Development of Medical Devices - 5 Tips
Medical devices are predicted to have a growing market potential over the next few years. What does this mean for the developers of such devices? Seven tips for everyday work of development of medical devices.
Medical devices lays the foundation for new services such as the ability to monitor vital signs more easily and permanently. The future of the medical device market, both for clinical and home-care applications, is promising. It is forecast to reach an estimated volume of The global medical devices market is projected to grow from $455.34 billion in 2021 to $657.98 billion in 2028.
Today, thanks to advances in science and technology, medical device manufacturers have more choices. However, developers are faced with everything from increasing material costs to quality control issues, growing competition and the need for accelerated time-to-market, as well as new compliance requirements.
5 Tips for Develop Medical Devices
A typical mobile device that can be used to measure a patient’s vital parameters serves as an example. These include body temperature, blood pressure, ECG, oxygen saturation or respiratory rate. All parameters are to be monitored via sensors. When developing such a device, the following points should be considered:
Medical devices are subject to strict safety standards and application guidelines for thermal conditions. The surface temperature for medical devices is regulated by the IEC 60601-1 standard. For devices that touch a patient’s skin, this means that the surface temperature of the device must remain below a certain value, which depends on the precise application of the device.
Choosing Materials for Medical Devices
Material selection is typically one of the first steps in designing medical devices. Medical devices require the use of non-allergenic materials that are highly durable and resistant to frequent cleaning and exposure to chemicals. Additionally, the material may need to be RF transparent to transmit RF signals. The easiest way is to use materials that are pre-certified for medical use. Working with an R&D team that has an extensive materials database and the simulation capabilities described above can greatly simplify and speed up the material selection process.
Electric Shock Protection
Accessible parts of the medical devices must be protected against current leakage in accordance with the IEC 60601-1 standard. The standard contains special features for medical devices that differ greatly from the specifications for consumer goods. If a risk of leakage current is identified during the design process, accessible conductive parts of the hardware must be replaced or secured with additional components to prevent this. In addition, medical devices need a leakage current measurement function and a control mechanism so that the device switches off automatically when leakage current occurs or exceeds certain limits.
Industrial and Mechanical Design Solutions
Very specific to medical devices is the requirement that they must be easy to clean without leaving residues. The medical devices are usually used for several patients. If cleaning between patient changes is required, It is therefore an important point that the devices meet certain IP classifications. Water resistance is particularly important because the devices are cleaned with antibacterial liquids, for example. A prerequisite for easy cleaning is also a design without hard-to-reach corners where residue can accumulate.
Other areas of the mechanical design process can be facilitated through the use of finite element analysis (FEM) calculations, drop test simulations, ingress protection and light guide simulations. When these areas are included early in the design process and supported by simulations to prove the design, the desired level of quality is achieved more quickly, paving the way for cost savings and faster time to market.
Failure Mode and Effects Analysis
Medical devices must be safe for the user even under single fault conditions (SFC) as specified in IEC60601-1. Situations for this are The :
- Interruption of the protective conductor or a supply conductor,
- Occurrence of an external voltage on an applied part
- Failure of the basic insulation or of temperature limiting devices.
Due to strict regulations, Failure Modes and Effects Analysis (FMEA) are an essential part of a device’s design process.