Tag Archives: Medical Devices

Spotlight Interview with Alex Santayana, Applications Engineer at NuSil








What do you hope attendees will gain at your webinar?

Innovative new medical devices are changing lives for patients around the globe. As engineers design these devices, they need biocompatible materials that offer long-term stability, high levels of purity and robust performance standards. Along with end-use requirements, they also need materials that meet their manufacturing needs.

Silicone is a unique, engineered material that can help solve many of these design challenges facing engineers. I’ll highlight the distinctive qualities of the material that make it stand out while offering insight into its many forms and processing methods. My goal is to make it easier to choose the right silicone for a medical device application.

What discussions do you look forward to having with the attendees?

Medical devices change lives every day, whether it’s a child hearing for the first time with a cochlear implant or a busy dad who no longer stops his day for injections because he has an insulin pump. Now device therapies are expanding in ways that might have seemed like science fiction just a few years ago. It’s exciting to hear how engineering teams are imagining and developing the next generation of devices, including personalized healthcare therapies. And I look forward to conversations about the ways silicones can help improve device performance and support manufacturing processes.

What do you enjoy most about your role?

I love working with silicone because this single chemistry is capable of an incredible range of properties. Fundamental changes to the polymer can yield everything from soft gels to hard resins, all without using harsh additives or plasticizers.

The best part of my work is when I can piece together the performance, processing and business needs of an application to identify the most suitable product — the silicone that optimally balances all a manufacturer’s needs. For medical device applications, it’s both satisfying and humbling to know that my skills and expertise can help engineers find solutions that make a genuine difference in the daily lives of so many patients and their families.

How did you get into the industry?

Ten years ago, I started working with silicone as a mechanical engineer involved in the design and manufacturing of elastomeric parts. Since then, I’ve supported customers leveraging silicones in a range of industries, including technology, aerospace, defense and medical. Although today my work is more focused on the raw materials, I still benefit from knowing how they are used to accomplish any specific design goal.

Where is your favorite place in the world, and why?

My favorite place is underwater. It’s the closest most of us will get to visiting an alien world where we can weightlessly float around while observing strange and exciting creatures we would never see otherwise.

You can register for NuSil’s webinar “The Future of ATMPs” here:


Spotlight Interview: Antal Solyom, Director of Medical Device Unit, HungaroTrial


Lead Auditor and Certifier Antal Solyom has worked for one of the most recognized Notified Body’s in Europe (TUV Rheinland) for 14+ years, and previously an additional 3 years at another Notified Body as a Lead auditor, and Head of Mechanical Laboratory. As a MS in Mechanical Engineering, his background provided the perfect base for gaining experience in a variety of non-active medical devices, adding over the years sterilization, clean room technology, biocompatibility and clinical data review knowledge. Leading the local certification office, and managing the worldwide-active auditors team, he earned a high level of experience in managing certification projects for a variety of medical devices for small and mid-size medical device manufacturers. Currently working for the leading CRO in Central Europe (HungaroTrial) these experiences are well used for projects coming from all over the world.

BRW:What do you hope attendees will gain at your event?

The Medtech sector faces the biggest challenge in the last 25 years. 2020 will be an incredibly tough year for all of us including the authorities and notified bodies. The new MDR brings a lot of interesting new aspects for all those associated with the industry. Understanding all the connections between the different parts of the regulation is not easy, not even for professionals. It takes a lot of time, effort and a need to immerse yourself as much as possible between the articles, chapters, and intense net of links between requirements.

Together with my colleague we put our combined 20+ years of experience in order to digest, filter and provide you the most important and challenging points of the changes, and to provide a clear supporting presentation of this information.

Because of the limited time, we can not present everything, but this is not our aim. Instead we will focus on important points which will capture your attention, and make it easy to prepare and plan for all important tasks for the next 2 years.

