Connected drug delivery

The need for connected drug delivery devices

Most people would agree that drug delivery devices have improved in recent years, particularly with the increased focus on usability (or ‘human factors’).  However, adherence remains a challenge and payers are looking for ways to increase the cost-effectiveness of healthcare.  One strategy for managing both issues is connecting drug delivery devices to the internet.

The potential benefits of connected drug delivery devices have been much discussed and can be summarised for stakeholders as follows:

  • Patient
    • Reminders
    • Training
    • Evidence for incentives
    • Hawthorne effect
    • Peer support
  • Carer
    • Reminders
    • Training
  • Payer
    • (Non)adherence data
    • Reduced costs (50% of patients suffering chronic illness do not take their medication as prescribed, costing US $100 billion to $300 billion annually in avoidable direct healthcare costs in the US alone [1])
  • Healthcare professional
    • (Non)adherence data
    • Additional support for least adherent
    • Adverse events
  • Healthcare provider, or regulatory authority
    • (Non)adherence data
    • Adverse events
    • Clinical trial data (pre and post market)
    • Population trends
  • Pharma
    • Adverse events
    • (Non)adherence data
    • Clinical trial data (pre and post market)
    • Reimbursement evidence
    • Market understanding
    • Product and training improvements
    • Increased sales by increased adherence. (Non-adherence causes US $637 billion lost pharma revenue annually [2])

The disadvantages of connecting drug delivery devices to the internet are:

  • Increased cost of devices and infrastructure.
  • Potential increase in usability risks.
  • Reliability risks due to technical complexity.
  • Concerns over data privacy and robustness against hacking and malware.
  • Unclear regulatory landscape due to the unfamiliarity of the technologies in the regulatory context.
  • Environmental concerns for disposal of electronic waste.

Nevertheless, for some drugs and indications the advantages are compelling, so we should look at how connectivity might be implemented in a drug delivery device.

Device strategies

There are 3 main strategies for implementing connectivity in a drug delivery device:

  1. An add-on, typically to an existing design.
  2. An upgrade, which is integrated but does not change the core functionality or use case.
  3. Built-in, which can change the core functionality and use case.

Many pharmaceutical companies and drug delivery device manufacturers already have devices either on the market or in late stage development.

An industry survey of inhalers, for example, shows various companies using one or more of the three strategies.  Note that we see the same trends in the injector industry.

Add-ons

Add-ons have the advantages that:

  • They can be added to existing devices, in most cases without interfering with the existing device function.
  • They could be reusable even if the existing device is disposable.
  • Patients could pay for the add-on themselves, whereas the existing drug delivery device might be paid for by an insurer or national health service.
  • There is less development risk due to limited revalidation of the existing device.

Propeller and Adherium are notable because they support a wide range of existing inhalers.

Propeller Health

Propeller Health’s smart phone app, and inhaler add-on

Adherium

Adherium’s add-ons fitted to various commercial inhalers, and Adherium’s smart phone app

Cohero provides a spirometer so patients can measure their lung function.  This combination of drug delivery device and diagnostic device is powerful because it can provide direct disease management results to help patients and clinicians assess progress and can enable payment-by-results rather than pay-per-dose.  Linking delivery devices with diagnostics was pioneered by the insulin pens (and to a greater degree, insulin pumps) and blood glucose meters used for diabetes.  The obvious benefit is that the drug delivery device can respond to changes in the biomarker in real-time.  In addition, it gives much better insight than measuring only the quantity and time of dose taken because the patient and healthcare professional can see how the body responds to the drug. Perhaps the diagnostics could be used to identify more subtle problems.  For example, if outcomes were poor in a certain area, an investigation might reveal poor training by the local healthcare facility.

Cohero's add-on

Cohero Health’s BreatheSmart™ app, HeroTracker™ sensors, and spirometer.

Inspair measures inspiratory flowrate so can determine both if the patient’s breathing profile is correct, and if they actuated the inhaler at the right point in their inspiration. Devices which provide feedback like this can be used for ‘continuous improvement’ training, which is more interactive and personalised than a static training video or patient instruction leaflet.  It helps with the ‘learn-ability’ of the device, which was identified as a major challenge in recent industry-wide research performed by Springboard.

