It’s been more than a half-century since Bill Cook began working with Charles Dotter, the “father of interventional medicine.” Together they invented the first device used for peripheral angioplasty and established a lifelong collaboration and friendship.

That collaboration shaped the way Cook Medical works today when it brings new products to market.  The  Peripheral Intvervention Division’s Director of Business Development, John Brumleve, outlines that process in Blue News Now, a newsletter of the American Venous Forum.

A History of Innovation: How Products are Brought to Market at Cook Medical

By: John Brumleve
Cook Medical
Director of Business Development
Peripheral Intervention

Cook Medical has a rich history of working with physicians to solve medical problems.

This history started 51 years ago when his radiologist cousin introduced our founder Bill Cook to the Seldinger technique. Shortly after starting to work on needle, wire guide, and catheter combinations, Bill met Charles Dotter—the father of interventional medicine– at the RSNA (Radiologic Society of North America) in Chicago. Together they developed the first device used for peripheral angioplasty.  This experience created a deep collaboration and friendship that lasted until Dr. Dotter’s death in 1985.

In the early days, Bill Cook was able to make rapid prototype examples based on physician input and develop iterative changes that developed into finished products throughout various fields of medicine.

Many things have changed in the medical device industry over the last five decades—increased global regulations, compliance law around physician/industry interactions, reimbursement, more complex technology in product development, and decreasing product life cycles.

However, the guiding principles of product innovation still carry on in many ways within the Cook culture. We still interact with physicians in various fields to develop life-saving medical products and procedures.

Cook innovation is an iterative process from a clinician’s idea to bench-top testing; from engineering design controls, verification and validation to clinical trials; from regulatory submission to the final product release to the market.

Cook Medical has many examples of working with physicians to develop innovative products. Some examples include:

• Dr. Cesare Gianturco, whose developments include the “Bird’s Nest” vena cava filter, Z-stent technology for both vascular and non-vascular applications and transcatheter embolization coils.

• Dr. Robert White, who pioneered treatment of pulmonary arteriovenous malformations (PAVM) using Cook Nester® Embolization Coils.
• Professor Rolf Günther with his Günther Tulip® and Celect ®Vena Cava filters.
• Dr. Ernie Ring and Dr. Josef Rösch, who developed access systems for the transjugular intrahepatic portosystemic shunt (TIPS) procedure.

In our industry, the methods of bringing forward product innovation have changed. Many of the established companies have evolved by acquiring technology through merger and acquisition to bring innovation to market instead of developing their own products.

The process begins when small start-up companies initiate a product idea. These device and bio-tech start-ups get seed funding from venture capital or angel investors in order to fund and initiate proof-of-concept ideas. At some point, larger bio-tech or multi-national device manufactures take notice and decide if the new technology fits in their product portfolio and purchase the device or product once a sufficient amount of risk has been eliminated. In many instances, large multi-national device companies have outsourced the product development cycle to smaller, more nimble, firms. Many have also outsourced the manufacturing of the product to various sub-manufacturers in order to reduce cost of manufacturing.

Cook still develops products very similar to the way Bill Cook initiated product development in the early days. Once we meet with the physician or company, our main goal is to understand the device attributes or features and relate it to the clinical requirements of the procedure in which the device will be used. Once we do this, we will then try to identify whether it is a good fit strategically for the organization. It is important to match strategic fit of the product along with the right engineering, regulatory, reimbursement, training, marketing, and sales teams.

Have an idea for a product?

Let’s say that you have an idea for a product. How do you interest a company to begin development of this product? There are some questions you might want to ask yourself before contacting a company to partner with:

1. Are there similar products on the market? If so, what makes this product different, e.g. what is the unique value proposition?
2. Is there something that is unique about this product that you think you can patent?
3. Why do you think it can be patented? You will need to contact a patent attorney if you want to look into patenting a product(s).

The next steps that you can expect from a company will be what we at Cook call “upstream product management.” This process includes marketing or engineering teams that develop the commercialization plan for product approval.

In this process, we will include:

• Marketing to identify needs and help select the product design and clinical inputs.

• Engineering to scope design, development, test, verify and validate product design-failure modes

• Regulatory to determine regulating pathway such as a 510K or a PMA.

• Clinical research organization, to determine, develop, and implement clinical studies to validate the safety and efficacy of the device/procedure (therapy).

• Reimbursement to evaluate and develop a reimbursement strategy based on current or new reimbursement pathways and codes.

So how do you select the right company? It’s an important decision.  You’ll need to understand their expertise, capability and their presence in the marketplace. You’ll also need to think about company culture and the people in that company that you know.

Ask if the company has a non-disclosure agreement to insure what you discuss with the company is held in confidence. Alternatively, you can submit a patent application for your device prior to contacting the company. Submitting a patent offers you more protection prior to speaking with potential partner companies, but also costs more at the beginning of the process.

Once you have selected the company you want to work with and they have agreed to develop your idea, it’s time to discuss your partnership.  You will need to determine what you seek from a business partner.  And you need to ensure that you DO feel like true partner, not “just a transaction.”

It’s best to disclose early on to the company your intentions on how you would like to proceed if you work together.  You and the company should determine how remuneration would be shared and how responsibilities will be delegated if they want to commercialize your idea. Each company has a preferred method of acquiring technology and they should be very open to share that with you.

The company will usually draft an initial agreement, including sketching out schedules going forward. Remember to think globally, as each country has different regulatory and compliance laws for consideration.

Some other benchmarks to take into account will be:

• Early feasibility testing—bench prototype
• Animal testing—how, where, when? What will be required of me?
• What is the regulatory pathway?
• Will you need to do a clinical trial?
• What is the expected development time frame for your device?
• What about product improvements? How will the proceeds from these improvements be shared?

Once the medical device has made it all the way through approved production, the product management and marketing teams will work together to ensure that the product is available and widely known among key audiences.

Cook works with clinicians to develop innovative medical solutions to treat patients worldwide, and we have been doing it for more than 50 years.  It’s very satisfying to look back and see the many devices that have saved many lives all due to a partnership between a physician and our own team.

If you have an idea that you’d like to bring to Cook Medical, we’d love to hear from you.  Visit our Innovation & Collaboration page and let us know what you are thinking.