What are the elements of a strategy session to generate clinical evidence?

Strategy development: The first step to success‍

The path to a successful clinical investigation begins with a sound strategy.

Generating clinical evidence for medical devices is a complex process that usually begins in a strategy meeting. Depending on your experience and the stage of your project, we will send you standardised documents or review the existing documents. This allows experienced and specialised consultants to prepare for the actual meeting in a structured manner.

The strategy session takes place in person so that the most important information can be assessed and the direction can be set.

A careful and clear focus is essential for efficiency in the complex process that follows.

Contents of a strategy session on evidence generation

1. planning and goal setting: the guidepost for the evidence strategy

• Vision and mission: Defining the long-term objectives and purpose of the innovative medical device.
• Objectives: Clear definition of the objectives of clinical evidence generation, such as proof of the safety, performance and effectiveness of the medical device, development process as DiGA or DiPA, initial evidence for selective contracts with health insurance funds, national or international authorisation studies, scientific research, clinical trial, etc.‍
• Regulatory requirements: Consideration of regulatory requirements in accordance with Regulation (EU) 2017/745 (Medical Device Regulation, MDR), 2017/746 (IVDR), DiGAV or other relevant guidelines such as MDCG 2020-6

2. internal and external analysis: the basis for well-founded decisions

• Presentation of the internal analysis: Assessment of the internal strengths and weaknesses of the planned (or previous) project, including resources, skills and competences within the company, existing clinical evaluation or potential use of the company's own data, status or classification as a medical device
• External analysis: Examination of external opportunities and risks due to any covered or uncovered medical needs, state of the art and knowledge, guidelines, competitors, required level of evidence, suitable target populations, observation periods, initial risk assessment, technological developments and regulatory requirements and those relating to the study design, including expected sample sizes

3. strategy formulation: the path to robust clinical data

• Development of strategies: Based on the results of the previous analysis, strategies are developed to achieve the defined objectives. This can be done via e.g. scientific literature and clinically relevant information from post-market surveillance, possible equivalence analyses, review of existing databases, clarification of regulatory aspects, definition of implementation strategies of any kind, start of the development of a study synopsis as far as possible.
• Prioritisation of initiatives: Identification and prioritisation of the most important strategic initiatives that contribute to achieving the objectives, including the associated work packages and, if necessary, a communication and project management plan. Develop timelines and milestones.

4. study design and methodology: the conception of evidence generation

• Resource allocation: Allocation of the necessary resources (financial, human, technological, contractual) to implement the strategies and their fixation in a study synopsis, clinical investigation plan or evaluation concept.
• Organisational structure and processes: Adaptation of the organisational structure and processes in order to effectively implement the strategy. This includes defining responsibilities, milestones and schedules.
• Communication beyond company boundaries: Effective communication of the strategy to all stakeholders, usually in several specialised companies, and alignment of cultural values as a basis for the close cooperation to come.

• Performance measurement: Definition of key performance indicators (KPIs) and regular review of progress against the set objectives
• Adjustment and corrective action: Setting thresholds and timing for any adjustments to the implementation of the strategy to ensure that the defined objectives can be achieved. This may include modifying tactics or realigning resources.

These phases are iterative and dynamic so that the strategy can be regularly reviewed and evaluated against the evolving study design and associated information or adapted to reality to ensure long-term success.

Creating a sound study concept that is strictly aligned with the overarching strategy is a multi-dimensional endeavour that belongs in the hands of experienced experts from different disciplines. It is the result of in-depth knowledge and careful listening.

No one is helped if mistakes are made here or if study concepts are simply "cobbled together" from various documents and samples from the Internet.

More information on study design for clinical investigations can be found here. Subsequent typical steps of strategy implementation include the regulated phases of design, planning and preparation, execution and control, data management and analysis, and subsequent reporting or publication at scientific conferences or in scientific journals.

At MEDIACC, we attach great importance to understanding the individual needs and objectives of our clients. Feel free to contact us for an initial consultation!