Welcome to Probelogic exclusive " Medical equipment repair" service
We are one of the most popular service company for your anything ultrasound related help.
We repair all brands ultrasound. We can reduce your cost. Experiencing performance difficulties with your medical equipments ?
Call probelogic. Get expert help
http://www.probelogic.com.au/services/general-equipment-servicing-repairs
Additive Manufacturing Discussion Panel – Developing a Roadmap for Regulatory...April Bright
FDA published guidance on additive manufacturing technical considerations in late 2017, outlining the Agency’s long-awaited position on use of the technology for medical devices. At the time, FDA said that the 31-page document was considered “leapfrog” guidance, a term reserved for the Agency’s anticipation that its initial thoughts on an emerging technology will change over time. In short, more questions and answers have arisen — and will continue to do so as the technology is adopted. This FDA guidance is critical to the additive manufacturing narrative. However, standards and best practices surrounding the technology are being discussed globally on a daily basis. This discussion puts representatives from ASTM, FDA, SME and DePuy Synthes in one room, for one conversation, that will provide attendees with practical, actual guidance not only for current times, but also for what is on the horizon.
The Future of Personalized Implants in Joint Replacement: Additive, Robotics,...April Bright
Orthopedics is primed for mass customization of implants thanks to advancements in additive, AI and robotics. Fully leveraged, the technologies can produce patient-specific implants that achieve clinical benefit, decrease cost and maintain O.R. workflow. Founder and Chief Medical Officer of Monogram Orthopaedics, Douglas Unis, M.D., shares his reimagined vision of personalized joint replacement implants and just-in-time inventory solutions.
Welcome to Probelogic exclusive " Medical equipment repair" service
We are one of the most popular service company for your anything ultrasound related help.
We repair all brands ultrasound. We can reduce your cost. Experiencing performance difficulties with your medical equipments ?
Call probelogic. Get expert help
http://www.probelogic.com.au/services/general-equipment-servicing-repairs
Additive Manufacturing Discussion Panel – Developing a Roadmap for Regulatory...April Bright
FDA published guidance on additive manufacturing technical considerations in late 2017, outlining the Agency’s long-awaited position on use of the technology for medical devices. At the time, FDA said that the 31-page document was considered “leapfrog” guidance, a term reserved for the Agency’s anticipation that its initial thoughts on an emerging technology will change over time. In short, more questions and answers have arisen — and will continue to do so as the technology is adopted. This FDA guidance is critical to the additive manufacturing narrative. However, standards and best practices surrounding the technology are being discussed globally on a daily basis. This discussion puts representatives from ASTM, FDA, SME and DePuy Synthes in one room, for one conversation, that will provide attendees with practical, actual guidance not only for current times, but also for what is on the horizon.
The Future of Personalized Implants in Joint Replacement: Additive, Robotics,...April Bright
Orthopedics is primed for mass customization of implants thanks to advancements in additive, AI and robotics. Fully leveraged, the technologies can produce patient-specific implants that achieve clinical benefit, decrease cost and maintain O.R. workflow. Founder and Chief Medical Officer of Monogram Orthopaedics, Douglas Unis, M.D., shares his reimagined vision of personalized joint replacement implants and just-in-time inventory solutions.
Real-World Evidence: The Future of Data Generation and UsageApril Bright
As data is captured through electronic health records, registries and unique device identifiers, the generation of evidence based on this data is expected to play a crucial role in informing orthopedic manufacturers’ decisions before and after regulatory approval. While regulators, payors, hospitals and manufacturers support this shift, they acknowledge that gaps remain in its optimal execution. Priority considerations include how to generate evidence to expedite regulatory market decisions, device indication expansion, postmarket studies, postmarket surveillance and reimbursement decisions. The National Evaluation System for health Technology Coordinating Center (NESTcc), an initiative of the Medical Device Innovation Consortium (MDIC), is leading the conversation with various stakeholders, including FDA and orthopedic device companies to support the sustainable generation of Real-World Evidence (RWE) using Real-World Data (RWD).
VIAS hosted Advanced Biomedical Simulation Seminar at Texas Medical Center Innovation Institute that featured presentations from leaders in the biomedical engineering field.
