title: Best practices in early phase medical device development: Engineering, prototyping, and the beginnings of a quality management system.
abstract: Kristy Fearis is the founder and president of KPConsulting. She has held various positions in the medical device and research industry. She has led programs for medical industry leaders Medtronic, Edward Lifesciences, and Kimberly-Clark Healthcare to develop and commercialize Class II and III devices. Although a true quality management systems specialist at heart, Kristy has a passion for effectively and efficiently applying quality systems principles to early stage development to maximize benefit while minimizing impact on resources and time to market. Kristy works with both precommercial and commercial companies to build and implement quality systems that are "right sized" and support both an effective business model and high product quality. Aidan Petrie is the cofounder and chief innovation officer of Ximedica. Aidan drives innovation in Ximedica's core markets of medical device development and consumer healthcare. With a focus on human-centered design, usability, technical innovation and industrial design, Aidan has helped bring hundreds of products to market. Ranging from simple drug compliance aids to wearable therapeutics, home monitoring products, and complex surgical systems, Aidan challenges his teams to rethink the role design plays in the success of each product. Covering topics around usability, sensor and wearable technology, and current trends in medical design and development, Aidan is a sought-after industry speaker and widely published author. In addition to his role at Ximedica, Aidan advises multiple startups in the healthcare space and has interests in a number of related companies. He sits on the Board of MassArt and teaches and lectures at the Rhode Island School of Design, Massachusetts Institute of Technology, the Harvard iLab, and others. Aidan holds an undergraduate degree from Central St Martins in product design/engineering and a Masters in industrial design from the Rhode Island School of Design.
authors.affiliation: KPConsulting, Owings Mills, MD. Electronic address: Kristyfearis@icloud.com.
authors.forename: Kristy
authors.initials: K
authors.lastname: Fearis
authors.affiliation: Ximedica, Providence, RI.
authors.forename: Aidan
authors.initials: A
authors.lastname: Petrie
mesh_terms: D018795:Device Approval; D004867:Equipment Design; D004864:Equipment and Supplies; D006801:Humans; D017749:Total Quality Management; D014481:United States