Medical Device Related Content Updated on CQ Site

We have added some updated content to the following pages for you to review:

Tips for Startups

Medical Device News

Events

Enjoy!

Quality & Regulatory Resources In High Demand for Medical Device Industry

The trend recently has involved at least one phone call or email per week from a medical device company requesting help–either full-time or consulting–in the areas of quality and regulatory. And the requests are coming from all types of medical device companies.

As a consulting firm providing solutions in quality and regulatory, I’m a little excited about this trend. But this also has me a little concerned, mainly because I want to understand why the sudden surge.

Are companies suddenly struggling with FDA regulations and ISO requirements? Are companies expanding into new markets requiring expertise from seasoned experts? Are companies losing resources? I honestly don’t know the answers. But I can tell you it has been difficult to find people to fill the requests.

If you have quality and/or regulatory experience or know someone who does, please contact us: 765 315 2736, info@creoquality.com.

Using LinkedIn to Expand Medical Device Network

During the past couple months, CQ has been in the midst of an experiment. No, we have not been mixing chemicals in a lab. No, we haven’t been tinkering with a medical device concept and prototype (at least not directly).

Our experiment has been more in the realm of growing our network and expanding our brand awareness. And I think it has been working. So what did we do?

The main thing that we did is get more engaged on LinkedIn. We found and joined several medical device related groups, including Medical Devices Group and Medical Devices and FDA. We made it a point to visit many of these groups every few days to review the topics being discussed. When we had something to contribute to the discussion, we added our comments. We also decided to post topics for discussion from time to time. Usually, the topics came from our current client engagements and needs. Through our review of the topics being discussed, we started to gauge the topics of interest in the medical device community. We used this information to help us with the content on the CQ blog.

How do I know it’s working?

We have made several new connections on LinkedIn since working on this experiment. We have exchanged emails and in a couple cases had phone conversations with many of these new connections. We have added several of these contacts to our TFMail email marketing list. We have been contacted by a few inventors / entrepreneurs looking for help with their medical device ideas, including the one described in a previous post, which has led to us reconnecting to others in our pre-experiment network and then making more new connections on LinkedIn. You get the point.

Basically, we found several receptive medical device communities through LinkedIn groups and have become active contributors. And we have found that this process is very cyclical and rewarding. We will continue the experiment.

Helping Medical Device Inventor By Paying It Forward

During the past few weeks, I have been helping a person I don’t know and have only met once via a Skype video call get feedback about his medical device concept. The person did not offer me any compensation, nor did I request any payment. I just offered to put some feelers out and see what kind of feedback and responses I could get.

Why? I know I have a top-notch network and am either already connected or easily could be connected with physicians who can and will provide feedback for the inventor. I know that I can help this person understand the medical device product development process just a little better. I know that if the idea isn’t worth pursuing, taking this approach makes the best sense for the inventor–spend as little as possible to find out if the idea is worth taking to the next step. I believe if the idea has merit, this inventor (and maybe others like him) will have an interest in working with Creo Quality.

Yes, it’s definitely a “pay it forward” kind of strategy. Yes, I realize I may never receive any revenue from doing something like this. And that’s okay.

While the feedback is still coming in, I did get one response from an expert in this particular device space. The expert is very interested in helping with a prototype and other business development / research activities. I connected him directly with the inventor.

FDA and Other Regulatory News for Medical Device Industry

We’ve updated the links on the Regulatory page. Quite a few FDA updates to review.

Several Medical Device Events in July 2012

There are quite a few interesting medical device related events throughout the Midwest, many in Indianapolis, in the month of July.

Check out the CQ Events page for all the details.

Looking for Physicians and Nurses to Evaluate Medical Device Concepts

I’m currently working on a few medical device ideas–some are mine, others are from inventors and entrepreneurs. I hope to get all of these ideas to a point where I will need feedback from physicians and nurses on the merit of the concepts.

If you are willing to help evaluate these ideas, and/or know others who are too, send me a message or give me a call at 765 315 2736.

