FDA launched new measures today opening up operations to consumers. How can we have the same openness in the 510k process for Device Makers? Read today's Five-Ten Blog.

So, we are now 6 days into the New Year, and already I am starting to see the euphoria wearing off on my friends and colleagues. You know, that hope that we all had at around 11:59 PM on December 31, that this time it was going to be different. Then we counted down the final seconds and all was right with the world. Over the weekend, my local gym filled up with people ready to go out and tackle the new year and get in shape. Then, some family time over the long weekend...maybe you spent it returning some gifts, meeting up with relatives, watching college football, or maybe just relaxing and enjoying the last few days of the holiday.

...then Monday came. BAM! And it hit most of us that it's back to work, and back to 'real life'. And, all of a sudden I can see the pressures of life settling back in to most of us. We have to be realistic and recognize that market pressures and regulatory forces within our industry stand in opposition to us, and can form roadblocks to our success as developers and manufactures of medical devices. That said, I still see this year as bringing lots of new opportunities and avenues to pursue success...in life and in business.

So, that's what this site is going to be about - my510k.com a new way to be successful by collaborating as colleagues in the Medical Device industry. Many of us who will use this site are certainly experts in our own right, with years of experience in the field. Many of us have developed strategies over time, and we have been able to get products to market. Our collective efforts have allowed our companies thrive despite these current conditions. As the FDA ramps up compliance enforcement and the economy continues to sputter, we will need to work closely with each other to keep the new product pipeline flowing. Whether you are in Engineering, Marketing, Manufacturing, Quality Assurance, or Regulatory Affairs, we all have a stake in the 510k process. my510k.com is a niche social network created to foster Design Control collaboration between departments and across the industry.

In this site we will work together, celebrating each others accomplishments and supporting each other when challenges arise. I am currently recruiting the network founders who will help get conversations started and Beta test the site. Full launch is planned for later this year. For now, any inquires about the site can be directed to info(at)my510k.com. Best of luck to all in 2010!