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.
Teamwork makes the dream work
In the drive for innovation, historically, OEMs have focused on research, development and manufacturing. However, changes in the industry landscape are not only demanding greater consideration of the supply chain and logistics but also altering the role that companies play in these processes. Kamaljit Behera, senior industry analyst transformational health at Frost & Sullivan, speaks to Emma Green about the opportunities provided by adopting a collaborative approach.
Recharge your batteries
Medical implantables are getting smaller and have the potential to revolutionise medical life over the next few decades. But progress has stumbled, not least because of the large and unreliable batteries most devices rely on. Andrea Valentino talks to Shad Roundy, an associate professor in mechanical engineering at the University of Utah, about the problems of traditional methods and how using wireless power sources could be the way forward.
A bright idea
Nowhere is smart packaging more relevant than in medical devices, where there is growing demand for functionality and an ability to meet human needs. Although such technology is in its relative infancy, it has huge potential for the industry but does require careful consideration. Emma Green speaks to Javier de la Fuente, assistant professor of industrial technology and packaging in the Orfalea College of Business at the California Polytechnic State University, about the key considerations.
Hot chips
Microfluidic devices have many exciting applications, but fabricating the necessary channel and feature dimensions can be time-consuming and costly. Jim Banks speaks to Bruce K Gale, director of the Utah State Centre of Excellence for Biomedical Microfluidics, about the costs and benefits.
Devil in the detail
As computers shrink, so do laboratories. As cancer grows, it gets worse. Liquid biopsies have shown promise in using the former to prevent the latter, but operating on the nanoscale comes with its own set of issues. Isabel Ellis asks Yong Zeng, associate professor of chemistry at Kansas University, about how his new device can identify cancer from tiny specks of previously disregarded extracellular material.