Diagnostic Consulting Network

IVD Research Director with over 18 years of research and product development experience in the diagnostics industries.

mikesurmanian — Wed, 10 Mar 2010 22:31:41 +0000

Most recently he was Scientific R&D Director at Genzyme Diagnostics in San Diego, CA. He was responsible for the development of Influenza and other respiratory virus rapid tests, established a cell and viral culture laboratory and was instrumental in introducing automation for the development and manufacture of lateral flow tests. Additional experience includes the instrument and assay development for a quantitative rapid cardiac test. Prior to Genzyme, he was the R&D Project Director at Quidel Corp. where he was responsible for the product development of rapid test in the women’s health business group. Before joining Quidel he was a Senior Research Scientist/Project Manager with Pacific Biotech, Inc. where he developed assays for Influenza, Chlamydia, Strep A as well as immuno fecal occult blood.

Biotech and IVD Operations Executive with over 25 years’ Industry Experience

mikesurmanian — Wed, 10 Mar 2010 22:30:54 +0000

Over 25 years experience building, managing, and improving manufacturing, quality, and supply chain systems and processes in innovative IVD and RUO diagnostics companies. Skilled in new product development processes, technology transfer, commercialization and scale-up. Expertise in identifying and eliminating defects and waste in pursuit of world-class cost, quality, and service. Hands-on problem solver, leader and facilitator of continuous and breakthrough improvement activities.

Assay Development and Project Management Professional

mikesurmanian — Wed, 03 Mar 2010 03:30:11 +0000

Over 18 years of research and product development experience in the diagnostics industries. Most recently he was Scientific R&D Director at Genzyme Diagnostics in San Diego, CA. He was responsible for the development of Influenza and other respiratory virus rapid tests, established a cell and viral culture laboratory and was instrumental in introducing automation for the development and manufacture of lateral flow tests. Additional experience includes the instrument and assay development for a quantitative rapid cardiac test. Prior to Genzyme, he was the R&D Project Director at Quidel Corp. where he was responsible for the product development of rapid test in the women’s health business group. Before joining Quidel he was a Senior Research Scientist/Project Manager with Pacific Biotech, Inc. where he developed assays for Influenza, Chlamydia, Strep A as well as immuno fecal occult blood.

DCN IS MOVING

mikesurmanian — Mon, 19 Oct 2009 19:35:28 +0000

DCN is moving to its new 8000 square foot facility on 9 November 2009. The address is 6354 Corte del Abeto,Suite B, Carlsbad, CA 92011. Other contact information will remain the same. (Telephone +1-760-804-3886. Fax +1-760-804-3866.) Watch for more details on the new facility and for the upcoming Open House to celebrate the move.

LATERAL FLOW WORKSHOP

mikesurmanian — Mon, 19 Oct 2009 17:29:54 +0000

DCN will be presenting and exhibiting at BioDot’s workshop on “Materials and Methods to Develop and Produce Quantitative Rapid Tests,” 9 - 11 November 2009. The workshop will be held in San Francisco, CA. This 2½ day course focuses on innovative technologies for quantitative rapid tests used in diagnostics. Dr Brendan O’Farrell will be presenting on a variety of topics including Development and Manufacture of Quantitative, Highly Sensitive Lateral Flow Assays based on fluorescent labels. Please enquire at info@dcndx.com for details.

MEDICA 2009

mikesurmanian — Mon, 19 Oct 2009 17:29:31 +0000

DCN will be exhibiting at MEDICA 2009 in Duesseldorf, Germany, 18-21 November. DCN will be exhibiting in association with Biodot, Ltd in Hall 2 and will be presenting our range of products and services, including the SymBioSys^TM assay development, device design and reader integration program for rapid diagnostics. Please contact Dr Brendan O’Farrell at bofarrell@dcndx.com to arrange a meeting to discuss your application.

NEW WEBSITE

mikesurmanian — Mon, 19 Oct 2009 17:29:16 +0000

Please check out our freshly relaunched website at www.dcndx.com. The site has a new look and feel, and has additional content relative to our newly expanded Consulting Services, Affiliates’ Network and SymBioSys^TM assay development, cassette design and reader integration program. Please let us know your impressions of the new site at info@dcndx.com.

DCN CONTINUES TO EXPAND

mikesurmanian — Mon, 19 Oct 2009 17:27:42 +0000

DCN is in the process of expanding our development teams, with the addition of several Research Scientist and Research Associate positions. DCN also offers ongoing opportunities for consultants in diagnostic industry-related fields. Please see dcndx.com/services/consulting for details.

Quality and Management Professional

mikesurmanian — Thu, 17 Sep 2009 01:43:43 +0000

Quality and Management Professional with over 20 years in the Medical Device/Diagnostic industry. Experience has been gained from starting in the Medical diagnostic business as a Project Engineer for Abbott Laboratories before moving in Quality and R&D Management in the early 1990’s. He has held many positions within both major international and start up companies across the globe. More recently founded a startup (2000), which has focused on providing training, management and leadership in New Product Development and Quality Management in the UK, EU, USA and China. Commercially aware, with a keen eye for detail to improve systems that will provide value adding enabling systems to allow efficient new product development and compliant quality systems that are tailored to business needs.

Regulatory Affairs Professional

mikesurmanian — Thu, 17 Sep 2009 01:43:23 +0000

RAC certified in both United States and European Union regulatory affairs by the Regulatory Affairs Professionals Society, of which he has been a member since 1997. Over 20 years’ experience in the medical devices and diagnostics industries in various roles, including product development, manufacturing, quality and regulatory affairs, augmented by over 9 years of direct experience in a regulatory affairs role in FDA-regulated industry. Knowledgeable of the regulatory requirements for devices and diagnostics in the major OUS markets, and has obtained market clearances in a number of foreign countries. He is a member of the American Society for Quality (ASQ) and is an ANSI/RAB-accredited auditor of quality systems for the medical device industry.