Medical Device Developments Volume 1 2020
Eudamed and EU MDR
Eudamed, a database to monitor the safety and performance of devices, has been postponed by the European Commission until May 2022, which coincides with the implementation date for the In-Vitro Diagnostics Directive (IVDD). However, the delay will not extend the date of the Medical Devices Regulation (MDR), which remains in May 2020. Medical Device Developments speaks to Michael Dohrmann, industry lead of health sciences and healthcare at Deloitte, about exactly what is required to ensure compliance.
The move towards dual sourcing
In the drive to get products to market faster, OEMs are keen to find one-stop-shop contractors. This means fewer sites to manage from a regulatory perspective and a reduced risk of supply chain confusion. Increasingly, manufacturers are moving to dual-sourcing arrangements, requiring at least one back-up supplier for each aspect of production to gain a competitive advantage over those juggling multiple contractor arrangements. Medical Device Developments speaks to Jack Sandahl, head of sourcing at Boston Scientific, about the considerations when implementing this approach.
Rapid prototyping: the pros and cons
In medical device design, as in engineering in general, ‘right first time’ is the cautious mantra often used to justify innovation based heavily on analysis and research. But does such a risk-averse approach deprive design teams of multiple insights that could make products so much better? Medical Device Developments speaks to Chris Hurlstone, director of engineering at Team Consulting, about the pros and cons of rapid prototyping.
American inventor John Wesley Hyatt, together with his brother Isaiah, patented the first injection-moulding machine in 1872. Over the next few years, the technology progressed slowly, producing products such as collar stays, buttons and hair combs. Today, injection moulding is used for creating products across multiple fields, including electronic, automotive and home appliance, as well as the medical device industry. Medical Device Developments speaks to Professor Denis Dowling about the applications of the technology today, particularly the value of micro injection-moulding.
Pros and cons of sourcing
There has been ongoing debate about the relative merits and disadvantages of insourcing versus outsourcing in manufacturing. In this discussion, deciding whether to buy machinery is an important consideration. Medical Device Developments speaks to Lars Hahn, head of international projects and sales at B Braun Group’s OEM and industrial business division about the best strategies when navigating outsourcing options.
3D printing medical devices in space
Astronauts face serious health issues, including hand injuries and risk of infection, during long duration space missions far from earth. Chile-based Copper 3D has received funding from NASA to test a new, 3D printing-based approach adapted for the unique space environment. Medical Device Developments speaks to co-founder Daniel Martínez about key considerations when manufacturing devices for this environment.
The role of robotics in manufacturing
Robotics provides huge value for manufacturing, offering packaging, assembly, and inspection tasks to boost quality while cutting time and costs. Medical Device Developments speaks to Joshua Gafford, a robotics specialist from Harvard University, about the potential applications of robotics and best practices when utilising them.
Linear actuators are mechanical device that convert energy to create straight-line motion to either lift, tilt, or move mechanical legs in and out. They offer a wide range of exciting applications. Medical Device Developments speaks to Terry Gourlay, head of biomedical engineering at the University of Strathclyde, about the potential of linear actuators for medical devices.
Machine learning microscope adapts lighting to improve diagnosis
Engineers at Duke University have developed a microscope that adapts its lighting angles, colours and patterns while teaching itself the optimal settings needed to complete a given diagnostic task. In the initial proof-of-concept study, the microscope was more accurate than trained physicians and other machine learning approaches. Medical Device Developments speaks to Roarke Horstmeyer, assistant professor of biomedical engineering at Duke, about the implications of their findings.
EU MDR is the newest set of regulation pertaining to medical devices within the EU. It aims to increase medical device safety and effectiveness, address weaknesses identified by manufacturers and to account for rapidly changing technological developments in the industry. Medical Device Developments speaks to Peter Ogrodnik, Professor at Keele University, about the potential of laser marking to ensure compliance and boost efficiencies.
A wirelessly-controlled and wearable skin-integrated haptic VR device
Skin is the largest organ of the body. But compared with the eyes and ears, it is a relatively under-explored sensory interface for VR or augmented reality (AR) technology. Researchers from CityU and Northwestern University have developed an integrated skin VR system which can receive commands wirelessly, and then simulate ‘touch’ with vibration. Medical Device Developments speaks to Yu Xinge, assistant professor at CityU about the applications for medical devices.
