DEMCON: High-end system supplier. Development and manufacturing of medical devices

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Avis Reed
5 years ago
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1 : High-end system supplier Development and manufacturing of medical devices

2 combines engineering and certification skills under one roof.

develops and manufactures medical devices used for diagnosis, therapy, care and self-care.

During the development process, the well-known V-model (specify, design, realise and verify) plays an important role in the various development phases.

Idea Function <- Solutions -> Storage of disks prior to first use Per piece in plastic Pre assembled in carrier together in plastic Disk handling Daisy wheel like Tray Per piece Disk

Disks in carrier Disks are fixed in storage box Scanning in device Disks are not fixed Ideas can vary from a solution for a clinical problem in daily practice in the area of

3 develops and manufactures medical devices used for diagnosis, therapy, care and self-care. Our customers include medical technology start-ups, established small and medium-sized enterprises and major OEMs acting in the field of medical technology. During the development process, the well-known V-model (specify, design, realise and verify) plays an important role in the various development phases. Depending on the idea and on the customer s wishes, the V-model can be run three times for the various phases, which are the proof-of-principle, prototype and pre-production phases. Idea Function <- Solutions -> Storage of disks prior to first use Per piece in plastic Pre assembled in carrier together in plastic Disk handling Daisy wheel like Tray Per piece Disk ID scanning Disk fixation in carrier Per seperated disc with a scanner (hand scanner or scanning plate) Disks are fixed in carrier Per batch. Disks in carrier Disks are fixed in storage box Scanning in device Disks are not fixed Ideas can vary from a solution for a clinical problem in daily practice in the area of diagnostics or the treatment of patients, to a pioneering innovation in the field of disease prevention. During this phase, it is important to listen closely to the customer and then jointly define the area of application, on the basis of which all the user and functional requirements can be drawn up. These requirements are the basis for the next phase, which is the proof of principle phase.

Proof of principle Prototype The aim of the proof of principle phase is to

into a prototype. risks and remove them at an early stage.

and working out the are developed for the various sub-functions of the ultimate

after which the most suitable concepts are chosen on the basis of layout,

As soon as the design is ready, all the components their applicability,

If necessary, the are ordered and the prototype is assembled.

when our quality lead engineers review the relevant norms the

4 Proof of principle Prototype The aim of the proof of principle phase is to identify the main project During this phase, the various concepts are combined into a prototype. risks and remove them at an early stage. To achieve this, concepts The focus is on elaborating the specification details and working out the are developed for the various sub-functions of the ultimate device, concept on system level (3D model, 2D drawings, circuit diagrams and after which the most suitable concepts are chosen on the basis of layout, software, etc.). As soon as the design is ready, all the components their applicability, manufacturability, cost price, etc. If necessary, the are ordered and the prototype is assembled. This prototype closely performance of the concept can also be tested in a POP configuration. resembles the intended end product so it can often be used during This is also when our quality lead engineers review the relevant norms the verification/validation process. It can also be deployed in (some of) and applicable standards for medical devices. the requisite certification tests if necessary, supported by our quality department. During the prototype phase, production techniques for low volumes are often used, such as rapid prototyping or 3D printing.

Pre-production After the device has been tested successfully and the design has been confirmed, the final phase can begin;

Here, the appropriate techniques are deployed and the process is specified in detail.

the manufacturing environment and drawing up the correct documentation (such as the work instructions, test protocol, etc.).

5 Pre-production After the device has been tested successfully and the design has been confirmed, the final phase can begin; this is the phase during which the product is made suitable for series manufacturing. Here, the appropriate techniques are deployed and the process is specified in detail. Examples include setting up the supply chain, realising the moulds for the injection moulding of components, configuring the manufacturing environment and drawing up the correct documentation (such as the work instructions, test protocol, etc.). All of the above elements are optimised for the expected manufacturing volumes. has the expertise to manufacture volumes ranging from single units up to several thousand devices per year.

6 was founded in 1993 and is a high-tech company with more than 200 employees at four locations. We develop medical systems for a very broad spectrum of applications in the medical instrumentation market. is certified to ISO 9001 and ISO Institutenweg PH Enschede The Netherlands T +31(0) Science Park Eindhoven EP Son The Netherlands T +31(0) Hogehilweg CC Amsterdam ZO The Netherlands T +31 (0) Mendelstrasse Münster / Westfalen Germany T +49 (0)

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