Farm Blog

Trends - Non-Medical Manufacturers Entering the Med-Device Space

I recently attended the 2009 Medical Design & Manufacturing Midwest (MD&M) trade show in Chicago as an exhibitor. Many of the attendees that stopped by the Farm booth were representatives from non-medical contract manufacturers. Was I surprised? Not really. This trend is becoming very popular since these manufacturers are looking for new markets to expand into due to the challenging economic conditions they face in their industries. The individuals that I spoke with are currently in the automotive and industrial industry and had asked for advice on how to successfully gain entry into the medical device space.

Entry for these manufacturers will require them to establish and follow an internal quality system compliant to FDA's Current Good Manufacturing Practices (CGMP's) as it relates to 21CFR820 and the FDA Quality System Regulations.

My Suggestions to them included the following:

• The first step - Compliance with ISO 13485 standards.
• Do you have a quality system in place and relevant SOP's?
• Complete a Gap Analysis Checklist to see where your current system is relative to the standard.
• Business and cost considerations in developing a quality system (and its subsequent certification) must be measured against the return of possible new business opportunities.

It remains to be seen if these non-medical manufacturers will take the leap or if they'll decide the cost of entry is just not worth the risk.

• Are there any additional obstacles you see posing as a risk to these manufacturers?
• Do you consider this trend a threat or an opportunity?

I'm interested in your feedback/comments...