Many of the stories in the mainstream media are contributing to a public outcry for greater regulation in the medical device space. This has resulted in greater enforcement from the FDA.  As an industry, there is a great desire to constantly improve and innovate to bring new therapies and devices to market. As an industry we need a platform to address the public and the regulators, to show all that we are doing as an industry to remain vigilant for the pubic health.

With that I am excited to start the open pre-launch (Beta) of my510k.com as a new way to collaborate with 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.   The site has some new features like Messages, Groups and Blog features to allow members to communicate about issues that are importat to them.  Whether you are in Engineering, Marketing, Manufacturing, Quality Assurance, or Regulatory Affairs, we all have a stake in the 510k process.

 If you want to join  my510k.com  as a Beta user, please register onsite using OpenID or Facebook.  If you need an invite code for standard registration please inquire via email. Full launch is planned for later this Spring. For now, any inquires about the site can be directed to info(at)my510k.com. Thanks to all who have helped so far!

…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!