| Nova Biomedical Corp. Press Release |  |
Accelerating Speed to Market - From Concept to Finished Device, Development Efforts Can Benefit from 'Thinking-Out-of-the-Box' Approach
Time to market for an IVD medical product is a key objective in any product development program. As the IVD market continues to grow at an attractive rate, the ability to shorten the development cycle is critical to financial reward.
Although "conventional wisdom" has been the watchword of the industry in the past, many IVD product developers are now taking more unorthodox approaches in directing their programs to remain on the fast track. Such approaches may involve a bit more exploration into unchartered waters where more risks are ventured in an effort to gain commensurate rewards.
No matter how conventional or unconventional the approach, a fundamental element of any IVD development program is to establish a timeframe and assemble the associated resources to make it happen. Because many companies do not have or cannot afford to utilize internal resources to meet the demands of the program, outsourcing has become an effective way of filling the void.
Outsourcing a Mainstay
Outsourcing is far from a new concept. As early as the 1500s, Michelangelo acted as a head contractor to commission a team of craftsmen to help bring massive artistic efforts, such as the ceiling of the Sistine Chapel, from concept to reality. Through the 1700s and 1800s, prisoners and other laborers were hired by governing bodies to build roads, railroads and water storage and distribution stations in the U.S. and France. While outsourcing diminished in the late 1800s and early 1900s, it picked up again in 1930 when Battelle essentially invented contract R&D.
Within the past few decades, outsourcing of manufacturing has become a common practice, particularly in the electronics industry. That paved the way for the medical device industry to adopt this approach. In fact, the global market for outsourcing IVD product development and manufacturing is $8 billion, with a foreseeable future growth rate of 20-25%, according to several industry estimates.
Access to world class technological and process innovations not available internally is a big reason why outsourcing can speed up the development process. Such expertise and skills can move a company ahead of its competitors in the race to introduce a unique medical product. At the same time, the IVD company can maintain its internal focus on core activities without the need to build staff and overhead or endure heavy capital expenses.
Key factors for successful outsourcing include determining a strategy, developing a plan and identifying the processes or activities to be outsourced. The first step in determining a strategy is to clarify organizational goals and define what is to be achieved by outsourcing and then recognize core competencies and align them with core processes.
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