Tag: Medical Therapy

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The end of grandfathering? What the latest regulatory changes mean for you

October 3rd 2017

The new European Medical Devices Regulation (MDR) introduced by the European Commission (EC) has led to a lot of discussion around the implications for getting products on to the European market. But what about products that are already on the market? What does the new regulation mean for these so-called ‘grandfather’ or legacy devices?

What are grandfather devices?

A grandfather or legacy device is a medical device that was already on the market and pre-dates an applicable standard, directive or regulation. Under the 1993 European Medical Device Directive, for example, some devices were exempt from meeting the new directive and allowed to continue being marketed.

In the US, the Food and Drug Administration (FDA) has a similar process with its 510(k) clearance route, which allows devices (e.g. blood glucose monitors) which are ‘substantially similar’ to a device marketed before 28 May 1976 to be marketed without going through the formal FDA approval process.

Why are grandfather devices a concern?

Best practice when it comes to developing medical devices has changed over time – each generation of regulation brings with it new requirements which need to be met. In recent times, the focus on human factors has been increased through the issuance of many FDA guidelines. Similarly, the MDR now brings more focus on to risk management and post-market surveillance. In addition to the general regulations, the technical standards which specific devices need to comply with also get updated regularly.

Previously, devices have not been required to be followed up on once they have been submitted and put on the market. This means that, even though best practice has moved on, devices can still be on the market for long periods without going through any scrutiny to ensure they are still safe and effective – as long as they have no serious incidents.

Similarly, where devices are submitted on a precedence justification – such as a 510(k) – then the original device which is being used as the basis of the submission may have been judged against a previous version of a standard or regulation. This means the original device may not be completely relevant to current standards and regulations – and so subsequent devices may not meet the full requirements for that type of product.

Of particular concern are devices which have a long history and hence each generation of devices is based upon the previous – a slow drift away from the first device which was analysed in full.

So what does the new MDR require?

As with most legal documents, the devil is in the detail. Hidden in the depths of the chapter on putting devices on the market there are two sentences of interest:

“Manufacturers shall ensure that procedures are in place to keep series production in conformity with the requirements of the regulation. Changes in device design or characteristics and changes in the harmonised standards or CS by reference to which the conformity of a device is declared shall be adequately taken into account in a timely manner.” Article 10, part 9.

This means that, once the MDR comes into effect, any devices placed on the market will need to be kept up to date with any changes in standards or regulations, rather than just submitted and placed on the market with no follow up.

When do you need to do this by?

Quite simply, every device available on the market must comply with the MDR by the date of application (26 May 2020).

There are certain exemptions or extensions attached to this deadline – as to be expected with any regulation which is trying to accommodate a large range of products.

But ultimately it comes down to the risk you want to accept. I would always recommend getting started as soon as possible to ensure you are ready when the deadline hits. The EC has provided a three-year implementation period because it knows that a lot of work is required to ensure all products are in compliance.

If you are affected by the changes and want to know more, get in touch with our team of quality and regulatory experts.

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Why you can’t afford to ignore post-market surveillance

September 6th 2017

The words ‘post-market surveillance’ (PMS) appear 129 times in the new European Medical Devices Regulation (MDR). This repetition is not accidental. The requirements for manufacturers to ‘actively and systematically’ gather, record and analyse relevant data for the lifetime of each device they market is work most companies had not been conducting effectively – and the European Commission wants that to change.

PMS is the proactive activities carried out by manufacturers to establish, implement and keep up to date a systematic procedure to collect and review experiences of their devices on the market. The purpose is to identify any need to apply corrective or preventive actions.

The MDR significantly increases the role of PMS, requiring a ‘post-market surveillance system’ to be an ‘integral’ part of a company’s quality management system.

And, in my opinion, PMS is integral to a successfully marketed device and business.

What does a successful PMS system need?

The MDR specifies that the manufacturer must plan, establish, document, implement, maintain and update a PMS system. The manufacturer is required to produce a PMS plan, specific to each of its products. This is key to the beginning of a successful, non-intrusive PMS system that can contribute to the development and long-term stability of a manufacturer’s device.

