Latest news on wearable bolus (large volume) injectors

We have received a great number of enquiries for the latest information on wearable bolus (large volume) injectors, especially since our article “The Rise of the Bolus Injector” was published.

Therefore, Springboard’s Director of Drug Delivery Device Development, Tom Oakley has written a brand new article for OnDrugDelivery featuring the latest technical, commercial and regulatory developments in the world of bolus injectors.

Head over to OnDrugDelivery to read the latest news on bolus injectors, or read the whole edition devoted to large volume injectors.

Devices covered in the OnDrugDelivery magazine include:

  • Unilife Precision-Therapy
  • Sensile Medical SenseCore
  • West SmartDose
  • Enable Injections
  • BD Libertas
  • SteadyMed PatchPump

If you are from a pharmaceutical company or medical device developer and would like to find out more about bolus injectors and their development, please contact Tom Oakley on +44 (0) 1223 422 273.

Massive demand for top medical device developers

Springboard has been featured in a new article about the demand for top medical device developers.

As a leading technology consultancy, Springboard excels in the development of devices for safety-regulated industries such as medical devices. These span drug delivery devices, diagnostics, minimally-invasive surgical tools, wound care and more.

See the full article at Business Weekly or, if you would like to get in touch now, call Tom Oakley on +44 (0) 1223 422 273.

Springboard attending Wounds UK 2014

The latest innovations in wound care will be on show at the Wounds UK Annual Conference in Harrogate, 10 – 12 November 2014.

Last year’s event had a several advanced technologies lurking between the traditional products. Diagnostics made an appearance, such as Woundchek’s protease test strip and a new partnership between Molnlycke Healthcare and Edinburgh University to identify infection risk. Perhaps we will see further steps towards patient-specific measurement of infection, performed rapidly at the point of case so that a personalised response can be delivered to that particular individual?

There was also a great deal of activity by the newly funded NHS Health Technology Co-operatives, who were stepping up the effort to evaluate the performance of new technologies. Peter Vowden, clinical director of the Wound Prevention and Treatment co-operative said he wanted to improve the abilities of companies to target the most important issues with their new inventions. Several exhibitors spoke of their interest in following the evaluation programme, and so this year, with several technologies having completed the process, we should learn which ones were considered to be most valuable.

It will also be interesting to see where the commercial direction is heading in future. KCI will have completed the first year following their merger with Systagenix, so perhaps there will be an indication of the direction the new combined company will be taking. And ConvaTec have announced they are seeking a buyer, so will no doubt be seeking to present those technologies which they feel will represent the most exciting opportunities for growth.

Keith Turner of Springboard will be attending the event. As a company which develops new wound care technology for clients, we are always interested to speak to people about where the opportunities lie and how the latest advances in technology can be embraced to create business growth. Please get in contact via the form below to arrange a meeting at the conference.

Hot topics in injectable drug delivery

Springboard’s Tom Oakley recently presented the latest developments of bolus (large volume) injectors at 2 major international conferences: the Management Forum in London and SMi America in New Jersey. Here is an update on the other hottest topics in injectable drug delivery… At the Management Forum, Amgen’s Mathias Romacker explained the trend to:

  • Higher concentration formulations; and
  • Larger doses with less frequent injections.

Interestingly, both of these trends point to an increased need for bolus injectors. 3P Innovation’s Tom Bailey and XstalBio’s Barry Moore showed the increased need for reconstitution devices, driven by the increased number of biologics being developed for subcutaneous delivery, especially therapeutic proteins. SHL’s Mats Persson described trends such as:

  • Moving treatment from the hospital to the home for increased patient convenience and lower treatment cost;
  • Using the injection device for drug product life-cycle management;
  • Larger volume and higher viscosity injections required by new drug formulations;
  • Increased emphasis by regulators on human factors studies;
  • Interest in polymer, as opposed to glass, syringes;
  • Autoinjectors for cartridges as opposed to syringes;
  • Instructions for use on and in devices; and
  • True end-of-dose indicators.

At the SMi America conference, Merck’s Scott Brown described the most common pitfalls of drug delivery device development, and Beroe’s Chanderkanth Gautam explained the opportunities and threats to electronic autoinjectors. In summary, developments in devices to inject drugs are being driven by:

  • New biologics which may require larger injection volumes, higher viscosities, or reconstitution;
  • Regulatory demands for human factors studies; and
  • The need for increased adherence, which may be addressed by electronic functionality in devices.

If you work at a pharmaceutical company or medical device manufacturer and want to know more, please contact Tom Oakley.