Biocorp Inspair

Biocorp Inspair

However, it is important to consider that add-ons have the obvious disadvantage that the existing geometry is not modified so:

  • Add-ons cannot be integrated into the existing device, and thus add bulk to the device, and there are additional use steps to attach them.
  • Technical possibilities are limited. For example, it is more difficult to sample the air flow.

Upgrades

A strategy to overcome the limitations of the add-ons is to upgrade an existing design.  Novartis is supporting the Propeller add-on [3], but is also upgrading the Breezhaler to the cloudhaler and adding built-in connectivity by working with Qualcomm Life. [4, 5]

Novartis Cloudhaler

Novartis Cloudhaler

H&T Presspart is working with Cohero to upgrade standard Metered Dose Inhaler actuators with connectivity. [6]  A notable feature of the Presspart strategy is that the connected functionality is optional.  That is, the drug delivery and dose counter functions are still entirely mechanical, so the patient can, in principle, use the device safely and effectively even if the electronic functions fail.

Presspart eMDI

H&T Presspart eMDI

An alert reader will notice that the upgraded devices do not change the use steps or core functionality of the devices.  If we want to use electronics and connectivity to change fundamentally the way the patients (and carers, trainers etc.) interact with their device, we need to build the electronics and connectivity into the device from the ground up.

Built-in connectivity

Devices which have connectivity built into them from the beginning can make significant changes in user interaction.  The design being built-in also allows more substantial changes to the device, such as advanced features and sensing options. For example, the 3M Intelligent Control Inhaler actively adapts the flowrate to suit the patient and delivers the dose automatically at the right point in the inspiration. A similar example is Opko’s Inspiromatic active dry powder inhaler, and Aptar is partnering with Propeller to develop a new connected metered dose inhaler. [7]

3M Intelligent Control Inhaler

3M Intelligent Control Inhaler

The disadvantages of built-in connectivity mirror substantially the advantages of add-ons.  For example, a device with built-in connectivity could be more difficult to make reusable, which adds built-in cost and environmental impact.

Uptake and retention of connected devices

Public interest in connected drug delivery devices has not been measured on a wide scale yet, but we can draw inferences from health-related smartphone apps.  More than 50% of US smartphone users downloaded a health-related app in 2015.  Individuals more likely to use health-related apps tended to:

  • Be younger,
  • Have higher incomes,
  • Be more educated,
  • Be Latino/Hispanic, and
  • Have a body mass index (BMI) in the obese range (all P<0.05). [8]

However, weekly retention of apps is poor, even for apps which tend to be associated with hardware such as Fitbit, Garmin and Nike+.

Market Share of the Top 5 Fitness Apps

Market Share of the Top 5 Fitness Apps

The reasons for people stopping the use of health apps were primarily:

  • High data entry burden 45%
  • Loss of interest 41%
  • Hidden costs 36%

Out of 1604 people, 662 (41%) said they would not pay anything for a health app. [8]

In November 2017, an analyst from Ernst & Young identified the following hurdles to the widespread adoption of connectivity in drug delivery devices: [9]

  1. Devices and services.
  2. Evidence.
  3. Data infrastructure.
  4. Business model.

Let us assess the progress and challenges in each area in turn.

Devices and services

Merck Group launched easypod for human growth hormone in 2006, which gained connectivity in 2012, [10] and RebiSmart for multiple sclerosis, which was launched in 2007 and gained connectivity in 2011.  They use the easypod Connect [11] and MSdialog [12] web platforms, respectively, for uploading patient data from the device and adding supporting information manually.

One of the challenges is gaining regulatory approval of medical devices that connect to smartphones, but AliveCor has pioneered the way here by being the first to gain FDA approval for smartphone-based medical device software with its atrial fibrillation diagnostic app.

In diabetes, Roche has bought the mySugr web platform, whose Bolus Calculator has Class IIb approval in the EU, and the logbook has Class I approval in both the EU and USA.

So, we can see that connected drug delivery devices are breaking through onto the market, and the regulatory approval and services around them are entirely feasible.