The plan must outline how to collect information from sources such as:

  •   information from vigilance, including trend reporting
  •   records referring to non-serious incidents and data on any undesirable side effects
  •   information from specialist or technical literature, databases and/or registers
  •   information from feedback and complaints, provided by users, distributors and importers
  •   publicly available information on similar medical devices

Reviewing of these sources of information must be systematic, and is required to be carried out within the manufacturer’s organisation by a person responsible for regulatory compliance.

A company can use existing processes, or implement new ones, to achieve the above. These could be:

  •   complaints procedures
  •   vigilance procedures
  •   checking of competent authority websites for information on adverse events or recalls of similar devices
  •   post-market clinical follow-up (PMCF) studies
  •   setting up key-word alerts on search engines
  •   social media
  •   feedback from users (via email/website/surveys)

The data gathered is to be used in ensuring the quality, performance and safety of the device. This is achieved through analysis of the information to assess for any significant increase in the frequency or severity of incidents that are not serious incidents or expected undesirable side effects. An assessment needs to determine if the new information could have a significant impact on the benefit-risk analysis conducted in the original risk analysis for the device. This is done by updating and improving the risk-management documents – for example, post-market data collected may indicate a risk has a higher probability of occurrence than first estimated. An update to the risk analysis may then initiate an update to the design, manufacturing process, labelling and/or instructions for use of the device. 

Challenges and consequences

One of the main challenges is the design of a quality management system which is conducive to the potential of multiple updates to processes, technical documents and even devices themselves. Speedy reaction to the possibility of adverse incidents will ensure any potential risk to public health is minimised.

Slow and reactive response to post-market data can be costly – in more ways than one.

The recent media coverage of court cases involving Johnson & Johnson’s pelvic mesh implants has shown what slow follow-up from manufacturers can lead to. The mesh had been predicated onto the market as the same material had been used for hernia repairs (see ‘The end of grandfathering?’ for insight into how the MDR is stopping devices being placed on the market without complying with the regulation). It is estimated that up to 100,000 women worldwide received the implant, which in some women has caused pain after the device began to erode into the surrounding tissue and organs, causing infections and complications. The mesh cannot be removed. A trial involving 700 Australian patients against three Johnson & Johnson companies continues in a federal court, as well as action in other countries such as the US. Johnson & Johnson has since stopped selling the product.

This is not the only case of devices being recalled after thousands of patients have been exposed to the device before any adverse incidents have been realised. In 2010, St Jude Medical stopped selling its Riata defibrillation leads after the silicone coating insulating the electrical conductor wires within the lead was found to erode prematurely – sometimes leading to a malfunction of the life-saving device. Also in 2010, DePuy removed its metal-on-metal hip implants from the market after the rate of failure of these implants was determined to be greater than the polyethylene acetabular hip implant.

What you need to do

The MDR’s emphasis on PMS could be seen as an additional burden on medical device manufacturers. But if you begin planning for the increased workload now, you can establish a PMS plan early, and revise and improve it throughout the three-year transition period. When the date of application (26 May 2020) comes round, you will then have an integrated, compliant system. And, in turn, a device that is safe, effective and performs as you intend it to.

 

 

cell therapies

To scale-up or scale-out? The challenge of commercialising cell therapies

July 11th 2017

Mark Varley 

Matt Brady 

Regenerative medicine and cell therapies have long been hailed as the holy-grail of medical treatment. Treatments that use the patient’s own cells to fight disease or regenerate damaged tissues sound like science fiction, however in research institutions around the world this is exactly what is happening 1, 2. For now though, the challenge of commercialising such research into cost-effective mainstream treatments remains for the most part unmet.

Last month CDP joined the World Advanced Therapies and Regenerative Medicine Congress in London. The main theme of the conference was the challenge of commercialisation – and how new technologies and innovations could help move therapies from the research lab to the hospital. The number one topic of conversation from those we met was:

How do I scale my cell therapy to become commercially viable?

