Successful development / production of a diagnostic system

Successful development and certification of an innovative diagnostic system for the mandible

epmodex AG, a medtech service provider based in Dübendorf, Switzerland, developed, certified and produced a diagnostic system for the mandibular joint on behalf of a renowned, traditional Swiss dental manufacturer. Misalignments of the temporomandibular joint are caused, for example, by teeth grinding at night and, in severe cases, can even lead to tinnitus. With the help of this system, patient-specific data can be recorded extremely precisely and comfortably in the three-dimensional space and bite splints tailored to the patient can be produced for correction. Temporomandibular joint disorders are often closely linked to aesthetic deviations in the face. The system is also excellently suited for this purpose and allows the dentist to work with a new type of treatment method. 

In addition to epmodex, Wymed AG as production partner and other service providers were involved in the implementation of this complex development project. 

The initial situation

Based on an extremely successful predecessor product, the customer wanted a design update combined with new application possibilities for production reasons. The order included both disposable and reusable components as well as a new packaging system. The new product was to have both trademark and design protection rights.  

From concept to direct certification

In close cooperation with the customer, epmodex first specified the most important requirements for the final product. This was followed by a verification concept, which resulted in a precise project schedule for the upcoming phases. By means of several prototype iterations, the usability was further tested and improved in various development stages. Using our ISO-14971 based Risk Management Process, all risks were identified and simultaneously migrated through design improvements. In parallel, verification and validation activities including clinical evaluation were performed and documented for later certification according to ISO-13485. With the support of GS1 Switzerland, the product was provided with a Unique Device Identification (UDI) mark. 

And then came MDR!

In order not to jeopardize market access and to meet the increased requirements of the new regulation, epmodex set up a completely new quality management system at the customer's site. At the same time, the technical documentation was again profoundly revised and the necessary documents for the market approval according to MDR 2017-745 were prepared. 

Successful series production thanks to highly efficient production collaboration

Together with our production partner Wymed AG, sample parts for various validation activities were manufactured and tested in a very short time. In close mutual exchange, valuable production-related experiences flowed directly back into the design and processes, which then resulted in time- and cost savings.  The medical product was thus brought to series production readiness in the shortest possible time. Currently, Wymed, within the framework of a Contract Manufacturer Organization (CMO), manufactures the individual components, organizes the required C-parts, carries out the required laser markings and surface treatments with its long-standing supplier network, and delivers the assemblies to the customer fully assembled, cleaned and packaged.

The most important facts about this project at a glance:

Result:

• Development of a novel diagnostic system for the mandible including specific packaging
• Installation of an MDR-capable QMS system at the customer's site
• Preparation of MDR-compliant documentation / market approval

Scope of services:

• Patent search and application
• Product development
• Usability engineering
• Risk management according to ISO-14971
• Assembly/ Manufacturing Technology
• Industrialization, design transfer, series production
• Documentation and verification according to ISO-13485 
• MDR- Remediation
• UDI & Traceability
• Quality assurance
• Product labeling and packaging
• Supply Chain Management

Time:

• 36 months

Human Resources:

• 7 employees (epmodex)
• 65 employees (Wymed)

Project scope:

• Analysis and brainstorming
• Conception
• Development
• Certification/ market approval
• Series production

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