A keynote address at the 7th Annual Orthopaedic Manufacturing & Technology Exposition and Conference (OMTEC) in June 2011 forecasted several changes in FDA regulatory policy and a concomitant evolution in the medical device market. The trend toward “negative innovation” is slowing the adoption of cutting-edge products—to the ultimate detriment of patient, doctor, hospital and manufacturer.
This increased emphasis on comparative effectiveness necessitates an expansion of data collection. This has some subtle implications. To counter increasing bureaucratic control, manufacturers need not just clinical outcome data, but also a comprehensive understanding of their own products’ geometry, the details of the results of their manufacturing process.
As W. Edwards Deming forewarned, foreign competitors throughout precision manufacturing—especially, but not exclusively, “Brand China”—are quite receptive to new ways of improving part quality while still decreasing cost, complexity and time to market. As we've seen in other industries, once we’ve lost the lead to foreign manufacturers, we’ll have a hard time getting it back.
Globally, the medical device industry remains competitive and promising. Even with the recent slowdown in Asia, global annual growth in the industry is projected to lie between five and 10 percent throughout the coming decade. This is still a great business to be in!
The challenge is to adapt to the changing times and find the best new ways of doing things. That’s only possible if manufacturers understand the available modern technologies.
Best practices have crystallized over the years and decades, but what might have been a best practice even five years ago might be dangerously antiquated now. American manufacturing firms, many of which are now struggling to survive, can't afford to ignore opportunities to reduce new product development time by 30% or more—and improve product revision program speeds by upwards of 50+%. To prosper, they will have to change.
The Project Triangle: A 20th Century Problem
The traditional approach to design is borrowed from the Triple Constraint model of project management. Quality, schedule and cost are usually assumed to exist in tension. Manufacturers have generally attempted to optimize two of the three, and have given up on the third. (See Exhibit 1.) This is no longer necessary for those who are willing to apply advanced tools to their enterprise’s continual improvement.
Exhibit 1: The Project Triangle