All articles by Ky Nikitha
Ky Nikitha
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.
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.
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.
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.
Learn from failure
Post-market surveillance is an essential aspect of maintaining patient safety. However, recent reports have unveiled serious concerns with medical device failure reporting. Emma Green discusses what led to these issues and how they can best be resolved by the industry.
Coat of charms
Despite considerable effort, the problem of infections related to biomedical devices and implants persists. There are a number of strategies that can be used for the design of antibacterial coatings. Kerry Taylor-Smith speaks to Krasimir Vasilev, professor at the University of South Australia, about the advantages and disadvantages of the available options.
The specialists
Historically, there have been a number of differences between large and small OEMs, including their approaches to outsourcing. Louise Thomas speaks to Jack Sandahl, fellow in a global sourcing role at Boston Scientific, about the important considerations for OEMs of all sizes.
The best way to build muscle
A wide variety of polymers are used as biomaterials. Biostable polymers are commonly used for medical device applications because of their resilience, especially within the human body. Although there are a number of these on the market, efforts to improve their physicochemical and biological properties are ongoing. Mehmet Kanik, a postdoctoral fellow at MIT’s Simon Centre for the Social Brain, speaks to Lynette Eyb about the use of thermoplastic polymers in artificial muscles.