When custom made is the only option

WCE celebrates milestone: delivering their 10,000th CMD

At the turn of the year, we reached an impressive milestone at William Cook Europe (WCE). We delivered custom-made device (CMD) number 10,000. It was during the COVID-19 lockdown, so it turned into a modest celebration of a very important milestone that deserves greater attention. Cook Medical’s products save lives, but what do we do if a patient cannot use a standard product? We create a CMD.

“The CMD program is important to Cook. The devices that are supplied globally from WCA and WCE make a huge impact in patient’s lives, who, for various reasons, cannot use a standard product,” said Robert Binskin, global CMD and Advanced Technology product manager.

“WCE has shown that a small and highly competent team can, in collaboration with one of Cook’s planning centers or in direct cooperation with the physicians, produce a custom-made device in 10 days and sometimes even faster,” Robert added.

While sitting together at William Cook Europe in Bjæverskov, John Mogensen, global product manager – Thoracic, and Bent Øhlenschlæger, global Research & Development program manager, tell the story about a young patient who was once helped by the CMD team and WCE. Prior to an open-heart operation, the patient needed an intervention using a custom-made graft. These are the kinds of stories that make an impression.

The patient survived, and 10,000 other devices from the CMD team at WCE in Bjæverskov have been developed specifically for the patients who need them.

The setup, the planning centers, and the team

Cook Medical’s CMD products are routed through one of the three, global planning centers.

“The planning team collaborates with the physicians to support them in finding an optimal solution for their patients,” said Rachel Doherty, global planning services manager.

The CMD team has established a streamlined process in order to quickly produce the best possible product for each patient. Manufacturing, regulatory, clinical experts, and other team members work closely together to increase momentum and respond to the physician with one voice.

The CMD team at WCE is a tight-knit team. They are proud of and happy with their devices. However, they also know that they could not get the devices ready on their own—and certainly not at the same pace—so this tribute applies to everybody at WCE and within the CMD program. The engineers draw up the documentation, and the Cook employees in production build the device.

The setup has been optimized, facilitating manufacture of a device in 5 to 7 working days, which is below the department’s target of approximately 10 working days. A goal that is more than adequate, because it often takes the physician about 20 days to get ready for a procedure.

What do the physicians say?

According to specialists from The Uppsala University Hospital and the German Aortic Center in Hamburg, there are no doubts about the impact of the collaboration with Cook Medical on their work.

Anders Wanhainen, a professor of Vascular Surgery at Uppsala University explains, “For a long time, Uppsala has had a great interest in the aorta—both clinically and in terms of research. At an early stage, we tested custom-made devices on complex aortic cases and understood the importance of our work. Consequently, we laid down an active strategy to be able to handle the entire process in collaboration with Cook. As an academic, you must be autonomous in order not to ally too intensely with industry, but still be able to cooperate. To us, the support is important. That we can discuss our considerations with Cook’s engineers and that we get the appropriate help and support.”

Wanhainen and Kevin Mani, a professor of Vascular Surgery at Uppsala University, both highlight the fast delivery time at WCE.

“They have been able to provide us with devices very quickly, in some cases it is very acute. They actually made a CMD for us during a weekend. In general, we are very satisfied with the delivery times from Cook in Denmark,” said Wanhainen.

“During a visit to the plant in Denmark, I was very surprised in terms of how much manual needlework it takes to produce these devices. It’s simply, really admirable,” Wanhainen said.

Mani continued, “We received good help from Cook Denmark. You have helped us produce very special solutions—and have done it very quickly.”

In general, there is a great deal of goodwill on the part of the physicians who work closely with the CMD team. Tilo Kölbel, director of the German Aortic Center Hamburg at The University Heart Center Hamburg, recounts.

“A large part of the 10,000 devices have likely gone to Hamburg, I use well over 100 custom devices a year,” explained Kölbel.

“I did my first CMD 15 years ago. In the early years, I planned most details myself, but since the planning center has proven very capable of evaluating and planning, we now save the time-consuming survey as we send the imaging to the planning center and give them an overall idea of what needs to be done. I don’t think there is as much experience in planning individual vascular devices anywhere else in the world—and my confidence has only grown over the years,” Kölbel said.

Kölbel believes that there will always be a need for custom-made devices.

“Many people will probably believe that CMDs could be the bridge to commercial products, but a large part of devices will probably always require the CMD pathway, simply because the human anatomy differs so significantly. There will always be patients for whom a custom-made device is the only option,” he said.

In general, the physicians are very satisfied with the cooperation with the CMD team.

“It is crucial to our work to have a close dialogue with the CMD team and that we know the delivery times. Therefore, we hope to continue the fruitful cooperation with our local Cook team,” said Kölbel.

Kölbel, Wanhainen, and Mani congratulate WCE and the CMD team on the impressive milestone, and I join them. Congratulations WCE on the 10,000 custom-made devices!

For more stories