2016 seems to become the year when it all comes together. The traditional domination of hardware and pharmaceuticals is being caught up by health-through-information.
With wearables becoming a commodity, the 5G standard approaching fast, enabling a revolution in IoT communication, health apps, electronic handling of prescriptions and patient dossiers, health becomes more and more about collecting, analyzing and acting on data.
The digitization of medical device products will have a profound effect on the way the industry conducts business and generates growth.
However, according to McKinsey, medical device companies have been slow to adopt, not necessarily when it comes to what they produce but rather how they produce it. I am often surprised to see how the digitization of the medical devices themselves rarely are matched by an equal digitization level of the development processes.
Ironically, the medical device industry, with its well-known dilemma of being required to provide high-quality innovative products in a regulated market is an exceptionally good candidate for process digitization.
The documentation requirements on a medical device manufacturer are both growing and changing, forcing the development effort to become increasingly focused on the paper trail.
For safety reason, compliance rightfully requires each step and decision to be carefully recorded. Even though being a just and fair requirement, the operational reality of such a process unrelentingly divides the attention of a professional R&D work force from innovation to administration. A traditional paper-based approach is simply not up to the task of managing the interconnected nature of the DHF.
Digitizing the development documentation process and rely on a unified repository for the design history file management will not only increase the efficiency of the work and free up valuable innovators from menial documentation tasks. It also makes it possible to automatically analyze and verify the completeness and consistency of the DHF artifacts, increasing the quality of output.
With a medical device ALM like Aligend Elements, allowing the digitization of work practices and document handling, the medical device manufacturer will match the innovation of his products with the efficiency of his processes.
Aligned Elements supports facilitating capabilities like:
- Electronically sign and release document
- Automatically route documents according to a workflow process
- Push released documents to external systems
- Collaborate on the documentation creation, management and review
- Perform real-time consistency checks at any time
- Synchronize documents and generate traceability tables with a single click
Read more about Aligned Elements here.