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?

How to find the best contract R&D partners

“Most of us understand that innovation is enormously important.  It’s the only insurance against irrelevance”

Gary Hamel

“Innovation requires the ability to collaborate and share ideas”

Bill Gates

Innovation is critical to all businesses. We live in a knowledge-driven economy and, especially in medical devices and drug delivery, giving patients the benefits of new and better products is clearly beneficial for all concerned: patients, payers, healthcare authorities, pharmaceutical companies, and medical device manufacturers.

Collaboration is more important than ever to manage technical risks and build on the best talent available throughout the development process.  But there are very few sources of good information on how to find the best companies to collaborate with.  This article gives an insight based on many years of experience in the field.

We hope that it is helpful and perhaps even interesting!

Working together

Step 1: Consider the pros and cons of working with external experts

Collaborating with external experts works best when you and the relevant stakeholders within your organisation (particularly the development team) see the value.

In some cases, there’s reluctance to collaborate, but it can lead to projects not working very well due to the limits of the skills, capability and equipment of your own development team.

In other cases, where you just want more people in your office or labs to work under your own supervision, a lone contractor may be more appropriate than an external R&D partner. Using contractors is a different mind set from working with external R&D companies because typically the latter will take on leadership to overcome hurdles in the way, and display a greater degree of autonomy on reaching a solution.

It is misleading to compare quotes to salaries. This is a common temptation, but when you consider the salary of yourself or your staff, you are not including pension, bonus, National Insurance, premises, training, recruitment costs, computers, software licences, under-utilisation, lab equipment, lab space, insurance, accounting and legal support and so on. If you add up those things for your internal team, you will find the market rate for R&D work. The quotes from potential partners should match this: they should be the market rate after all. When coupled with rapid and reliable progress on solving a valuable problem, the cost-effectiveness should be clear.

If you and your team do see the value in an external collaboration, move to Step 2…

Step 2: Think about what you’re asking for

What is it that you need?  This will inform what you’re looking for in an external partner.

When it comes to specifying the size and shape of a project, there are 3 competing factors:

  • Quality.
  • Time.
  • Cost.

Typically, you can optimise a project for any 2 of the above.

Step 3: Find out from peers who is good

Reputation is everything. A really good innovation partner will have a good reputation which others in your field will know about.  If you don’t know who to ask, maybe former colleagues at another company can help [Springboard has gained many clients this way].  You can always get in touch and ask us!

You may already know that a company’s name being well-known correlates strongly with its marketing budget, and not necessarily with the quality of its work.

It is about the people, not the brands.  We have found that the most important ingredient in successful development projects is the quality of the people.  Two qualities stand out as being vital:

  • Their technical and project management ability; and (no less)
  • Their ability to communicate and work with you (and you trust them).

Really good engineers and scientists will be able to use the right technique and equipment even if they have not used exactly the same things before.  On the other hand, it could be folly to expect mediocre engineers and scientists to develop market-leading high performance, usable and safe products, or fix non-trivial technical problems.  Perhaps ask yourself this provocative question: “How many opportunities do I have to get this project right?”

There is sometimes a downside to really capable people: they can be arrogant and therefore not so good to work with.  The best way to assess this is Step 4…

Step 4: Talk with the potential partners

It is worth spending the time to speak with potential partners because a website or word-of-mouth cannot give the full picture about the quality and attitude of the people actually working at the potential partner company.  By definition, case studies on websites will be very old because they have to be outside of confidentiality terms.  Therefore, the people that developed those devices might not be working at that company anyway.

Talking with the company can help you assess:

  1. Would I want to work with these people?  Are they listening to me?
  2. Are they capable people who I trust to deliver the project successfully?
  3. Do they understand the constraints of the project?

