How can medtech sustain growth in the year ahead? Here are the top five priorities for 2023:
It’s not the sheer amount of information that challenges medtech companies—it’s how they ingest it. Large multinational companies often maintain countless pockets of regulatory information across the enterprises. They may lack harmonized processes for disseminating and interpreting this information, which means they cannot get the full benefits of their regulatory intelligence solutions. Employees can be assigned to process and interpret this information but that keeps them from performing more value-added activities. The stakes couldn’t be higher: medtech companies found to be in noncompliance may have their products pulled from the market, resulting in sometimes insurmountable financial and public relations challenges, as well as patient safety concerns.
The medtech industry has craved a solution: a centralized repository that would ensure all stakeholders could access, analyze, and share regulatory information even as employees join and leave the company. The ideal solution should make it easy for stakeholders to assess the impact of each regulatory change on their product portfolio. It should also facilitate disseminating the information throughout the organization so that all subject experts can evaluate it and determine what immediate actions the company should take to safeguard compliance. The solution should also track every step to make this information visible across the organization and to regulators. In seconds, regulators will be able to find evidence that the organization either found the regulation to be not applicable—and read the justification—or track the steps the company took to remain compliant.
Lacking such a solution, many of today’s companies are coping by using ordinary databases and devoting additional headcount. But these databases don’t work well with today’s regulatory information management (RIM) solutions, which store product data.
What the industry needs is a way to transform the stream of new regulatory information into a meaningful format and connect it to the product information in their RIM solution. Most regulatory information services don’t provide their data in the right format. When organizations can overcome this hurdle with an automated, digital RIM solution, they’ll be able to feed regulatory information into the earliest stages of the product design lifecycle where it can have a profound effect on overall product development and approval.
Medtech companies that hope to engage key opinion leaders (KOLs) face two key challenges. First, the universe of KOLs is large and continuously evolving; and medtech companies have finite time and resources to spend on KOL engagement. Many organizations lack alignment on a common process for identifying and prioritizing KOLs, leading to uncoordinated or lower-impact efforts. Second, all companies want to engage with top names in the industry and are challenged to identify the up-and-coming experts who will be influential months or years down the road; let alone build those relationships early. Medtech companies that lack comprehensive, current data on market influencers will spend too much time with the wrong people while missing out on time with the most influential contacts. As a result, they’ll experience delayed product adoption and reduced impact on the market. Even more significant, they’ll lose marketshare to competitors who do connect with the right KOLs.
At the heart of the problem is manual collection of KOL information. Scientific activity, including publications, clinical trials, and conference presentations, is available online for free, but is housed in multiple places and requires manual effort and significant time to consolidate. Furthermore, this information changes daily—or even hourly. Even a well-equipped team can’t possibly keep up with every new publication on a relevant topic, every conference agenda around the world, or every comment a KOL makes on social media. Inaccurate or incomplete data could cost you credibility in front of an important KOL.
Medtech companies need a way to not only identify and prioritize their KOLs, but also drive ongoing engagement with them and increase the value of each engagement and collaboration opportunity. It starts with developing a consistent method for identifying, prioritizing, and segmenting KOLs, and mapping them to the highest-impact opportunities. This method must be available to stakeholders across the enterprise so that marketing, sales, and medical affairs are all defining and identifying KOLs in the same way. It’s also critical to have a complete view of who in the organization is engaging with KOLs and in what ways. This will enable stakeholders to remain coordinated on when and how they are reaching out to KOLs.
Technology can help. A real-time customer intelligence platform will provide a single source of truth for the organization’s KOL strategy and enable companies to measure the impact of their targeting and engagement efforts using key performance indicators (KPI).
Most medtech companies lack a single source of truth for KOL activity. Instead, they focus on maximizing individual engagement opportunities (i.e., a major industry conference) rather than the universe of opportunities. Significant time and resources are spent on planning individual events instead of optimizing long-term relationships with the portfolio of KOLs who are most impactful.
We have entered a new era of continuous global regulatory change. The new Medical Device Regulation (MDR) took effect on May 26, 2021, bringing significant compliance requirements for device companies. The final deadline for MDR compliance to have all devices conform to the MDR is coming on May 25, 2024. Similarly, diagnostics companies must prepare for the In-Vitro Diagnostics Regulation (IVDR) deadline, which is approaching May 26, 2028.
These new regulations bring challenges such as:
Both regulations come with certification hurdles and a time-intensive process of notified body designation. Although most medtech companies are used to getting inspected by notified bodies, only 20 percent of in-vitro diagnostics (IVD) companies use external auditors, while 80 percent rely on self-certifications. Thus, IVD companies face a steeper learning curve despite the later deadline, and they must comply with a brand-new regulation that touches every corner of their business—from R&D and production, to supply chain and more. They must also find a Notified Body, learn the unfamiliar process of interacting with them, and hire experts to help them prepare their technical documentation.