As a lead auditor for 14 years at a leading Notified Body, and being a certifier for 10 years, I realized the most significant problems and mistakes that manufacturers face. But nowadays there is no normal time: we are in the middle of the biggest change in medical regulation. This will trigger millions of questions, most of which cannot be answered yet, however attending conferences and round table meetings with regulators and authorities over the last year we have collated additional knowledge to support these questions.

BRW:What discussions do you look forward to having with attendees?

Understanding the relations and links between the chapters of the regulation is not easy, and triggers a lot of questions which are hidden in the deeper interpretation of the MDR. Based on the conferences attended in the past, together with the experience gained we have a good understanding of the most concerning points for the manufacturers, and we are prepared for these questions. Transition period and how to prepare and plan in the most effective way for it is a real deal for the manufacturers. How to gain advantage in some way is also a possibility for others. There is also a heavy side for other companies, who were not needed to work together with notified body’s until now because of the low risk level of their products – they have no transition period – they need to comply with the MDR right from May 2020.

All these cases will trigger questions which we are already prepared to answer, and will have the right response for the right manufacturer.

BRW:What do you enjoy most about your role?

As an engineer the possibility to take a peek into the manufacturing of the most developed and state of the art products of the “big” players in the last 17 years was far beyond all expectations when I started to work. The Medtech sector has provided me experience from real life situations, all together with real-life problems, and discovering solutions. This is I think the reason why I like my profession, and each day provides a new possibility to give something back to this industry with the regulatory support that we provide at the company.

BRW:How did you get into the industry?

Right after the university I was eager to start life as fast as possible – so I started at a company in the Quality Management field. After 3 years the possibilities were too finite – so I felt that I need to expand my horizons. Falling into the medical sector was a coincidence – but ever since that everything else was intended and planned. 3 years at the National Notified Body was a great opportunity to learn – and I used every minute of it for gaining knowledge from one of the best and experienced colleagues with many years behind their shoulders. After the possibilities became limited within the company, I felt it was time for something new. One of the leading Notified Body in the world was seeking auditors and experts in this area. Applying for that position began a 14 year long journey in this area with many challenges and possibilities. Travelling all over the world, auditing many companies around the world provided me unique experience in the regulatory field along side developing a strong relationship with competent authorities over the last 10 years.

BRW: Where is your favourite place in the world and why?

If it is outside, and close to nature I like every corner of the world, and I had the opportunity to experience many countries and continents. Be it the wild forests in Brazil, the National Parks in US, experiencing the cherry blossom in Japan or breathtaking mountains in Swiss Alps – the joy is the same – being close to nature is awesome. Being a skier from a family with multiple national champion skier parents provided me the possibilities to enjoy the nature even at the most highest altitudes throughout Europe.

Antal will be presenting HungaroTrial’s webinar: “The most challenging points of the transition period from MDD to MDR – and their solution” on the 5th December at 4PM London/11AM New York/8AM San Francisco. To learn more and register please click here.


British Army’s Ice Maidens to showcase innovations used on Antarctica expedition at Medical Innovation 2018

Major Natalie Taylor, a member of the British Army’s six-strong female team to cross Antarctica unassisted, will share insights into the 61-day expedition with visitors at Medical Innovation 2018. The Ice Maiden showcase will unveil the state-of-the-start physiological monitoring sensor technology used to measure the team’s heart rate, respiration and skin turgor, along with glucose, salt and sodium levels remotely.

The session will explore how wireless sensor technology, developed by the Hamlyn Centre, Imperial College London, can monitor and aid the care of individuals in remote and extreme locations. Research Associates, Dr Bruno Gil-Rosa and Dr Salzitsa Anastasova-Ivanova of Imperial College London will further the discussion and highlight the clinical relevance of data generated by small-form wearable sensors to aid the delivery of medical attention to military and civilian patients.

The Ice Maiden team will return to the spotlight to explore the endocrine effects of arduous military training on women, led by Squadron Leader Rob Gifford, Research Fellow Centre for Cardiovascular Science – DMS. The session will explore the data collected from the Ice Maiden expedition, in a bid to understand the nuances of female hormone physiology in arduous training.

