If your clinical research does not evaluate aspects relevant to patients and users of your product, then you will get nowhere.
The selection of clinical outcomes in clinical research involving health products has been a topic of discussion in recent years. An example of this was the discovery by the American agency for quality and research in health care (Agency for Health Research and Quality - AHRQ), which found that in studies financed by the entity in a very common disease among men, the benign hypertrophy of prostate, there was no relationship between the assessed clinical outcome (urinary flow rate), although positively valued by doctors, with the user's perception of symptomatic improvement. The standard clinical outcome had no correlation with the patient's perception of severity or discomfort.
This connection search movement with the end user, also called in English the "patient centricity," has been a growing concern in pharmaceutical markets and health requirements for devices; and receiving special attention from regulatory agencies on health. After all, in the modern and digital world we live in, a dissatisfied user sharing his opinion on social networks produces losses for the company.
It is important to keep in mind that an investment in generating clinical research should preferably capture 3 types of results: clinical results that make sense to the community of health professionals who will use and recommend the technology, outcomes with a positive impact on quality of life and convenience to the end user, and finally economic results that justify the incorporation of the technology in the market.
Generating scientific observations and capturing valuable technical information over the entire life cycle of a health device should be a concern for every technology owner.
Interventional and observational studies have distinct and complementary roles, being essential in generating evidence for health devices. Interventional studies are more prevalent during the period of generating clinical information for the purpose of registration. However, registry-type observational studies, after the technology's arrival on the market, are ideal for capturing data on durability, adverse events and the effectiveness of commercial health products.
There is great expectation of growth in the short and long term for health devices on the world market. Do not expect to encounter problems with registration or marketing to develop a strategy to capture technical information about your product.
Producing information from your health device can differentiate you from competitors and generate the opportunity to share your product's valuable information with stakeholders.