MedTech and IVD – What’s the buzz

As we bid goodbye to 2021, it is time to reckon, to take stock of the lessons learnt, to devise ways to pave the path ahead for 2022, and change the trajectory of healthcare. With Make in India program gaining momentum, there has been a spur in innovations pertaining to devices and equipment. Covid-19 brought about a radical shift and provided a thrust to virtual and home-care-driven systems including cost-effective life saving devices. The coming year will predictably witness an impressive increase in telemedicine, data analytics, artificial intelligence (AI), automation and machine-based learning with surgical devices meant for various neurological, cardiovascular, oncological procedures, and the like. Evidently, the year 2022 is likely to see a major focus and investment from public and private sectors in this area with the continuous efforts of the government and healthcare professionals.

MedTech advancement is accelerating growth and transformation for clinicians who have embraced the technology and rely on algorithms and software for learning, training, improved diagnoses, management, and treatment outcomes. Digitization in the form of cloud systems, extended reality, and AI have seen almost 80-percent increase during the pandemic. Additionally, robotics and neural language processing (NLP) seem to be the driving force of the future. Collaborative efforts from stakeholders are pivotal to scale up the MedTech sector. Also, a reduced tax regime on commercialization would increase the viability. With the convergence of regulatory norms among ASEAN countries with international standards, the digital ecosystem looks favorable. According to research, the global value of the MedTech market could be around USD 657.98 billion by the year 2028.

In-vitro diagnostic products (IVDs), falling under section 201(h) of the Federal Food, Drug and Cosmetic Act, are subject to pre-market and post-market controls. The spectrum ranges from reagents, calibrators, kits, control materials, instruments, and systems aiding in diagnosis, prevention and treatment of a disease and its sequelae through collection and examination of human specimens. These have proved to be a boon for patients and clinicians alike, ranging from simple pregnancy kits and blood glucose monitors to more complex genetic testing and sequencing panels. The pandemic underscored the importance of accurate diagnostics and a resilient regulatory framework for IVDs.

May 26, 2022, will usher a new era with the longstanding IVDD (In-Vitro Diagnostic Directive) being replaced by IVDR (In-Vitro Diagnostic Regulation) after a transition period of five years. The progressive rollout of IVDR, however, has been adopted to maintain undisrupted flow of the essential healthcare devices in these unprecedented times. The requirements for high-risk devices (class D), such as HIV or Hepatitis tests, will be enforced from May 2025; for low-risk devices (class C), including influenza tests, it has been extended until May 2026 and for lower risk devices (class B and A) the implementation begins from May 2027.

Conformity assessment bodies (notified bodies) shall monitor these devices for safety and performance requirements independently. However, the lack of sufficient number of operational notified bodies (53%) is a pertinent issue. With the new IVD regulations being implemented, almost 22 percent of the current IVD tests available in the market may be discontinued in the future. Majority of this loss will come from small/medium manufacturers making niche products in small volumes.

Although MedTech and IVD are exciting next-generation technological advancements with immense potential for success, the challenges associated cannot be overlooked. Foremost is the high cost and the fact that many medical devices are not covered by insurance. Regulatory hurdles in the form of cumbersome approval process are deterrent for many. Cybersecurity would be a major concern with digital evolution. Data security and patient privacy are paramount. Counterfeiting, data theft, and lawsuits are on the rise as well. It will be interesting to witness where these roads lead to!