Cell therapies are broadly divided into two different categories depending upon where the cells are sourced from:

Autologous Therapies – using the patient’s own cells

Allogeneic Therapies – using cells from a donor

The allogeneic (off the shelf) therapies can expect to follow a business model similar to current biopharmaceuticals. A single batch of cells could be produced on a large scale that can provide multiple doses to treat a significant number of patients. This business model requires centralised scale-up to benefit from economies of scale to reduce the cost of treatment. There is significant existing knowledge and manufacturing know-how in scaling up biopharmaceutical processes so a scaled up allogeneic therapy would appear to be the easiest route to market.

Unfortunately scale-up is not just about making the reactor growing the cells bigger. In cell therapies, the therapeutic agent is the cells themselves. It is critical that the cells retain their appropriate phenotype and function to ensure the quality of the treatment. As the number of cells increase this can become increasingly challenging, as the greater cell numbers lead to increased chance of inhomogeneity of culture – and hence of cellular performance being altered. The greater volumes also introduce challenges of how to scale the harvesting process, downstream processing and formulation technology. Doubtless much work remains to demonstrate that these substantially biologically based challenges for scale up of allogeneic therapies can be successfully overcome.

The autologous (patient specific) therapies offer a new and exciting option to personalise and target treatment specific to the patient’s unique situation. This requires a new and exciting manufacturing process which is scaled-out to produce a single batch of therapy per patient, more locally to that patient. This means the cost of each batch cannot be reduced through traditional economies of scale and hence new manufacturing techniques are required to overcome cost barriers.

Generating a greater number of individual batches – each one specific to a single patient – brings about a range of additional logistical obstacles. First, cells must be harvested from the patient, who is already suffering compromised health, for example by extracorporeal blood filtration. The harvested cells then need to be transported from the hospital to a manufacturing facility, the cells are then processed (currently by highly trained scientists) before being cultured, purified, stored and shipped back to the hospital for administration – all the while retaining sterility and reliable traceability to the patient.

Reducing the cost of these autologous therapies must be achieved by advances in engineering and manufacturing technology. The number of complex and open-process steps that are common in research labs need to be reduced through the development of new automated technologies. This will allow multiple batches to be produced in parallel, with reduced burden of oversight by highly-trained scientists. These new processes must be GMP-compliant and closed for sterility.

For these autologous therapies the traditional model of centralised production breaks down. Since economies of scale seem unlikely to arise to enable the creation of a low-cost centralised production facility for these strictly individual therapies, there is no rationale for transfer of cells and therapies to and from a single location. Cost and time drivers for these transfers then become dominant, and will lead to cell processing being performed increasingly locally to the patient. This pressure towards increasing localisation is likely to reinforce the requirement for processing technologies to be capable of delivering reliable results without scientist oversight or with a single remote scientist reviewing multiple batches and sites – leading to a virtuous circle driving increasingly localised production and the likelihood of production taking place close to, or even on site at major hospitals.

Indeed as the only brake on localisation will be equipment utilisation and unnecessary overheads while not in use, over time the introduction of increasing numbers of therapy types will increase equipment utilisation per head of population and so drive production of certain therapies out to health centres and GP surgeries. However this has an associated increased cost of overheads so capacity must be accurately judged. Key to this whole development will be robust methods for achieving complete end-to-end traceability of the cell products, along with and monitoring of the status of the product to give confidence in performance.

So should I target scaling-up or scaling-out?

Currently it is not clear whether scale-up or scale-out commercialisation will become the norm as groups actively pursue therapies in both spaces. What is clear is that significant innovation will be required within this space to move from the current highly manual research and development processes to automated, appropriately-scaled systems which can produce therapeutic doses at a cost that allows these exciting therapies to reach the mainstream.

The traditional paradigm of coming up with a product concept and then throwing it over to the manufacturing “silo” for a different team to work out how to scale production will not work for these therapies. Final manufacturing process needs to be addressed from the start to ensure a therapy is developed which can be scaled to allow commercialisation.

CDP has experience in the development of innovative laboratory technology and bespoke GMP manufacturing processes. Alongside a growing team of biomedical engineers with experience in regenerative medicine labs, we are well placed to aid potential clients in navigating these process development and manufacturing challenges. If you would like to discuss how we can help, do please get in touch at hello@cambridge-design.co.uk.

