Jeff Castleberry, P.E.

Experience

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  American Cyanamid

  Jan 1984 - Jan 1991

  Director R&D, Director Operations

  $100M Davis+Geck Div of $4B conglomerate American Cyanimid - acquired Vitalmetrics in 1989Responsible for the commercial operations of a precision urine-meter with body core temp monitoring for cardiac surgery - first product - acquired by CR Bard.Led development through commercial launch of a novel lighted-irrigating-suction surgical instrument system - second product - acquired by Davis+Geck.- Established a Tijuana, Mexico cleanroom operation for low cost clean-room product assembly in 9 months and under budget Show less

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  MDC

  Jan 1992 - now

  Principal Consultant, Mentor

  Provide strategic assessment and planning of innovative technologies, new product ideas and ongoing projects. Collaborating with physicians and university researchers on establishing the foundation and fundraising of new companies along with plans for development, regulatory approval and early commercialization. Mentoring company development. As needed, hold key leadership roles to facilitate company formation and advancement.

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  The Larren Corporation

  Jan 1992 - Jan 1996

  Vice President of Operations

  Contract product development services specializing in turnkey medical device projects- Co-led a staff of 27 talented project managers, engineers, designers and technicians in a profitable fee-for-service organization that was attractive for strategic acquisition by Battelle.

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  Battelle Memorial Institute

  Jan 1996 - Jan 1998

  Business Unit Manager, Medical Product Development

  Battelle acquired The Larren CorporationEstablished Battelle’s Surgical Environment and Technology Center.

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  Plexus

  Jan 1999 - Jan 2002

  Director of Operations

  Fortune 500 contract engineering and manufacturing services companyCo-founded divisional site for contract product development services to high tech, industrial and medical device companies. Responsible for business development, operations and client management.- Built a local team of 30 dedicated project managers, engineers, designers and techs to support multiple concurrent clients achieving profitability 6 months ahead of plan.

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  CardioOptics

  Aug 2002 - Mar 2008

  Vice President of Operations

  Venture Funded, Emerging technology stage, commercialized an infrared endoscopy system to view structural heart features through flowing bloodCo-led product development, quality and outsourced manufacturing operations for a computerized laser-IR camera-monitor system and disposable steerable IR catheter-endoscopes. Led a team of 17 in R&D, Quality and Manufacturing Operations.- Co-led efforts for US-FDA regulatory clearance and UL approval for direct vision of heart structures in 100 days, avoiding the cost/time penalty of a multiyear PMA submission required to validate this new imaging modality. - Established a network of contract manufacturing operations for domestic medical equipment assembly, service and production of sterile disposable catheter-endoscopes. Incorporated low-cost disposable fiber optics assembled in Veracruz MX saving over 50% of domestic production costs. Show less

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  EndoShape

  Jun 2008 - Feb 2017

  President, Chief Operating Officer

  Grant to Venture Funded - Early commercial stage, competing in the peripheral vascular embolization market. www.endoshape.comP&L responsibility, leading concurrent technology and product development, manufacturing operations, regulatory and quality, IP portfolio and facilities management. Co-leader in capital/investor development (fund raising), and strategic business development. Leverages network of flexible resources for capital efficiency. ISO 13485 certified. - Grew business from University of Colorado project to a well funding manufacturing organization. Delivered first generation commercial device in 2.5 years. Raised $23m over 5 years. - Built a strong core for concurrent polymer research, product development and operations- achieved US-FDA regulatory clearance of a new vascular implant leveraging a new, never-used-before radiopaque crosslinked polymer.- First-In-Man trial in the Dominican Republic for treatment of Pelvic Congestion in women Show less

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  ALLOTROPE MEDICAL INC.

  Mar 2017 - Apr 2023

  Chief Operating Officer

  Acquired by Northgate Technologies Inc (NTI), Allotrope Medical is focused on improving laparoscopic and robotic surgery through StimSite™, a proprietary system for stimulating ureters hidden behind the peritoneum. Concern for potential injury during lower abdominal surgery (hysterectomies, colon resections, etc.) can slow surgical progress increasing operating costs and extending anesthesia time. Verifying ureter position and peristaltic function - on demand - during the case supports clarity in procedure records, while ureter exercise reduces cystoscopy time at the end of procedure. Show less

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  ForCast Orthopedics, Inc

  Jun 2017 - Jun 2022

  Co-Founder, CEO/President, Board Member

  Founding CEO through 2021. ForCast Orthopedics is focused on improving patient outcomes through better treatment for periprosthetic joint infection. Current treatment options are all surgical, expose the patient to greater morbidity and reflect low success rates. ForCast's ADK (Antibiotic Delivery Knee) Spacer and RIDDS (Remote Implantable Drug Delivery System) delivers physician selected antibiotic directly into the joint capsule to achieve therapeutic concentrations to eradicate bacteria and biofilm in-situ. This improves the opportunity for stable/functional implant retention while reducing systemic exposure to sub-therapeutic levels of antibiotic that can cause antibiotic resistance. Visit www.forcastortho.com Show less

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  Aspero Medical, Inc.

  Sept 2022 - now

  Chief Operating Officer

  First Product: Ancora-SB for small bowel enteroscopy is now FDA 510(k) cleared!Consulting Dir of Operations since 2021.Aspero Medical is advancing endoscopy and enabling intraluminal surgery through novel devices that improve access, stability, traction and precision instrument manipulation. Like the progression of minimally invasive surgery, from open surgery to laparoscopic surgery to robotic surgery, Aspero is well positioned to accelerate the same translations in endoscopy with the goal of reducing patient morbidity, improving provider capability (and therefore profitability) and lower overall cost to payers. See us at www.asperomedical.com Show less