Latest news on Pre-Filled Syringes

The recent SMi conference on Pre-Filled Syringes brought together experts from the pharmaceuticals, manufacturing and materials industries to reveal and discuss the latest innovations and market trends for the important Pre-Filled Syringe sector.

The highlights were:

  • The sources and types of leachables by Joel Richard of Ipsen
  • Filling syringes will high concentration monoclonal antibodies by Yuh Fun Maa of Genentech
  • Incorporating human factors and patient centric design by Alex Jaksch of BD
  • Smart labelling by Thorsten Kircher of Schreiner MediPharm

The smart labelling presentation in particular showed some fascinating possibilities whereby labels could have RFID or NFC chips embedded, which can transmit information to a smartphone, for example redirecting it to a website.

If you wish to find out more about the latest developments in Pre-Filled Syringes, please feel free to contact Tom Oakley on +44 1223 422 273.

Top 3 devices from Trauma Innovation 2014

I’ve just got back from the Trauma Innovation 2014 conference – Europe’s largest gathering of military, humanitarian and emergency healthcare professionals. It was held on 14 – 15 January at the Royal College of Surgeons, London, and showed the latest innovations, strategies and case studies in trauma management.

One of the things that came through loud and clear was that survival rates and outcomes for major trauma cases are improving year-on-year. There are many reasons for this. One is the large stimulus given by the recent military experiences (a staggering fact that was dropped in during the conference was that the US Military trains 6000 medics every year!) and another is the redoubled efforts to examine, learn and disseminate good practice.

Of the devices on show, three highlights stood out for me as being especially innovative:

1. The iTclamp – at first glance surprising, it is used at the scene of injury to stop bleeding from deep and wide cut wounds especially in awkward places. It pulls the skin edges together over a wound using teeth and seals the edges using ribbed bars, a bit like a bulldog clip. This can instantly stop bleeding until the patient can be recovered to an emergency room where surgical techniques can take over for a permanent fix. But the details I liked were:

  • The packaging presented the device to the paramedic in a ready-to-use format the moment the lid was ripped off, making it easy and very quick to apply.
  • There was a sweetly-designed one-way clutch built in that locked the clamp in any position – simple, robust and very compact.
  • It incorporated a release mechanism, so the device could be released and reapplied with a single hand if a wound continued to bleed.

2. The Droper – a completely electricity-free IV infusion pump. This used the energy stored in springs in a scissor-jack-like mechanism to pressurise an IV-bag, generating a consistent pressure broadly independent of its fullness or emptiness. The flow rate can then be set using conventional variable restrictor valves. Since it requires no electricity, it can be used in all the places there is none (disaster zones, floods, earthquakes, in collapsed buildings, down mines or on patrol), as the logistics of shipping electricity and batteries is a common bugbear of disaster relief, third world and military medics alike. What I liked about it was that:

  • It doesn’t need hanging up in use like a regular IV drip- once pressurised it can even be laid beside the patient, in any orientation, so it is practical in the many real environments encountered outside a hospital.
  • The robust components – no fussy, unreliable manufacturing issues there.

3. The MOVES® – a portable life-support system for use on stretchers in pre-hospital care. Though incorporating several functions, it was built around an oxygen generator that incorporates a recirculating breathing path and a CO2 scrubber. Hence oxygen breathed out by the patient is not wasted as normal, and only that fraction passed into the bloodstream needs replacing with newly generated oxygen. I thought its best features are:

  • Changing the way oxygen is delivered in this way neatly breaks the paradigm that increasing the flow rate requires proportionately larger and heavier generators.
  • The shape format of the device was chosen so that it could mount beside the patient on a stretcher and be no taller than him, and so give greatest flexibility when transporting people in confined spaces
  • The incorporation of rapid release tracks along the top edges, so that ancillary equipment can be quickly fixed and securely positioned.

These are three devices that address very different problems in the care of trauma patients. What is the similarity between them? The way their creators have used innovation to solve old problems in new and unusual ways, have underpinned them with good detailed engineering design, and have paid attention to their use cases in real-life operating environments by real people.

These are all areas in which Springboard excels. If you would like to talk about how we can help you develop your next generation product and gain a march on your competitors, give me a ring on +44 1223 422274.

David Foster, Jan 16 2014

Springboard attending the Trauma Innovation Conference Jan 2014

Springboard will be attending the forthcoming Trauma Innovation Conference in London at the Royal College of Surgeons on the 14th and 15th of January 2014.

Techniques to treat patients immediately after injury through to the emergency rooms of hospitals are developing rapidly and have resulted in major improvements to survival rates and outcome. More can still be achieved especially by pooling latest ideas and learnings. This conference will gather together experts, leaders and innovators from many areas: paramedics; first responders; trauma surgeons; equipment providers; and the humanitarian, disaster relief and military sectors.

