2004N-0181 - Critical Path Initiative; Establishment of Docket
FDA Comment Number : EC2
Submitter : Mr. James J. Rogers Date & Time: 06/29/2004 06:06:06
Organization : Coastal Consulting Group, Ltd.
Device Industry
Category :
Issue Areas/Comments
Comment Issues
7. For each problem identified, what role should FDA play and what role should be played by others?
Agency - 100%.
3. For each problem identified, please indicate the type of drug, biologic, or device to which the hurdle applies.
All devices
1. Hurdle Identification. Please describe the product development issue, the nature of the evaluation tool that is out-of-date or absent, how this problem hinders product development, and how a solution would improve the product development process.
Early regulatory involvement - many small and start-up medical device companies continue to "go it alone" and/or do not see the need for RA/QA oversight and guidance until human clinical studies are planned. As expected, this often results in incomplete design requirements, resulting in costly product development delays, maverick "we'll fix it later" product launches, and/or production and product quality issues.

30% of all device Warning Letters continue to address the failure/lack of design controls. The "kinder and gentler" inspection approach by the Agency has done a huge dis-service to the regulatory professionals who have tried to preach RA/QA mantras to executive management, only to fall on deaf ears.
8. What factors should guide FDA in setting priorities among the hurdles and solutions identified?
Follow the money trail. What priorities result in the greatest savings in time and money product development costs? What priorities are the least expensive for the Agency to implement?
5. Nature of the Solution. For each problem identified, please describe the evaluation tool that would solve the problem and the work necessary to create and implement the tool/solution. For example, would a solution come from scientific research to
Industry education.
Outreach to the medical device personnel with executive responsibility.
Tighter inspections and warning letters.
The design controls regulations have the greatest potential to mandate regulatory involvement (by force of law), however, FDA did not specify WHEN design controls should apply to a given design and development process, and no FDA documents provide guidance on this issue. I have seen medical device companies which do not begin design controls until final selection of color schemes, and ultra-conservative approaches applied to every bolt, nut and screw in a prototype device.

2. Please rank each hurdle identified in Question 1, above, in priority order according to which hurdles create the most severe product development problems.
Product development horror stories continue propagate the perception that the medical device development arena is a rich man's game, requiring deep pockets, a steely and an-yielding resolve, and a thick skin for investors and management alike.
6. For each solution identified, please indicate which could be accomplished quickly, in less than 24 months, and which require a long-term approach?
Short-term. Update the Do It Right design control guidance documents.
Mid-term. Amend the design control regulations.