velixX GmbH - System Development
Perfect solutions for complex challenges
VelixX is the first network-based development service company in the medtech industry. Using a novel approach called “NextGen Development” velixX develops diagnostic and medical devices as a service and takes on tasks that are out of the ordinary.
velixX was founded in 2010 by senior development engineer Manfred Augstein. In the two decades that he has spent mainly at Roche Diagnostics, Manfred experienced firsthand how big players in medtech and pharma changed their strategy from in-house development to outsourcing. Therefore, he engaged with a lot of development service companies and gained insight into how they work and how some were performing well while others were not. He found, that especially larger offices would put their employees on projects for which they were not the best match or lacked expertise. The bureaucratic processes necessary in larger companies generated a lot of overhead and did often lead to subprime performance. He thought that development projects should somehow be leaner, faster and combine not just the people that are currently available within a single company but the best experts for the topics at hand. This would require a large pool of people for the expertise and at the same time a lean structure with a small team for fast and effective decisions which is contradictory.
Manfred found the solution and called it “NextGen Development” which would rely not on one big company to provide all the necessary personnel but on a network of small companies, research institutions and freelancers. He went on to found velixX as a network-based development company that would combine the power of a huge development office with the lean structure and efficient dynamics of a small, owner-managed company.
How NextGen Development works
velixX itself is a lean owner-managed company, specialized in managing system development projects for diagnostic and medical devices. But instead of running a large team of engineers within the company, it builds upon a network of specialized engineering companies, manufacturers, research institutes and senior experts. From these resources, velixX creates a team that is specifically tailored to the task at hand. If needed, further experts and institutions join temporarily for specific topics.
velixX takes over project management, coordination and serves as the main contact towards the customer.
Advantages of NextGen Development
In medical technology, and especially in the field of In-Vitro-Diagnostics, innovation is created at the interface where technological devices, bio-chemistry, regulatory affairs and many other tasks come together. With NextGen development the project team members are true experts in their respective fields offering vast amounts of ideas and knowledge. velixX’s project managers are experienced in harnessing this knowledge to create new solutions and excellent systems for the complex tasks in the medtech environment.
The team size is very versatile and allows velixX to offer its services to small start-Ups as well as multinational corporations. Also, the size of projects can range from small consulting tasks to entire development projects.
The lean structure of velixX itself allows for a very fast reaction. Project teams can be assembled quickly and start the project without delay.
Since each project poses its individual tasks and challenges no two projects will be alike. Nevertheless, one can distinguish between the following services:
velixX supports clients in answering the most pressing questions in the beginning of a project. Through the broad network velixX can deliver estimations of time and cost of the project, manufacturing cost of the product to be developed or a comparison of potential solutions.
Feasibility studies are the first step towards a sound concept. velixX provides functional evaluations and builds a first functional prototype.
The new EU-regulation has introduced a lot of uncertainty into the market. For in-Vitro-Diagnostics velixX offers consulting for clients that aspire to gain an IVD certificate.
Sometimes a development project hits a road block or unexpected technical difficulties arise. The broad range of topics that are covered by velixX’s network allow for a holistic analysis.
With the roots in In-Vitro-Diagnostics, velixX has great expertise in disposable parts and offers the development from first drawings to production-ready assembly lines
If needed, velixX can develop an entire device as a service including production and certification.