MedTech: We explain the new standard of excellence for patient care

Por
Eden Experts
February 1, 2023

MedTech Lifecycle Excellence is an innovative system that dictates how medical device companies must assemble and manage top quality equipment throughout its entire life cycle.

By using cutting-edge intelligent technologies, current process design approaches and versatile ways of working, MedTech companies significantly improve the way they build safe and effective devices.

For example, the PACS/RIS integrated to manage operations of medical institutions, are an example of these MedTech tools that help improve processes and therefore the performance of the institution.

These improvements are confirmed by the results of a current McKinsey analysis, where it was discovered that this “intelligent quality” technique brings tangible results such as:

  • 25-35% increase in development efficiency and start-up time;
  • 25% increase in the effect of quality improvement initiatives;
  • 25-40% increase in the efficiency and speed of the main quality control processes
  • 80% reduction in deviations and/or non-compliances.
  • Productivity and speed doubled between approximately 50 and 100% when optimizing tests.
  • Eliminated paperwork, automated processes and machines moved to the production plant.

7 Business Advantages of Implementing MedTech Practices

In the same way, MedTech Lifecycle Excellence offers companies the opportunity to introduce best practices into their processes to obtain visible effects throughout the product lifecycle.

What does this really mean? Let's forget about business jargon and take a look at each phase of the MedTech lifecycle and what companies must do to achieve authentic and measurable excellence in each of them.

  1. Establish the problems and user requirements that have not been met.
  2. Build a schedule for the project, the expenses, the regulatory route and the probable revenues.
  3. Formulate safe, high-quality products that meet user needs with a persistent design control course of action.
  4. Submit it to official review with guarantees.
  5. Deliver your product with a successful transfer from design to production, distribution network establishment, advertising, product registration and reimbursement strategy.
  6. Perform a effectiveness monitoring of your product with post-marketing surveillance that provides full traceability of quality events, including non-compliances and consumer complaints.
  7. Improve the quality of life with your item by meeting the needs of users.