1. https://ct.catapult.org.uk/sites/default/files/Clinical-trials-database-2016-1.pdf
2. https://www.fda.gov/biologicsbloodvaccines/cellulargenetherapyproducts/approvedproducts/

Key trends from the American College of Cardiology Conference

Key trends from the American College of Cardiology Conference

April 11th 2017

Matt Brady 

Reflections on two themes from the day;

– Usability: Continuity from marketing, through R&D, to regulatory
– Connected devices and systems: Realising the benefits

Usability: Continuity from marketing, through R&D, to regulatory

We were struck by the frequency at which we heard terms like “usability,” “workflow” and “seamless integration” during presentations on the latest cardiology suites – and by the consistency of that message across different vendors.  That’s in addition to the usual array of “smaller, faster, smarter” innovations which indirectly claim usability benefit.

We continue to be impressed by the variety we see in device companies’ approaches to usability as a function.  Since regulators took steps to clarify expectations around identification and mitigation of use risks from around 2007 (e.g. IEC 62366) there’s been a tendency for human factors / usability engineering to be addressed by regulatory departments.  We believe this approach places unnecessary constraints on achievable levels of both use risk mitigation (as required by the regulator) and especially user experience (not required by the regulator – but critical to market success)!

Happily, companies are increasingly realising that given their investment in bringing users and devices together for formative usability studies, an efficient opportunity exists to develop the user experience in parallel.  Hence we see the beginning of the rehabilitation of usability engineering as a function within R&D and new product development (NPD) groups –alongside other engineering disciplines.  Interesting variations include summative studies being run by the marketing team at one company we met, which stands to reason given the marketing function’s historical focus on user requirements.

However, rarely do companies achieve the continuity needed between upstream marketing, R&D and regulatory functions.

We strongly believe that both use risks and user experience should be tested from the earliest stages of concept development – enabled by means of prototyping at an appropriate level of fidelity for the stage of development.  In order to extend this continuity right back to upstream marketing it’s essential to objectively identify and prioritise user needs, to support development of a compelling set of user requirements before commencing concept creation.

Concepts can then be generated against user needs which are known to be both important and poorly met; and user-tested for how well they meet those needs. This is appropriate and seems obvious once articulated, especially considering the logical alternative: generating concepts in a vacuum and user-testing them without clear objectives.

Nevertheless in practice it remains a rarity to seeing this level of continuity, meaning that the competitive advantage available for getting it right should be compelling.

Connected devices and systems: Realising the benefits

With the global cardiac monitoring market projected to be worth $28 billion by 2021, it was no surprise to see numerous connected monitoring devices at ACC.  Whilst various innovations were on show, most fell into two groups: implantable cardiac monitors (ICMs) and mobile (wearable) cardiac telemetry devices (MCTs).

The prize for the successful development of this segment is surely great.  For example, up to 40% of ischemic strokes are caused by asymptomatic atrial fibrillation  and such cases are increasing.  Screening for (treatable) atrial fibrillation using low-cost devices and efficient systems promises to slash this figure, with clear benefits for patients and payer alike – but how to realise these in practice?

In hardware, we’re seeing a move away from dedicated “bedside” uplink devices (Medtronic’s Reveal LINQ), to Bluetooth smartphone connections (St Jude’s Confirm RX ICM), and perhaps towards on-board 3G/4G connectivity (National Cardiac’s upcoming Liba3 MCT).  The on-board option is not inevitable: whilst the Bluetooth solution has its challenges, the potential benefits are significant.  Challenges include regulatory (“app as medical device”) and cybersecurity (see James Baker’s column, Med Device Online).  However the potential benefits of Bluetooth versus on-board uplink may prove compelling, for example:

– device cost, weight and size;
– linking ECG data with patient observations (St Jude’s Merlin.net);
– enhanced patient engagement (and adherence) via app.

Done right, the adherence point may prove decisive.

