 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 | |||
|
 | |
|
|
Sienna Partners Blends Consulting and Training Columbia-based Sienna Partners was formed in 2000 to provide consulting and training in manufacturing, quality, and regulatory systems to medical and high-tech companies. Its two principals, Judi Smith and Tom Wiggins, have over 35 combined years experience in the field. They first met at a small medical diagnostic and instrument company — Tom was head of Operations and Judi was head of Regulatory Affairs and Quality Systems. What they soon realized was that when Manufacturing and Regulatory/Quality work together to develop and implement practical systems, the process is much smoother, more efficient, and less painful. It even led to a more successful FDA inspection! When their company decided to relocate to Minnesota, Judi and Tom chose to stay in the Baltimore/Washington area and put their philosophy to work in a partnership. Since Maryland has a large number of medical and high-tech companies, this was the perfect location to offer their services in helping companies' transition from research to development and commercialization. Their mission is to provide top-quality consulting and training in the areas of process, manufacturing, regulatory and quality systems, enabling their clients to improve the profitability and establish/maintain the regulatory compliance of their business. In Judi's prior industry work experience, she has been responsible for the clinical trials, quality systems, regulatory submissions, and approvals of a multitude of biological, in vitro diagnostic, medical device, and drug products. Tom's prior work experience includes engineering and manufacturing management in a variety of consumer, communications, and oceanographic and medical diagnostics. Local clients include: Cylex Inc., Protiveris, and Coagulation Diagnostics Inc. However, they also have clients in six other states and two foreign countries. Protiveris approached Sienna Partners to help in their product development efforts and to identify technical partners to support the development. Sienna Partners assisted in formulation of a product concept, identification and management of specialty vendors to develop product subsystems. In addition they prepared the manufacturing sections of the corporate business plan, allowing product development and funding activities to move ahead. Coagulation Diagnostics was looking for assistance in developing a device to simplify the steps involved with their assay. Sienna Partners developed a working prototype that reduced the number of operator steps while providing greater safety during blood handling. They also helped the company meet FDA requirements for Design Control. Cylex, Inc. came to Sienna Partners with a new product that had been in research and development for 3 years. The product was a new technology that helped physicians assess the functioning of their patients' immune cell system. Over a twelve month period, Sienna was able to help move the product through final development, clinical trials and FDA submission. Sienna helped Cylex make the transition from R&D to FDA-registered manufacturing in under eighteen months.
|
| |
