Identifying and Defining a Strategic Pathway for Clinical Data Through Design Development and Clinical Evaluation

The collection of quality clinical data is crucial for ensuring the safety and effectiveness of any novel medical device on the way to seeking regulatory approval. However, companies can effectively identify and define the strategic pathway for clinical data through design development and clinical evaluation.

Here are some necessary steps that should be taken when developing a design for your clinical data study:

1.???????? Understand the intended use and indication for use of the device.

2.???????? Refer to the intended performance data, including such factors as ease of use, position, performance in spontaneously breathing and mechanically ventilated patients, intubation and difficult airway management.

3.???????? Analyse performance data as well as the clinical development plan. Performance data should be categorized into four types, each with its own respective performance, clinical performance, clinical benefit, and claim. The thorough clinical development plan will include human studies, mannequin and cadaver studies and difficult airway case reports.

4.???????? Consider the clinical development plan’s regulatory status and type of design. The pre-market phase should involve a feasibility pilot RCT, mannequin studies, cadaver studies, and case reports. The post-market phase should include follow-up studies to support safety and performance, as well as registry studies and case reports.

5.???????? Ensure that there is enough good quality evidence for the clinical evaluation. This should include clinical data and evaluation results that allow a qualified assessment of the device's safety and achievement of intended clinical benefits. Compliance with regulatory requirements, good laboratory practice and the ISO14155 standards is important.

6.???????? Emphasize the importance of a clinical evaluation report, which should include the intended performance, clinical performance and clinical benefits of the device. This data should be weighed against the risks and support the intended use, indication for use, intended user and all claims.

By following these steps, companies can be sure to identify and define an effective strategic pathway for clinical data through design development and clinical evaluation.

The acquisition of good quality clinical data is not only essential to ensuring the safety and effectiveness of a medical devices, but additionally creates a solid foundation upon which to build a successful regulatory approval submission.