The system side proved the more compelling conversation topic at ACC.  How should the system be developed in order to deliver the hoped-for benefits?  For example:

– Who will provide diagnoses based on these vast streams of data, and how will the health economics and reimbursement develop to support this activity?
– “The Cloud” will be a key enabler, as everyone seemingly agrees, but what functions will it provide?  Can algorithms make diagnosis more efficient – and, given the human challenges around accurately reviewing reams of data, less error-prone?  How will such algorithms be validated?
– Can the data from these devices be effectively made available to other parts of the healthcare system?  For example as an input to regular health checks, or to provide ECG history during treatment of adverse cardiovascular events?
– Can algorithms support clinical and treatment decision making by leveraging anonymised “cohort databases” of ECG data paired with treatment outcomes?

Much work remains in this space, and whilst improving device cost and usability will be important, the wider system view will be essential to achieve the prize!

1 Strokes atrial fibrillation patients rise despite improved treatments

First principles of biomedical engineering – they’re closer than you think

April 5th 2017

It’s important to realise that beyond the realm of classical engineering principles lays the softer, squishier world of biology and medicine. By being intimately familiar with human anatomy, biomedical engineers are able to more rapidly question whether their concepts are truly viable prior to embarking on further development, using an often-neglected set of first principles – the fundamentals of human body design.

Using a scalpel, I slowly cut the failed tricuspid valve out of the heart of the cadaver. We had been told that our donor body had died of heart failure but nothing prepared me for the sensory impact of the hard, black necrotic tissue surrounding the three leaflet structure – it appropriately reflected what “dead” should look like physically. That was about half a decade ago and not a day goes by where I don’t reflect on my time spent wrist deep in a cadaver, and how it shaped how I approach my work as a biomedical engineer.

When you start designing medical devices, it’s tempting to seek out simplifying assumptions in order to get 80% of the solution in 20% of the time. We can model the circulatory system with pipes, we can model the lungs with foam, and we can model the bones with metal. Reasoning by analogy is often the first step to taking a first principles approach, utilising equations that govern the fundamental processes of our world. And there’s nothing inherently wrong with this approach until you discover that by simplifying the problem definition you’ve missed out on a wealth of potentially more appropriate and lucrative solutions as well.

Let’s take, for example, the case of my former cadaveric colleague’s heart – he had had an aortic valve replacement at one point in his life. Simplifying the complex procedure of heart valve replacement, we could think of the problem like fixing a broken piece of plumbing: restrict the flow of fluid, remove the defective valve, put the new valve in, and let the fluid flow resume hoping that everything worked the first time. And for valve replacement, that’s been more or less the gold standard since advancements made to cardiopulmonary bypass (artificial heart and lung) machines enabled the heart (blood flow) to be stopped during surgery. Using the plumbing mentality, it’s difficult to imagine how you could improve on this procedure which is why it’s important to question and occasionally reject the simplifying models we use for medical device design. Finding the optimal level of detail at which to examine the problem is critical to the success of the endeavour.

In reality, heart valve replacement has started heading towards the plumbing equivalent of replacing leaky valves from your neighbours couch by snaking tools through their plumbing, into the main pipes, back into your flat to the leaky valve and there, instead of taking the old valve out, you just put the new valve in on top of it. This procedure, known as Transcatheter Aortic Valve Replacement (TAVR), in which a new valve is implanted into the heart by navigating through an artery in your leg, is expected to worth $5.5B USD by 2020. If we remained focused solely on the heart valve in absence of the larger circulatory system and body-scale system as a whole, the ability to utilise a less-invasive approach would have been lost before the first ideation session even began.

Ultrasound Elastography is another example where conventional analogies fall short of an optimal solution. Frequently surgeons will probe or palpate tissue with their fingers to try and differentiate boundaries of different structures, like a tumour amongst healthy tissue. This physical sensation can aid with the detection of diseases in certain organs, particularly when the tumour doesn’t show on certain imaging modalities but relies on subjective tactile feedback and cannot be used in regions that can’t be palpated. Obviously then we need to improve the ability of existing imaging systems to “see” the tissue but there’s something significantly cleverer available.

