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Why is clinical strategy so important in medical device development?

 At medXteam, the focus is on clinical data. In this context, as CRO, we not only carry out clinical trials with medical devices in accordance with MDR and ISO 14155, but also offer all other options and forms of data collection and product approval as well as market surveillance. Right from the very beginning of a product idea, but also with regard to the MDR transfer of existing products, the clinical strategy plays an important role. It not only paves the way for the collection and evaluation of the necessary clinical data, but is also the basis for time and cost planning. This blog post looks at exactly this fundamental role: What is the clinical strategy and why is it so crucial?

Abbreviations

MDR Medical Device Regulation; EU Regulation 2017/745

PMCF Post-Market Clinical Follow-up, clinical follow-up

CEP Clinical Evaluation Plan

CDP Clinical Development Plan

Underlying regulations

EU Regulation 2017/745 (MDR)

1 Introduction

The development of a new product or the MDR transfer of an existing product presents medical device manufacturers with extensive challenges. One of these is the early development of a clinical strategy. The MDR explicitly requires the creation of a clinical development plan in Annex XIV. This plan is intended to cover all phases from idea to market and beyond, including exploratory studies, feasibility studies, pilot studies, confirmatory studies such as pivotal clinical trials and post-marketing clinical surveillance. The definition of milestones and the description of possible acceptance criteria are essential components.

The importance of such a clinical strategy can be attributed to several key factors. On the one hand, it enables clear structuring and planning of the development process. By defining goals and criteria at an early stage, development time and costs can be controlled efficiently and potential risks can be minimized. On the other hand, the clinical strategy serves not only to meet regulatory requirements, but also to ensure that the product will later bring the greatest possible benefit to patients. It supports manufacturers in making evidence-based decisions at an early stage and in being able to classify the product in terms of its clinical performance, safety and benefit.

In addition, the clinical strategy provides valuable input for risk management. A key part of the strategy includes conducting a comprehensive literature search to integrate existing knowledge about similar products or technologies and identify potential risks at an early stage. This information is crucial to assess, manage and ultimately minimize risks.

How this works and what needs to be taken into account is described below.

2. Product idea, start of development or new beginning with the MDR

Regardless of whether it is a new product, an idea for a new product has been born or the existing product needs to be adapted to the MDR requirements, it is always necessary to check which data and clinical data are required to create the initial clinical assessment become. Once this has been created, it must then be updated regularly and clinical data must be collected in the area of ​​clinical follow-up (Post-Market Clinical Follow-up, PMCF). In addition, a so-called clinical development plan (CDP) must be created in the clinical evaluation plan (CEP), which basically contains exactly that, namely which data are needed and must be collected. In order to be able to determine this, a clinical strategy is needed.

2.1 What is the clinical strategy?

The clinical strategy is a comprehensive, systematic approach that guides the identification, collection, analysis and updating of clinical data throughout the entire life cycle of a medical device. It is used to evaluate and document the safety, effectiveness and performance of the product, both during initial development and when adapting to regulatory requirements such as the Medical Device Regulation (MDR). The core of the clinical strategy is the creation and regular updating of an initial clinical assessment. This evaluation requires careful consideration of what specific data and clinical evidence is needed to support the benefits and risks of the product.

The clinical strategy forms the basis for the Clinical Evaluation Plan (CEP), which includes a Clinical Development Plan (CDP). This CDP defines in detail what data and clinical evidence is required to create the clinical assessment and how it should be collected. This includes both the planning and execution of pre-market studies (such as first-in-man studies, feasibility studies, pilot studies and pivotal clinical trials) as well as the ongoing collection of post-market data through Post-Market Clinical Follow-up (PMCF ) Measures.

The clinical strategy is therefore the basis for the continuous collection of (clinical) data throughout the entire product life cycle. By planning clinical data and assessments early and systematically, the clinical strategy helps to minimize risks, increase development efficiency, identify existing gaps and ultimately accelerate the market launch or MDR transfer of medical devices.