Evidence

Payers and regulators (not to mention patients and healthcare professionals) will want to see clinical evidence for the efficacy of connectivity.  Fortunately, the evidence is mounting.  Data from Propeller Health, for example, shows reduced short-acting beta agonist use, [13] reduced hospitalisations and reduced emergency room visits. [14]  Adherium claims similar clinical evidence. [15]

If efficacy is proven for certain indications, we would still need evidence for preference and adherence.  Fortunately, several studies have been done in these areas too.  For example:

  • An observational study on the RebiSmart device found that 91% liked using the device, and 96% found it ‘easy or very easy to use’. [16]
  • An autoinjector preference patient survey found that 82% of BetaConnect patients were ‘highly satisfied’ compared to 67% of RebiSmart and 60% of ExtaviPro patients. [17] The first two devices have connectivity, but the latter does not.
  • A retrospective adherence study on patients with multiple sclerosis using RebiSmart found ‘greater than 95% adherence’ over a 140-week duration (N = 110). [18]

Unfortunately, evidence of malware and hacking has also appeared.  For example, remote hacking exploits have been demonstrated on some Medtronic insulin pumps, [19] Hospira infusion pumps, [20] and Animas OneTouch Ping insulin pumps. [21]

Data infrastructure

It is logical for companies to roll out their connectivity infrastructure using the following building blocks:

  1. Adding connectivity to the drug delivery device.
  2. Optionally connecting the drug delivery device to a ‘mobile medical app’. This can be an app running on a smart phone (such as AliveCor’s KardiaMobile app), or on a dedicated device (such as Abbot’s FreeStyle Libre device).
  3. Cloud storage and web apps that can be accessed through a web browser.
  4. Electronic Health Records.

The main cloud computing providers (Amazon Web Services, Google Cloud Platform and Microsoft Azure) have various offering that are HIPAA compliant, so can be used for some medical data in the United States, but HIPAA compliance is not regarded as strong enough protection for the data of EU citizens.  The  General Data Protection Regulation (in force from 25 May 2018) places further requirements on the controllers and processors of personal data.

Several companies and collaborations are creating cloud technologies to handle data from connected medical devices. For example, Salesforce.com (in the form of its force.com platform), Qualcomm Life and Philips HealthSuite are working on patient data platforms.  Roche bought Flatiron which developed the OncologyCloud, claimed by them to be the ‘industry-leading electronic medical record for oncology, advanced analytics, patient portal and integrated billing management’, [22] Medicom is handling the data services for Bayer’s BetaConnect device, and Redox is developing a way to share healthcare data between heterogenous technologies.  In effect, Redox can take data from any input, perform transformations and analytics on it, and convert it into a given Electronic Health Record format.

Business models

Payers are trying to reduce costs, so simply adding connectivity and expecting to be able to charge more is not a convincing strategy.  However, a holistic view of the health economics of a given indication can reveal compelling business models in some cases.

Example business models already in use include:

  • A collaboration between Amgen and Humana whereby Amgen analyses real-world evidence from Humana’s members with data from wearable devices, apps and smart drug delivery devices. [9]
  • A collaboration between Amgen and Harvard Pilgrim Healthcare whereby Amgen will fully refund the cost of Repatha if the patient is hospitalised by a stroke or myocardial infarction. Naturally, Harvard Pilgrim will need to show that the patient had adhered to the Repatha regimen and connectivity is a convincing way to do this.
  • Abbot did not get reimbursement initially when it developed the FreeStyle Libre flash glucose sensor, so sold it direct to patients. It has since been approved for purchasing by the UK National Health Service. [23]

Summary and final thought

From what Springboard sees in its day-to-day work, every company involved in drug delivery devices either has a connected technology or is developing one. Clinical evidence for improved adherence exists, and evidence for other clinical benefits is mounting.  The data infrastructure exists, although systems are not familiar to patients or healthcare professionals yet, and there are legal hurdles to overcome when transferring patient data between legal jurisdictions. Traditional business models have struggled, but innovative business models are progressing.

Connected drug delivery devices are already with us, and more are coming to market.  The idea that connectivity itself will solve the adherence problem is unrealistic.  However, for the first time, healthcare professionals will be able to identify who is adherent and who is not, which will allow them to refocus efforts on those who have the most difficulty adhering.

