Ximedica, a Providence, R.I.-based provider of product development services for medical device, pharmaceutical and healthcare companies reports adding to its human factors and product testing research capabilities.
From upgrades to processes, the addition of four new observation rooms in its two U.S. locations and the hiring of senior team members, Ximedica's leadership claims the company is preparing to respond to "increased industry need" for human factors evaluations.
“We have always driven our business to meet the needs of our clients and as this base grows to include emergent startups, established medical device manufacturers and now pharmaceutical companies it is more and more evident that there is no one size fits all in usability studies due to variety of subjects, the wide variety of programs and the increasing burden put upon them by different regulatory bodies," said Aidan Petrie, chief innovation officer and co-founder. "It was a simple decision to review and redraft a number of our SOPs (standard operating procedures) related predominantly to research practices and human subject protection that allow us to provide the right level of rigor for each study while maintaining a competitive cost structure. We believe this is an unprecedented offering in the landscape of human factors/usability service providers today.”
To further support the need for studies, Ximedica has built out four observation rooms onsite in its Providence and Minneapolis, Minn. facilities to allow sophisticated video recording and streaming in a controlled environment. In addition the team has added five new members in the past six months including a human factors veteran from Siemens Healthcare and a clinical expert.
“Offering different levels of rigor associated with our human factors and usability capabilities is simply another move in keeping with our flexible and nimble processes that can be tailored to meet the needs of the organizations we partner with on straightforward assignments to being able to meet the highest rigors required by our pharmaceutical clients," according to Michael Pereira, senior vice president of technology and operations. He has overseen the firm's upgrade.
Core to these updates is the adoption of a formalized process on how to plan, conduct, analyze and report human research studies aligned with good clinical practice standards, company officials said.
“Our research practices have always applied the rigor needed for protection of participants and high quality data, but by codifying these practices in our SOPs, we have strengthened our ability to manage human research according to established principles of ethical conduct and methods of ensuring scientific integrity of the process and data generated. This adds considerably to the trust we have already built with clients and with regulatory authorities that review our work,” said Tom Varricchione, senior vice president of clinical and regulatory affairs.
Recent changes the company has made include the following:
• Ability to identify early and subsequently tailor the levels of controls on a study to clients’ needs from the outset;
• Policies regarding privacy and scientific misconduct;
• Appropriate controls for protection of health information (data encryption, etc.);
• Required training on human subject study procedures; and
• Onsite observational facilities and usability labs that ensure tighter control of data protection and cost control.