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Medical Device Developments Vol. 2 2023

This issue's cover story: Even the most bio-available implant materials have a level of failure risk. Most require the use of special coatings or the support of drugs, that’s why biomedical engineers have spent countless hours experimenting with materials compatible for use in the human body. 3D-printing technology is helping to accelerate this process by allowing researchers to have greater flexibility when fine tuning the blend of materials in the bio-ink that will determine the properties of the final product. Dermot Martin speaks to two experts in the field to learn how their work could lead to materials with a unique combination of properties.

Outside of materials science, there's an area of study that's had a marked impact on healthcare – more specifically in the field of surgery – for years. The use of minimally invasive tools like laparoscopes and endoscopes mean that many surgical interventions that once required long stays in hospital are now done as outpatient procedures. Andrea Valentino talks to Dr Paula Gomes of the British Standards Institution to learn about the advantages of minimally invasive technology, the role that contract manufacturers can play in meeting the demand for products, and how robotics and AI could bolster the field further.

Advances in medical devices mean nothing if you can't get the products themselves into the hands of healthcare professionals, and that's why the Advanced Medical Technology Association, or AdvaMed as it's more commonly known to the industry, is calling for collaboration at the pubic and private level to prioritise medical devices in the supply chain. Andrea speaks to Scott Whitaker and Abby Pratt from AdvaMed to learn more about the organisation's recommendations.

Other topics covered in this issue include the role that sensors play in managing disease, the use of computational fluid dynamics to improve experimentation protocols and a new technique that harnesses sound to 3D print devices with specialised properties.

Medical Device Developments Vol. 1 2023

This issue's cover story: Automation has brought efficiency and cost benefits across a range of manufacturing industries – but what happens when a mistake can pose a risk to the end user? This is the question medical device manufacturers must answer, something they do with high-tech inspection protocols, ensuring each unit is produced to an exact specification. Andrea Valentino talks to Ken McClannon at Jabil Healthcare, and Professor Anil Bharath at Imperial College London, to understand how these so- called vision systems work and how they might be boosted by machine learning technology.

Manufacturing is just one case in which predictability driven by technology can add significant value to the field of medical devices. In one of the major frontiers of the industry, mastery of bioelectronics, there's a whole host of devices in research labs held back from the clinic by their inability to conform to the complex surfaces of the human body. Peter Littlejohns speaks to a research duo that may have solved that problem for some, using simulation software driven by mathematical modelling to determine the optimal parameters for conformability.

Another situation in which the perfect fit is vital for success is implant surgery, and for one specific knee operation, Richie Gill, professor of mechanical engineering from the University of Bath has developed a way to bring the reduce the complexity and thus the complication rate – all by using a 3D printer to improve the implant. Kim Thomas speaks to Gill to find out why the operation could be lifechanging for those in pain due to osteoarthritis.

Also discussed in this issue are one university's plight to help start-up medical device companies, an injectable biomaterial with heart-healing potential and a device that could improve the quality of life of those suffering from ALS.

Medical Device Developments Vol. 2 2022

This issue's cover story: We're always hearing about the latest promising development for treating cancer, but the tried-and-true methods could still do with a dose of risk-reduction. For instance, nearly half of all cancer patients will undergo radiotherapy, and yet devices used to protect healthy tissue tend to be standardised and not patient-specific. Kim Thomas speaks to two experts in the field to find out how 3D printing is bringing more individualised protection to market, and reducing the risk of damaging healthy tissue.

Turning our attention to another area of medicine that carries patient risk, we look at the role that silver could play in eliminating bacteria from catheters. Among UTIs acquired in the hospital, approximately 75% are associated with a urinary catheter, which is why researchers looking at a new way to take advantage of silver's bactericidal properties while reducing its toxicity see coating catheters as the perfect use case for their coating. Abi Millar speaks to the lead researcher.

Outside of the world of innovation, the biggest story in town has been MDUFA V. After a long negotiation period between the industry, the FDA and Congress, the new user fee agreement was passed on September 30. Medical Device Developments editor Peter Littlejohns discusses with Peter Weems, director of Policy and Strategy at Medical Technology and Imaging Alliance how the talks evolved and what the resulting deal means for the industry and for medical device innovation at large.