Researchers realised that “seeing” a tumour depended on the type of information being made available. Traditional x-ray imaging relies on the absorption of ionizing radiation by anatomical structures and maps this absorption onto a display, whereas palpation creates a tactile sensation map in the physician’s head. So instead of thinking, “we need a more sensitive imaging system to detect the differences in radiation absorption in the tissue”, they realised that they could blast the target tissue with ultrasound waves, mimicking a palpation then measuring the resulting mechanical properties by observing the response to this “push”. What was created is a novel imaging system that provides a tactile map of tissue stiffness, enabling doctors to more clearly see the tissue they’re interested in without requiring physical access to it.

As efficiency and cost reductions pressure healthcare systems globally, the demand from next generation medical devices requires successful inventions to not only improve outcomes but reduce costs compared to the existing gold standard. By recognising that your medical device needs to be designed with respect to not only the classical mechanical and electrical first principles but the anatomical first principles as well, you can get that much closer to a safer and more effective device.

To speak to Jeremy further or to find out more about our medical device and drug delivery capabilities contact hello@cambridge-design.co.uk or phone +44 (0) 1223 264 428.

CDP at MD&M West 2017 in Anaheim

January 27th 2017

Cambridge Design Partnership is exhibiting at Medical Device and Manufacturing West (MD&M West) in Anaheim, California from 7th – 9th February this year.

Our booth is number is 1425 in the Electronics West zone. Details on how to find us.

MD&M West is the world’s largest medical design and manufacturing event, with leading medical design experts attending to network and showcase latest innovations in medical device design and manufacturing.

Exhibiting for the fifth year running, Cambridge Design Partnership will have live demonstrations on its booth of two connected devices, the multi-award-winning – First Response Monitor and diialog™.

A number of our sector experts will attending MD&M West 2017 including:

Alan Cucknell, Front End Innovation Leader
Alan is a seasoned innovation professional. His systematic, evidence based approach builds on his formal engineering education and nearly fifteen years’ experience tackling strategic business and technology challenges. Alan will be happy to discuss your innovation challenges and suggest new approaches to help you achieve success.

James Baker, Senior Electrical Engineer and CDP Partner
James is a chartered engineer with a Master’s Degree in electronic engineering. He leads the connectivity and electronics capabilities at CDP, applying his experience to projects covering all forms of sensing, communications and wearable technologies. James can advise you on developing healthcare products that feature complex embedded functionality and are simple to use.

Dr Jez Clements, Senior Mechanical Engineer and CDP Partner
Jez is a professional engineer with a PhD in orthopaedic implants. He has led several major medical device development programs across diagnostics and drug delivery. Jez helps clients overcome tough engineering challenges and will be happy to discuss how CDPs capabilities can help accelerate your development portfolio.

Dr Dom Freeman, US Business Leader
Dom has over 30 years’ experience in the medical device design, with deep knowledge of the blood glucose monitoring market and magnetic resonance imaging. She is also an expert in IP strategy. Dom will be available to discuss how outsourcing product innovation and engineering development can benefit your business and overcome key challenges to growth.

To arrange a meeting during MD&M West, please get in touch.

We hope to see you in Anaheim.

IMPLEMENTING MEDICAL DEVICE CYBERSECURITY James Baker is guest columnist on Med Device Online

January 10th 2017

Connectivity is ubiquitous – it’s moved beyond an overhyped buzzword and become part of life. Offering ever-advancing levels of access, control, and convenience, widespread connectivity also increases the risk of unauthorised interference in our everyday lives.

In what many experts believe was a world first, manufacturer Johnson & Johnson recently issued a warning to patients on a cyber-vulnerability in one of its medical devices. The company announced that an insulin pump it supplies had a potential connectivity vulnerability. The wireless communication link the device used contained a potential exploit that could have been used by an unauthorised third party to alter the insulin dosage delivered to the patient.

It’s not hard to imagine the devastating impact to both consumers and the company if the reported vulnerability had been exploited. However, risks such as security will not prevent evolution of connected devices – demand for ever-increasing levels of convenience and access are driving the continued evolution and adoption of these products and services.

Cyber-security considerations shouldn’t be viewed as stumbling blocks for the connected device concept. Rather, it’s another of the many product requirements which, if considered and specified correctly at the design stage, can be implemented robustly. Above all, cybersecurity can be validated as part of a wider-reaching regulated device development process. It can’t be considered an isolated element to be bolted on, since it inherently helps to define the system architecture of what is developed.