Miniaturised, wireless oxygen sensor
Researchers are developing a sensor the size of a Band-Aid that will measure a baby's blood oxygen levels, a vital indication of lung health. Unlike current systems used in hospitals, this miniaturised wearable device will be flexible and stretchable, wireless, inexpensive, and mobile, potentially allowing the child to leave the hospital and be monitored remotely. Medical Device Developments speaks to Ulkuhan Guler, assistant professor of electrical and computer engineering and director of WPI's Integrated Circuits and Systems Lab, about how the concept of the technology.
Internet of things
Providing treatment and diagnosis to remote locations is an ongoing challenge for the healthcare. However, IoT-enabled embedded medical devices, offer huge potential to identify diseases and provide treatments in a timely manner from such locations. Medical Device Developments speaks to Joel Goldsmith, senior director of digital devices at Abbott, about the latest IoT developments.
New organ-on-chip possibilities
Microfluidic or 'lab-on-a-chip' devices are commonly used to analyse blood and other fluid samples, which are pumped through narrow channels in a transparent chip the size of a postage stamp. A new chip takes that technology one step further by adding a 3D cavity along the channel, which creates a mini-vortex where particles spin around, making them easier to observe. Medical Device Developments speaks to Sara Baratchi, co- researcher and biologist at RMIT University, about the potential applications.
Scientists have developed a new approach for making metal-metal composites and porous metals with a 3-D interconnected ‘bicontinuous’ structure in thin films at size scales ranging from tens of nanometers to microns. Metallic materials with this sponge-like morphology could have a number of exciting applications. Medical Device Developments speaks to Karen Chen-Wiegart, assistant professor in Stony Brook University's (SBU) Materials Science and Chemical Engineering Department, about the potential of these findings for biomedical sensing.
The use of ceramics in medical devices is changing rapidly, and the material is now being used in increasingly complex products and techniques. Medical Device Developments speaks to Andy Weymann, chief medical officer at Smith & Nephew, about some of the latest innovations.
Material engineering meets neurobiology
A tiny neural implant, capable of delivering multiple medications and coloured lights and controllable from a smartphone, could speed up research into mental illnesses, such as addiction and depression. Using materials engineering knowledge, scientists from Korea Advanced Institute of Science and Technology and Center for the Neurobiology of Addiction, Pain and Emotion at the university in Seattle designed a device that uses Bluetooth low-energy to deliver drugs and light to specific brain cells. Medical Device Developments speaks to Michael Bruchas, a professor at the University of Seattle, about the implications for neural devices.
With a wide range of healthcare, energy and military applications, stretchable electronics are revered for their ability to be compressed, twisted and conformed to uneven surfaces without losing functionality. By using the elasticity of polymers such as silicone, these emerging technologies are made to move in ways that mimic skin. Medical Device Developments explores the potential of silicon with Matt Pharr, assistant professor of mechanical engineering at Texas A&M University.
Novel coating techniques
There has been an enormous growth in the application of coatings onto medical devices in recent years. Recently, novel coating techniques such as laser treatments, low temperature atmospheric plasmas and microblasting techniques have also been developed for the deposition of bioactive coatings. Medical Device Developments speaks to Denis Dowling, director of the I-Form Advanced Manufacturing Research Centre at University College Dublin about the latest developments.
Valves in point-of-care testing devices
Point-of-care testing (POCT) is a rapidly expanding area of healthcare, driven by increasingly advanced medical technologies which allow for easier and faster clinical decisions to be made. One of the most important advances in recent years has been the ability to transfer complex analytical or diagnostic processes into a single microfluidics platform. Medical Device Developments speaks to Thomas Dietrich, managing director of IVAM Microtechnology Network, about how to choose valves for these devices.
Many medical devices have to be disposed of after to preserve patient safety while some can be designed to be reused after disinfection. It is worth considering what the cost of sterilising reusable devices will be and whether it outweighs the benefits of the waste reduction of single-use devices. Medical Device Developments speaks to Nancy Anderson, Greenhealth Exchange Contracting Vice President at Practice Greenhealth, about how to improve the sustainability of sterilisation.
Medical device fraud is a relatively well-kept secret in the healthcare industry. While the pharmaceutical industry has accepted the dangers counterfeiting poses, there are suggestions that device manufacturers are grossly underestimating the problem. Medical Device Developments speaks to Douglas Moyer, adjunct assistant professor at Michigan State University, about the state of the problem and the technologies to combat it.
Most companies in the air freight market are currently engaged in adopting new technologies, strategies, product developments, expansions, and long-term contracts to maintain their dominance in the global air freight market. With the advent of new technologies on a regular basis, players are striving hard to incorporate the latest technology to gain a competitive edge above the rest. Medical Device Developments speaks to Bruce J Stanley, president-principal at the Stanley East Consulting Group, about recent innovations to optimise logistics.