The Backstory at CDG

Choosing a Regulatory Submission Plan

We don't usually associate 'choice' with regulatory submissions. Usually we think of the requirement for a 510k or PMA as being cut and dried--the decision is already made, our job is to figure out what the decision is.

In this e Conference I've invited Janice Hogan (of Hogan an Hartson) to teach us how we, as manufacturers of medical devices, do have choices about our regulatory strategy. The type of submission we need depends on the claims we want to make for the device. The claims we want to make may be influenced by market forces as well as the device's physical performance.

For example, if I have a department full of people who know how to file a PMA, I'll be sure to word my claims so that a PMA is required and I can roadblock for my competitors. But if I'm a start-up firm and getting venture capital is my worry, I'll go after the easy claims first. My primary goal being to demonstrate that I can get a submission through FDA and generate income.

Work with the words...that is part of the message Janice will bring. If you are a regulatory professional in medical devices you should plan to attend this lively and informative e Conference.

FDA Globalization Act - Coming Soon

The FDA Globalization Act was introduced in Congress this month by Congressman John Dingell. If passed, the Act will have several implications for medical device manufacturers. Among them: 1) manufacturers will be assessed a registration fee when registering their manufacturing facilities, the funds will help pay for many new federal requirements, 2) manufacturing sites will be inspected immediately upon receipt of the registration fee, 3) the plant will be inspected again when the establishmet begins to manufacture, 4) no Class II or Class III device may be imported before initial inspection, 5) device labeling must indicate the country of manufacture, 6) commercial importers will be required to register and pay a fee, 7) manufacturing sites will be issued a unique identification number following registration, and the registration ID number may be used for other purposes, and finally 8) the Secretary shall establish and maintain a corps of inspectors dedication to inspection of foreign manufacturing sites.

I applaud the requirements, both as a consumer and as a consultant. As a consultant I have seen, first hand, some of the poorly manufactured products that are imported from certain foreign manufacturers. And as a consumer I have worried for my family's health. 

Global trade has been good for me and my consulting business. It has brought in foreign Clients. It has exposed me to other ways of thinking. It has given me an opportunity to travel the world in a way that I would not have been able to otherwise. But globalization has come at a cost, and one cost has been the safety of our own medical products. This is unacceptable because, ultimately, it is a direct threat to me.

FDA has been weakened under the Bush administration, it has too few inspectors and reviewers and is losing its most experienced people. That is a loss for all of us and it is time FDA be strengthened and reinforced.   

Here is the link, in case you want to read the draft Act for yourself:
http://energycommerce.house.gov/FDAGlobalAct-08/Dingel_60AXML.pdf

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