Fostering innovation and ensuring patient safety

Fostering innovation and ensuring patient safety were key at the latest edition of RegTalk, hosted by Futurise Sdn Bhd in collaboration with the Medical Device Authority.The event focused on “AI Medical Devices in Malaysia – Balancing Innovation & Safety.” It was held at the Siemens Healthineers Experience Centre, Kuala Lumpur, Malaysia.

The session convened regulators, industry leaders, and policy experts to investigate the opportunities and obstacles of artificial intelligence in healthcare. The discussion emphasised the importance of maintaining a delicate equilibrium between the promotion of innovation and the assurance of patient safety, clinical validation, and ethical data use.

Futurise is a wholly-owned subsidiary of Cyberview Sdn Bhd, which is regulated by the Ministry of Finance and provides public policy advisory.The Government of Malaysia has mandated it to administer the National Regulatory Sandbox, which serves as a key enabler of regulatory solutions to expedite innovation and future-proof Malaysia’s economy.

MDA is the government agency dedicated to supporting the Malaysia medical device industry. This is a federal statutory agency that operates under the Ministry of Health Malaysia, working to implement and enforce the Medical Device Act 2012 (Act 737). The primary goals of the Act are to tackle public health and safety concerns associated with medical devices while also promoting the trade and industry of these devices.

Welcome Address

Shafinaz Salim, Acting CEO of Futurise, delivered the welcome address, underscoring Malaysia’s pivotal moment in digital health.  “The convergence of AI and medical technology presents extraordinary opportunities from predictive diagnostics to real-time patient monitoring. Yet, these advancements also introduce new complexities that must be navigated carefully especially when it comes to public safety, clinical validation, and ethical data use,” said Shafinaz.

National Regulatory Sandbox

Additionally, she disclosed her intention to collaborate with MDA in the establishment of Malaysia’s inaugural regulatory sandbox for medical devices.”This proposed regulatory sandbox is more than a testing mechanism. It is a strategic platform to accelerate responsible innovation, by allowing innovators to safely trial AI-driven medical technologies within a controlled environment under the oversight of MDA. Our aim is clear and that is to support industry growth while safeguarding public health, in full alignment with MDA’s mandate,” she added.

Furthermore, Shafinaz underscored the significance of fostering innovation by establishing progressive regulatory frameworks. “To achieve this vision, we must address a crucial challenge: regulation. Innovation thrives in environments that allow experimentation, and this is where regulatory sandboxes can play a transformative role. The sandbox framework allows industries to experiment with new ideas without the immediate constraints of existing regulations, enabling rapid prototyping and faster scaling. As Futurise is mandated by the Government to drive the National Regulatory Sandbox, we believe the regulatory sandbox is the perfect enabler and plays a crucial role in this.”

Malaysia would be able to pilot and validate AI-driven medical technologies in a risk-managed environment, observe and respond to real-time challenges, build confidence among innovators, clinicians, and the public, and ultimately fast-track the adoption of safe, patient-centric innovations into the healthcare ecosystem by establishing a regulatory sandbox for medical devices.

Keynote Address & Panel Session

Senior Director of the Pre-Market Control Division at the Medical Device Authority (MDA), Aidahwaty M. Olaybal, delivered the keynote address. She underscored the significance of regulatory frameworks in ensuring that innovation is consistent with patient safety and trust. Regulatory oversight must remain adaptable and forward-thinking in order to address emergent risks as AI-driven technologies continue to evolve, she emphasised.

Additionally, Aidahwaty underscored the importance of collaboration among regulators, industry, and healthcare professionals in order to establish a resilient ecosystem that effectively balances public confidence with innovation.”Striking the right balance between innovation and safety requires centring collaboration, bringing together developers, clinicians, ethicists, and regulators in a shared space of co-creation.”

“It also demands rigorous real-world validation, beyond lab environments, to ensure AI devices perform reliably in diverse clinical settings. Regulatory sandboxes offer the ideal environment to test and iterate safely. And importantly, education must remain continuous for developers, users, and decision-makers alike, so that we evolve alongside our technology,” said Aidahwaty.

Idamazura Idris @ Harun, Senior Director of the Policy and Strategic Planning Division at the Medical Device Authority (MDA), Dr. Ylu-Cho Chung, Head of Research Collaboration at Siemens Healthcare Singapore, and Ella Al-Hakim, Associate at Asia Group Advisors, participated in the panel discussion, which was moderated by Deepak Pillai, Partner at Christopher & Lee Ong Malaysia.

The panel covered important topics such as international best practices, regulatory harmonisation, ethical challenges in the use of AI, and methods to ethically hasten the adoption of AI-powered medical devices.

The occasion served as a reminder of how crucial public-private cooperation is to ensuring that Malaysia maintains the highest standards of safety and trust while solidifying its position as a pioneer in digital health innovation.

Futurise and collaboration

Futurise emphasised that the development of a facilitating ecosystem will necessitate the active involvement of stakeholders throughout the healthcare value chain, including regulators, clinicians, innovators, investors, and patients.

Futurise and MDA will prioritise the alignment of innovation with patient-centric outcomes as they continue to develop the regulatory sandbox framework. This will guarantee that Malaysia’s healthcare system remains both progressive and trustworthy in the era of artificial intelligence.

This result of RegTalk 2025 establishes the foundation for a more comprehensive roadmap in which regulatory sandboxes will function as a critical mechanism for testing and refining breakthrough innovations in a structured environment. This will support Malaysia’s aspirations in digital health and contribute to ASEAN’s collective endeavour to develop safe and sustainable healthcare solutions that are powered by technology.

Picture Source:FUTURISE SDN BHD