Medical Device Developments Volume 1 2019
FDA regulation of digital tools
The 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 precertification pilot programme and a working model of this will soon be released. This model will outline critical components of the pilot such as precertification of companies, the premarket review process and post-market surveillance, according to the FDA. Additionally, the US agency has issued draft guidance concerning the FDA’s stance on reviewing devices with multiple functions, confirming that it will take a hands-off approach towards certain functions of digital devices. FDA Commissioner Scott Gottlieb speaks to Medical Device Developments about the implications of this new regulation for the industry.
The future of combination products in the EUMedical device companies are concerned they may have to postpone plans for the commercialisation of drug/device combination products because of delays in obtaining marketing authorizations due to a lack of clarity about approval rules. RAPS (Regulatory Affairs Professionals Society) discuss how to best manage this shifting regulatory landscape.
Historically, OEMs have made a distinct effort to become more and more vertically integrated. Whether it was injection moulding, sub-assemblies, packaging, machining, or even sterilisation, companies are prepared to pay large sums of money to bring these technologies in-house. The rationale for doing so is relatively easy to justify: greater perceived control of the supply chain, quality, cost, lead times, etc. However, over the last number of years, this line of thinking is changing. As companies bring more and more activities in house, they face new challenges. With each new technology, a new skill set is required: additional hires, additional training, even additional shop floor square footage. Jack Sandahl, Fellow, Fellow in a supplier and materials management role at Boston Scientific discusses important considerations when making this decision.
Stamping: Still relevant for medical device manufacturing?
Developing a metal medical device requires balancing a budget, deadlines, design considerations, and more. In light of rapid technological advances, deciding upon the best process to maximise manufacturing efficiencies can be challenging. Steve Larsen, senior research and development manager at Boston Scientific discusses important factors when determining the best process as well as providing an insight into the future of metal manufacturing.
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 both industry and academia. Pezhman Ghadimi, from the enterprise research centre at the University of Limeric speaks to Medical Device Developments about how to select the best supplier when seeking sustainability.
Disruptive technologies in medical device manufacturing
Since we entered the fourth age of the industrial revolution, known as Industry 4.0, manufacturers have begun to explore a wide range of new technologies. One of the significant developments within the industry has been the increasing use of robotics, which offer manufacturers a way to streamline production lines, helping to increase productivity and optimise workflows. Emma Bairstow, industry lead for medical devices at Deloitte speaks to Medical Device Developments about how to best implement these technologies into manufacturing processes to maximise efficiencies whilst minimising costs.
How collaborative robots are bridging the gaps in manufacturingCollaborative robots or "cobots" are a new class of robots that are bridging the gap between fully manual assemblies and fully automated manufacturing lines. Lightweight, flexible, easily programmable and safe to implement, collaborative robots can meet short-run production challenges faced by manufacturers that are adjusting to advanced processing in smaller batch sizes.Dylan P. Losey from Department of Mechanical Engineering at Rice University speaks to Medical Device Developments about how best to integrate these cobots into manufacturing processes.
Most current photonics devices are fabricated from rigid materials on rigid substrates, limiting their applicability. Researchers at MIT have developed a method for making photonic devices that can bend and stretch without damage. MIT Associate Professor Juejun Hu speaks with Medical Device Developments about the application of this technology for medical device manufacturing.
Flexible photonic devices
Flexible electronics made from exotic materials
Engineers at the University of British Columbia (UBC) have developed and fabricated a novel ultrasound transducer that could lower the cost of ultrasound scanners to as little as $100. Their patent-pending device is portable, can be powered by a smartphone and could pave the way for creating wearable ultrasound devices. Carlos Gerardo, research lead, speaks to Medical Device Developments about the possibilities of this technology for medical devices.
The vast majority of medical devices today are made from silicon, the second most abundant element on Earth after oxygen. Whilst it’s not the best semiconducting material that exists, silicon is the most readily available and thus the dominant material used in devices. Now MIT engineers have developed a technique to fabricate ultrathin semiconducting films made from a host of exotic materials. The new technique provides a cost-effective method to fabricate flexible electronics made from any combination of semiconducting elements, which could perform better than current silicon-based devices. Jeehwan Kim, associate professor in the departments of mechanical engineering and materials science and engineering, speaks to Medical Device Developments about the potential applications of their research.
BioelectronicsThanks 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. Medical Device Developments speaks to Lan Yue, assistant professor of research at USC about the potential of this technology for medical device manufacturers.
