Tips for human factors validation study investigators recruiting representative user participants

Embedding human factors engineering (HFE) and usability studies early in medical device design and development cycles can yield benefits beyond regulatory compliance for manufacturers.

Par Joe Fegelman et Natalie Shortt LES POINTS PRINCIPAUX PAR EMERGO by UL La conception...

EMERGO BY UL SUMMARY OF KEY POINTS: Connected medical device design and develoment paradigm shifting...

EMERGO BY UL SUMMARY OF KEY POINTS: The European GDPR has ramifications for how medical device human factors researchers collect and manage data related to study participants, even outside of the EU. Human factors researchers should work with their clients (if they serve in a consulting capacity) and other third parties (e.g., vendors) to define roles and responsibilities early during study planning and develop best practices that comply with GDPR requirements. All participant data management decisions and rationales should be properly documented to demonstrate GDPR compliance.

EMERGO BY UL SUMMARY OF KEY POINTS: Investigations of preventable medical errors in the US healthcare system in need of revamp; Scale of fatal medical errors hindering more rigorous investigations; Multidisciplinary approach incorporating human factors components needed to address ongoing medical use errors.

EMERGO BY UL SUMMARY OF KEY POINTS: Medical device usability test administrators are often challenged by no-show participants. Steps such as overrecruiting, rescheduling and partial participation allowances can help mitigate this challenge.

Par Allison Strochlic LES POINTS PRINCIPAUX PAR EMERGO by UL : Les dispositifs médicaux conçus et mis au point pour les utilisateurs finaux cliniques négligent souvent le facteur de l'expérience du patient. Les professionnels de l'IFH et de l'aptitude à l'utilisation devraient tenir compte de l'impact de leurs conceptions non seulement pour les cliniciens, mais aussi pour les patients destinataires de tels dispositifs. La conception d'instruments et de systèmes qui favorisent une meilleure expérience positive pour les patients mérite une attention particulière.

EMERGO BY UL キーポイントのまとめ： 臨床治療のエンドユーザーのために工学・設計された医療機器は、しばしば患者体験要素を見落とします。 HFE およびユーサビリティ専門家は臨床医のみならず、当該機器を受け取る側の患者に対する設計の影響を検討すべきです。 良い患者体験を生み出す機器とシステムの設計には細心の注意が必要です。

EMERGO BY UL SUMMARY OF KEY POINTS: Medical devices engineered and designed for clinical end-users often overlook the factor of patient experience. HFE and usability professionals should consider the impact of their designs not just for clinicians but also patients on the receiving end of such devices. Designing devices and systems that better foster positive patient experiences deserves closer attention.