Our Leadership

Siddharth Desai

Founder & CEO

Siddharth Desai has extensive R&D, Operations and Technical leadership experience across a broad spectrum of medical devices, including significant experience in Biomedical, Optical, Infusion, Combination Products, Orthopedics, and Pain Management products. He has been involved in developing a vast array of products, from 'head to toe' with innovative phacoemulsification equipment, Intraocular lenses, combination drug delivery products, ultrasound gel less solution and single use endoscopes.

• Led R&D and Operations for Baxter Healthcare, Allergan, Kimberley Clark, and MicroAire Surgical spanning over 30 years
• Launched three startup companies with expert and innovative clinicians
• Held engineering leadership in a vast array of companies over the entire globe; managed operations and led transfer of products to low-cost facilities
• Developed comprehensive supply chain strategies from California to Boston, Germany to Greece, Penang to Fuzhou
• Led 3 start up companies from concept to commercialization; responsible for raising capital and applications for SBIR grants
• Patent portfolio of over 30 patents; passion to improve human lives enabled launching of products and platforms

Dale Gloyeski

Manufacturing & Technical Transfer Leader

Dale Gloyeski has over 30 years of experience in Medical and Combination Device Manufacturing.

• Led technology transfers for a variety of medical devices: IOLs, Phacoemulsification Equipment, Arthroscopy, IV Containers, and Ablation Catheters
• Technical Transfer expertise to provide rapid start-up and meeting of COGS targets
• Device manufacturing process development per design requirements
• Documentation of SOPs, Test Plans, Validation Protocols and Final Reports
• Effective and efficient product and process qualifications into manufacturing
• Design Change Plan executions to meet quality and regulatory requirements
• Execution of continuous improvement (CIP) projects to provide cost reduction opportunities
• BSME, MBA and Certified Quality Auditor

Andrew Sharp

Systems & Technology Leader

Andrew Sharp is a seasoned engineering and technology leader with a proven record of success in medical device development.

• Seasoned engineering and technology leader with proven record of successes in medical device development
• Core skills in the medical device development domain
• Complementary skills and additional add on skills in Human Factors, Electromechanical System Development, Manufacturing System Planning, Firmware for the Systems, IOT and Connectivity Software
• Strategic portfolio planning process including Product Roadmap, Technology Roadmap for an endoscopy system including Arthroscope, Wireless Camera, RF Ablation tool

Sheshindar Kothur

Lead Mechanical Design Engineer

Sheshindar Kothur has strong experience in electro-mechanical R&D and medical device mechanical design.

• R&D design of electro-mechanical systems, including mechanisms, housings, and integrated assemblies
• Medical device and healthcare product design with focus on safety, precision, and usability
• 3D CAD modeling, detailed engineering drawings, and GD&T
• Design analysis including stress, deformation, and performance validation
• High-quality renderings for design reviews and stakeholder communication
• Collaboration with R&D, manufacturing, and quality teams for DFM/DFA
• Concept-to-production support across the product development lifecycle

Al Rego, PhD

Regulatory Affairs & Quality Advisor

Al Rego, PhD is a seasoned Regulatory Affairs and Quality leader with over 30 years of experience.

• Expert in development of medical device regulations and implementation for start up companies to established companies
• Pharmaceutical Industries: NDA and Clinical studies planned and organized
• Experience in performing, directing, designing, and evaluating clinical and non-clinical studies for pharmaceuticals and medical devices
• Selective expertise includes chemical stability testing, medical device evaluations, statistical design and interpretation, and regulatory submissions
• Expertise in chemical hygiene plans, analytical chemistry methodologies, and sterilization validation
• Supported over 21 start up companies in their FDA/GMP compliance and ISO compliance
• Approval of over 45 products with 510(K) and CE mark
• Adjunct Professor at UCI for medical device RA/QA subjects