The coronavirus pandemic is a double challenge for many companies in the life sciences field. As the global Covid-19 death toll passes a million and cases continue to spike heading into the last quarter of the year, medical device companies are still adapting to the rapidly evolving needs of the market – whether it’s dealing with sales declines for equipment used in elective surgeries or struggling to keep up with demand for personal protective equipment, ventilators and testing equipment, which has at times been overwhelming.
On top of that, the medtech industry – in common with virtually all other sectors – is working out the best ways to respond to the immense disruption that Covid-19 has caused to daily working life. Device development, sales, recruitment, quality management and clinical investigations aren’t optional for most device companies that want to stay afloat during this unprecedented period of disruption, and now all these functions must be carried out under the yoke of social distancing measures that, while wholly justified, make it harder than ever to collaborate effectively.
Although these two factors form a nasty one-two punch for the medtech sector, each also represents an emerging opportunity for the industry. Just as the clinical impact of Covid-19 has driven huge demand in respiratory equipment, testing assays and remote healthcare technologies for developers agile enough to seize it, the challenges of remote working also present opportunities for businesses to embrace digital tech in a way that could bring operational benefits long after the novel coronavirus becomes no more than a bad memory for the world.
“While the Covid-19 outbreak is an overwhelming humanitarian crisis, it also presents an opportunity for reform in healthcare delivery,” noted global management consulting firm McKinsey in April. “For forward-looking companies, taking steps now to fundamentally reimagine the system, patient journey, and their interfaces and relationships with healthcare providers is critical.”
Here are some of the main ways in which medtech companies are adapting their operations to deal with a distanced world.
Personnel: tapping the global talent pool
With remote and home working becoming the norm across many industries, medtech included, there are new obstacles to overcome for companies to recruit and nurture talent. In the early days of the coronavirus’s spread in March and April, many companies froze their hiring processes due to uncertain demand and plummeting revenues. But as the world’s pandemic year limped on, the industry has slowly begun to adapt.
While hiring the right person and bringing them into an existing team is more complex when employees aren’t able to physically meet each other, extended periods of lockdown are bringing a necessary evolution in recruitment.
Chief among these might be the de-coupling of recruitment from geographic location, as noted in July by Richard Warren, CEO of medical recruitment firm RBW Consulting, in a guest editorial for Med-Tech News.
“As a search agency, we have already seen companies open their talent pool to candidates from different cities, countries and continents,” Warren wrote. “Hiring with a more location-agnostic mindset encourages greater diversity. Diversity introduces new perspectives and ideas which can lead to greater innovation. Life sciences organisations that can make the most of the best talent around the world will have a greater chance of success, particularly when expanding into new markets.”
Shifting sales strategies
Life science sales strategies have long revolved around industry reps forming strong relationships with their customer base of healthcare providers and clinicians. While there’s no doubt that these relationships will in many cases remain important, even before the distancing requirements created by Covid-19, this model was starting to show its age as purchasers continue to move towards pharmacoeconomic and value-based analyses when considering drugs and medical technologies.
McKinsey has argued that the societal changes brought on by Covid-19 should encourage medtech companies to develop better digital tools to reach and engage with customers, including “online customer service representatives, webinars with key opinion leaders, professional education, and conferences for professional industry associations”.
“Some medtech firms are also rapidly expanding other digital capabilities – for example, shifting investment to digital media, digital detailing, or creating digital product demonstrations – to further strengthen go-to-market models,” the firm noted.
Strategy consultant Simon-Kucher & Partners, too, has championed digital engagement as a response to Covid-19 in medtech sales, but also emphasised the opportunity to re-tool the sales workforce to focus more on making a comprehensive economic case for their medical device products.
“In today’s environment, compelling [health-economic] evidence may represent the most powerful lever for medtech to move the needle,” wrote Simon-Kucher senior partner Peter Ehrhardt and partner Raf Onclin. “The disruptive nature of the crisis provides an opportunity to steer in the new direction quickly, easily, and also at a fraction of the cost, as internal talent will be more motivated to redefine their roles in light of the fact that ‘business as usual’ is simply not possible.”
Digital tech: clinical investigations, quality management, auditing
One of Covid-19’s most obvious impacts on medtech – and clinical development as a whole – has been the added challenge of conducting clinical investigations with the added burden of physical distancing. With in-person site visits less feasible, major regulators such as the US Food and Drug Administration have been encouraging the responsible use of virtual site visits to maintain trial continuity while minimising risk. At the same time, the market for remote patient monitoring technologies has been given a kick-start, offering lucrative opportunities for well-positioned device and software companies.
Perhaps the greater burden for device developers is managing quality processes and keeping up with regulatory requirements in an age of distancing. Given those challenges, electronic quality management systems (eQMS) have been gaining more market traction as manual, paper-based systems show their cracks.
Making quality management systems digital eases the process of tracking quality in the cloud rather than on paper, and products offered by the likes of Qualsys and Greenlight Guru are designed to give remote visibility over all aspects of device development, from document control and compliance to risk management and remote auditing.
The heightened demand for remote visibility over quality and regulatory compliance is also driving innovation in the eQMS space. In September, Greenlight Guru – which specialises in eQMS for medical devices exclusively – announced the launch of Greenlight Guru Visualize, which visualises a device firm’s quality network, using machine learning and natural language processing to make the complex intersections between subsystem quality processes more naturally traceable to teams.
Remote device development and outsourcing
Of course, there’s still an immense human challenge involved in continuing to collaborate on device design and development in a remote world. It may be a longer road before device developers are equally capable whether at home or in the office, but the journey has already begun.
Steve Fowler, senior consultant at medical device consultancy Team Consulting, elaborated on this theme in a blog for the Cambridge Network earlier this year, noting that team chat apps such as Slack have become key tools for “communicating within projects and tracking an individual’s progress”, while project management software like Jira has helped keep an eagle eye on the broader development programme. Even so, creative thinking may be required in particular situations.
“Unforeseen travel restrictions recently prevented us from visiting our client’s manufacturer as part of a knowledge transfer exercise,” Fowler wrote.
“This was a critical activity in the project as we needed to guide them through the assembly of an optical examination device that we had designed. So, undeterred by the setback, with some awesome remote working tools and a helping hand from IT, we setup a ‘remote lab’ for knowledge transfer across the ether of the internet.”
Outsourcing, too, will likely see a bump as some companies continue to struggle with continuing all development functions in-house. An August report published by Technavio projected growth in the medical device manufacturing outsourcing market of $39.25bn between now and 2024, at a compound annual growth rate of almost 11%.
And for smaller companies, more flexible outsourcing options have emerged, such as Kolabtree, which connects industry to freelance scientists and experts in relevant fields, including clinical research, data analysis, clinical evaluation and technical documentation.