Although it wasn't included in the MDUFA V legislation, many in the medical devices industry and beyond have been pushing for the VALID Act to pass in Congress and level the playing field between lab-developed diagnostic tests and in vitro diagnostics sold and regulated as medical devices. Peter Littlejohns also hears from Mayo Clinic's head of regulatory affairs, who explains why tightening the FDA's grip on labs too much could carry patient risk.

Medical Device Developments Vol. 1 2022

This issue's cover story: Space exploration has yielded many scientific developments over the years, with healthcare one of several areas that has benefited. Both NASA and the International Space Station (ISS) Laboratory recently signalled their desire to continue this trend by seeking new proposals to demonstrate the manufacture of biomaterials in microgravity. Mae Losasso finds out what could be possible from several experts in the field.

There's plenty of innovation going on right here on earth, and in a recent feat of engineering, a team at University of California San Diego managed to increase the resolution of electrocorticography sensors by 100x the standard seen in surgical theatres. Tim Gunn learns just how transformative the technology could be for neurosurgery departments by speaking to the duo looking to bring the device to the market.

It's an unfortunate fact that innovations without a clear and measurable patient impact don't tend to enjoy the same prestige as those indicated in life-saving treatments. But that doesn't make them any less valuable to a hospital. Elly Earls speaks to the lead researcher on a team that designed plasma-based anti-fouling and bactericidal surface treatments that could reduce the number of bacterial hospital acquired infections.

Other features in this issue include a critical look at state intervention to increase semiconductor production, an exclusive look at the inner workings of MedPhab's photonics-based medical device pilot line and a Q&A with industry veteran and supply chain expert Jack Sandahl on the current and future relationship between medical device companies and contract manufacturers.

Medical Device Developments Vol. 2 2021

This issue's cover story: It's best not to advertise this to vaccine refusers, but microchips are being injected into people – in clinical trials, at least. They've been touted for their ability to constantly monitor patient vitals, allowing for more reactive treatment, as well as better monitoring of long-term conditions. Mae Losasso assesses their potential with Daniel Andersson, associate professor in physiology at Karolinska University Hospital in Sweden, who recently ran a study into using chips for temperature monitoring; and Chen Shi of Columbia University, designer of a chip no larger than a mote of dust.

There's a considerable amount of future gazing in this issue when it comes to implants; even those of a more traditional nature. Hip and knee replacements are two of the most common operations carried out in orthopaedic departments, but that doesn't mean they've been perfected. There's constant development into new technologies in the field that can improve, among other things, the longevity, biocompatibility and strength of artificial joints. Lynette Eyb looks at one EU- funded project called BioTrib and asks project coordinators Professor Richard Hall and Dr Michael Bryant about their vision for the next generation of artificial joints.

Not all of the innovation covered here is into devices implanted inside the body though, as this issue also focuses on how labs are creating 3D replicas of tailor-made organs to give surgeons a better idea of what they're up against. Tim Gunn speaks to Richard Arm, flexural composites research fellow at Nottingham Trent University, and Mike McAlpine, associate professor of mechanical engineering at the University of Minnesota, about their novel approaches to combining 3D printing with advanced materials, and what they might need for surgical practice and medical device design.

If that isn't enough to whet appetites, this issue of the magazine also includes an interview with the FDA's Jeffrey Shuren, a promising new technique for environmentally friendly electrospinning and an expert run down of the efficacy of each type of face covering and mask on the market.

Medical Device Developments Vol. 1 2021

This issue's cover story: Prosthetics are among the original medical wearables, but technological advances haven't necessarily made them more popular. Answering why might just unlock the potential of a whole range of other devices. Tim Gunn finds out how new approaches to control, comfort and feedback are helping scientists understand how biology overlaps with technology, and enabling users to better identify with their artificial limbs.

That work is only becoming more applicable across the industry. Whether the technology monitors, manages or stimulates, someone's probably trying to make it into a wearable, but few manufacturers are likely to achieve the balance of innovation and functionality necessary to make a meaningful breakthrough. In the first of a number of articles offering a deep dive into the world of wearables, Abi Millar explores the development strategies behind some notable success stories. From there, Elena Beletkaia illuminates how lasers and photonics can add even more capabilities to future devices; Andrew Tunnicliffe considers how to shrink AI's hardware footprint; and Allie Anderson speaks to the inventors of a new manufacturing technique that improves silicone's comfort, biocompatibility and performance by making it permeable.