If you are from a pharmaceutical company or medical device manufacturer and wish to talk with us at Springboard about any medical device development questions, please get in touch.

References

[1] Iuga AO, McGuire MJ, “Adherence and health care costs”. Risk Manag Healthc Policy, 2014, Vol 7, pp 35–44.

[2] Forissier T, Firlik K, “Estimated Annual Pharmaceutical Revenue Loss Due to Medication Nonadherence”. Capgemini and HealthPrize white paper, 2016.

[3] Tyer D, “Novartis Signs ‘Connected Inhaler’ Deal with Propeller Health”. PMLive, Feb 2017.  Accessed May 2018

[4] “Network Connected Inhaler for COPD”. myAirCoach. (Accessed May 2018)

[5] Pai A, “Novartis, Qualcomm Life to Develop Connected Inahler for COPD”. MobiHealthNews, Jan 2016. (Accessed May 2018)

[6] H&T Presspart eMDI product webpage. (Accessed May 2018)

[7] Comstock J, “Propeller Health, Aptar Partner to Create Connected Metered Dose Inhalers”. MobiHealthNews, Feb 2016. (Accessed May 2018)

[8] Krebs P, Duncan DT, “Health App Use Among US Mobile Phone Owners: A National Survey”. JMIR mHealth uHealth, Nov 2015, Vol 3(4), epub.

[9] Handschuh T, “Smart Devices – How to Unlock Their Potential in the Real World.” Presentation at PDA Universe of Prefilled Syringes and Injection Devices, Vienna, Nov 2017.

[10] “Merck Serono Launches easypod™ Connect in Europe”. Merck Serono press release, Oct 2011. (Accessed May 2018)

[11] easypod® Connect product webpage. (Accessed May 2018)

[12] RebiSmart MSdialog product webpage. (Accessed May 2018)

[13] Merchant RK, Inamdar R, Quade RC, “Effectiveness of population health management using the Propeller Health Asthma Platform: A randomized clinical trial”. J Allergy Clin Immunol Pract, May-Jun 2016, Vol 4(3), pp 455–463.

[14] Merchant RK et al, “Interim results of the impact of a digital health intervention on asthma healthcare utilization”. J Allergy Clin Immunol, Feb 2017, Vol 139(2), p AB250.

[15] “The Medication Nonadherence Epidemic”. (Accessed May 2018)

[16] D’Arcy C et al, “Patient assessment of an electronic device for subcutaneous self-injection of interferon ß-1a for multiple sclerosis: an observational study in the UK and Ireland”. Patient Prefer Adherence, Jan 2012, Vol 6, pp 55–61.

[17] Limmroth V et al, “Autoinjector preference among patients with multiple sclerosis: results from a national survey”. Patient Prefer Adherence, Aug 2017, Vol 11, pp 1325–1334.

[18] Solsona E et al, “Impact of adherence on subcutaneous interferon beta-1a effectiveness administered by RebiSmart® in patients with multiple sclerosis”. Patient Prefer Adherence, Mar 2017, Vol 11, pp 415–421.

[19] Goodin D, “Insulin pump hack delivers fatal dosage over the air“.  The Register.  Accessed July 2018.

[20] Finkle J, “FDA warns of security flaw in Hospira infusion pumps.”  Reuters.  Accessed July 2018.

[21] Finkle J, “J&J warns diabetic patients: Insulin pump vulnerable to hacking.”  Reuters.  Accessed July 2018.

[22] Kewon A, “Drug Giant Roche Buys Former Google Execs’ Flatiron in $1.9B Deal”. BioSpace, Feb 2018. (Accessed May 2018)

[23] Woodfield J, “FreeStyle Libre to be available on the NHS from November”. Diabetes.co.uk, Sep 2017. (Accessed May 2018)

Consultancy or manufacturer?

Let us suppose you need a new product developed.  You have 3 choices:

  1. Develop the product entirely in-house.
  2. Contract a consultancy to develop the product for you.
  3. Contract a manufacturer to develop the product for you.

