Careful Planning Is Key to Accelerating Product Development
The demand for specialty products combined with rapid changes in technology present a challenge to medical device manufacturers: how to accelerate new product design to maintain competitiveness. Vytas Pazemenas, president of Aubrey Group (Irvine, CA), a medical device engineering firm, emphasized this sense of urgency during a conference session at MD&M West.
Knowing the costs of faster product development at the outset can help motivate both the development team and management, Pazemenas said. A financial model can show the effect of performance shortfalls, delays in product introduction, and increases in product and development costs. The results of financial modeling can then be used in determining suitable trade-offs that will ensure the product is produced on time and on budget.
There are several elements to consider when increasing development speed, Pazemenas said. The "fuzzy front end," or the time from identification of need to product development, is "an area of exceptional opportunity for cycle-time reduction." He offers a number of different strategies to reduce delays. Companies should first measure the time involved, thereby calculating the cost of delay. Companies can also start working on a product's design before planning is finished. Developing new technologies as separate projects and having a master plan for new product development are two more ways of saving time.
To accelerate time to market, companies can enact concurrent development by working on marketing, engineering, and regulatory affairs simultaneously. Another time-saving measure is to assume excess capacity, including having extra people available to quickly finish tasks. Maintaining clear scheduling objectives and planning for small iteration loops instead of large ones can help, according to Pazemenas.
Once a company has organized for speed, it must define the right product. Seeking customer input by involving them in discussions is the starting point. Risk/hazard analysis should be done automatically very early in the process to avoid potential problems with FDA. Teams should also define the performance requirements clearly and keep product specifications flexible to accommodate time constraints. Successful designs and techniques should be reused.
Make regulatory approval part of the product strategy by adding a regulatory affairs expert to the development team, Pazemenas added.
"Technology and market forces will demand faster development times in the future, so industry can't rest on its laurels," said Pazemenas. However, he urged companies to carefully consider the attendant risks before rushing to shorten development times. "You have to involve more people at the same time, so it's messier. As a result, more management attention is required." David Bowen