4 Digital Trends That Will Speed the MedTech Product Lifecycle in 2021

MedTech organizations have accelerated modernization efforts to keep up with COVID-19 disruptions and speed product development. Companies and health authorities came together to develop new diagnostic tests and devices faster than ever before by embracing new, digital ways of working. From faster study designs to enabling remote audits, there are many examples of industry collaboration to drive innovation.

Looking ahead, digitization across the total product lifecycle will continue as companies embrace modern solutions that streamline processes across MedTech. Here are the top MedTech digital trends that can’t be ignored in 2021, from our Veeva industry experts.

• 1. Growing evidence needs will force clinical data management modernization
  —Kevin Liang, senior director, clinical strategy, Veeva MedTech

MedTech studies have grown increasingly complex in recent years, requiring data collection and analysis on a scale much larger than ever before. Companies are not only having to deal with growing volumes of data, but also new requirements from the EU MDR that place greater scrutiny on data management throughout the total product lifecycle.

To keep up with evolving regulations and the growing complexity of studies, we expect to see the industry shift toward more connected, digital, and transparent ways of managing its clinical data. Modern systems will be crucial for tracking, analyzing, and sharing larger and more diverse data sets both pre- and post-market. They’ll also allow companies to better integrate real-world data from mobile devices and wearables with the data they’re collecting in controlled settings.

Manual processes and legacy systems are no longer sufficient in this new world where accurate and meticulous data collection is of utmost importance. The companies that invest in modern cloud systems will speed clinical development and gain the agility they need to adapt for the future.

• 2. An increase in inspections and audits will drive large-scale quality transformation
  —Carl Ning, senior director, quality strategy, Veeva MedTech

In 2019, the FDA issued 49 Class I recalls—the most the industry’s seen in the last four years. ¹ Meanwhile, non-routine external quality events, such as FDA 483s, warning letters, and consent decrees, have cost the industry an average $7.5 billion to $9.5 billion per year. ²

Realizing the need to improve quality processes while continuing to innovate, many companies are seeking more advanced quality management systems (QMS) that will enable greater collaboration between internal teams, external partners, and regulators. Once the pandemic starts to wane, MedTech organizations will see an increase in health authority inspections, making 2021 an especially critical time to drive large-scale quality transformation.

With companies now required to show product quality using real-time data collected during post-market surveillance, fully automated electronic health authority submissions and non-electronic submission outputs will help ensure timely adverse event reporting and more proactive complaints handling. We will also see improved applicability of advanced technology such as artificial intelligence (AI), which has been somewhat nascent within the field of quality management, to help organizations maximize predictability.

A continued focus on remote inspections, remote audit management, and post-market surveillance will fuel transformation in tangential areas such as recall management and device tracking. These efforts will ultimately help companies stay on top of evolving regulations and drive industrywide improvement across product quality and patient safety.

• 3. The shift to remote auditing will digitize quality and improve supply chain continuity
  —Seth Goldenberg, vice president, Veeva MedTech

When COVID-19 hit earlier this year, the Medical Device Coordination Group (MDCG) approved the use of remote auditing in specific cases to help ensure the continued supply of medical devices during the pandemic. While these changes were initially made out of necessity, auditing groups and MedTech companies are increasingly finding remote audits to be a much more efficient alternative to the traditional, in-person way of working.

As a result, remote auditing will become a permanent component of the quality workflow next year, even once travel and onsite restrictions are lifted. Not only will auditors be able to access required files more easily, collaboration across regulatory, quality, and clinical teams will also improve. Longer term, the shift to remote auditing will drive companies to digitize quality processes and improve supply chain continuity.

The companies that invest in modern cloud quality systems will be in a much better position to reap the benefits of remote auditing. With content and data stored and accessed in one central application, they won’t have to worry about updating multiple files in different systems, making information sharing much faster and easier. As teams get used to these new ways of working, we’ll eventually see less reliance on paper, fewer onsite audits, and a much more sustainable model for the future.

• 4. Evolving commercial models will place greater importance on claims management
  —Terri Howard, director, regulatory strategy, Veeva MedTech

With COVID-19 significantly decreasing the number of face-to-face interactions happening between HCPs and sales reps this year, many companies invested more heavily in broad-reach marketing tactics, like TV advertising, to get in front of more customers. But with this greater push toward direct-to-consumer marketing also came the need for solid claims management and coordination between regulatory and commercial teams.

This year we will see companies make a concerted effort to better manage the creation and usage of marketing and product claims across the organization. With more connected systems and processes, marketing teams will have the clarity they need around permitted claims or usage limitations, while legal and regulatory gain visibility into how claims are being used at the local level.

The modernization efforts will ensure regulatory compliance, reduce risk, and help companies gain greater insight into the effectiveness of their claims in relation to the performance of their marketing campaigns. Moving forward, integrated claims management will create compelling upstream and downstream effects that can @veevasystems using hashtag #MedTechPredictions.

¹  FDA, U.S. FDA Medical Device Recalls Database, 2020
²  McKinsey & Co, Capturing the value of good quality in medical devices, 2017