Second Source Medical LLC (SSM) is a medical device contract manufacturing company in San Jose,CA. Our experienced staff assists clients with their process and assembly needs and create solutions to address their requirements. SSM occupies an 8500 sq ft lab and controlled environment space dedicated to manufacturing and process engineering.
Our goal is to enable clients to meet their manufacturing needs by providing engineering and manufacturing support to expand clients' capabilities. Creating cost effective solutions to the typical resource constrained manufacturing projects, SSM is focused on enabling clients to achieve their potential.
Established in 2004, Second Source Medical was founded to meet the growing manufacturing needs of medical device companies seeking to out-source their manufacturing operations. The current medical device industry has seen a trend toward focusing company efforts on key technologies/critical core competencies while moving away from the traditional vertically integrated business model. SSM provides engineering and manufacturing capabilities to companies looking for a new way of successfully managing the changing business environment.
Partner and Managing Member
Mr. Tsugita has over 20 years experience designing and developing medical devices and biomaterials for the interventional, surgical and drug delivery markets. His interest in the medical device industry began while working at ALZA Corporation developing and evaluating polymeric coatings and membranes for transdermal and oral osmotic controlled release drug delivery systems. Leveraging this experience along with a BS degree in polymer processing and materials, Mr. Tsugita has focused his career on bringing new medical products to market. His list of accomplishments also include 40 issued US patents and 4 published scientific peer review papers.
Mr Tsugita has worked on a wide range of devices including:
Abbott Laboratories continuous cardiac output oximetery catheters
Nitinol & stainless steel guidewires
Hydrophilic coated neurovascular catheters
EMBOL-X blood filters
Vascular & non-vascular stents
Target Therapeutics detachable embolic coils
Landec surgical incise drapes & adhesives
Balloon occlusion catheters
SciMed guidewire filters
With an entrepreneurial spirit, Mr. Tsugita started a successful consulting business, ENDO Consulting, in 2000. He has worked with small venture funded companies like IMETR-X, Inc. and large multi-national medical device corporations like Boston Scientific Corp. as a senior manager and lead developer. Projects ranged from designing new medical implants to developing and implementing design changes for existing commercial product lines to extend product lifecycles. Based on these experiences, Mr. Tsugita saw the need for creating a new manufacturing pipeline for medical devices. Second Source Medical LLC (SSM) was founded to provide manufacturing opportunities for entrepreneurs and Fortune 500 companies in an ISO 13485:2003 certified environment.
Vice President, Quality Assurance & Regulatory Affairs
Partner and Managing Member
Mr. Lee has over 30 years experience in Quality, with 28+ years of combined experience in Quality Assurance and Regulatory Affairs in the medical device and biotechnology industry. He has provided leadership roles for small start-up companies and Fortune 500 corporations develop and manage their quality assurance programs and regulatory strategies. He has served and held key management positions in Quality Control, Inspection, Quality Engineering, Auditing, Regulatory Affairs, and Regulatory compliance. He has guided companies with their regulatory approval strategies, written submissions, design dossiers, technical files, and provided support for clinical trial activities.
His vast experience includes ocular implants, dental implants, sterile injectables, cardiac catheters and accessories, surgical instruments, cardiovascular implants, embolic protection, drug delivery systems, and electro physiology devices. He has served as a quality and regulatory consultant, helping companies gain product approvals, CE mark, and FDA and ISO 13485 quality system compliance.
His background includes companies such as Collagen Corporation, Nellcor, Cordis Corporation, Boston Scientific, and J& J Interventional Systems.
His work includes poster presentations at the IEEE Engineering in Medicine and Biology Society, corporate and ASQ statistical training, and as a seminar speaker for SPC training.
He is an ASQ Certified Quality Engineer and is ISO 13485:2003 lead auditor trained. He holds a undergraduate degree in Biology and a graduate degree in Quality Assurance.
Vice President, Finance
Ms. Tsugita has over 40 years of experience in finance and accounting. She has been responsible for managing SSM company finances and has been the primary driver to incorporate the company ERP system into daily company operations.