Software as a Medical Device for a pharmacy network

Find out how we helped a pharmaceutical company reduce medication errors by developing a Software as a Medical Device (SaMD) product that calculates the optimal medication dosage for each individual patient.

  • industry

    Healthcare

  • Country

    USA

  • Team size

    10+

  • Implementation

    8 months

About the client

Our client is a medium-sized pharmacy network that operates in multiple US states. The company employs condition-specific pharmacists that work together with physicians to help patients with a wide range of chronic conditions.

Business context

The pharmacy network needed to reduce the number of medication errors, unburden their staff, and automate the prescribing process with a SaMD solution for personalized drug dosage recommendations. To achieve the client’s goal and develop an efficient software solution, we set the following agenda:

  • Ensure that the solution can process patient data such as medical histories, lab results, current medications, genetic information, and lifestyle choices
  • Integrate software with prescription drug monitoring programs (PDMPs) to speed up the medical prescribing process
  • Develop a clear and intuitive UI/UX that allows prescribers to easily navigate the system
  • Prepare detailed documentation to help the client obtain FDA approval

Solution overview

  • We analyzed the client’s current business condition and elicited critical requirements. This also helped us define the day-to-day pain points of pharmacists to develop a solution that is convenient for them and adds value to their workflow.

  • Enabling full-cycle patient data processing

    The client wanted their SaMD solution to process large amounts of patient health information to provide accurate drug dosage calculations. Thus, we needed to integrate with the company’s existing EHR systems. They contain the most vital patient information, sufficient for the SaMD to work as planned. We used the Redox API service for seamless, fast, and cost-effective integration with several EHR systems and for comprehensive patient data aggregation.

     

    Integrating with prescription drug monitoring programs (PDMPs)

    To provide prescribers with quick and easy access to a patient’s full prescription drug history and speed up the medical prescribing process, we offered to integrate the SaMD solution with the PDMPs. This integration allowed prescribers to automatically pull patients’ information into the SaMD system, calculate a Narx Score, and make accurate drug dosage calculations in minutes.

     

    Designing a user-centered UI/UX

    Our task was to keep the software design minimalist and clear, avoiding distractions so that pharmacists could use the software intuitively and confidently. Navigation through the software system is straightforward, allowing users to make drug dosage calculations for multiple patients in seconds and with just a few clicks. 

     

    Software screens are designed to follow prescribers’ needs in a logical order, such as adding a new patient, pulling patient data from other systems, calculating the drug dosage, and then sharing calculations with the patient or clinician. The central screen of the SaMD solution is the drug dosage calculator so prescribers can jump into calculations right away if they already have all patient data. We also created a separate screen showing prescription history over time. 

     

    Elaborating on software documentation for FDA clearance

    The client was obliged to pass the FDA approval process and asked us to prepare detailed industry-standard project documentation. To do this, we closely negotiated with the client’s legal team. Our team delivered accurate documentation that met the client’s expectations and supported the client during the whole FDA clearance process. The client obtained FDA clearance and was able to successfully release the product.

Value delivered

As a result of our tight cooperation, the client launched a SaMD solution and simplified the medical prescribing process. Below, we provide some tangible outcomes of this project.

Before:

  • Manual drug dosage calculations were error-prone and could disrupt the patient treatment process

  • Pharmacists spent lots of time calculating medication dosages, as they had to search for patient and drug use data distributed across different systems

  • Prescribers needed extra time to manually login into different PDMPs’ portals to retrieve patient information

After:

  • A standalone system automatically defines accurate drug dosages

  • The patient processing time was reduced by 30 percent due to software-enhanced prescription decision-making

  • Direct integration with the PDMP reduced the drug dosage calculation time per prescription by 10 minutes

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