Read full article.

ablation-catheter-technology-cardiology

CDP and Kings College London develop innovative steerable catheter to treat cardiac arrhythmia

August 4th 2016

Innovative design and technology consultancy Cambridge Design Partnership has worked with King’s College London to develop a novel steerable catheter which King’s researchers had designed.  The catheter is designed to improve the treatment of cardiac arrhythmia – a range of conditions which can lead to stroke or heart failure that affects 2 million people a year1 in the UK alone.

The new steerable, micro moulded catheter enables targeted delivery of radio frequency energy to specific points in the heart tissue for corrective treatment. Compared with traditional catheters, the new device has been designed to be quicker and easier to manoeuvre into the correct position, improving the accuracy of positioning and minimising damage to healthy tissue, which should improve success rates of the treatment.

Cambridge Design Partnership won a four-way competitive bid to further develop the device created by King’s College London, involving helix-shaped interlocking tubes that would allow improved steerability and greater compatibility for robotic control over other catheters on the market. The team at Cambridge Design Partnership successfully refined the initial design, enabling the device to meet key regulatory and biocompatibility requirements, whilst ensuring suitability for commercial manufacture. Through CDP’s experience of developing highly technical medical devices, the team was able to miniaturise the design to allow improved space for the delivery of ablation energy and irrigation. The new catheter design is also assembled from micro injection moulded sections, incorporating features that enable the device to be built on an automated assembly line at reduced manufacturing cost.

Matt Brady, head of Medical Therapy, Cambridge Design Partnership, said: “The steerable catheter is an extraordinary product, with innovative features that enable corrective treatment to be delivered to very specific areas of the heart. By enabling greater accuracy and quicker treatment time, we believe it is possible to preserve more healthy heart tissue, and increase the success of the treatment. It’s been hugely exciting to be involved in this joint project with King’s College London and use our expertise to bring such an innovative product one step closer to commercial use.”

Professor Kawal Rhode, Professor of Biomedical Engineering at King’s College; London, commented: “We have been delighted with the results of Cambridge Design Partnership’s work on this project. The team was chosen for the strength of their existing experience in developing catheters across both start-ups and global corporations.  We were very pleased with the engineering approach and practical improvements that they managed to incorporate. They delivered fully moulded parts, and specified other components and the assembly route which fully met our aspirations for the project.”

King’s College London is now undertaking extensive lab testing of the catheter device, with clinical trials expected to be take place in two to three years.

1 Arrhythmia

For further information on this project, please email: hello@cambridge-design.co.uk

For Enquiries to King’s College London:
Please contact Dr. Rob Glen, King’s Commercialisation Institute
Robert.glen@kcl.ac.uk 020 7188 6209
Kings Commercialisation Institute

New connected wearable device helps medics save lives in disasters and on the battlefield

August 6th 2015

Innovative technology and design consultancy Cambridge Design Partnership today announces that it has developed the world’s first wearable device designed to measure and monitor the vital signs of multiple trauma patients for emergency response in disasters and battlefield situations.

The First Response Monitor is designed to help medics monitor both heart rate and respiratory rate. Respiratory rate is often neglected by automated monitoring systems and has been described as the ‘forgotten bio-sign’, as many existing wearable monitors focus on heart rate alone and those that do measure respiratory rate have low accuracy or are difficult to use in an emergency situation. However, the benefits of accurately monitoring respiratory rate are clear, and when combined with other parameters – such as heart rate and body temperature – can indicate life-threatening conditions such as sepsis.

When designing the new compact device, Cambridge Design Partnership interviewed a range of army medics about their needs and challenges in multiple casualty emergency situations. An unmet need was identified for a low-cost device to bridge the gap between manual methods of vital signs measurement – which can be laborious and challenging amidst the noise and stress of a disaster or on the front line – and more expensive patient monitoring systems.

The lightweight, robust and low-cost wearable biometric device not only monitors patients but collects and transmits data in real-time, enabling the medic to care for a greater number of casualties, providing more effective casualty triage to deliver improved patient outcomes.

