Let’s just say what we’re all thinking: 2020 was rough. It threw pretty much every element of our lives into disarray, and we suddenly had to become experts at navigating a new way of working, schooling and socializing. It was disruptive, and it was challenging, but it was also transformative. While the past 12 months might have felt like 12 years, it’s time to look forward to what the future holds. If 2020 was the year of disruption, 2021 will be the year of mastering change.
The medical device industry is no stranger to change, but in the face of a global pandemic’s impact on business, many medical device manufacturers faced immense obstacles. The pressure to keep up with emerging technologies transformed a demand to shift entire production lines to meet medical device demand for critical equipment. The medical device industry emerged from 2020 a little beat up and bruised, but those that were able to adapt successfully will act as models for 2021 and beyond.
1. Market Demands Increase Pressure to Be Agile
The novel coronavirus and the disease it causes, COVID-19, put the medical technology industry at center stage with an unprecedented need for critical supplies and required a recalibration across the entire value chain to servehealth care’s most acute needs. As manufacturers adapted with agility to fulfill skyrocketing demand for products like ventilators and other medical equipment, the shift underscored the need for manufacturers to be nimble and scalable to accommodate a rapid shift in demand and changing environments. While some companies were able to adapt quickly, others found themselves struggling in the face of massive upheaval.
As the pandemic spread across the globe, the medical device companies that were able to pivot had already adopted digitization and could transition production lines quickly. While there is still an outstanding question surrounding the longevity of these gains, it has become clear that companies that embrace digitization are better able to adapt in the face of uncertainty.
One unforeseen impact of the pandemic was the postponement of elective procedures and the associated reprioritization of nonessential devices. 2021 will revealhow fluctuations in demand for noncritical procedures will impact the industry – from sourcing through production. A likely resurgence for both elective and delayed essential procedures in 2021 will further pressure medical device organizations to consider how digital tools can help them maintain flexibility in the next normal.
According to a McKinsey & Company report in 2020, “the flexibility and resilience that digital will add to operations as manufacturing ramps up again once the current crisis is over, will allow those organizations that transform successfully to gain a significant advantage over slower-moving competitors.”
2. Adapting to Consumer Expectations with a Renewed Focus on Quality
In 2020, how we ordered food, consumed entertainment and conducted business meetings seemed to change overnight. In areas of health care and medical technology, people have come to expect virtual health care appointments via telehealth and wearable technologies for remote monitoring. In short, the pandemic intensified existing digitization trends and highlighted consumer expectations of products and services – that they be delivered faster and served in a digital-first format.
3. Connection Operations Without Endangering Employees
COVID-19 has accelerated new ways of working, chief among them a shift to digital interactions and workforce agility. Recent data show that we have vaulted five years forward in consumer and business digital adoption in a matter of around eight weeks during the global pandemic.7 According to Forrester, 18 million U.S. workers will work from home in the wake of the pandemic.8 By 2024, 50% of factorywork is expected to be done remotely, according to Gartner research.9 Yet critical gaps remain where paper- based processes hinder visibility and efficiency on the shop floor, wherepen and paper are used to track vital manufacturing steps and spreadsheets are used to maintain data.
The pandemic has exposed weaknesses in manufacturing, such as managing a remote workforce, and has created a sense of urgency around accelerating efforts to digitize and connect areas of operations that are offline and disconnected. While engineering and manufacturing personnel must be on the shop floor, individuals in operational support roles interacting with different sites worldwide can work from anywhere. Beyond basic videoconferencing applications in the office and tablets on the shop floor, more advanced solutions, such as fully electronic device history records (DHRs), are also helping maintain safe distancing as manufacturing operations continue.
By using digitization to develop new or enhanced ways of operating their businesses, manufacturers will experience reductions in machine downtime, improvements in
labor productivity, increased throughput and decreased quality costs.10
In this new normal, manufacturers will focus on ensuring workforce safety and productivity on the shop floor while enabling roles that don’t have to be on the shop floor to stay connected and actively engaged in manufacturing processes remotely.
4. Increased Regulatory Pressure to Modernize Systems
The 21st Century Cures Act, signed into law in December 2016, gave the U.S. Food and Drug Administration (FDA) the tools to begin modernizing regulatory programs. Since the Cures Act passed, the FDA has made several updatesto help accelerate the development, assessment, review and surveillance of medical devices.
Among the significant updates is the agency’s Technology Modernization Action Plan (TMAP), a three-pronged action plan aimed at modernizing the use of technology to advance the agency’s public health mission. The plan, which describes near-term actions the agency is taking to update its use of computer hardware, software, data and analytics, places significant emphasis on the notion of moving to a more digital environment via the cloud.12 In addition to getting behind developing technologies, the FDA’s transformation is designed to encourage the entire life sciences industry to follow the agency’s lead in modernization and match the pace of innovation.
Meanwhile, many device companies face the European Union’s Medical Device Regulation (MDR)/In Vitro Diagnostic Regulation (IVDR) – and the changes to processes, data gathering, and documentation that come with it – making it all the more crucial that medtech companies continue modernizing.
The pandemic only accelerated pressure to modernize systems and processes involved in quality and regulatory management. This includes the need for digitization, remote or hybrid audits, changes to submissions and approval processes and more, leading many companies to reimagine and reevaluate their digital infrastructure altogether. Asthe FDA and other health agencies take steps to modernize, medtech manufacturers that embrace and adapt will evolve technologically and enhance their compliance activities’ effectiveness, ensure quality and accelerate time to market.
As the medtech ecosystem and medical device regulations continue to evolve in conjunction with the continued pressure to meet demand while adhering to quality expectations, medical device companies must embrace digital transformation and shifts in mindset to remain competitive. Digital technologies and industry challenges will continue to evolve and impact the way medical devices are regulated and manufactured.
MasterControl’s business excellence solutions serve as the foundation of quality and compliance for hundreds
of medical device companies worldwide. Providing much more than enterprise quality management system (EQMS) automation, MasterControl allows companies to efficiently manage change within manufacturing operations with a fast and flexible system that provides real-time data and analytics to keep your business ahead of the competition and on the cutting edge of digital transformation.
Source: Master Control Inc.