By MasterControl (MedilinkWM Patron)
Perhaps nowhere is the life sciences industry seeing such rapid change and evolution as in medical devices. At the beginning of each year, it’s intriguing to look into a crystal ball to get a glimpse of what the upcoming year will look like. Given how fast technology evolves, if you so much as blink you could miss out on critical insight regarding some new trends.
The massive amounts of information flowing at light speed compounds the already foreboding challenges with making business decisions. With the help of highly seasoned auditor and regulatory compliance guru Walt Murray, we look at five trends that will significantly impact the medical device industry in 2018.
Murray, CLA (QSA/IATCA/IRCA/RAB), CSSMBB, a globally recognised regulatory compliance and risk management consultant, currently serves as principal consultant for PinPoint Consulting. He is a CQEH&S lead auditor and is certified in quality and environmental (AQS) systems auditing.
Speaking of technology, digital device technology will continue to set the pace for the medical device industry. This will be especially true for software-enabled products in disposables as well as reusable devices. Medical device manufacturers are encouraged to keep a close watch on the emerging trends and be ready to adapt to new ideas and methodologies.
#1 Software in Medical Devices Will Become More Common — and Complex
Digital technology is becoming infused in nearly every sector of healthcare delivery. The inclusion of software in medical device development means medical devices are becoming more complex. Nevertheless, the benefits of innovative technology to both providers and patients are exponential.
The growing complexity of technology in devices is prodding manufacturers to revamp some of their approaches to design and development. This includes devoting even more time and effort to device planning — particularly with:
• Design control – Design approval is more challenging with software-based medical devices because there is a higher risk of defects or functionality discrepancies surfacing later in the production process or bugs being discovered during validation.
• Risk management – With the complex nature of software development, risk management must be performed with a greater level of detail both at the design stage and throughout the device’s life-cycle.
• Cyber-security – Cyber-security concerns can pop up anytime and anywhere in a device’s life-cycle. Security issues do not have a grace period. They are a priority that must immediately be assessed for risk and mitigated.
#2 Atypical Medical Device Technology Will Become More Typical
Companies outside of the healthcare sector continue to channel their expertise and technology toward the development of products used in medical treatment. This trend will likely intensify competition among all sectors on the medical device playing field.
However, in many cases, disruptive innovators will still need to depend on the industry “street smarts” of incumbent organisations to handle system complexity and navigate the regulatory environment. There are nuances to medical device manufacturing that could trip up non-traditional companies coming out of the gate.
• Communication must be conclusive and recorded. Nontraditional companies might not be aware that every syllable of research data, design concepts, storyboards, functional specifications, emails, meeting minutes and notes scrawled on a whiteboard must be captured in system records that are available to all the stakeholders.
• New devices aren’t always used right away. New device technology often requires health care providers to change their processes in order to use the new devices. Developers of medical devices should consider pacing themselves with new device technologies as some devices may require providers to customise their workflows around using the new product. Some providers may be hesitant to do this until there is a wider need for a device.
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