Medical Devices: The Role of Regulations in Augmenting Digital Transformation

In the current healthcare paradigm, technology is increasingly assuming a business-critical role. The healthcare sector is witnessing a strong wave of digital transformation and it is in turn contributing to the growing size of the MedTech market. However, digital transformation is not uniform across all aspects of healthcare and one area that can pace the transformation better is that of medical devices.

The Regulatory Conundrum: An Opportunity Waiting to Be Realized

Successful digital transformation initiatives rely on numerous internal and external factors. They include:

• Synergy across people, processes, and technology
• Maturity of the digital strategy
• Global technology and market trends

One of the aspects that tend to have long-term impacts on the digital transformation and innovations roadmap across organizations is the ever-evolving regulatory landscape. Trends in the regulatory space are a crucial consideration when it comes to charting out short, mid, and long-term digital goals and by extension, business value. This is especially true for a sector that is as tightly regulated as the medical devices industry.

On the other hand, a lack of regulatory clarity could set an enterprise’s digital transformation initiatives back significantly. In the recent past, organizational transformation initiatives have either failed to lift off or have been stifled due to various regulatory barriers.

While various governing and regulatory bodies are constantly establishing guidelines and mandating prerequisites and best practices, the compliance agenda remains fragmented and highly ambiguous. Currently, only a small portion of the medical devices space is tightly regulated, meaning that emerging trends and demands remain outside the purview of the regulations. As a result, much is left to interpretations and medical device enterprises, and they are often more focused on compliance than on innovations.  Given the rapidly changing global regulatory landscape, medical device manufacturers are hard pressed to navigate risks of non-compliance and subsequent financial and reputational repercussion. Along with that the lack of regulatory harmonization across geographical regions, and medical device makers have global risk management nightmare on their hands.

With the MedTech market growing in leaps and bounds, medical device manufacturers have a lot to gain both in terms of technological evolution and business value. However, for that to happen, regulatory bodies must be more proactive and forthcoming in their decision making. Without their forward-looking approach and all pervasive innovation supporting regulations, medical device enterprises will remain shrouded in uncertainty and continue delaying large-scale digital transformation.

With Steadfast Policies in Place, the Sky is the Limit

While other facets of healthcare such as documentation, communication, and value-based treatment have seen large-scale digitization, aided by nimble and proactive decision-making on the part of regulators, the same is not the case with the medical devices space. For medical devices, players need to ensure the success of their digital transformation. They need to complete timely interventions to undertake even the smallest initiatives, right from upgrading infrastructure to deploying processor changes, governments and regulatory bodies need to aid and encourage them in their pursuits to eventually make healthcare more dynamic and inclusive, to shape new outcomes and experiences.

Potential areas of benefit of digital transformation in the MedTech industry:

• Inventory management
• Logistics and distribution
• Device maintenance
• Product development
• Warehouse operations

Self-care and invasive diagnostics have been on the policy agenda even before the pandemic disrupted healthcare, but in the new normal, sophisticated medical devices are no longer a future goal. Policies must be focused on ensuring safe and fast outcome with enhanced user experience at the best prices. Digital transformation is the centerpiece of this agenda. Apart from a cultural and architectural shift, the regulatory focus must also move from only compliance to monetization of innovation and data governance. Over the course of my experience working with leaders in the MedTech space, I have witnessed three specific areas where innovation is at the cusp of receiving a regulatory boost. These are:

• Staying abreast of evolutions and standardizing regulations: Regulatory bodies will assume the role of proactive drivers of changes. While safe and enhanced healthcare outcomes are the focal consideration for regulators, the emphasis on technology in the enablement of healthcare will only increase. This will, in turn, increase the importance of continuously tracking emerging technologies in the healthcare space and deliberating the transformation manufacturing and delivery of medical devices. The evolutionary incline of technology will also considerably reduce turnaround and the adoption of an innovation-led approach.
• Harmonizing patient needs with new-age medical devices: Regulators have always rightly taken a safety-first approach to medical devices. But this approach has deprioritized innovations on the strategic agenda in favor of compliance. With the trend of shifting priorities, regulations are bound to consider, and eventually center around the changing needs and habits of end-users. Policies will morph to accommodate the requirements of patients. Medical device manufacturers will also increasingly focus on making safe, data-backed medical devices that are also easy for patients and caregivers to use. Greater emphasis will be given to iterative manufacturing processes and validation practices.
• Incentivizing innovation mindedness and digital healthcare: In the new normal, regulations will catalyze the adoption of innovative and increasingly digital operations. So far, the ambiguities around regulations have stifled digital transformation in the medical devices space. To overcome this barrier, policies will need to be framed in a manner that manufactures are assured of their investments in digital tools and processes for the long term. Assurance in the form of conducive, forward-looking policies and regulations will make enterprises prioritize digital transformation to expedite research and development and optimize business value. Similarly, governments can support enterprises and encourage innovations by offering tangible benefits in form of easier taxations, research grants, and advanced orders.    

Innovations and Regulations Bridging the Gap Between a Better Tomorrow

It is difficult to look past the role of technology in the enhancing medical devices and its production. In fact, much like other industries, first movers stand to gain significantly from technological implementations. However, it is important for medical device manufacturers to take a step back and prioritize their goals. For now, areas of innovation that are still largely unregulated takes priority.

We stand at the cusp of a healthcare revolution, aided largely by technology and digital transformation, and medical devices stakeholders can no longer be left behind. With robust, definite regulations, not only will the enterprises get the much-needed clarity to chart their course, but patients will also benefit from the innovation-led healthcare offerings.