The Backstory at CDG

FDA's New Sentinal Initiative for Monitoring Device (and Drug) Safety

In a Press release issued 22 May 08, HHS Secretary Mike Leavitt announced new efforts to help FDA improve the safety and quality of medical products. By 2014 FDA will proactively access Medicare Part D (drug reimbursement) information and private-payer information to determine what, if any, adverse events have occurred. The report is available at: http://www.fda.gov/oc/initiatives/advance/reports/report0508.html.

I have more reactions to this as a consumer than as a professional. I know first hand that delayed-type hypersensitivity reactions are underreported. My own allergic reactions were reported and were, frankly, boring to my doctors once they determined that I would live. Furthermore, it wasn't clear what caused the problem, I was exposed to half-a-dozen medical devices during a procedure, any of which could have been the sensitizer. Since there was no way to know, no one knew what to report, including me.

Accessing masses of data and looking for patterns may be the best way to identify what's causing what--both for drugs and devices. It's a little 1990-ish to have the FDA looking at my private medical information, yet a practical necessity for the safety of all. 

The CMS final rule and a related fact sheet may be viewed at www.cms.hhs.gov/PrescriptionDrugCovGenIn/08_PartDData.asp

Our History

CDG is probably the oldest CRO established exclusively for medical device clinical research. I say that because we started in 1990 under the name of Clinical Design Group. But it was three years before we booked our first clinical research consulting job. In the beginning, I couldn't even get manuscripts published on clinical research at Medical Device & Diagnostic Industry. The editors would happily publish anything I could write about biological safety, but clinical research manuscripts got 'lost' on their desks.

So I say: we were a medical device CRO before the world wanted one.

Here's a timeline of our history.

In Nov 1990 I establish Clinical Design Group with cheerleading and advice from my husband, Frank. It was a sole proprietorship owned by Nancy J Stark. I believed the clinical research departments of the device world need a resource where they could get expertise, experience, and assistance. I bought a DEC computer, built a desk out of a door and two file cabinets, and went to work in a spare bedroom of our house.

One of the first jobs I sold was to develop a two-day seminar on writing clinical protocols for Barnett International. I earned $5000 for preparation and delivery! But I learned that I had two important natural talents: I am well-organized and I have the gift of gab. Presenting seminars, and later webinars, became a mainstay of the business.

My first book, Good Monitoring Practices, was published in 1996; and was followed for four more titles and three edited manuals. At the time I had to make a decision: find a publisher and get prestige but no money, or self-publish with no prestige and laugh all the way to the bank. Being an entrepreneur first, I chose the second path.

I hired my first research assistant, Maria Sikirica, in Feb 1996. Maria worked part time out of her home doing research activities for CDG.

In July 1997 I incorporated as Clinical Design Group Inc, an S-corporation with Nancy J Stark as the President and only officer. It was a big event, finally I felt like a 'real' company. By this time Maria was working onsite, rather than out of her home. She sat at a tiny desk in the hallway, on a wooden chair beside a hot Southern window. She never once complained.

In 1999 I joined the International Standards Organization's Technical Committee 194. TC 194 is charged with preparing the ISO series of biocompatibility standards (ISO 10993 Parts 1-20, Working Group 4) and the ISO series of clinical research standards (ISO 14155 Parts 1-2, Working Group 2). I become very active in WG 2, and eventually become co-chair of the US delegation, sharing this position with Dr. Kimber Richter of FDA. In 2003 we publish the standard still in use today, but in the meantime have been extremely busy on a complete Good Clinical Practices standard for medical devices, this new standard should be released as a committee draft at any time.

Consulting and CRO-ing also became a big part of the business, representing about half of our gross annual income. In 1999 I expand our business model and establish a Network Staff of experienced professionals who will fulfill the performance requirements of consulting contract that CDG signs. I recognize that there is only so much consulting time a single human being can log; but with a staff of professionals the time is limited instead by sales. Lynette Chiapperino becomes a Network Staff Associate that year; she is still working with me today. We are now officially defined as a consulting, contracting and training firm.

The business was growing and we were limited by space, so in the summer of 2000 we searched for a larger home. We explored commercial space in the neighborhood, but eventually settled on the first floor of a three-flat residential building. Maria began working full-time, and there we were with 2000 square feet of empty office space. That week-end Frank and I went to the used office furniture stores. We lucked upon an ensemble of traditional wood furniture by Kimball. I bought three desks, two end tables, a conference table, and eight matching chairs. Never again have I seen such quality available in a used furniture store.

The Office Cat, Millifiore, arrived that summer. A kitten, she would allow Maria's five-year-old daughter to pick her up. The two of them spent many hours in the living-room/reception area. To this day Millie comes to work each day, often arriving before I do.

We were so busy with books, training, and consulting that in Feb 2001 I hired an Office Assistant to handle the routine needs of order fulfillment and supplies management. That position is held today by Sharon Etter, who has been with us since 2004. Sharon also fulfills the role of Corporate Artist, designing most of the artwork we use.

We were constantly getting job applications from artists, only to discover the local Chamber of Commerce had listed us as a design house because they had no idea what we did. So in Apr 2001 we changed our name to Clinical Device Group, figuring the world either wouldn't notice or would assume they had gotten it wrong all along.

In Jan 2004 I established the Clinical Device Institute, with the long-term goal of having a virtual "university" available for medical device, pre-approval professionals available online, on demand, anytime.

In June 2004 I started the money-losing Clinical Device Forum. I laugh that it costs money to operate and brings in no income, but it is my gift to an industry that has treated me well. The Forum is an online conversation between clinical research, IRB, regulatory, and biocompatibility professionals who share ideas, resources, and solutions. Today we have more than 1500 members and can be found at www.clinicaldeviceforum.com.

In June 2004 I was identified by MD&DI as a "Notable Person" in the medical device industry. It is an honor that I hold in high esteem. Later, in May 2007 they would invite me to sit on their Editorial Advisory Board.

We produced our first eConference with a guest speaker in October 2004. The speaker was Steven Schurr, Esquire and he spoke about negotiating contracts in clinical research, including Investigator's Agreements, clinical study agreements, and financial agreements. Every clinical research manager should know the basics of contract law. The bi-monthly eConference series has become a regular feature of our business.

In Apr 05 the workload had again become so heavy that I am sinking, so I hired my first Executive Assistant. Today that position is held by Julia Baresch. Julia handles our bookkeeping, research, quality control, and manages the Forum.

In Jan 08 we moved our webcast business to Adobe Connect, where we finally have access to the full seminar room and learning management tools we need to build a virtual university. We are another step closer to online, on demand, anytime learning.

Maria is promoted to Managing Director in Feb 08, in recognition of her outstanding contributions to the company over the past decade plus. She is our total Information Technology Department, always taking us to the next level of sophistication and knowledge. Thank you Maria, I could not have built the company without your constant input and support!

In Mar 08 I am accepted into ISO TC 232, the technical committee tasked with writing standards for continuing education and training.

Looking forward—CDG will continue to grow in the breadth and depth of its learning products and their sophistication and ease of delivery; and we will continue to deliver ethical and scientifically valid consulting services.

Best regards,

Nancy J Stark, PhD, President