Major Taylor and Squadron Leader Gifford join a programme of high-profile, international speakers who will deliver thought-provoking presentations as part of this year’s two-day conference, led by Defence Medical Services (DMS). Attendees will hear the latest research on the patient and career journey and the innovation that seeks to improve the outcome for both. A wide range of topics under the theme of prolonged care – starting with preparedness and finishing with rehabilitation will see expert speakers from DMS’ national and international collaborators illustrate the challenge and innovative solutions with real-life vignettes.

The history of medical innovation

Exploring the history of medical innovation, Dr Emily Mayhew, Resident Historian with the Institute of Blast Studies, Imperial College London will provide a fascinating account of the history of medical innovation and how the healthcare system has evolved, in light of the First World War Centenary.

Speaking about the session, Dr Emily Mayhew, said: “We need to remember that there is a history of medicine. Quite often we stop ourselves looking further back than a decade, and certainly fail to appreciate the relevance of research and knowledge from the previous century. I believe this talk is important to everyone in the medical community and I hope to encourage those from the technical innovation community to listen closely to hear the wider needs of medical professionals.”

Emerging Technologies

Civilian and military healthcare professionals are invited to join Air Commodore Rich Withnall, Medical Director and Colonel Mike Smith, Defence Professor of General Practice, DMS to discuss the emerging technologies making an impact on the delivery of healthcare services. They will be joined by Professor Guang-Zhong Yang, Director, The Hamlyn Centre, Imperial College London who will provide a fascinating glimpse into the future of emerging biosensor and monitoring technologies.

International experts will go on to explore how the implementation of robots, artificial intelligence (AI) and physiological sensors and imaging can meet the requirements of operational challenges. Simon Toh, Consultant Surgeon and Director of Victory Institute for Minimal Access and Robotic Surgery will demonstrate how robotics can revolutionise surgical procedures.

Developments in Chemical, Biological, Radiological and Nuclear (CBRN) medicine; the role of virtual reality (VR) and augmented reality (AR) for pre-deployment Medical Emergency Response Team (MERT) training; and the importance of holistic casualty care for the effective delivery of prolonged field care will also be explored. As requirements change there is a pressing demand for new technology within the industry. A new initiative, led by jHub – the recently launched innovation centre for Joint Forces Command –  provides a unique opportunity for businesses with game-changing medical technology, processes or clinical innovation to submit solutions that could be used by the UK Armed Forces in the future via an open call. jHub, which has a £20m fund for solutions new to MOD, aims to fast-track successful proposals through procurement within 1 year or less. Businesses can submit their ideas at the Medical Innovation website.

Reflecting its position as the leading event for civilian and military healthcare professionals, attendees will also be able to join representatives from NHS Forth Valley, North Ambulance Resilience Unit and the West Midlands Ambulance Service for insights into humanitarian challenges and emergency preparedness. Further sessions will provide insights into pre-hospital care and resilience, with speakers from the Ministry of Defence, DMS and NHS England (South West).

Civilian collaborative partnerships will also illustrate the innovations in damage control and resuscitation surgery, offering learnings on how to mitigate and treat injuries ranging from hearing loss to sepsis, while other sessions will include the use of novel patient testing and advances in medical management, as well as research from defence institutions.

Colonel Mike Smith, Defence Professor of General Practice & Primary Care, Defence Medical Services, said: “The Defence Medical Services has chosen the prolonged care theme for Medical Innovation 18 as it reflects the reality that medical care is not always delivered in an optimal location. The event is an opportunity to bring together both civilian and military expertise from across the specialities to witness and discuss recent advances and innovations in this field.”