In the past, companies would develop products themselves, entirely in-house.  In recent years, that model has become less common as companies have reduced their internal R&D teams and looked for collaboration to bring new products to market.

In some markets, engineering and design consultancies have delivered development projects as a service.  More recently, manufacturing companies have hired development engineers and set up development labs.   This article discusses the pros and cons of each method.  If you would like to know more, or have any feedback, do not hesitate to get in touch.

Development strategy Pros Cons
In-house
  • Knowledge stays in-house.
  • Limited IP leakage (other than employees leaving, indiscretions etc.).
  • Lower cost if, and only if:
    • Team and facilities are already in place, and
    • Recruitment, training, site and maintenance costs are not in your budget, and
    • Your team is fully utilised on productive projects at all times.
  • Limited to the skillset of the existing team.
  • Psychological inertia due to historical products and constraints.
  • Large expense of keeping the team when they are not fully utilised.
Consultancy
  • Highly skilled people available. This can make all the difference between a device passing tests and getting to market on time, or languishing in endless cycles of fire-fighting modifications. Removing even one redesign-revalidate cycle can easily save far more money than using a low-fee-rate manufacturer.
  • Flexible team structures.
  • Best option for an impartial view of which technologies would work best.
  • Impartial as to which manufacturer to use: consultancies are the best option if you intend to have more than one manufacturing source for risk mitigation.
  • Some consultancies, particularly those that specialise in your industry, will have relevant up-to-date experience from other projects.
  • Can have high fee rates (particularly those with > 100 employees).
  • Might not have experience in manufacturing. You can ask who will be working on the project, and what their experience is.
  • Consultancies with internal projects might save the best ideas for themselves. Springboard does not have internal projects.
Manufacturer
  • Fee rate can appear lower than consultancies.
  • Sometimes, deep knowledge of a given manufacturing process.
  • Good at making incremental changes to existing products, but not at innovating new products.
  • It will be very difficult to transfer manufacture to another party because the design will be optimised
    for their processes, and there will be no documentation or data necessary for transfer to another company.
  • Manufacturing costs will be high because they will need to recover their costs and make more profit than otherwise to make up for Net Present Value, and their risk.
  • Most manufacturers are trying to build up their own IP portfolio. This might mean they save the best ideas for themselves, or put some of their IP into your product.
  • Limited to the skillset of the existing team.
  • Psychological inertia due to knowledge of their existing processes. For example, if the company is very experienced with aluminium tooling, can you guess what your tools will be made from, even if steel tooling would have been a better option?

The rise of the bolus injector

Engineers and scientists are working hard to revolutionise the way patients take new and existing drugs.

Many of the new drugs under development are ‘biologics’, which tend to be unsuitable for taking orally (as a pill) because the liver metabolises them. A classic example of a widely-used biologic drug is insulin for diabetes mellitus.

Therefore injection is the most common way of taking biologics.

Some of the biologic drugs, particularly monoclonal antibodies, require large masses to be injected.  In order to inject a large drug mass, we have two choices: increase the injection volume, or increase the concentration of drug in the formulation.

Problems with increasing the injection volume

Injecting a large volume requires either:

  • A high flow rate, which can be painful and unsightly; or
  • A long duration of injection, which can be uncomfortable and difficult to maintain injector position.

In addition, many injection devices are limited to 1 mL volume because:

  • Historically many autoinjectors were based on the 1 mL BD Hypak; and
  • It is extremely expensive to refit the aseptic filling lines that have been built for 1 mL syringes.

Problems with increasing the drug concentration

Increasing the concentration of the drug in the liquid increases the formulation viscosity, which cannot become too great because:

  • Patients are demanding thinner and thinner needles, which strongly increases the resistance to flow and would increase injection duration to unacceptable periods for viscous drugs;
  • Injection devices contain typically a glass syringe, which breaks if too much force is used to drive the formulation through the needle; and
  • Many drugs, especially those based on proteins, aggregate (stick together) above a certain concentration.

Autoinjectors without glass syringes

There are various autoinjector technologies which do not contain a glass syringe, such as:

  • The Crystal Zenith range from West Pharmaceutical Services; and
  • The Oval Medical autoinjector.