And yet wearables and prosthetics are still only a sliver of the sector. They may be changing how people think about healthcare and medical devices, but it's regulators that set the definitions for both. Deep breaths, now. On 26 May, the EU's new Medical Device Regulation was finally fully implemented. Thankfully, in this edition, Gabriel Adusei lends his expertise to help readers understand just what's happening and how they can best adapt to the shifting environment.

And it's all shifting: the FDA is trying to come to terms with the implications of AI, and Covid-19 variants are reaching terrifying new peaks in poorer countries. There are seismic changes ahead in how cost is weighed against risk in the post-pandemic supply chain, and bioelectronic medicine is bringing medical devices together with pharmaceuticals. In the eye of that storm, however, is something that doesn't change: the patient. Focus on their needs and you'll make it through.

Medical Device Developments Vol. 2 2020

On the cover this issue: We have too few disposable masks for our healthcare workers and too many for the health of the planet. Several months into the worst pandemic in living memory, fears of spreading infection have largely over-ridden environmental concerns about plastic waste – but climate change is even more of a threat than Covid-19. Anna Demming reports on some of the emerging materials and technology for personal protective equipment that might help us turn the tide on both.

No matter how advanced those materials might become, they still need to be manufactured and transported to their end users, opening up the other big question posed by Covid-19: what it means for the future of the supply chain. It's a question we tackle from every angle. Jack Sandahl, global sourcing fellow at Boston Scientific, gives his expert view on the pandemic's impact; Abi Millar investigates India's renewed push to become a world-leading medical device hub; and Tim Gunn speaks to some of those most affected by the sudden falls and rises in demand to work out whether reshoring is more than political rhetoric, and if diversification is feasible while companies are fighting to claw back lost revenues.

The struggle against Covid-19 is going to be a long, slow grind. We can frame what's come before in terms of what we've lost, or look at the incredible things it's made possible. As discussed in this edition, technology pioneered by Nasa during the space race is already shaping the medical devices of today and tomorrow – and even allowing development to continue remotely. This is no time for us to shy away from 'moonshots'.

Medical Device Developments Vol. 1 2020

This issue's cover story: The topic on everyone's mind is, of course, Covid-19, which has now infected over 3 million people worldwide. Medical device companies have been playing a crucial role in responding to the pandemic, particularly while ventilation has been the lone treatment for the most severe cases. As the UK scrambled to increase its stockpile of breathing aids, it was the country's Formula One teams that made the most telling impact, but why did they succeed where other non-specialist manufacturers have failed? Tim Gunn discusses the advantages of high-speed techniques like rapid prototyping for the industry with Chris Hurlstone, director of engineering at Team Consulting.

Covid-19 might be disruptive for the industry, but the wide-ranging innovations that have long defined it certainly haven't stopped. Will Moffitt speaks to Michael Bruchas, professor of neurobiology at the University of Washington School of Medicine, about a tiny neural implant developed by the Korea Advanced Institute of Science and Technology. As it's controlled from a smartphone, it could turn the devices we're most familiar with into platforms for researching mental health issues like addiction and depression.

Even as the first lockdowns are scaled back, there's no telling what Covid-19 might do to global health, or ask of medical devices, over the coming years. As the magazine was getting ready to go to press, the European Parliament delayed EU MDR to May 2021, one of many knock-on effects the pandemic is having on the sector. Supply chains and manufacturers remain at risk, but development is just as unpredictable.

Medical Device Developments Vol. 2 2019

On the cover this issue: Bouncing, bending and bonding to bone, glass is looking more and more like a miracle material. The liquid-like solid is showing its worth in everything from healing wounds to replacing intervertebral discs. Tim Gunn talks to Professor Julian Jones of Imperial College London and Professor Aldo Boccaccini from the University of Erlangen-Nuremberg about the properties of bioactive glass that make it so valuable for medical devices.

Also, with uncertainty around Brexit and what it means for the NHS, it is easy to have missed some important signals that support the greater use of structured data within the health service. Global Medical Device Nomenclature Agency's Mark Wasmuth outlines how medical devices can be more accurately identified.