David Foster is a Director at Springboard, which is a contract developer of advanced technology and specialises in engineering exceptional devices for regulated markets.

Springboard can help with engineering and prototyping, usability engineering, verification and validation, and planning and management of the scale-up to clinical trials and production. If you would like to arrange a meeting at the conference, please call +44 1223 422274.

Where should innovation in Wound Care be focused in 2014?

How can Wound Care technology companies grow their profits?

Many of the answers to this question were on display recently at the annual Wounds UK conference in Harrogate. A great deal of the market sales volume is in standard products such as bordered foam dressings but, as every senior manager will be aware, it is difficult to grow a business with poorly differentiated products, especially when under intense cost pressure from suppliers in the emerging economies. This means innovation is required to solve a valuable need in a way that other competitors cannot match. Get yourself some Intellectual Property and you’re in a strong position.

A good example of innovation in wound care has been negative pressure wound therapy. For many years, KCI had the market sewn up with a broad patent and was able to deliver real benefits to patients. But now, with the patent defences overcome by litigation, a whole slew of competitors have launched negative pressure products, with multiple products on show at Wounds UK. This competition has led to a tenfold decrease in daily revenues from this type of product.

So, where are Wound Care companies are looking next for innovation?

Improved usability is one hot topic, and is nicely exemplified by CircAid‘s compression stocking, which was acquired in 2012 by Medi. One issue faced by patients is the need to wear multiple layers of stockings, each providing a certain pressure. The sum of the pressures needs to add up to the right level, such as 45 mmHg for the prevention of leg ulcers. CircAid’s new product allows adjustable pressure to be set in a single layer, wrap-around stocking, so it is simpler for the patient to wear while at the same time providing flexibility to the healthcare professional.

Another trend is that the value of new products is under scrutiny by healthcare providers. The NHS in England increasingly is seeking an evidence base in favour of adoption of new technologies. The new product must be shown not only to work, but also to be cost-effective when compared to the health economics of alternative treatment pathways. Health Technology Co-operatives have been set up to evaluate new technologies, and above all they are concerned to make sure that companies spend their time solving the right problems. The first wound care devices are going through the evaluation process now, and many of the exhibitors at Wounds UK are lining up to have their new products evaluated. This means that approval by the NHS increasingly should become a criterion that shapes innovation. While global healthcare systems have different systems, the underlying message is the same to all innovators: your product will only be profitable if it successfully meets recognised needs in a cost-effective way.

As an innovator in Wound Care technology, Springboard has compiled a report of innovations from the show. It offers insight into where the trends lie and how companies are tackling innovation in 2014. Executives and managers at wound care companies are welcome to contact us to arrange a meeting to present the report, free of charge.

Springboard to present bolus injectors at Management Forum

Springboard has been asked to present ‘The rise of the bolus injector‘ at the Management Forum on Injectable Drug Delivery.

We will build on a recent research project by the Cambridge University Judge Business School that Springboard sponsored.

The presentation will answer the most important questions for drug delivery professionals, such as:

  • The changing needs of patients and new drugs
  • Could autoinjectors and infusion pumps meet the needs?
  • Bolus injectors: a new class of injection device
  • Example devices
  • What to expect from the draft standard ‘ISO 11608-6’ on bolus injectors

The Management Forum on Injectable Drug Delivery is one of the leading meetings of pharmaceutical and device professionals, and we highly recommend it to managers and executives working in pharmaceuticals, medical devices, clinical medicine, government, academia and patient support groups.

If you would like a face-to-face meeting at the event, please contact Springboard on +44 (0) 1223 422 273.

The presentation will be made available to Springboard’s current and potential clients after the congress so please get in touch if you are interested.

‘How devices can grow pharma profits’ presented at Management Forum Congress

Tom Oakley, Director of Drug Delivery Device Development at Springboard, recently presented at the Management Forum Congress in London on ‘How devices can grow pharma profits‘.

The key challenges facing pharma were discussed, along with real-world examples of how devices can grow pharma profits by:

  • Increasing drug value
  • Giving extended patent protection to drugs
  • Increasing the barrier to entry for generics and biosimilars
  • Using existing drugs for new indications
  • Increasing usability or addressing different user groups
  • Changing the pharma company from a drug manufacturer to an integrated healthcare provider

Please contact Tom Oakley on +44 (0) 1223 422 273 if you represent a pharmaceutical or medical device company. We would be happy to run through the presentation with you.