For more information on this year’s conference programme and to register for the event visit www.medical-innovation.eu

Expert interview with Sqn Ldr Robert M Gifford, of Defence Medical Services, and the University of Edinburgh Centre of Cardiovascular Sciences


  1. Please give a brief overview of what your session will cover at Medical Innovation 2018?

The endocrine effects of arduous military training on women: evidence from Antarctica and  Sandhurst

High rates of adverse reproductive, psychological and bone health-related outcomes have been reported in military women, compared with men or civilian women. While the reasons for this are poorly understood, hormones are thought to be responsible, since they mediate differences in sex.  Sqn Ldr Gifford will present data from two observational studies which have attempted to understand the nuances of female hormone physiology in arduous training and their impact on reproduction, stress and bone.

The Army Ice Maidens were the all-female first team to complete an Antarctic ski traverse unassisted. The expedition provided a unique investigation of the absolute extremes of exercise, with detailed dynamic hormone testing, body composition measurement and high resolution bone architecture scans to explore the impact of the expedition on women and the rates of recovery.

The Commissioning Course at the Royal Military Academy, Sandhurst is an arduous, year-long basic military training course undertaken by male and female Officer Cadets. The Female Endocrinology in Arduous Training (FEAT) Study’s objective is to understand the reproductive, stress, bone health and nutritional changes in 60 women in military training ab initio. The preliminary findings compare a subgroup with a cohort of 10 men.

The session will describe the studies from Antarctica and sex comparator aspects of the FEAT Study and discuss their findings, before exploring the implications for women entering arduous training.

2. What do you think understanding the future of such an unexplored topic looks like, and how will it shape the way medical practices develop?  

 From what is already known, women and men experience different medical outcomes during military training and employment. By understanding the biological underpinning these differences we aim to develop evidence-based mitigation strategies to promote training equity (rather than just equal opportunities). As well as protecting our women from injury and illness, an improved understanding of the aetiology will equip policymakers and individuals to make evidence-based decisions about training and employment. Furthermore, studies like these may allow medical practice and military training design to become more closely aligned. Emerging technologies like mobile health applications and sensors can enable long term data collection, allowing doctors to assess and improve training outcomes. Using these data we could ultimately generate tailorable training programmes to avoid undue risk to Defence personnel without compromising combat effectiveness.

3. What is your understanding of ‘prolonged care’ and ‘preparedness’ and its relevance to the wider medical community? Any recently publicised events are welcome examples.

The causes of many psychological and musculoskeletal injuries are related to individual physiology, however the precise causal pathways are poorly understood. Our research aims to understand the features of arduous military training and employment which cause physiological strain. Understanding risk factors will allow prolonged field care (PFC) providers to identify and manage risk, allow medical operations to be planned and commanded with a better expectation of risks to individuals, and identify ‘left of bang’ interventions, by describing and mitigating individuals’ injury risks during selection and training.

The Ice Maidens recently demonstrated exceptional biological resilience during an exceptionally arduous exercise exposure – far greater than has been seen in specialist military training. The reasons for this could be simple factors, for example they had an incremental training package rather than an abrupt-onset one, and they were afforded appropriate rest, where possible. These may be salutary lessons for preventing injury in the field.

Through the FEAT Study, we aim to validate and deliver mobile health applications which we hope could facilitate data collection across meaningful durations of training and deployment, and implement positive behavioural change to mitigate against illness or injury. Such platforms could also have great benefits to PFC delivery, allowing data collection from PFC providers.

4. What developments have been made in medical innovation in the last 12 months that particularly stand out, and why?

A study using mobile apps for research data collection has recently been published in the Canadian Armed Forces (Ahmed et al. Nutrients, 2017). The results are promising, and mobile health applications may represent a force multiplier for prolonged field research and behaviour change interventions, from prevention of injury and illness to delivery of military healthcare. However, significant concerns have been raised about data security with commercial health apps. We have therefore commenced the development of an app to coincide with the completion of the FEAT Study, to implement the behaviour changes highlighted or as a platform for further research that will be indicated.

5. What, in your opinion, present the biggest challenges to the development of ‘prolonged care’?

The PFC environment is largely undescribed, therefore prolonged field research is necessary to understand the challenges this environment provides. Such research could take place in training or operations. It should combine qualitative and quantitative approaches, to create a provider-centred depiction of the potential challenges and how these can be managed.

