Scientific publications for rapid and deep market entry of innovative medical devices

Well-written study designs are crucial for manufacturers of medical devices as they form the basis for the success of clinical investigations. A well-written study design ensures that the clinical investigation fulfils the relevant scientific and regulatory requirements and that the safety and effectiveness of the product can be demonstrated.

Well-written study designs are essential for the market entry of innovative medical devices, but are not sufficient on their own to ensure rapid and deep market entry.

A customised and sophisticated publication strategy is necessary for the successful market entry of an innovative medical device. This requires in-depth knowledge and experience of the importance of generating scientific evidence and the significance for market access in this area.

The elements of a successful scientific publication strategy include

• Targeted selection of publication channels: Choosing the right journals and conferences is crucial to effectively reach the target audience. This includes both traditional and open access publications to ensure maximum visibility.
• Quality of publications: Well-written articles and reports that meet scientific and regulatory standards are crucial. They must be clear, concise and structured to increase credibility and gain the trust of the medical community. Particular attention should be paid to keywords relevant to the field and to addressing unmet medical needs from the outset.
• Visibility: Open Access publications can increase the visibility and accessibility of research results, which is particularly important in order to achieve broad acceptance quickly. Presentation at relevant conferences over several cycles increases visibility non-linearly.
• Strategic planning: A clear strategy that defines the objectives of the publication is necessary. This includes planning publication timelines and coordinating with other communication efforts to deliver a coherent and effective message scientifically.

Overall, well-written study designs are the first step, but the success of an innovative medical device also depends on the effective communication of study results through reports and publications. This helps to overcome regulatory hurdles as well as gain the trust of the medical community.

Benefit from a successful scientific publication strategy:

• Physicians and other healthcare professionals are often conservative and need to rely on solid scientific evidence before recommending or prescribing new products. Well-presented study results published in high-impact journals or at national scientific meetings can give visibility to a new product, answer unanswered scientific questions and increase confidence in a new product.
• Authorities often require the publication of results in order to fully fulfil regulatory requirements. This accelerates the publication of scientific evidence and enables the inclusion of a new treatment or diagnostic in the guidelines of professional societies.
• Publications in international scientific conferences and journals help to increase the scientific credibility of a product. They make it possible to make the results accessible to a broader scientific community and to promote discussion about the product, thereby improving it if necessary. They often also enable exciting discussions with specialists and opinion leaders in the field, and these people support an innovative product in various ways.
• In addition to authorisation, reimbursement by health insurance companies is an important factor for market success. Scientific publications can help to demonstrate the clinical benefits of a product, which can be decisive for reimbursement decisions.

Overall, a well-designed publication strategy supports not only the market launch, but also the long-term establishment of the product in the market by facilitating scientific acceptance and regulatory approval.

Principles for writing clinical investigation reports and publications

High-quality publications should be produced in accordance with the guidelines of the EQUATOR network to improve the quality and transparency of health research. Over many years, the EQUATOR network has provided a variety of reporting guidelines developed specifically for different types of studies. These guidelines are structured tools that help authors to present the essential information in their research reports clearly and completely for authorities, scientists and physicians.

The most important of these guidelines include, each related to different study designs:

• CONSORT: For randomised controlled trials to ensure transparency and completeness of reporting.
• PRISMA: For systematic reviews and meta-analyses to support the systematic presentation and synthesis of evidence.
• STROBE: For observational studies in epidemiology to improve the reporting of cohort, case-control and cross-sectional studies.
• STARD: For diagnostic accuracy studies to promote clarity and completeness of reporting.
• SQUIRE: For quality improvement studies, to standardise the reporting of quality improvement initiatives.

These guidelines help to ensure that research reports are sufficiently detailed and transparent to be understood, reproduced and included in systematic reviews and guidelines by other researchers.

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