Poster Q16 - Beginning with the End in Mind: Conducting a Validation Literature Search Before Technology Verification

Introduction: In this study, we adopt a "begin with the end in mind" approach, reversing the traditional research sequence to prioritize patient outcomes over technical specifications. Initially, we thoroughly define the patient need by reviewing existing literature to understand the desired impact on patient care. This step ensures a comprehensive grasp of the health issue's prevalence and the specific improvements sought in patient outcomes.

In the development of medical devices, traditional approaches often prioritize meeting technical specifications over directly assessing the impact on patient outcomes. This research proposes a paradigm shift: initiating the validation process with a comprehensive literature search focused on patient outcomes rather than solely on verifying technology strategies. By first understanding whether there is statistical evidence that supports improved patient care if the technology functions as intended, we aim to ensure that the development efforts align more closely with clinical significance.

This study outlines a novel shift in thinking for conducting literature searches that prioritize patient outcomes. Prior to launching the conventional FDA design waterfall -- which meticulously translates functional specifications into design specs and tests for technical validation -- our approach begins with identifying gaps in clinical trials and patient outcome studies. By leveraging this outcome-first strategy (See Figure 1), we propose a framework that directs research and development efforts towards innovations with proven potential for meaningful clinical impact.

Materials and

Methods: By "flipping the script" and conducting verification studies in advance of traditional validation studies, this approach ensures that the technology development trajectory is influenced by robust evidence of potential clinical impact from the outset. This subtle shift in perspective enhances the likelihood that the resulting medical device will meaningfully improve patient care, aligning technical development with validated clinical needs. Project research begins with the following three steps:

1. Defining the Patient Need: Before researching for predicate technology, conduct a systematic review of existing literature to identify the specific health issue, its prevalence, and the desired impact on patient care.
2. Literature Search for Clinical Impact: Identify existing studies that evaluate the impact of similar or related technologies on patient outcomes. Develop a comprehensive search strategy using relevant databases (e.g., PubMed, Cochrane Library) and keywords focused on clinical outcomes, patient benefits, and impact studies. Apply inclusion and exclusion criteria to select studies that provide statistical evidence of patient outcome improvements linked to the technology or analogous solutions.
3. Gap Analysis: Synthesize findings from the literature search to identify areas where clinical evidence is lacking or inconclusive. Map these gaps against the defined patient need to highlight where future research should focus.

Results, Conclusions, and Discussions: We have initiated and refined several searches using the method described earlier; here a typical strategy is presented. In this example we seek to find recent publications in the area of pediatric cardiology where a quantitative clinical trial was conducted that would link the use of wearables to patient outcome measures. The sample search script is:

(wearable OR "wearable technology") AND (pediatric OR child OR children) AND (impact OR effect OR outcomes OR "patient care")

In PubMed, this produces 900 results; when filtered by “clinical trials” over the past 5 years, 49 papers result. When those papers are selected in which data is available for analysis, only 15 papers result. A review of those paper provided seven papers that provided some insight on the use of wearables whereby a clinical outcome was related to the intervention.

Based on the exploration of outcomes, it became evident that the search strategy needed to focus on the parents' role in accepting technology as part of their child's care. Through a series of about a dozen increasingly refined searches, a pivotal paper was discovered that provided valuable insights into how parents' perceptions of technology influenced their willingness to adopt it. This finding highlighted the critical impact of parental attitudes on the integration of technology in child care.

The full paper dsicusses how the strategy and perspective outlined here provides a unique perpsective on the importance of the Need Statement and Validating Clinical trials that assist in identifying priorities in wearable device design.

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