Our Leadership Team
Vice President, Quality + Compliance
Dr. Bruker has 25+ years of experience in the medical device industry in the areas of orthopedics, sports medicine-arthroscopy, ophthalmology, and general surgery. He has led unmet needs analysis-driven product development from concept to commercialization. His expertise encompasses compliance with US and EU regulations for medical devices and combination products, development of guidelines for evidence-based medicine, technology landscape analysis, strategic planning, due diligence, auditing, and project management. Dr. Bruker is an experienced CGxP auditor for CMC, Clinical, and Laboratory, with an emphasis supporting products that contain device aspects. He has served as a member of Pharmacovigilance groups at Fortune 500 companies evaluating complaint and adverse event data for further action. As the head of clinical research at a major big pharma company, Dr. Bruker led Clinical Trial Design and IFU reviews. As a clinician, Dr. Bruker has performed and continues to perform post-therapy patient interviews.
Dr. Bruker has implemented and optimized R&D processes for medical device development in order to cut down the cycle time and increase productivity. He has designed and implemented design control processes in compliance with FDA and ISO requirements and has participated in audits by regulatory bodies. He has been an advisor and trainer to large-cap pharmaceutical companies in combination product regulations and the Quality System Regulation (QSR). He has been a key member of the Quality Councils responsible for the operational integrity of the QSR and decisions on product recalls. Dr. Bruker has written Clinical Evaluation Reports (CERs) in accordance with the latest EU medical device guidelines and participated in reviews and symposiums with Notified Bodies on the changes to EU regulations for medical devices. Dr. Bruker was a member of the Medical Device Innovation Consortium (MDIC), a collaborative effort between the US FDA and industry focused on Regulatory Science. Dr. Bruker was one of the authors of the “Blue Print for Early Feasibility Clinical Studies” sponsored by MDIC.
He has implemented evidence-based medicine principles into the product development process to respond to different levels of evidence required by start-ups as well as large cap-medical device companies, considering technical, budgetary, and regulatory requirements as well as reimbursement expectations. Dr. Bruker has expertise in polymer processing (injection molding, extrusion, compression molding rapid prototyping), application of rheology to solve fluid flow problems, surgical procedure development, and failure mode and effect analysis in the context of medical devices and combination products. Dr. Bruker has performed intellectual property mapping and established strategic planning processes within the framework of disease states as well as technology applications.
In the orthopedic space, Dr. Bruker has designed a multitude of products and has navigated them through commercialization. He was a pioneer in the development of novel bio-resorbable polymer-based products in the sports medicine field in general and their application to joint preservation in particular. He has collaborated with major teaching hospitals in the development of test methods and novel carrier systems for healing and regeneration. He has spearheaded the development of an in-situ cartilage regeneration system that has been successfully evaluated with randomized controlled trials in the EU and US.
Dr. Bruker was a member of the Osteoarthritis Research Society International (OARSI) committee tasked by the FDA to critically evaluate the guidelines on “clinical development programs for the treatment and prevention of osteoarthritis.” He has led surgeon advisory boards and focus groups, and he has expertise in the development and use of Patient Reported Outcome (PRO) instruments for use in claim construction that meet FDA requirements.
In the Ophthalmology space, Dr. Bruker has been involved in process development for contact lens manufacturing, intraocular lens design, testing, and development through commercialization. He has co-chaired development councils with innovative start-ups in addressing presbyopia and has led clinical trial design teams and participated in discussions with the FDA in clinical trial design issues for new cataract surgery procedures and implants. He was in charge of the pilot plant for intraocular lenses that produced articles for clinical and pre-clinical studies.
In general surgery, Dr. Bruker was involved in design and materials development for hernia repair, lung resection, and mesh development for pelvic organ prolapse.
Dr. Bruker has supplemented his expertise in medical device research and development with application of comparative effectiveness analysis. He has developed Markov models to compare effectiveness of procedures and devices.
KYMANOX TEAM HIGHLIGHT: Meet Dr. Izi Bruker