Michael co-founded Tsunami Medical, an intellectual property and technology company and seven medical products companies. The most recent, NxThera Inc. is located in Minneapolis. Two more companies were founded on his technology, Salient Surgical (now Medtronic) and Vessix Vascular (now Boston Scientific). He has licensed technologies into fourteen different companies. His education is also eclectic with undergraduate work in Natural Science and graduate work in Medical Microbiology, Physiology and Executive Management.

Ross Meisner, Managing Partner, Dymedex Consulting, LLC
Ross is co-founder and Managing Partner of Dymedex Consulting, a recognized leader in understanding medical market dynamics. Ross has 24 years of experience building high- tech companies: he has co-founded four start-ups, managed two international joint ventures, and directed international market development at Medtronic. His experience spans medical technology, management consulting, internet financial services, and the semiconductor industry.

Randy Nelson, President, Evergreen Medical Technologies, Inc.
Randy Nelson is founder and President of Evergreen Medical Technologies, Inc., a contract medical device development, testing, and manufacturing company located in St. Paul, MN. Mr. Nelson is also an Adjunct Faculty member of the Carlson School of Management, University of Minnesota. He has a Mechanical Engineering degree from the University of Minnesota and an Economics degree from Willamette University.

Danny Sachs, MD, "Serial Entrepreneur"
Danny is a physician entrepreneur, founder of several venture-backed device companies including Respicardia, Kspine, and Mainstay Medical. He was previously a venture capital investor with Investor Growth Capital, and served on the faculty of Harvard Medical School in the Division of Emergency Medicine. He earned an MD from the University of Michigan, and MBA from Harvard.

Brian Scovil, Sr. Vice President of Operations and Chief Compliance Officer, Torax Medical, Inc.
Brian joined Torax in 2012 as Sr. Vice President of Operations overseeing the Manufacturing, Quality, R&D, Compliance and Regulatory areas. He brings over 25 years’ experience with medical device development and manufacturing. Prior to joining Torax, Brian operated as the Sr. Vice President of R&D, Product Development Improvement at the Corporate level for Boston Scientific Corporation. Brian also held Sr. Vice President roles for Boston in their Cardiac Rhythm Management and Cardio Vascular divisions. Brian began his career at SciMed where he held manager and director roles in Guide Catheter Operations, Quality and Manufacturing Engineering and Advanced Process Technology and Process Development areas.

Brian has a Bachelor of Science degree in Mechanical Engineering from the University of Minnesota.

Chengli Song, Executive Director and Deputy Dean, Shanghai Institute for Minimally Invasive Therapy, University of Shanghai for Science and Technology
Professor Song is Executive Director at the Shanghai Institute for Minimally Invasive Therapy and Deputy Dean of the School of Medical instrument and Food Engineering, University of Shanghai for Science and Technology. He had his PhD of Mechanical Engineering from UK Cardiff University and Master of Biomedical Engineering from Southeast University, Nanjing China.

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