When it comes to managing data, manufacturers in the healthcare and medical technologies sector face many of the same challenges that pharmaceutical and biotechnology firms need to overcome. Various aspects of the development, manufacturing, marketing, distribution, and use of medical devices are subject to strict regulations. With high volumes of data being digitized, there is a distinct need to both protect and manage this information centrally, and adapt and issue it to multiple domains, such as healthcare providers or consumers. Failure to meet these obligations may lead to potential risks to patient safety and result in severe financial penalties and sanctions.
All of this and more can be managed centrally with Viamedici multi-domain MDM.
1
Medical technology and healthcare companies deal with huge amounts of complex data such as product information, clinical trial data, and patient information. They need to keep a detailed record for each device, from the development and manufacturing stages through to marketing, packaging, distribution, and use. Keeping this data accurate and up to date is a challenge when information is stored on different systems – but there is no room for error.
Viamedici MDM brings together the data from multiple systems and stores it centrally in one place. Through MDM, companies can eliminate errors, duplicates, and inconsistencies to improve the quality of the data. A single source of truth is created that is accurate, reliable, and can be shared across the organization and with the partners involved in the production processes.
2
Many medical devices need to be maintained at various intervals throughout their lifetime to make sure they continue to work properly. But without accurate and detailed information on a device’s location and condition, this is extremely difficult to organize and can be detrimental to patient safety.
The maintenance of medical devices can be managed through MDM by tracking their location, usage, condition, and service history. By consolidating this information, routine maintenance activities can be planned more easily, making sure that the medical devices remain in a safe and efficient working condition.
3
Understanding who the end users of the medical devices are is vital in the event of product recalls. A record of use must be maintained throughout the service life of the medical device.
Viamedici MDM enables companies to track where medical devices are used and by whom, enabling them to react swiftly in case a product needs to be recalled.
4
Keeping up with and navigating the landscape of ever-changing regulations and legal requirements for products in the medical technology industry is complex.
Built-in rules in the MDM solution check that product information complies with the latest industry regulations before it is published. This also gives the manufacturer peace of mind in the preparation of regulatory submissions.
5
Complex products may need to be manufactured with a different configuration to take into account the needs or constraints of the facility where the medical equipment will be installed, for example. On the other hand, durable medical equipment may need to be configured slightly differently for the end user. If the product information is not managed centrally, this can lead to unnecessarily long lead times and new products take a long time to design, manufacture, and launch.
Through the centralized management of all product information, manufacturers can quickly access the relevant data, adapt the configuration, and create variations to meet the new requirements of the user or the facility. Centralized access to the data speeds up the manufacturing and delivery process. Likewise, if new variants of an existing product are created, the golden record is used to quickly manufacture them and launch them on the market.
6
Due to increasing threats of data breaches, regulatory bodies such as HIPAA and the FDA have imposed ever-increasing regulations with regard to protecting digital data. In light of limitations regarding what information can be shared and with whom, regulatory compliance and careful management of data are imperative.
Viamedici multi-domain MDM incorporates cutting-edge, robust security technology to protect sensitive information, such as patient data and trade secrets. Through central management and roles-based access, only authorized people have access to confidential information.
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