The transition to the EU Medical Device Regulation, digital health, and big data are just a few of the challenges the industry is facing. This is the time for medical device companies to reflect on their performance and identify where they can resolve to improve in 2019.
BOULDER, Colo. (PRWEB) December 20, 2018
New Year’s brings reflection and desire to improve for individuals and businesses alike. Heading into 2019, with major changes in regulations in the European Union (EU) on the horizon, Jim Kasic, president and CEO of Boulder iQ, suggests five resolutions for medical device companies to consider.
“The transition to the EU Medical Device Regulation (MDR), digital health, and big data are just a few of the challenges the industry is facing,” says Kasic, whose company is an expert consulting firm specializing in regulatory, clinical and quality compliance services for medical device and in vitro diagnostic companies. “This is the time for medical device companies to reflect on their performance – financial and otherwise – and identify where they can resolve to improve in 2019.”
1. Prioritize technical documentation. “The countdown to May 26, 2020 – the transition deadline for the MDR – has begun,” Kasic says. Medical device companies need to have resources and plans in place early in the year, he says, to handle a plethora of requirements: confirm the classification of their devices; determine which conformity assessment route to choose; reexamine technical files (as they are about to get thicker); prepare for more stringent clinical evaluation requirements (CERs); comply with new identification and traceability (UDI) requirements; and expand post-market surveillance (PMS) efforts. “Whether a medical device company uses in-house or consulting experts, they must have demonstrable, current knowledge of global regulations and guidelines,” states Kasic.
2. Make sure each product group is working with a quality and regulatory expert. With the transition to the MDR, it can be easy to miss a step in the complex quality and regulatory area, according to Kasic. Dedicated resources can review and audit existing systems, identify gaps and areas for improvement and compliance, assess risk and help bring a company’s quality management system into compliance.
3. Consider users earlier in product development. “Terms such as ‘user experience design consulting’ and ‘design thinking’ are not just catchy phrases,” says Kasic. Instead of creating a device and then determining its compatibility with users, start with users and the use environment, and design from there. “Engaging patients, and not just providers, is a key factor for medical device companies,” he adds.
4. Truly innovate for local markets. “Everyone likes to say they have an innovative company or innovative solution,” says Kasic. “But true innovation in the medical device industry includes innovation in the product mix.” Creating, designing and developing products for localized markets around the world is critical to success.
5. Up your practices. “Best practices have earned that designation for a reason,” comments Kasic. January is an excellent time to take a hard look at strengths and weaknesses, and identify where and how to improve or implement best practices. “Whether it is gap analysis, audit preparation, or a full review and overhaul of product verification and validation procedures, the work will reap bottom-line results.”
“Sticking to resolutions is often harder than making them,” concludes Kasic. “These suggested resolutions are first steps in helping medical device companies develop products that will improve the health of patients. The next step is for device manufacturers to put in place plans and systems to make their unique resolutions reality.”
About Boulder iQ (http://www.boulderiq.com)
Boulder iQ is an expert contract consulting firm for medical device and industrial product design and development. Formed as a merger between Boulder BioMed and Samson Design Associates Inc., Boulder iQ offers regulatory, quality and clinical compliance services for medical device and in-vitro diagnostic companies, and design, development and manufacturing for medical device, consumer and industrial products. The company is based in Boulder, Colorado.