In area of interest, the critical factor not to miss is that prevention is better than cure, and ‘left of bang’ interventions begin at selection and training. The sex-differential in a variety of pertinent conditions, such as heat illness, stress fracture, post-traumatic stress disorder and infertility highlights that more can be done to understand and optimise physiology in order to develop mitigation strategies.

6. What are your priorities for the next year ahead?

Following the completion of the FEAT study, we aim to highlight the findings to policymakers, in order to implement effective preventative measures. It will be necessary to involve non-medical stakeholders and approach this creatively to avoid degrading the quality of training. Further research will also be required to better understand potential mitigating factors, such as the beneficial effects of sleep and strategies for coping with stress.

Medical Innovation attracts attendees from the military and civil healthcare community, from trainees to surgeons and scientists to policy makers, as well as industry suppliers of medical equipment and services. In your view, who/which professions will your session appeal to?

I very much hope policy makers, scientists with an interest in sports and nutrition physiology, trainees, and industry partners involve in mHealth might be interested in the session.

Dr. Gerallt Williams, Director Scientific Affairs, Aptar Pharma

Dr. Gerallt WilliamsAfter obtaining his Ph.D. from the University of Wales, UK in 1985, Gerallt has held various industrial positions at Monsanto Inc. (UK), Fisons Ltd (UK), Valois (France) and Inhale/Nektar Therapeutics (USA).

Gerallt is now in charge of scientific affairs for the Aptar Pharma Prescription division, Le Vaudreuil, France and is engaged in the development of new devices for nasal, inhaled and injectable drug products.

What made you partner with Business Review Webinars?

Aptar Pharma wanted to reach out to a more global audience in order to share our enthusiasm about intra-nasal drug delivery which is a relatively new drug delivery approach and creating a webinar in partnership with BRW offered us the possibility to achieve this goal.

What do you enjoy the most about your role?

Developing new products that will hopefully bring some relief to patients suffering with difficult medical conditions is ultimately what we are trying to do day in and day out in our roles in the drug delivery industry – the enjoyment is in the journey.

What is your favourite place in the world and why?

I’m Welsh and I’ve been living in various countries during my career including Wales where I was born and grew up, England, the US and France. I feel well in France because I can enjoy a variety of unique experiences … while being so close to the UK!

What about nasal drug delivery are you most looking forward to sharing with the audience?

Although nasal drug delivery is somewhat of a niche area in the pharmaceutical industry we hope to share with the audience the future potential of this drug delivery approach, how ground-breaking and innovative research is being pursued with the possibility to open up a brand new way to treat some very serious and debilitating conditions which are predicted to become more prevalent over the coming decades.  Intranasal route is simple to access and non-invasive, it can be versatile (self-administration vs third-party’s-administration) and used for local and systemic/CNS nose-to-brain treatments – “The nose is the only natural corridor where the brain meets the outside world”.

What do you hope the audience will learn from this webinar?

The webinar is part educational, part setting the scene in the market place and part science and technology. Hopefully the audience will find some new information by participating in the webinar and may be able to identify opportunities for developing products for some of the unmet medical needs in this area via the nasal drug delivery approach.

Join Dr. Williams in the upcoming Aptar Pharma webinar: The Nasal Drug Delivery Journey: from Systemic to Nose-to-Brain? Register Now!

The Useful Guide to Unique Device Identification

For the sake of patient safety, the ability to track and trace medical devices at a global level is paramount. However there are some key considerations to be aware of when implementing UDI.

Download our useful guide to discover the benefits of UDI, discover how it is tracked, who it is relevant to and more: http://www.prisymid.com/resources/blog/399-the-useful-guide-to-unique-device-identification.

You can also register for the PRISYM ID webinar ‘How the GUDID Was It?’ to discuss UDI has changed the medical device labeling landscape. Register now.