Product development is generally very worthwhile, but requires good planning of the validation and verification phase. The idea of ​​making one’s own idea a reality captivates many entrepreneurs and inventors. Nevertheless, there are, especially with medical devices, some points to consider.

In this field senetics offers:

  • Planning of the verification: preparation of the test plan
  • Planning the validation including the preparation of technical documentation
  • Verification performed in the senetics test laboratory
  • Examination of the risk management file
  • Conduct clinical evaluation
  • Conducting usability tests
  • Preparation of the technical documentation for the CE marking

 

Requirements for usability

Every system that works with a human-machine interface (HMI) should be developed in a user-oriented manner. For example, a medical device must take into account the regulatory requirements that have to be fulfilled als well as the needs of the user. Novel products should be developed in such a way as to include possible ethical, legal and social implications (ELSI). Only in this way an optimal user acceptance can be achieved. In addition, the product must be practical, it should be as reliable as possible with high usability and capture data available at a moderate price. Furthermore, the technology should facilitate the everyday life of the user, without causing the stigmatizing of strangers. Of course, the security of personal information against unauthorized access is another important aspect. Only authorized persons, such as a doctor, should be given access to the information, for example, for diagnosis or therapeutic decision. Important factors must already be considered in the early stages of system development, especially in the area of ​​usability and risk management.

Planung einer Usability-Studie

Design Verification

The following applies to a medical product: Depending on the functional principle, duration of application and other specifications, the product can be classified in certain medical device risk class. This determines the route of the approval process and is divided into four levels of low to high risk.

Furthermore, the correct functioning of the prototype has to be investigated. The senetics healthcare group’s testing laboratory carries out a large number of electrical, mechanical and biological functional tests, which after completion drive the development of a maximally safe medical device. The mechanical and electronic testing of novel technologies includes the review of functionality and safety aspects to ensure potential human-machine interface (HMI) risk factors, taking into account ethical, legal, and social implications for achieving optimized user adoption.

Validation of the risk management file

This is crucial to ensure the protection of users in any situation. The Admissions Division considers those under ISO 14971 risk management as e.g. in a Failure Mode Influence Analysis (FMEA) to find and minimize any potential hazards. The aim is to establish the safest possible medical device on the market. This includes both the product and the accessories. In the case of wearables, the measurement unit and associated applications, such as apps on the smartphone, are relevant components of risk assessment.

Herefore, it is advisable to accompany the product development by preceding analyzes, such as the fault tree analysis (FTA) to identify possible hazardous situations. In addition, the determination of the measurement process in a so-called gray-box analysis reveals critical process steps that need to be considered. In addition to technical aspects such as the fulfillment of basic requirements for safety and essential performance features according to DIN EN 60601-1, the testing of biological safety according to ISO 10993 is of crucial importance in the process of certification of medical devices. This includes various analysis steps, which differ depending on the area of ​​application of the new technology and can be covered by the needs of the biolab. Thus, the testing of an invasive sensor is more complex compared to the validation of a system applied only superficially to the skin.

Vorbereitung Funktionale Sicherheit

Biological Validation

In addition to the testing of the material and the technology for cytotoxicity, sensitization and irritation or intracutaneous reactivity, genotoxicity and the implantability of the system are to be tested for invasively used medical devices, for example. Thus, the characterization of the material as well as the interaction between technology and tissue are largely determined by where and how a future medical device can be used.

The tests are to be carried out on the final end product, however, prior checks are already recommended in the development phase. In the context of product development, we carry out accompanying tests to enable you to carry out a biological safety assessment at an early stage. An overview of all possible tests can be found in senetics Biolabs.

Proof of clinical efficacy

Therefore, in addition to a clinical evaluation, which refers to the comparison of a novel product with previously tested and approved technologies based on comparable published data sets, it is often necessary to conduct additional clinical trials. These demonstrate the functionality of a developed system in a study. As needed, the Approval Department conducts clinical assessments and / or exams from requesting a study to analyzing the data. For certification to be as easy as possible during the development process, it is advisable to contact the responsible regulatory authorities during the product development phase in order to facilitate a standard-compliant development and documentation process towards the CE certificate. Taking into account the above-mentioned project steps, these not only interact better as a whole, but also accelerate the market entry time and at the same time ensure that unforeseen cost items are kept to a minimum.

Completion of product development: series introduction

Once all necessary product development steps have been completed, the series introduction can start. After the above steps, all relevant design changes should be included in the product design. There is a design freeze, that means no changes can be made afterwards. From this point on, the series introduction can start.