Posted by Tristan Sedgwick on Mon, Nov 23, 2009
We are pleased to announce the launch of the Farm blog. Our intention for launching this Blog is to engage, inform and inspire you. Who are you…?
- Our clients
- Prospects
- Vendors
- Employees
- Future farmers
- Industry-innovators and thought-leaders
At Farm we believe that two heads are better than one and collaboration is the key to uncovering and discovering new ideas and innovations. Over the thirty-plus years we’ve been in the product development business, we’ve learned that networking is critical and we felt that this blog would be a great way to establish an open forum to bring together a diverse mix of successful industry professionals to talk openly by sharing each others experiences and knowledge. We hope to engage you with topics that are informative and inspirational, and invite you to contribute to the conversations. We encourage you to subscribe via email or RSS feed - Your interaction is fundamental in making this blog a success. Feel free to shoot us an email too; we welcome your comments and suggestions and look forward to an on-going, thought-provoking dialogue with you!
Thanks,
The Farm Team
http://www.farmpd.com/ info@farmpd.com
Posted by Joe Civiello on Fri, Nov 20, 2009
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:
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The first step - Compliance with ISO 13485 standards.
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Do you have a quality system in place and relevant SOP's?
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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.
I'm interested in your feedback/comments...