The Medical Device Vigilance Market involves processes adopted by medical device manufacturers, importers and distributors to monitor and evaluate incidents related to medical devices which are reported by healthcare professionals, patients or any other person. The vigilance activities aim to identify, document and report on issues or problems with a specific device that may potentially affect patients' safety and risks. Medical devices are subject to strict regulatory requirements and it is essential for companies to comply with vigilance guidelines. Advancements in technologies has led to development of innovative devices such as TMS systems for neurological disorders, but their safe usage needs to be ensured through effective post-market surveillance.

The Global Medical Device Vigilance Market is estimated to be valued at US$ 103.36 Mn in 2024 and is expected to exhibit a CAGR of 9.0% over the forecast period 2024 to 2031.

Key Takeaways

Key players operating in the Medical Device Vigilance Market are BrainsWay, Magstim, Nexstim, Salience, MagVenture A/S, eNeura Inc. BrainsWay has a wide portfolio of Deep TMS systems used in treatment of depression, anxiety and addiction disorders. Magstim leads the market with MRI-guided TMS devices being used by clinicians globally.

The growing incidence of neurological and psychiatric diseases is driving the demand for medical devices subjected to vigilance. According to WHO, over 800,000 people commit suicide each year making it a major global public health issue. TMS systems are seen as viable alternative to medications and psychotherapy based treatment for mental health conditions.

Advancements in TMS coils and stimulation depths has enhanced its clinical applications. Integrating TMS with neuro-navigation allows for precise targeting of brain areas. Devices are being miniaturized to enable home-use and make treatment affordable and accessible to patients. Connected devices enable remote monitoring of patients.

Market Trends

One of the key trends in the Medical Device Vigilance Market Growth is the adoption of software solutions to streamline vigilance operations. Companies are leveraging AI and digital technologies to automate report retrieval, real-time signal detection and risk evaluation. This has helped improve transparency, optimize resources and ensure timely safety corrective actions.

Another trend is outsourcing of vigilance activities to specialist Clinical Research Organizations (CROs). This allows manufacturers to focus on product development while leveraging expertise of CROs to handle regulatory reporting. Third-party oversight also offers independent evaluation of safety issues.

Market Opportunities

One of the major opportunities in the market is expanding post-market surveillance programs in under-penetrated regions. While developed countries have established vigilance systems, it needs to be strengthened in developing countries with growing medical device imports.

Secondly, collaborations between device manufacturers and research institutes present an opportunity to jointly conduct real-world clinical evaluations of devices. Such real-evidence generation will help expansion of approved clinical indications in time.

Impact of COVID-19 on Medical Device Vigilance Market growth

The COVID-19 pandemic has significantly impacted the growth of the medical device vigilance market. In the pre-COVID scenario, the market was witnessing steady growth owing to rising awareness regarding safety and risks associated with medical devices. However, during the pandemic, markets across the world registered a temporary decline due to lockdowns and restrictions imposed to curb the virus spread. Device production and supply chain was hampered significantly, thereby affecting the market growth negatively. However, with the priority now being on faster production and regulatory approvals of essential medical equipment like ventilators, masks, PPE kits etc, the device vigilance process gained more importance. Device recalls increased manifold during the pandemic highlighting the need for stringent post-market surveillance. It is expected that the demand for medical device vigilance will rise significantly in the post-COVID period as regulatory compliances will become stricter and manufacturers will focus more on product safety and quality. Technologies supporting remote monitoring of devices will also see higher adoption. Overall, while the outbreak posed short term challenges for the market, it has highlighted the necessity of device vigilance for public health preparedness during crises.

Among regions, North America currently holds the largest share of the medical device vigilance market in terms of value. This is attributed to presence of major players, well established regulatory frameworks and greater awareness levels in countries like US and Canada. Furthermore, increased investments in healthcare infrastructure and stringent regulations enforced by FDA regarding medical device safety keeping patients protection as top priority contribute to North America's dominance. However, Asia Pacific region is emerging as the fastest growing market owing to rising healthcare expenditures, growing medical technologies industry and increasing focus of international players to tap opportunities in developing nations of the region. China, India and other Association of Southeast Asian Nations (ASEAN) countries are expected to drive the future growth momentum of APAC medical device vigilance market.

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