2.2 Building a clinical strategy

The development of a clinical strategy is a complex and indispensable process that covers wide-ranging areas and is deeply embedded in the planning and implementation of the development and evaluation of medical devices. The methodological structure and content of such a strategy are discussed in detail below. The clinical strategy is a comprehensive concept that covers various aspects to ultimately enable well-founded conclusions regarding the product.

2.2.1 Product description with intended purpose

The clinical strategy begins with the detailed product description. This covers the intended purpose of the product, including the technical features as well as the intended indications and contraindications. In addition, the target groups, i.e. patients and users, are defined. This initial classification is fundamental in order to correctly position the product in the medical context and forms the basis for all further steps.

2.2.2 Specific development process

The specific development process for the product is then shown. The relevant performance and safety regulations in accordance with Annex I of the MDR are taken into account. This means that the product is classified further in order to be able to draw the right conclusions for further action.

2.2.3 Documents and evidence

Another essential component of the clinical strategy is the definition of the documents to be created and the evidence required in accordance with Annex II and III of the MDR for the technical documentation of the product. These documents include in particular the necessary documents and test procedures for verification and validation of the product, as this may be important for deciding on the correct route of clinical evaluation.

2.2.4 Identification of similar products

An important step within the clinical strategy is the identification of similar or even equivalent products. This analysis makes it possible to use existing knowledge and data to support the development and evaluation of your own product. By comparing with similar products or applications in the same area of ​​application, it is possible to better estimate what clinical data is already available or required and how it can best be collected.

2.2.5 Literature and safety database search

The clinical strategy then naturally includes a literature search and a search in safety databases for similar or equivalent products. This research serves to record the current state of the art and to ensure that all relevant clinical data and information about safety aspects and similar applications, the area of ​​application of the medical device, etc. are taken into account.

2.2.6 Classification of the product in the application context

The targeted classification of the product in its application context is based on the knowledge gained from the previous steps. In particular, the comprehensive literature search makes a significant contribution to this. By analyzing existing data on similar or equivalent products and assessing the current state of the art, important insights into the practical application conditions and the needs of the target group can be gained.

The integration of this diverse information makes it possible to classify the product in the application context. This not only takes into account the theoretical intended purpose of the product, but also reflects its use in real clinical or home environments. This allows a realistic assessment of product performance under typical application conditions, which in turn optimizes product development and evaluation.

2.3 Conclusions from the clinical strategy

The careful development of a clinical strategy for medical devices brings with it far-reaching conclusions that are crucial to the direction of the product and its explicit strategy. These conclusions not only provide guidance for the clinical evaluation and development process, but also help to optimally prepare the product for market and use or for MDR transfer.

2.3.1 Foundation for the clinical assessment route

The clinical strategy lays the foundation for the clinical evaluation route and strategically aligns the planning of the development process. There are three possible ways to do this:

1. Clinical assessment using your own clinical data

The decision to conduct our own clinical trials is necessary if no alternative routes via performance data or data on equivalent products are viable, or if the product has innovative clinical claims that must be clearly supported with clinical data. This approach often involves higher costs and a longer time frame.

2. Performance/verification data (MDR Art. 61(10))

Using verification and performance data, as well as additional literature on similar products, is another possible route whenever direct demonstration of compliance with essential safety and performance requirements based on clinical data is deemed inappropriate. This approach is typically time and cost effective, but requires sound justification as to why it is considered appropriate.

3. Data on equivalent products

The use of data on equivalent products is another possibility, provided such products exist and clinical data on them are available. This route has long been the gold standard of clinical evaluation. Due to the increased MDR requirements in particular

  • implantable class IIb and
  • all Class III products

as well as increased requirements for proof of equivalence, e.g. B. for software, this hardly takes place anymore. If this route is nevertheless possible, the need for own clinical data can of course be avoided, which of course potentially accelerates the development process.

2.3.2 Identification of further risks and side effects

The comprehensive collection and analysis of data as part of the clinical strategy helps to identify further, previously unknown risks and side effects. These insights are also of great value for risk management and enable a more precise assessment of alternative uses of the product. By identifying potential risks early, measures to minimize risks can be implemented and the safety of the product for users and patients can be maximized.

