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

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