These autoinjectors may be able to deliver viscous drugs, but still tend to be limited in injection volume due to the discomfort of injecting large volumes quickly and the difficulty in holding the autoinjector steady for long enough.

The bolus injector

The solution may be a different class of injection device: the bolus injector (sometimes called a ‘patch pump’, although this term is also used for ambulatory infusion pumps).

A bolus injector may be described as a device with performance and usage between current autoinjectors and infusion pumps:

  • A bolus injector is typically attached to the patient’s body for a few tens of seconds to a few hours, unlike an autoinjector which is held in the hand. Therefore a bolus injector may be able to deliver a larger volume than an autoinjector because it does not need to be manually held in position during injection, and could contain a larger drug reservoir. In addition, avoidance of a glass syringe may enable delivery of more viscous drugs.
  • A bolus injector is normally designed to deliver its payload promptly, unlike an infusion pump in which the duration of delivery is a key parameter in the therapy (such as a constant, low flow rate, basal dose of insulin 24 hours per day). The bolus injector is only attached to the patient for the few minutes or hours that it is delivering its dose.

Example bolus injectors

There too many bolus injectors in development to list here but some examples are:

BD is developing the Libertas bolus injector built around a pre-filled BD Neopak syringe.

BD Libertas bolus injector

BD Libertas

West has launched the Smart Dose injector for Amgen’s Repatha drug.  The device is based on the Crystal Zenith plastic cartridge.

West SmartDose

West SmartDose

Enable Injections is working hard on its eponymous device, which takes a different approach to the prefilled devices above:  the drug is supplied in a separate vial or syringe, then a filling pump fills the injector with the drug formulation shortly before attaching the injector to the body.  This means that the device avoids some of the regulatory hurdle of proving drug stability for many months before use.

Enable Injections

Enable Injections

SteadyMed is developing the ‘PatchPump’ platform which uses an expanding battery to force drug out of a flexible primary drug container.

SteadyMed PatchPump (R)

SteadyMed PatchPump (R)

Sensile Medical has various formats of pump based around its core micropump technology.

Sensile SenseTrial

Sensile SenseTrial

Ypsomed is promoting its YpsoDose concept based on 5 mL or 10 mL prefilled glass cartridges.

Ypsomed YpsoDose

Ypsomed YpsoDose

Bespak has created a prototype demonstrator of a HFA gas-powered bolus injector, called Lapas.

Bespak Lapas

Bespak Lapas

There are many other devices in development, such as the NeuroDerm continuous subcutaneous infusers.  Others have been mothballed or cancelled, or otherwise fallen by the wayside such as the Roche Single Injection Device (formerly MyDose), Ratio Drug Delivery’s NuPrivo, and Unilife’s Precision Therapy.

If your organisation is developing a bolus injector and you have recommendations for improving the list above, please get in touch.

Challenges for new bolus injectors

Many bolus injector designs use a novel primary pack, and pharmaceutical companies are very reluctant to risk their drug launch on new materials and designs. Device developers are trying to reduce the risk by using materials that have been used with drugs before.

The second challenge is that a new primary drug container is likely to be incompatible with the pharmaceutical companies’ aseptic filling lines, which are extremely expensive and time-consuming to build and validate.

In addition, some bolus injectors have advanced features such as automatic needle insertion and electronic control which increase development complexity.

Finally, new devices must meet the newly raised regulatory demands on usability (human factors).

The future

The drug delivery device industry is working hard to define the requirements and test methods for acceptable bolus injectors, which is likely to become ISO 11608 part 6.

We expect that bolus injectors will become a familiar part of the drug delivery device space, and that they could enable exciting new therapies such as regenerative medicine.

If you would like to know more about bolus injectors, or have a need to procure or develop one, please get in touch. Springboard develops injection technologies, and conducts technology scouting, technology procurement, due diligence and usability engineering projects for our clients.

Full disclosure: the author has worked on numerous injection device developments for pharmaceutical companies and device manufacturers, and has been asked to attend the meetings to draft ‘ISO 11608-6 Needle-based injection systems for medical use – Requirements and test methods – Part 6: Bolus Injectors’.

This post was originally posted on 19 September 2013 and has been updated since.

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.

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.

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.