In the fast-evolving landscape of In Vitro Diagnostics (IVD), the difference between a technology that stagnates and one that revolutionizes patient care often lies in collaboration. A strong partnership between manufacturers and end-users can unleash the full potential of innovations, ensuring they resonate within real-world healthcare environments. In this article, we highlight the key role of microbiologists and physicians in this partnership with manufacturers, using the implementation of rapid Antimicrobial Susceptibility Testing (rAST) as an example. However, many of these considerations can be transferred to other technologies and settings.

Ensuring New Technologies Address Relevant Healthcare Needs
Clinical insights are essential in guiding the development of innovative devices. To achieve successful implementation, diagnostic technology must effectively meet clinical needs in specific settings and satisfy users´ requirements. For example, clinicians´ input is key during the development of a rAST system in relation to:

• Panel layout: Clinicians help identify which antibiotics and microorganisms should be included in AST panels to align with local resistance patterns and treatment guidelines.
• Workflow compatibility: Input from healthcare professionals ensures that new solutions integrate seamlessly into existing diagnostic workflows, minimizing disruptions that could impede adoption.

Without these insights, manufacturers risk launching sophisticated solutions that may lack practical clinical utility. Technologies that are developed with clinician input lead to more effective treatments, ultimately benefiting patient care.

Ensuring the right context for technology implementation
To effectively meet healthcare needs through rAST, it is crucial to consider the context of implementation. Unlocking the full potential of rAST in an equitable manner requires not only a 24/7 microbiology laboratory but also the involvement of a dedicated antimicrobial stewardship team or infectious disease consultants. Clinicians can play a vital role by:

• Identifying barriers to technology adoption: Clinicians can support manufacturers in assessing existing infrastructure to pinpoint obstacles that may hinder seamless integration of new technology, such as staffing gaps and limitations related to work organization in the laboratory and in the ward.
• Advocating for change: Clinicians can advocate with Hospital Administration for the necessary changes to ensure that the context is adequately prepared to support the implementation of new technologies.

Usability and Design: Optimizing Workflow Integration
Even the most advanced diagnostic technologies are unlikely to gain acceptance if they are difficult to use. In relation to rAST, microbiologists provide essential feedback on:

• Device usability: They can test whether devices are user-friendly, thus minimizing learning curves and reducing errors.
• Device adaptability to testing volume: Microbiologists of large institutions need a rAST system that adapts to a variable daily number of samples for analysis, ensuring the ability to conduct simultaneous tests. Samples should be loaded immediately as they became ready, without waiting for the completion of prior analyses.

By engaging closely with microbiologists, manufacturers can refine their rAST technologies to bolster both efficiency and user acceptance.

Validating Technology Performance
To gain clinical acceptance, an IVD technology must demonstrate accuracy and reproducibility that meet or exceed established standards. Microbiologists using rAST systems are essential in validating clinical performance. This involves performing comprehensive studies to assess how well a rAST technology performs in real-world settings. This independent validation is crucial for achieving regulatory approval, fostering both healthcare professionals´ and patients´ confidence, and facilitating widespread adoption across healthcare settings.

Implementation and Scientific Education
The introduction of a new diagnostic technology, such as rAST, requires engagement at all levels of healthcare delivery. For example, microbiologists can play a key role in:

• Guiding implementation inside the hospital: They can work with physicians in integrating new technologies into diagnostic workflows and clinical pathways.
• Educating various stakeholders: Microbiologists and physicians can provide training for other clinical stakeholders and hospital administrators to ensure comprehension of the technology’s value and limitations.

Proper teamwork is key. Even advanced tools can falter without proper buy-in from all involved.

Generating Real-World Evidence
Clinicians can significantly contribute to technology adoption by:

• Conducting Real-World studies: These studies are essential for assessing the impact of new diagnostic tools on laboratory efficiency, turnaround times, and clinical decision-making in clinical settings. By analyzing how these diagnostics are utilized in everyday practice, clinicians can provide valuable insights into their effectiveness and practicality, ultimately contributing to improved patient care and resource allocation.

This strengthens the credibility of new solutions and facilitates broader adoption in healthcare systems.

Developing a Business Case through Health Economics Data
Healthcare decision-makers require a clear business case to invest in new technologies. Microbiologists and physicians can play a key role in proving the benefits of using new rAST technology through Health Economics and Outcome Research (HEOR). If you are interested in learning more about the role of economic evaluation in healthcare, you can read our blog article Economic Evaluation: Why it matters in healthcare.

Post-Market Surveillance and Feedback
Once implemented, the role of physicians and microbiologists in monitoring performance of a rAST system continues in:

• Monitoring performance: Microbiologists play a role in identifying any device deviations in accuracy over time. They ensure that any safety concerns are documented and reported to the manufacturer and pertaining authorities.
• Providing feedback on product improvement: Microbiologists can provide manufacturers with suggestions on how to enhance panel layout, product capabilities, and troubleshooting procedures.

Developing Protocols and Best Practices
Standardization is key for ensuring that rapid AST delivers consistent, high-quality results across various healthcare settings. Microbiologists help by:

• Ensuring Optimal Technology Use: Microbiologists and physicians can develop protocols defining patient selection criteria to avoid unnecessary or misapplied testing.
  Defining Best Practices: Microbiologists can establish comprehensive guidelines that encompass all aspects of the testing process, including sample collection, handling, and processing, as well as interpretation of results and reporting.

Their expertise guarantees that technologies are utilized effectively to maximize clinical impact.

Conclusion: A Collaborative Effort for Real-World Impact
Establishing and nurturing collaborations between manufacturers and healthcare professionals is essential for the successful adoption of innovative technologies. As the demand for advanced diagnostic and therapeutic solutions grows, leveraging the collective expertise of clinicians, microbiologists, and other healthcare stakeholders becomes imperative. Working together can lead to innovations that ultimately enhance patient experiences and care quality.
With our extensive network of Key Opinion Leaders across various specialties, we can assist you in identifying the right collaborations, mapping influential experts, and facilitating strategic interactions aimed at accelerating your product adoption. Contact us to learn how we can help you build valuable partnerships that not only enhance the efficiency of your innovations but also ultimately improve patient care across diverse healthcare settings.