Semiconductor Technology for Implantable Medical Devices
Implantable medical devices have huge number of applications for both diagnostics and treatment. The advances of micro technology, combined with the development of novel biomaterials has enhanced the biocompatibility of these devices. Despite these advances, an ongoing challenge is whether power can be supplied sufficiently and continuously for the operation of the entire system. This is particularly important in light of the increase in wireless communication in implanted devices. Achraf Ben Amar from the University of Quebec, speaks to Medical Device Developments about different power sources available and how to choose the best one for your device.
When choosing a motor, the need to balance multiple factors such as service life, cost, speed and temperature conditions can make it challenging to know which one is best. A recent development is an axial flux motor that uses printed-circuit-board traces for electromagnetic coils. It was created by Carl Bugeja, an embedded-software developer speaks to Medical Device Developments about how the technology works and its application for medical devices.
Printing an electrical motor
Coatings and surface treatment
Medical device manufacturers must contend with a variety of challenges to differentiate products in a highly competitive market, placing a greater emphasis on functional coatings applied to medical devices from implants to scalpels, needle drivers, bone saws, and reamers. When manufacturers began coating instruments, the primary purpose was improving aesthetics for identification during surgery. Original equipment manufacturers (OEMs) are moving beyond aesthetics by applying titanium nitride and other physical vapour deposition (PVD) coatings to improve wear resistance, reduce galling between sliding component, increase lubricity, and help retain sharp edges on cutting instruments. Professor Denis Dowling from University College Dublin speaks to Medical Device Developments about the factors to consider when using PVD coatings.
Physical vapour deposition (PVD) coatings
Glass for implantable medical devices for cardiovascular disease
Glass is now the go-to for implantable medical devices (IMDs) which incorporate wireless interrogation. This is because of its ability to provide electrical insulation of microfabricated metallic coils or antennae. Glass has huge potential for the development of IMDs for a number of conditions, including cardiovascular disease, the leading cause of death in Western society. Anubhav Bussooa, School of Engineering, University of Glasgow,
The invention of a novel “ceramic ink” by a research team at City University of Hong Kong (CityU) has made possible the development of the world’s first-ever 4D printing for ceramics. Objects created using 4D printers could have several advantages over static 3D-printed parts. By using external stimuli such as heat, light or humidity to trigger transformations, engineers may no longer need to add motors to machines for simple tasks. The technique also means manufacturers could create devices bigger than their printers, as the objects can be programmed to unfold and spread after printing. Led by Professor Lu Jian, vice-president (Research and Technology) and Chair Professor of Mechanical Engineering, researchers have developed a printer which combines four different printing techniques – aerosol, inkjet, direct ink write and fused deposition modelling – and a range of printable materials, including hydrogels, silver nanoparticle-based conductive inks, liquid crystal elastomers and shape memory polymers.
Green polymer-based filmsScientists make new 'green' electronic polymer-based films with protein nanowires
An interdisciplinary team of scientists at the University of Massachusetts Amherst have produced a new class of electronic materials that may lead to a 'green,' more sustainable future in biomedical and environmental sensing. Scientists say the work shows it is possible to combine protein nanowires with a polymer to produce a flexible electronic composite material that retains the electrical conductivity and unique sensing capabilities of protein nanowires. Microbiologist Derek Lovley, from the University of Massachusetts speaks to Medical Device Developments about the value of these films for medical devices.
Microfluidics-based devices to identify early genetic markers of cancer
Cancer DNA changes in response to its environment, favouring alterations that help it survive long-term. These include both large and small changes. The latter can be almost invisible. To detect these small modifications, O'Keefe and her team created a digital microfluidics platform called HYPER-Melt, which stands for high-density profiling and enumeration by melt. Chrissy O'Keefe from John Hopkins University talks to Medical Device Developments about how this technology could revolutionise cancer detection.
A number of disposable sensors are now available to monitor fluid control in medical devices. These tend to be low-cost because there are no electronics located in the sensor. Medical Device Developments explores the potential of these sensors for the industry. Dr Thomas R. Dietrich, CEO of IVAM speaks to Medical Device Developments about the potential of these sensors for mobile and point-of-care diagnostics.
Disposable liquid flow sensors
The global market for sustainable packaging is rapidly developing. A growing awareness of the environmental hazards related to the disposal and recycling of packaging waste as well as government initiatives and increasingly stringent packaging regulations are key factors driving this growth. However, medical device companies are still lagging behind their personal care, food service and shipping counterparts. Adam Gendell, associate director, of the Sustainable Packaging Coalition speaks to Medical Device Developments about key principles to consider when selecting sustainable packaging.
Optimising delivery within the supply chain
The heavy regulation from design to delivery can make optimising the logistics process highly challenging. Optimising the shipping process provides time and cost savings, as well as the ability to offer exceptional customer service. Bruce J Stanley, a principal at the Stanley East
Consulting Group, discusses the key strategies to maximise the efficiency of logistics procedures.