The key challenge for medtech manufacturers under MDR is that there are only about 30 Notified Bodies, creating a major bottleneck for certification. It is widely expected that by May 2024, medtech companies will temporarily remove 15 to 20 percent of legacy products from the market pending their certification, even if they submitted them years ago. To make matters worse, many emerging SMEs don’t have a designated Notified Body and may have trouble finding one that accepts new clients, making them less attractive to investors.
To build a sustainable MDR operating model, medtech companies should:
Since the beginning of the COVID pandemic, the technology market in most industries has boomed to account for new demand and new ways of conducting business in a more digital world. The expectation of a new normal drove investments, growth, and innovation across the board, but we are seeing today that many industries may have overestimated the lasting demand as the world has started to return to normal. This is particularly true for clinical trials and the emergence of novel strategies for conducting decentralized trials. As soon as lockdowns prevented sponsors, patients, and subjects from getting to trial sites, there was a push to see how to conduct trial activities such as enrollment, follow-up visits, and monitoring in a technology-enabled manner. However, the overall adoption of full decentralized trials in medtech has been slower to become reality, as limitations in single point solutions have left the industry without a connected ecosystem to support all key stakeholders that need to come together to enable a successful clinical trial.
In 2021, Veeva conducted a clinical survey and asked the medtech industry which technology could have the largest impact on their clinical strategy over the next two years. Most respondents reported they wanted better technology for their in-house processes, such as electronic trial master file (eTMF), clinical trial management system (CTMS), and clinical data management system (CDMS). A recent 2023 follow-up survey revealed similar results: indicating that medtech companies want to make sure their houses are in order from a technology standpoint. This is understandable as trial sponsors operate their business and teams in a more remote manner post-pandemic and require reliable access to their data and documents from anywhere.
But medtech companies would do well to think about the bigger picture. To support wider adoption of decentralized clinical trials, it’s essential to implement a digital ecosystem that can support the varying needs of all key stakeholders: sponsors, CROs, patients, and sites. A successful roll-out requires buy-in on technology and procedure from all stakeholders involved in clinical trial conduct.
Certainly medtech companies must prepare for the move to digital clinical trials by making sure they have reliable systems in place from their own operational perspective, but also need a vivid perspective on what it takes to engage with sites and patients in the process. Research sites and study participants have their own requirements on how technology can support their needs, and applications that are not developed with that in mind will struggle to gain acceptance. Even with technology developed specifically for these stakeholders, they may struggle to bring overall efficiencies to trials unless they are all connected and operating together with a sponsor’s own systems. When put together in a cohesive way, digital clinical trials can bring both efficiency and compliance to the study process, while also delivering equal value to all stakeholders. The net results of a well conceived strategy can also lower the burden of trial operations and add essential benefits of enrolling studies faster and with a more diverse subject population.
Any medtech considering getting into digital clinical trials should be sure to begin by forming a comprehensive vision for these trials. Rather than using them as a temporary cost-cutting measure, they should contemplate the long-term pros and cons of running digital trials. A poorly conceived DCT program can expose a medtech company to more problems than benefits. But an effective program can allow a medtech to run faster, more cost-effective trials that gather far more data in a way that’s easier for everyone involved.
The pandemic presented medtech organizations with a host of challenges, including the need to find additional suppliers. Faced with constant part shortages, medtech organizations have compensated by forming longer lists of suppliers so they can get the parts they need more quickly. They’ve also begun scrutinizing not only the supply chains of their suppliers, but those of their suppliers’ suppliers, hoping to identify any potential problems well in advance. Armed with this information, medtech organizations can work with their suppliers to develop potential solutions and establish alternative sources of materials—or even move operations to different parts of the world where it’s easier to gain access to parts.
Medtech companies can benefit by having systems in place that streamline or automate the steps involved in acquiring a new supplier or transitioning from a previous one. Any supplier quality management system should provide the analytics to evaluate potential risks in the supply chain and make it easy to launch proactive strategies to address them. Although medtech organizations often try to build custom solutions, this approach can be time- and resource-intensive. There are many reliable purpose-built solutions on the market that offer innovations such as external collaboration with suppliers.
What’s the biggest risk for medtech organizations that procrastinate implementing the right technology to address their supply chain challenges? Delays in getting parts result in long lead times, dissatisfied customers, and missed opportunities to improve or save lives. Time spent chasing down parts is time that can’t go towards new product development and manufacturing. And any deficient supplied parts can come back to haunt manufacturers in the form of product recalls that can come with nine-digit price tags.
Medtech companies that implement the technology to support agile supplier quality management processes can evaluate challenging situations and make smart decisions quickly. Running processes digitally in one common system enables the supplier quality management team to update documentation and send it to the regulatory team in seconds. Internal and external teams can collaborate in one place to make sure the work gets done, rather than trading emails for days.
By focusing on these five priorities, medtech companies can avoid getting distracted by short-term market fluctuations, non-compliance, or supply chain disruptions in 2023. Leaders will position themselves to take advantage of technology and processes to streamline the product development lifecycle to get products to market and patients faster.
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