Topics covered simulation platform for medical devices, stents, heart assist devices, tissue modeling, drug delivery equipment and orthopedics.
Real-World Evidence: The Future of Data Generation and UsageApril Bright
As data is captured through electronic health records, registries and unique device identifiers, the generation of evidence based on this data is expected to play a crucial role in informing orthopedic manufacturers’ decisions before and after regulatory approval. While regulators, payors, hospitals and manufacturers support this shift, they acknowledge that gaps remain in its optimal execution. Priority considerations include how to generate evidence to expedite regulatory market decisions, device indication expansion, postmarket studies, postmarket surveillance and reimbursement decisions. The National Evaluation System for health Technology Coordinating Center (NESTcc), an initiative of the Medical Device Innovation Consortium (MDIC), is leading the conversation with various stakeholders, including FDA and orthopedic device companies to support the sustainable generation of Real-World Evidence (RWE) using Real-World Data (RWD).
VIAS hosted Advanced Biomedical Simulation Seminar at Texas Medical Center Innovation Institute that featured presentations from leaders in the biomedical engineering field.
Topics covered simulation platform for medical devices, stents, heart assist devices, tissue modeling, drug delivery equipment and orthopedics.
3. Founder Owner/Operator
Ridge Medical Designs, Inc.(2001-2015)
Benchmark Devices, Inc. (2007-2015)
Consulted on over 50 surgical or clinical procedure products
Concept to delivery of 175+ medical device manufacturing,
process development, and testing equipment
4. 55+ Companies Consulted
Ortho Noble
Endosuture
Flexion Medical
Integrated Vascular Systems
Lazarus Effect
Luminatal
Neostim
Osiro Vascular
PH Surgical
Radio Therapeutics
Seattle Medical
Vreman Scientific
Thermocure
Treus Medical
WLGore
5.
6. Key member of founding team, Co-developed P.E.T. imaging prototype, Linac
Target, Rotating Test Bed for Proof of Concept Radiation Therapy System
Co-developed Alpha Product Spinning Gantry and sub-systems
Provided Benchmark Devices Model shop for project use
Principal Mechanical Engineer (2015-Present)
7. Co-developed TOGO device architecture, and readied device for Human Clinical Trials
Developed instruments for minimally invasive gastrointestinal surgery
Developed cable actuated clamping systems that enabled remote gastric tissue compression of 150lbs
Supported out of state cadaver and animal lab product and procedure development
Senior Mechanical Engineer (2004-2006)
8. Employee #43, Co-developed core da Vinci instrument architecture
Participated in Human Clinical Trials in East Germany
Developed robotic instruments for minimally invasive cardiovascular, gastric and thoracic surgery
Developed cross-functional knowledge related to surgical robotics in electronics, mechanical engineering, software programming, and system analysis
Managed surgical instrument and sterile accessories, design thru approval
Understands the human clinical setting for minimally invasive CABG and valve procedures
Supported cadaver and animal lab product and procedure development
Developed American and German surgical instrument suppliers
Primary Inventor Medtronic “Octopus TE” endoscopic beating heart stabilizer
Senior Mechanical Engineer (1997–2001)
9. Founding engineer, assisted in the creation of company infrastructure, SOP’s, machine shop & engineering lab
Managed implantable device design and development phases
Created material and process specifications
Created V & V protocols, reports, FMEA
Managed key suppliers
Led and participated in design review, technical, brainstorming meetings
Led process development in laser and resistance weld schedules, hermetic electronic enclosure packaging, glass to metal seal
development, adhesives cure schedules, process equipment, testing equipment
Supported clinical temporal bone evaluation and experimentation
Founding Product Development Engineer (1994-1997)
10. Associate Engineer (1989-1994)
Managed company wide fatigue testing efforts
Created prototypes and production electrodes for defibrillation and pacing leads
Designed and fabricated all FDA life testing equipment
Designed and fabricated coil winding machines, fixtures and prototypes for clinical trials
Managed and mentored one technician
Projected budgets and forecasted goals for department
Developed global fatigue testing methods