All articles by Ky Nikitha

Ky Nikitha

Myopic medicine

In order to achieve sustainability in manufacturing operations, it needs to be incorporated in all stages of the supply chain. One key aspect is obtaining sustainable components from eligible suppliers. Recently, this topic has gained greater attention from industry and academia. Ben Wicks from Team Consulting speaks to Emma Green about the status of sustainability within medical device manufacturing.

Next evolutionary step

Thanks to bioelectronics, devices are starting to replace drugs for a wide range of conditions. Bioelectronic medicine explores how targeted electrical signals can harness the body’s natural mechanisms to diagnose and treat a range of diseases, helping the body heal itself. Emma Green speaks to Lan Yue, assistant professor of research at USC, about the potential of this technology for medical device manufacturers.

Your own devices

The US FDA plans to develop a new regulatory framework for reviewing ‘software as a medical device’ and has also issued guidance regarding the FDA’s regulatory process for digital tools. Aiming for a more ‘streamlined’ review, the FDA has updated the software pre-certification pilot programme and a working model of this will soon be released. Stephanie Webster speaks to Sundeep Karnik and Matt Singer from ZS about the implications of this new regulation for the industry.

Fit to print

Manufacturing has traditionally been a long process from initial design to finished part, and in light of the highly regulated environment, the medical device sector is conservative in its approach. But the industry’s use of stock component offerings and the rise of industrial-grade 3D printing could drive a shift towards an on-demand approach. Emma Green speaks to Brennan Miles, senior consultant at Team Consulting, about the present and future application of this method.

Global regulatory trends: how do they impact quality management systems?

Kim Trautman, executive vice-president, NSF International, explores the convergence of worldwide regulatory trends impacting quality management systems, to include risk management, clinical evaluations and post-market surveillance.

Look to nature for inspiration

Throughout his 20-year career, Professor William Murphy of the University of Wisconsin-Madison has looked to nature for inspiration. He has designed ‘bio-inspired’ materials for a host of medical applications, ranging from brain-on-a-chip techniques to materials that deliver messenger RNA for tissue regeneration. But how is his pure research being translated into real-world settings? Abi Miller investigates.

iDoctor

With the development of computer technology in the past century, treatment of diseases and development of technological solutions for diagnosis and therapy made a big step forward. Thomas Dietrich, CEO of IVAM, discusses the role of AI in driving progress in the industry.

Built for you

Operating on fractures in arms and legs when parts of the bone are missing not only risks the misalignment of the two sections as they heal back together, but also new breakages. Now, several teams are experimenting with 3D-printed bone scaffolds that encourage regrowth tailor-made for the patient’s anatomy. Greg Noone talks to Professor Georg Duda, of the Julius Wolff Institute for Biomechanics and Musculoskeletal Regeneration, and Christabelle Tonna, a member of the BioSA project at the University of Malta, to find out more.

Bon voyage

Engineers at the University of New South Wales (UNSW) in Australia have developed micro-submarines powered by nano-motors that can travel inside the human body, self-navigating to particular locations. Kang Liang, researcher at the UNSW School of Chemical Engineering and School of Biomedical Engineering, speaks to Stephanie Webster about the implications for medical devices.

In the loop

As technologies, power supplies, sensors and electronics evolve, so do the possibilities they bring. Closed-loop devices will likely be the enabler for real personalised medicine. Andrew Tunnicliffe talks with Robert W Gereau, vice-chair for research in the Anaesthesiology Department at Washington University, about his work and what the future holds for personalised medicine as the industry stands on the threshold of a device revolution.