PIONEERING MEDICAL TECHNOLOGY – FROM IDEA TO APPROVED PRODUCT
It all began with a problem – and a brilliant idea. Professor Hans Wiksell, founder of the medical technology company NeoDynamics, recognized that breast cancer biopsies involve certain problems and risks. He discovered a method that provides better, safer and less invasive sampling.
Each year more than 8,000 breast cancer diagnoses are made in Sweden – between 20 and 25 women fall ill each day.
Diagnoses are achieved with the help of different types of biopsies, i.e. tissues samples. Today, they are mostly carried out using spring-loaded core needles that are shot into the breast through the suspected tumor. The lesion may be calcified and hard and difficult to penetrate. Often several tries are required before a good sample is obtained, which is, obviously, traumatic for the patient. Some have even suggested that the tissue destruction and bleeding that result may contribute to the cancer disseminating to other parts of the body.
NeoDynamics, with inventor Hans Wiksell at the wheel, has discovered a gentler and safer method for taking tissue samples, which makes it possible to reach very small and problematically located suspected cell mutations with greater accuracy.
Thanks to the new method, samples that are often acquired through surgery can be obtained earlier in the process. This involves a better planned personal treatment process, which results in a greater chance of curing the patient and more cost-effective care from a social perspective.
Outsourced product development
The discovery and diagnosis of cancer at an early stage is crucial for saving the life of the patient. This was the premise that NeoDynamics was founded on in 2004. NeoDynamics is an innovative company that specializes in developing medical technology solutions that improve the patient experience and provide high-quality, cost-effective results. In 2012, the company was successful in gaining the backing of Vinnova and new capital from other private investors but was still lacking in product development resources.
Competence in a number of areas is required to develop a medical technology product: industrial design, regulatory expertise, electronic and mechanical engineering, software development, technical documentation and much more. Hiring all of these specialists is absurdly expensive for a small startup such as NeoDynamics. Also, a quality system that fulfills certain standards in order for medical technology products to be approved on the markets is also required.
NeoDynamics needed a cooperation partner with the right competence and a certified quality system in order to develop its biopsy product. Etteplan got the job.
“Etteplan’s expertise in medical technology and regulatory issues and the company’s certified development process were decisive factors for NeoDynamics in deciding to start up cooperation concerning this unique innovative product,” says NeoDynamics’ CEO Peter Sellei.
The project involves the design and development of a production-ready biopsy instrument that meets official requirements for medical instruments, including the creation of a technical document that forms the basis for CE marking and all of the further technical documentation.
Production and other aspects will be outsourced to other companies in the future. NeoDynamics has focused its resources on what they know best – innovations within the field of medical technology and how the product can be brought to the markets. It has been important to know what the product development will cost in order to ensure that there is sufficient capital for its launch on the markets and for the sales work that is required in order for the product to succeed.
Close cooperation the whole way
Cooperation between NeoDynamics and Etteplan began in spring 2012. From the very beginning the customer was looking for close cooperation. Etteplan serves as NeoDynamics’ R&D department and both partners interact closely throughout the project.
The assignment began with a concept phase that focused on the basic idea and how it could be implemented. The pros and cons of various concepts were examined. What are the risks? Is it commercially viable? Finally, a concept was selected and in June 2012 the parties signed a contract for a complete solution.
Project model for medical technology product development
The work is based on Etteplan’s comprehensive project model, which includes a quality system for developing medical technology products specifically. This system ensures that Etteplan stays on top of timetables and budgets and that all of the regulatory demands are met.
Following the concept phase the product is developed thoroughly according to the established functional demands. The development phase includes industrial design and usability in order to ensure that the product will be functional and easy to use. To this end, a reference group that consists of prominent doctors from Sweden and Germany is closely connected to the project.
The entire development process is documented and summarized in a technical document. All of the material is scrutinized by a notified body in order to certify that the product meets the required standards such as EN 60601-1 and EN 62366.
When it comes to this type of product that will be used on people, everything is strictly regulated and the approval process is long. The launch of the finished product on the market is expected to take place in 2016.
Multidisciplinary project within core area
Developing a product from start to finish, including approval for the strictly regulated medical technology markets, is part of Etteplan’s core area of expertise. The creation of technical documentation for the product is also one of Etteplan’s basic services.
At the height of the project some six to eight people from Etteplan were working on it full-time. All-in-all around a dozen different types of experts in various fields have been involved – which shows what is required in order to develop a product on your own. Hiring twelve people is both difficult and expensive especially when one or more of them may only be required for a short period of time, for example for carrying out a risk analysis.
“It is not possible for a young innovative company like NeoDynamics to do everything itself. Our core competence is the medical technology idea and our understanding of how it can improve diagnostics and biopsies in breast cancer cases. We don’t need to become the best at product development; it is far too expensive to build up a full R&D unit that also understands the regulatory demands placed on the product,” Peter Sellei says.
The project’s name is Fourier CNB. CNB stands for Core Needle Biopsy and Fourier is a mathematician whose theories and laws are the foundation for the innovation. (separat ruta)
Original text in Swedish by Karolina Nordwall.