There has been ongoing debate about the relative merits and disadvantages of insourcing versus outsourcing in manufacturing. However, recently, companies have become more interested in new ways of working. Within the UK this has taken the form of partnerships with Academic Health Science Networks in order to capitalise on the expertise of academia and industry. Plus, Heavy regulation from design to delivery can make optimising the logistics process highly challenging. Kim Thomas talks to Bruce J Stanley, president-principal at the Stanley East Consulting Group, about key strategies designed to maximise the efficiency of logistics procedures.

MD&M West Show Guide 2020

By 2025 the global medical device manufacturing market is expected to exceed $600 billion, driven by the aging population, increasing prevalence of chronic diseases, advancements in technology, and other factors.

As MedTech surges ahead, professionals in this dynamic industry need one place to cross paths annually to swap ideas, find inspiration, overcome challenges, and source products to keep their engineering projects humming. Enter Medical Design & Manufacturing (MD&M) West — the world's largest medical design and manufacturing event.

MD&M West, now in its 35th year, is where engineers and executives from across the globe converge before going on to change the lives of patients. In addition to the three-day conference covering MedTech, 3D printing, and smart manufacturing, the event offers the opportunity to meet suppliers and experts leading the charge to disrupt healthcare.

Medical Device Developments Vol. 1 2019

The cover story in this edition: although the use of plasma treatments for medical device coatings has been around for some time, in recent years it is enjoying something of a renaissance. Andrew Tunnicliffe talks with Professor Denis Dowling about its potential and its limitations.

Also, with uncertainty around Brexit and what it means for the NHS, it is easy to have missed some important signals that support the greater use of structured data within the health service. Global Medical Device Nomenclature Agency's Mark Warmth outlines how medical devices can be more accurately identified.

And, 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. Karen Taylor, director of the Centre for Health Solutions at Deloitte, speaks to Emma Green about how to best implement these technologies into manufacturing processes to maximise efficiency while minimising cost.

Medical Device Developments Vol. 2 2018

Automation and artificial intelligence are having a major global impact, not least in manufacturing. Use of this technology means better data insights, improved trouble-shooting and faster procedures, resulting in a more efficient factory flow. Emma Green explores the current and future developments in artificial intelligence, including the use of robotics to enhance the manufacturing process.

Also, the EU Medical Device Regulation is the most dramatic legislative reform for the sector since the mid-90s, and it is now in effect, although the industry is still in the midst of a transition period. Professor Dr Herman Pieterse, of the University of Ghent and Profess Medical Consultancy, outlines the considerable demands being made on device companies and how they are adapting to change.

Plus, the market for silicon adhesives continues to grow, more than 60 years after first coming into use in the medical device sector. What makes this material so popular, and what are the latest trends and innovations? And, Brexit is coming at an inopportune time for medical devices, say GlobalData. EU directives are currently transitioning to a new Medical Devices Regulation and In Vitro Diagnostic Regulation, which are already having a profound impact on the medical devices industry and on the availability of medical devices to EU citizens.

Medical Device Developments Vol. 1 2018

In the search for an alternative to opioid drugs for chronic pain, new devices are coming to the fore. Eleanor Wilson speaks to Dr Allen Burton, Abbott's medical director of neuromodulation, about the future of using electrical impulses to speak the language of the nervous system.

David Callaghan explores how advances in laser diode technology are making devices more portable and patient-friendly, compensating for the shortcomings of photoacoustic imaging, and being cost-effective and less bulky. He speaks to Dr Andreas Kohl of Quantel Laser and Dr Manojit Pramanik, assistant professor at Nanyang Technological University.

Also in this issue: Kerry Taylor-Smith finds out more about custom 3D-printed implants that are being used for robotic surgery to treat bone cancer patients and Sally Turner draws comment from experts about how medical device manufacturing execution systems (MES) are transforming the market.

Medical Device Developments Vol. 2 2017

Car maker Lamborghini and the Houston Methodist Research Institute have joined forces to investigate how carbon fibre composite materials can improve medical devices. Dr Alessandro Grattoni tells Bradford Keen how this could lead to breakthroughs in prosthetics and more.

The use of additive manufacturing at the factory level is having a profound effect on medical technology. Robert Cohen, of Stryker, speaks about the newest technologies, while James Coburn, senior research engineer at the USFDA, explains how regulators are responding.

