3 to 1 Design Process: Three preliminary prototypes were created to evaluate the ergonomics and practicability of each designLaunching a new medical device can be a daunting task for any company, especially for a young startup. Innovators are becoming increasingly aware of the gaps and missing links in their knowledge for entering today's highly competitive markets. To fill up these gaps in know-how, they seek to enlist the help of experienced professionals for lifting off the all-important first project and securing its serial production stage. Here is the story behind one such successful international collaboration that went onto win the Red Dot Product Design Award 2013.

When the innovators at Hemacore (a young biotech company based in Moscow, Russia) decided to bring their promising new diagnostic device to the market, they sought out the support of velixX GmbH (a system development company based in Mannheim, Germany). The goal was to encase the device’s core medical technology into a device with outstanding ergonomics and a signature appearance, clearly distinguishable from the routine blood coagulation analysers in the market.

velixX GmbH teamed up with WildDesign GmbH & Co. KG (a multinational design company of German origin) to develop an intelligent and ergonomic design for Hemacore's “Thrombodynamics Analyser T2”, that won the prestigious Red Dot Product Design Award, this past summer. The jury commended its compact design and functionally attractive features such as the colorful light ring, which offers a quick and intuitive display of experiment progress.

Design refinement discussion in a face to face meeting at velixX GmbH. Clockwise (from top): Mr. Roland Wulftange, Dr. Sergey Karamzin, Mr. Manfred Augstein, Mr. Markus Wild, and Mr. Igor Pivavarov“We take pride in addressing specific technological needs of young medical device companies – big or small, unlike most other product development support companies that are only keen to take up full-scale product development projects,” said Mr. Manfred Augstein, founder and CEO of velixX GmbH. “Whether our client needs short, 1-2 day workshops (for project plan refinement) or full-scale support (to bring their medical innovation to the market), we offer it all. In fact, velixX GmbH was created to offer rapid and reliable access to the entire spectrum of competencies ranging from those of technology experts and industry professionals to academic researcher institutions (e.g.: IMTEK, Freiburg) – tailored to fulfill every need of our client while maintaining their autonomy over the entire product development process,” he added.

Mr. Pivovarov, CEO of Hemacore, said he was really “impressed by the professionalism of velixX, as they delivered milestones exactly within the scheduled time with the highest quality.” He added that “all development issues were discussed and corrected in a very timely manner and it was a great fulfillment of all my expectations.”

“The great advantage of working with velixX was the quick and informative feedback to our requests. One can really feel that our project matters to them and they are really interested in its success,” said Dr. Sergey Karamzin, Head of Design Office at Hemacore. “Their expertise in product design and mechanical and electrical engineering helped us to choose the right partners and get the desired results. Regardless of the many alterations in the original concept that appeared during the design process, our project was smoothly completed within our tight time frame of six months,” he added.

Modeling the LED light ring assembly | Evaluation of component assembly | Design variations of various parts of the deviceIn addition to the limited time frame, another “big challenge was the coordination between collaborators located in different time zones” said Mr. Jost Griesemann, Medical Engineer at velixX GmbH. This was effectively overcome by formulating a detailed statement of work before the project began and by “always maintaining an up-to-date specification sheet” he added. The teams “established weekly telephone conferences” and routinely “documented every activity in a special Jour-Fixe protocol, which meant nothing got lost and everybody stayed on the same page,” said Mr. Markus Wild, founding Director of WildDesign. Face-to-face meetings were also organized at key stages of design refinement. These steps were vital for maintaining a continuous thread of communication between all teams.

Systematic planning, rigorous brainstorming and extensive prototyping were key for overcoming the manifold design challenges that cropped up along the way. To begin with, all expectations and goals for the design project were discussed and clearly outlined (in the alignment phase). Thereafter, three different prototype models for the product housing were constructed to evaluate the ergonomics and practicability of each design. The best features from each of these prototypes were then amalgamated into one main prototype (the 3-1 design process). This new prototype design was further refined in several stages including in face-to-face brainstorming meetings organized with all partners (the design refinement phase).

“The experience and knowledge of project engineer, Mr. Manfred Augstein, made all the difference,” said Mr. Wild of WildDesign. “Far sighted, he managed the process of concept development, product design and manufacturing without micromanaging our responsibilities. He supported mechanical engineering design aspects with suitable and smart engineering solutions that made it possible to meet our tough timeline.”

Envisioning the end-user environment at the start of the project helped to make a highly ergonomic and user-friendly device, ready for market and research useEvery minute detail was carefully examined to build a long-lasting and user-friendly device. This included envisioning of the end-user environment and gaining a spatial and procedural understanding of the device. A giant LED light ring and its creatively designed PCB board were tailor-made to visually enhance the overall style and appeal of the device. The extent of clockwise illumination in the light ring was especially designed to offer an intuitive estimate of experiment progress to the user. Another special detail added, was that of color-switching in the light ring when shifting from incubation phase (green) to the main experiment phase (red). The mounting base plate was also selected to match the overall style of the product housing while having sufficient weight to increase resistance to vibrations. The ease of assembling and fine-tuning procedures were other key aspects of the design process. High quality components were exclusively selected to build a robust, durable and accurate device.

Since the device is meant for use in hematology studies, its design was carefully thought through to minimize contact or contamination with blood plasma samples. Smart sensors were integrated into the device to start it without requiring touch and also to rapidly identify a device within a multi-unit system. The final result was a device equipped with modern, user-friendly interface and a scalable, space-saving design that allows for easy stacking into a multi-unit assembly for high-throughput, even in small laboratory spaces.

From Left to Right: Mr. Igor Pivovarov (CEO, Hemcore LLC), Mr. Markus Wild (Director, WILDDESIGN GmbH & Co. KG), Mr. Manfred Augstein (CEO, velixX GmbH), Mr. Roland Wulftange (Project Leader, WILDDESIGN GmbH & Co. KG)This project has highlighted the power of efficient collaboration and the tremendous core competencies offered by velixX and its partners in the field of medical and healthcare product development. Dr. Karamzin of Hemacore, shared that “the technical level of the design was very high and detailed allowing us to start manufacturing without any delays and achieve our desired results from the very first attempt. We believe we finally have an innovative medical product with outstanding design and usability."

The device has successfully passed clinical trials in Russia and has also started sales there since last November. It soon plans to enter the European and US markets, with the CE mark expected in 2014. Ms. Elena Chinarina, the Brand Manager from Hemacore said that “today, one can buy Thrombodynamics Analyser in Europe, as a RUO [Research Use Only] device.”