Medical Consultant (m/f/n)
GUARD: GUideline Application In Real-Life Digital Tool
In a world of fragmented care, management of patients with type 2 diabetes (T2D) and cardiovascular and/or kidney disease or high risk, has focused primarily on primary care practitioner's expertise which often limits treatment decisions to only a few typical parameters as well as local and individual practices (including programs, initiatives, etc.) that are not necessarily following current guidelines, resulting in increased risk for cardiorenal complications and subsequent unnecessary loss of patient's lifetime.
GUARD focuses on a smart and effective tool that integrates into the practitioner's information infrastructure. It analyses an individual patient file and identifies and flags areas of attention and provides treatment recommendations based on guidelines. For measuring success, physicians can generate reports about their performance and monitor the quality of their approaches. Additionally, it provides patients with key information about their health status and actions to be taken and helps them executing their treatment plan.
The tool is currently piloted in Canada. For 2022/23 it is to develop versions for the US and German markets based on the respective local guidelines. In Europe, and also potentially USA/Canada, the development will follow standards for Software as a Medical Device (SaMD).
Background to the assignment
As part of the project GUARD, we plan to continue to work on the pilot software and digitalization of the current T2D guidelines.
For strategic reasons, we have decided to outsource the medical evaluation of the T2D guideline entirely to external providers, as there are no suitable resources and expertise for this internally. Because of this, the contractor holds a unique position and provides significantly different services than the internal staff.
Concrete, detailed description of services
The services shall be provided within the framework of an agile development method in close collaboration with the technical /development team. The concrete activities required in each case to implement the services commissioned shall be agreed iteratively between the parties within the framework of sprint meetings and implemented by the Contractor within the respective sprints following the sprint meetings. Prior to each sprint meeting, the contractor shall independently check, on the basis of its professional expertise, which individual services are reasonable and feasible within the scope of the assignment in the respective sprint. The sprints each have a duration of 3 weeks, so that the sprint meetings take place at intervals of 3 in weeks. Within the individual sprints, the contracting parties shall coordinate the respective technical requirements for the services to be provided in daily meetings. After completion of a sprint, the Parties shall conduct a "Sprint Review'' in which the Contractor reports on the feasibility and status of the services performed by it in the previous Sprint and makes a recommendation on how to proceed with regard to the services that proved to be unfeasible in the respective Sprint. All of the meetings and exchanges described above shall take place exclusively in the presence of a central contact person named by us, who shall coordinate the project on our internal side. The organization and scheduling of the meetings described above in which the Contractor is involved shall be organized and carried out by the Contractor and coordinated with us.
The Contractor shall provide the following services and consult the technical team on the following topics:
- Creation of decision logic
- Identify critical patient parameters and define decision logic (IF/THEN rules) based on relevant guidelines and prescribing information
- Document a rationale for the defined rules and explain borderline cases
- Define how the individual rules interact (priorities, hit policy)
- Provide additional medical user-information to be included in the tool
- Document source/references of information included in tool
- Identify potential risks
- Validate decision logic
- Validate defined decision logic with several experts/societies to reduce bias and to improve accuracy
- Define patient test cases for the validation process . This task includes the generation of clinical case data sets for testing which are close to patient cases occurring in clinical practice.
- Define key performance indicators for the validation process
- Lead the internal Medical-Legal-Regulatory (MLR) approval process reviews for the prototype/SaMD product . This includes coordination of review team (meetings if required) and conduct and document the medical review for medical correctness of the documents.
- Iterate and Learn
- Keep track of changes in the scientific literature (guidelines, product monographs and local regulatory changes), share results and discuss implications for the project
- Communicate and consult with the local country teams, experts and societies with regards to the product development, collect feedback, and clarify questions.
- Analyse medical feedback from users and identify product updates and improvements based on results from user research, and make suggestions for product development.
Possible timelines to be kept
Ready Pilot milestone till 1.10.2022 / Start of Design Control for SaMD.