Medical Device Company Needs Regulatory / Quality Resource

I’m working with a disposable medical device company based in central Indiana who is in need of at least one full-time resource in regulatory affairs / quality assurance. The ideal candidate should have at least 5 years medical device experience with a primary emphasis on regulatory, preferably U.S. and outside U.S. (including EU, Canada, South America).

If you or someone you know is interested, please contact me directly at 765 315 2736 or via email.

Updating Content on CQ Website

Behind the scenes during the past few weeks, we’ve been jamming and brainstorming to figure out ways to deliver interesting and relevant content to CQ website visitors. If you happen to read our blog posts, you get this information all the time. We thought we would tweak a few things to make it even easier for others to get this information too.

Here are some of the new updates:

  • Changed the main navigation menus. We had too many choices and sub-choices. So we consolidated some, eliminated others, and added some new ones. Check it out on the CQ page.
  • Added “Medical Device News” page (which is also on main navigation). From time to time, we will update the content of this page, sharing links and interesting news stories from the medical device industry.
  • Added “Tips for Startups” page (which is also on main navigation). We will share tips and advice we discover and share this information with you.

We have a few other things we are in the process of updating. We’ll share when it’s ready.

Networking Tips

You might have read the post about a recent call I received from Mary looking to connect and network with medical device professionals. The next day, we came across 21 Tips to Use at a Networking Event by Mark Hunter at The Sales Hunter website.

I’d like to share a couple of the tips from the article:

  • Stop selling and start listening! When you meet someone for the first time, use it as an opportunity to get to know them. Don’t try to sell them anything. Rather, begin to establish a relationship.
  • During the course of a conversation, use the other person’s first name two or three times. People always like to hear their own name and it will help you to remember it when the discussion is over.
  • When you meet someone for the first time, you have 72 hours to follow up with them before they will completely forget about meeting you.

The article shares many other useful networking tips. Additionally, here are a few of my own:

  • Pay it forward. Find out how you can help the person you are meeting. Try to make meaningful connections for them either at the event or when following up via email.
  • In my experience, I’ve rarely met a potential client at a networking event. However, there have been many occasions when I’ve met another service provider who has a similar clientele interest. Try to seek complimentary connections out at networking events.
  • Go to where the people are. Often times, the topics presented at networking events might be marginally interesting to me. But the event is not about me. I have to evaluate if the topic will bring a large crowd and attendees whom I am interested in meeting.

Where to Meet Medical Device Professionals in Indiana

I had a call earlier this week from Mary. Mary started her career in the medical device industry. Several years ago, she put her career on hold to raise her kids. Now that Mary’s kids are older, she has an interest in getting back into the medical device field. Mary started networking in her local business community. Several of the contacts she made suggested that Mary contact Creo Quality for what to do next.

I’m glad Mary called. We’re happy to help. Interestingly, Mary’s question was one we’ve heard many times before. It just hit me that since Mary and others have had this question, maybe I should spend a little bit of time writing down my response for others to review too.

Mary is interested in networking and meeting medical device professionals in Indiana. I suggested that she check out the following:

  • INpact – A network of medical device service providers. INpact’s program is structured around issues around medical device product development. Monthly events are attended by service providers (such as designers, engineering firms, regulatory, quality, intellectual property), inventors, entrepreneurs, and startups.
  • Indiana Biomedical Entrepreneur Network (IBEN) – Monthly events feature topics pertaining to medical device / life science startups. Attendees include inventors, entrepreneurs, startups, service providers, and investors.
  • Indiana Medical Device Manufacturers Council (IMDMC) – Frequent events typically focused on FDA-related medical device issues. Attendees are typically comprised of Indiana’s medical device manufactuers.
  • Indiana Health Industry Forum (IHIF) – Monthly lunch events draw larger crowd but attendees represent a much broader spectrum of backgrounds. Plus, IHIF caters more to life sciences industry as a whole rather than just medical devices.
  • BioCrossroads – They host and sponsor a few events throughout the year. Again, like IHIF, BioCrossroads has a wider scope of life sciences and has historically skewed more towards pharmaceuticals.