Also in this issue: Medical devices are driving innovation in sensors as demand for smaller parts grows. We examine how low-cost components and high functionality are shaping the market. Plus, scientists and manufacturers are increasingly using resins in medical devices. Dave Callaghan explores how this ancient material is now a key factor in implants.

Medical Device Developments Vol. 1 2017

As the demand for miniaturised parts continues to strengthen, lasers have assumed a pivotal role in the machining process. Medical Device Developments investigates.

Sophie Peacock speaks to Dave Hampton of Camstent about how developing new coating products is paving the way for a safer hospital environment.

Also in this issue: Patient safety is only the beginning of the cybersecurity hazards posed by medical internet-of-things devices. Medical Device Developments looks into the issue. Plus, Dr Gabriel Adusei discusses the challenges and benefits that the medical device industry in Europe, the US and, of course, the UK will face when Brexit comes to fruition and Kim Thomas speaks to Lewis Mullen, manager in advanced technology at Stryker, about how 3D technology is changing as it becomes mainstream.

Medical Device Developments Vol. 2 2016

A soft robotic gripper invented at the École Polytechnique Fédérale Lausanne (EPFL), Switzerland, is gentle enough to pick up an egg, yet strong enough to carry 80 times its own weight. Sarah Williams speaks to EPFL's Jun Shintake and Herbert Shea about what it could mean for the medical industry, from automated manufacture to prostheses.

Students in Mexico have printed plastic supports for broken limbs that are breathable, able to prevent infection and ulcers, and ten times lighter than plaster casts. Designer Zaid Badwan explains the development of this potentially revolutionary technique.

Also in this issue: Medical Device Developments explains why contract manufacturers in the single market look likely to be placed under increased scrutiny by regulators, and Oliver Hotham reports on a US military hospital that has developed a way to bring the sensation of touch to artificial limbs with new sensors and haptic technology.

Medical Device Developments Vol. 1 2016

When joint replacements repeatedly fail and extensive bone loss occurs, additional revision using a standard orthopaedic prosthesis is often unfeasible and many patients are turned away. Sarah Williams speaks to Michael Colling-Tuck of JRI Orthopaedics to find out how 3D-printed implants are making the inoperable operable and to Nottingham Trent University's Manolis Papastavrou about research into an exciting new approach to 3D printing that could improve treatment options.

With a raft of new regulation on the way from the European Union in the near future, there promises to be a number of testing years ahead for medical device manufacturers. Dr Gabriel Adusei, a medical device consultant at Triune Technologies, outlines how the industry should expect to be affected by the changes and what impact this may have on the med-tech sector.

Also in this issue: Kerry Taylor-Smith speaks to Mr Bobby Qureshi of the London Eye Hospital - the first surgeon in the UK to use femtosecond lasers - about the technology and Medical Device Developments investigates the outsourcing landscape in 2016 with Cirtec CEO Brian Higley and Medi-Vantage president Maria Shepherd.

Medical Device Development Compendium 2016

Medical Device Developments Vol. 2 2015

In 1958, the first pacemaker fully embedded in the human body began its work. No one believed the technique would be a success. But today, in Germany alone, about 130,000 patients each year receive such an implant, giving them a significantly improved quality of life. In the latest edition of Medical Device Developments, CEO of IVAM Thomas Dietrich explores the future of this pioneering technology.

Jack Sandahl, adjunct professor in the manufacturing operations management programme at the University of Minnesota, and fellow, supplier and materials management at Boston Scientific, explores the current contract manufacturing landscape and shares his five-step process for driving performance excellence.

Also in this issue: Sophie Peacock speaks to Dr Blayne Welk, a urologist practicing in Canada, about the increasing medico-legal concerns regarding transvaginal meshes, and Dr Tolou Shokuhfar of Michigan Technological University, and director of In-Situ Nanomedicine Laboratory, explains how advances in nanotechnology might improve the biological performance of bone implants and reduce infection rates.

Medical Device Developments Vol. 1 2015

Miniscule robots that can seek out problem cells and provide targeted treatment inside a patient's body could one day become the norm. As engineers at the University of Texas at Austin trial the world's smallest, fastest and longest-running nanomotor, Dr Donglei (Emma) Fan talks to Medical Device Developments about a new 'bottom-up' approach to nanomechanics.