The small device clips onto a patient’s nose and monitors breathing rate and heart rate, giving ‘at a glance’ indication of both parameters, and this data is added to a trends graph showing how these measurements have changed over time. This enables the medic to focus their efforts on providing care rather than taking measurements but also enables the care giver to understand how the patient’s condition has changed over time. The data can then transmitted using Bluetooth low energy to a smartphone app or tablet, enabling other data analyses such as multiple patient triage or situational awareness across the group.

Although the device has been primarily designed with first response medics in mass casualty incidents in mind, it has applications in many other fields – such as civilian medicine where additional monitoring of conditions has demonstrable benefit in patient outcomes, wellness monitoring and within sports for training and performance monitoring. The technology can also be developed to provide a low-cost solution for low resource healthcare settings.

Speaking about the new development James Baker, Partner, Cambridge Design Partnership said: “At Cambridge Design Partnership we’re always looking for ways to find a solution to a clear, unmet need. With the First Response Monitor we’ve combined our expertise in wearable connected devices with our extensive medical experience to develop a technology for effectively measuring breathing and heart rate. The monitor can help save lives in a variety of environments and we’re really keen to speak to partners about developing the potential applications further.”

AAMI human factors for medical devices course returns to Europe

October 16th 2014

Innovative technology and design consultancy Cambridge Design Partnership today announced that due to the huge success of Europe’s first AAMI Human Factors for Medical Devices course they will be sponsoring more courses in 2015.

Cambridge Design Partnership worked with the US based Association for the Advancement of Medical Instrumentation (AAMI) and Pure Insight to bring the course to Europe for the first time in April 2014 and the course was hugely oversubscribed. In response to demand from medical device development companies, which deem the course content as a ‘must have’ piece of knowledge for their medical device development teams, a course has been scheduled for January 2015.

Cambridge Design Partnership have recognised the importance of Usability Engineering in medical device development programmes for many years and are keen to share this enthusiasm with the wider development community by teaming up with AAMI and Pure Insight to bring this definitive course to Europe.

This course delivers practical Usability Engineering techniques that can be implemented in any medical device development programme and gives insights into creating usability submissions for both the USA and the EU regulatory regimes.  With new guidelines proposed in the US, medical device companies worldwide need to be vigilant in understanding how to navigate these changing regulatory landscapes. The AAMI course not only addresses Usability Engineering itself, it also looks at the growing harmonisation between global standards, streamlining device submissions.

The course leaders are the highly regarded Dr. Ed Israelski who is the convener of international HF medical standards with IEC and ISO and Dr. Robert North, who is a co-author of the FDA human factors standards. This course is exclusively the only event held in Europe where companies can talk directly to an FDA representative who hosts a question and answer session and gives delegates the benefit of the latest insight into streamlining submissions as well as common submission errors and deficiencies.

“At CDP our experience developing novel medical devices shows us that effective Usability Engineering is crucial to commercial success, not only to meet regulatory requirements but to enable new products to succeed in a competitive marketplace. When developing fast moving consumer products companies naturally place the user at the centre of the design process,  but when it comes to safety critical medical devices sometimes the complex technical and clinical requirements overshadow basic patient needs. This course explains the processes you can use to ensure your devices are easy and safe for patients to use.  Medical device manufacturing companies must demonstrate this to the regulators and this course explains how this is achieved.” Comments Mike Cane, Founder, Cambridge Design Partnership.

Cambridge Design Partnership is a leading technology and product design partner focused on helping its client’s businesses grow. Some of the world’s largest companies trust CDP to develop their most important innovations.

Cambridge Design Partnership specialises in the healthcare, consumer, energy and industrial equipment markets and its multidisciplinary staff have the expert knowledge to identify opportunities and solve the challenges its clients face.

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Contact Abbie Meliniotis or Laura Cavaliere at CDP for more information:
lc1@cambridge-design.co.uk / avm@cambridge-design.co.uk /+44 (0) 1223 264428

Media contacts: Andrea Berghäll, EML Wildfire Technology PR
cdp@emlwildfire.com / +44 (0) 208 408 8000