I also shared with Mary that we try to post many of these events on the CQ blog.

2010 Wrap Up

We’re fortunate–very fortunate–because we can claim 2010 as the best year ever for Creo Quality. About a year ago, we established 2 goals for our business:

  1. Help three entrepreneurs initiate product development activities during 2010.
  2. Increase Creo Quality’s top-line revenue by 25% in 2010 (against 2009).

How have we done?

During 2010, we have worked with over a dozen early-stage entrepreneurs. I wish I could report that most have entered into product development. But in these economic times, most inventors and entrepreneurs have had a difficult time raising funds. We have helped a few of these companies get to the next step. Another outcome of our work was creating a tool we call “Building The Business Case“. It’s a high-level snapshot / checklist / workbook to provide a little guidance and direction for entrepreneurs. Feel free to download and use it for your ideas (and send it our way for review).

At last check a few weeks ago, revenue for the year is up over 30% from 2009 (and we still have a couple more weeks to go). Again, in these times, we are truly blessed to be in this position. This has allowed us to explore and invest in some pet projects, such as Big Ideas. This has also allowed us to provide more “free” assistance to inventors and entrepreneurs.

Creo Quality is looking forward to 2011 and will be setting some lofty goals. We plan to continue helping entrepreneurs, to expand Big Ideas program, and to begin working more closely with communities and economic development organizations.

Thanks for being part of our journey.

2010 Big Ideas Awards Recap

On Saturday, July 10, the Big Ideas contestants, judges, and donors gathered together along with interested community members to hear the judges’ final results.  Only three of the twenty ideas submitted were not represented by their contestant at the event.

Each “Big Idea” score was the sum of two scores:

  1. the straight total of points awarded by all the judges
  2. the number of times a judge placed the idea in the top four

So, who were the winners?

4th Place ($200):

Bob Johnson to build a campground in Morgan County

3rd Place ($400):

Raquel Zike to build a Skateboard Park in Morgan County

2nd Place ($600):

Jennifer Blankenship to turn the old Harman Becker building into a Community Center

1st Place ($800 & 1 year Membership to Rainmakers):

Betty Trusty to create a calling system to check on the elderly and homebound individuals in the county, which she calls TrustContact.

The evening ended with networking time and we are pleased to report that several connections were made among attendees that will potentially help even those ideas that did not win to move forward.

See you at next year’s Big Ideas event!

CQ Hires Amanda Schoolcraft for the Summer from Purdue University

Welcome Amanda Schoolcraft!

We are excited to announce that we have hired intern Amanda Schoolcraft fro Purdue University for the summer. Amanada graduated  from Martinsville High School in 2008 and was the recipient of the Greater Martinsville Chamber of Commerce Scholarship. She is now a sophomore in the Weldon School of Biomedical Engineering at Purdue University. Amanda is studying Biomedical Engineering at Purdue and will earn her BSMBE by May 2013. Prior to working with us this summer she is working in a research lab in order to get a head start on her thesis. She is looking for industry experience and therefore will be a great fit for our team this summer.

Perhaps of more interest is that we have decided to offer a portion of Amanda’s time with us as probono to start-ups. If you are a start-up and need help with some daily tasks, please let us know.

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Life Science Job Opportunities

Ann Clifford, of Safari Solutions, asked that I share some job information with all of you. There are three open positions at Polymer Technology Systems that they are seeking referral candidates to potentially fill.

Polymer Technology Systems, Inc. (PTS) has played an active role in the life sciences industry since 1992.  Their revolutionary medical diagnostic devices test cholesterol and other indicators in the blood for cardiovascular disease, diabetes, and other chronic conditions.  Launched worldwide in 2003, the CardioChek family of diagnostic devices is now used by thousands of physicians, pharmacists, and wellness programs around the world.

Open positions include:

  1. Manager – Point of Care Testing
  2. VP of R & D
  3. Senior Engineer

You can view details of these positions on our Safari Solutions career site:  Job Opportunities for Polymer Technology Systems.

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