Following the Protect Medical Innovation Act 2015, the US medical device excise tax may soon be repealed. Two and a half years since it came into force, the tax has already had a significant impact on the industry, presenting opportunities, as well as challenges. We explore how the outsourcing market has been affected and the implications for contract manufacturers partnering with cash-strapped OEMs.

Also in this issue: Matthias Lorenz, deputy chairman of IVAM Focus Group Medical, explains how OEMs decide how to outsource microelectronic products; Dr Dale Athey, CEO of OJ-Bio, explains how medical device designers can take advantage of advanced electronics to test for illnesses remotely; and Procyrion CEO Benjamin Hertzog discusses the need for minimally invasive cardiology tools.

Medical Device Developments Vol. 2 2014

Medical science has come a long way since the first implantable pacemakers were developed in the 1950s. With advances in technology and the emergence of lithium anode cells came increased power management, and in the last few years, we've witnessed some amazing developments.

In this edition of Medical Device Developments, Jack Wittels learns more about the future of leadless pacing and other electrophysiological trends that are changing how patients' heart conditions are treated.

Ellen Roche, a PhD candidate at Harvard University's School of Engineering and Applied Sciences, introduces us to 'soft robotics'. Instead of rigid structures, flexible materials such as silicone elastomers are used to more accurately mimic structures in the body. Roche discusses her work in the field and how it could ultimately lead to devices that help to repair the heart.

Also in this issue: We catch up with the latest in spinal cord injury management - motorised exoskeletons. The technology is relatively simple, but the results are incredible as UK woman Claire Lomas proved when she completed the 2012 London Marathon using the ReWalk. The device allows paralysed patients to walk again and has just received FDA approval for personal use. Mukul Talaty runs us through his research on the safety and efficacy of the product and considers whether or not it represents the future of paralysis treatment.

Medical Device Developments Vol. 1 2014

Smaller is better in this issue, which emphasises developments taking place on a microscopic scale. We talk to Joseph Kahn, professor of electrical engineering at Stanford University, who has developed a prototype micro-endoscope as thin as a human hair. Devices of this kind could enable dozens of new procedures across oncology, brain surgery and even gene therapy.

We also chat to Frederick Balagadde, assistant investigator at K-RITH in South Africa, who makes a compelling case for using microfluidics in the fight against HIV/AIDS. While lab-on-a-chip (LOC) devices have been trumpeted as the future of diagnostics, how can they get off the ground in the developing world?

Another area attracting hype is additive manufacturing, or 3D printing. Professor Kenneth Dalgarno of Newcastle University explains what lies behind the buzz. Elsewhere, Digicom Electronics' Mo Ohady and David Estes walk us through the EMS company selection procedure, Dr Joachim Storsberg of the Fraunhofer Institute explains new uses for biopolymers and Michigan State University's Dr Douglas Moyer talks treating counterfeiters as competitors.

Medical Device Developments Vol. 2 2013

Some manufacturers are realising the benefits that subcontracting to EMS providers can bring, but others are reticent. Frost & Sullivan's Lavanya Rammohan evaluates the medical market's outsourcing potential.

Can the potential of robotics, 3D printing and nanotechnology in the automated manufacture of medical devices truly be realised? We ask Navigant's Scott Thiel. Also in this edition, Chuck Parker, Continua's executive director, explains why he considers M2M communication technology to be critical to the future of healthcare, Tactiq's Alan Johnson outlines what risks must be addressed in the management of power sources for portable medical devices in the critical care environment, and Zeljko Loncaric, marketing engineer at congatec, explains how microprocessor evolution is driving up efficacy within the industry.

Medical Device Developments Vol. 1 2013

Yves Verboven, director market access and economic policies at Eucomed, discusses the multiple pathways that manufacturers need to understand when seeking funding and reimbursement for medical technology for different European countries, and also the solutions.

Elsewhere, Medical Device Developments speaks to consultant Bruce Stanley about how companies can successfully navigate the regulatory landscape and, with increasing numbers of medical device manufacturers embracing automation, Mike Wilson of the British Automation & Robot Association and Todd Olson of NACS discuss its possibilities and drawbacks. Plus, Sachin Shrikant Malgave of Indo-US MIM investigates metal injection moulding and Professor Ian Ward of the University of Leeds talks about some of the leading-edge research in the field of materials innovation.

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