2.3.3 Identification and closure of gaps in clinical data

Another critical aspect of the clinical strategy is the identification of possible gaps in the required clinical data. The early detection of such deficits makes it possible to take targeted measures to adequately close these gaps. This can be done through additional in-house data collection (e.g. planning a clinical trial, as a clinical claim cannot yet be proven using clinical data), the collection of post-market or PMCF data or the re-analysis of existing data.

3. Literature search for clinical strategy

On the one hand, the literature search as the core of the clinical strategy makes it easier to classify the product into its area of ​​application. It also leads to the identification of potential risks and helps in the development of risk mitigation strategies. It ultimately supports the formulation of a long-term clinical and development strategy based on the exact data it collects.

The literature search process takes place in several steps:

Fig. 1: Literature search process

Defining the search strategy : The first step is to carefully plan the search strategy. Relevant keywords and search terms are defined that form the framework of the research.

Choosing the right databases : Because of the wealth of information, choosing the right databases is crucial. Each database has its own strengths and specializations that need to be taken into account.

Carrying out the search : The databases are systematically searched using the defined keywords. This phase requires patience and care to ensure that no relevant information is missed.

Analysis and selection of data : After collecting the information, the results are critically evaluated. The most relevant and well-founded studies and reports are selected that help answer the question.

The analysis of “state of the art” data required for the clinical strategy captures the current state of the art.

The literature search includes four steps:

Fig. 2: Literature search step by step

Fig. 2: Literature search step by step

4. Conclusion

Developing and implementing a clinical strategy for medical devices is a crucial step that goes far beyond simply meeting regulatory requirements. It offers a structured approach to systematically evaluate and document the safety, effectiveness and performance of a product. This process makes a significant contribution to optimally adapting the product to the needs of users and patients while at the same time meeting the regulatory framework.

Through the detailed planning and analysis that a clinical strategy requires, medical device developers and manufacturers can make informed decisions that impact the entire life cycle of the product. From initial product conception through market launch to post-market monitoring, the strategy enables ongoing evaluation and adaptation of the product to changing clinical and regulatory requirements. This applies both to new developments and product ideas and to the MDR transfer of an existing product.

The choice of route for clinical evaluation, be it through own clinical data, performance data or data on equivalent products, lays the foundation for the development process and largely determines the time and costs involved. In addition, the systematic detection and assessment of risks and side effects as well as the identification and closure of gaps in the clinical data enable continuous improvement of the product and its (planned) use.

In summary, it can be said that the creation and implementation of a clinical strategy is not only a regulatory necessity, but also represents an opportunity to optimize medical devices and ensure their success in the market. It promotes an in-depth examination of the product and its application context, improves quality and safety for end users and patients and supports efficient product development. In an industry characterized by innovation and constant change, clinical strategy is a central pillar for the long-term success of medical devices.

5. How we can help you

As CRO, we support you throughout the entire process of generating and evaluating clinical data and in the approval and market monitoring of your product. And we start with the clinical strategy!

In the case of clinical trials, we consider together with you whether and, if so, which clinical trial needs to be carried out, under what conditions and in accordance with what requirements. We clarify this as part of the pre-study phase: In 3 steps, we determine the correct and cost-effective strategy with regard to the clinical data collection required in your case.

If a clinical trial is to be carried out, basic safety and performance requirements must first be met. The data from the clinical trial then flow into the clinical evaluation, which in turn forms the basis for post-market clinical follow-up (PMCF) activities (including a PMCF study if necessary).

In addition, all medical device manufacturers require a quality management system (QMS), including when developing Class I products.

We support you throughout your entire project with your medical device, starting with a free initial consultation, help with the introduction of a QM system, study planning and implementation through to technical documentation - always with primary reference to the clinical data on the product: from the beginning to the end End.

Do you already have some initial questions?

You can get a free initial consultation here: free initial consultation 

medXteam GmbH

Hetzelgalerie 2 67433 Neustadt / Weinstraße
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