Here is a list of common pitfalls to watch for:

  1. Be aware of the A-team/B-team.  You might be talking to some experienced, capable people during the negotiation and planning, only to find that you get a completely different set of people working on the project once it starts.  You can minimise this risk by seeking assurances about who would be working on the project: the partner should be able to at least be sure of the project leader.
  2. Ensure the correct incentives.  If the potential partner has internal projects, it will be wanting to secure its own IP.  If it has experience in your field, it is probably going to want to secure its own IP in your field.  Development contracts can say that IP will belong to you, but perhaps you do not want an incentive for people working on your project to keep the best ideas for their company.  The best way around this is to use a partner which does not have internal projects at all.
  3. Location is almost irrelevant.  If you work for a leading multinational organisation, you probably want to find the best team in the world to deliver your projects – why not?  The probability of having an excellent team available down the road is slim.  If you do, that’s great!  If you do not, it does not tend to matter these days whether they are 500 miles away or 1,500.  Weekly web conferences cover most project updates, and regular face-to-face meetings are easy in this age of cheap and convenient air travel.
  4. Size is important, but maybe not how you think.  A partner who is too small (one or two people) might not have the breadth and depth of the skills that you need, and you would be at the mercy of any one person being sick or taking holiday when you need them most.  A large partner will prioritise their largest projects. If your project is many millions of dollars in each phase, great! if not, you might find you are not at the front of the queue for resources if you use large partners.
  5. Will the rest of your company treat your partner well?  You may have found the right partner who you trust and you’re really keen go get a great project going. It helps the relationship, and therefore chances of success, if your procurement department agrees to reasonable payment terms, and your accounts department fulfils its obligation to pay on time.

Step 5: Decide who you want to work with

This may be the hardest step.  There are any number of approaches to come to a decision…

Factors such as trust in the people, and your belief in their ability to deliver are hugely important.  Therefore, a spreadsheet of metrics (beloved by procurement departments) is probably not the best way to decide between potential partners.

Perhaps the best way is to think about which partner you would prefer to have a long-term business relationship with, and see if their match to the current project need is good enough.

 

We hope that you have found this post helpful!

If this post has teased any thoughts or questions, please either write a comment below, or get in touch.  We would love to hear from you.

 

Springboard moves into new premises

Fast-growing product and technology innovator Springboard has expanded into larger offices at St John’s Innovation Park in Cambridge, UK, having outgrown its space in the Innovation Centre itself.

A steady flow of new projects for international clients has required the scale-up and Springboard has built additional capacity into its new HQ.  Now, the labs and offices are under one roof in a 4,000 sq ft unit, which also has self-contained meeting rooms and reception area.

Springboard team

Springboard’s capabilities have been in strong demand, and its project portfolio has been international from day one, driven by recommendations (word of mouth) between major medical device and pharmaceutical companies, especially where they have run into problems with a medical device.  Its focus has already enabled a number of big-name clients to launch devices that they could not have otherwise, and in the process saved time and money in product development. Cul-de-sacs have been moulded into highways of success for a large number of satisfied clients.

The consultancy’s reputation for troubleshooting and technical excellence spread across Europe and the United States. We are proud to say that more than 80 per cent of Springboard’s work is repeat business.

Some problems with delivery devices – injectables for example – cannot be solved “simply by throwing man hours at it”; in-depth technical insight and world-class engineers are required. And that is exactly what Springboard has provided since opening its doors.

Springboard has put much time and effort into recruiting, mentoring and training the best team possible.  The diversity and depth of skills now far outstrips that of the founders and includes skills in physics, optics, thermodynamics, fluidics, materials science, biotech, mechanics, systems engineering, electronics and manufacture engineering. This means the company now takes on cross-disciplinary projects and creates teams that have the breadth of knowledge to ensure success.  Recruiting talented people is a time consuming challenge, but of even more importance is creating an environment in which they can flourish. The company’s focus on professional development means people have opportunities to take responsibility and grow their careers at the company.

This broad church of capability is exactly what the founders wanted to achieve – a turnkey capability in the segment, rather than being pigeon-holed simply for one area of expertise.

We believe another strength of Springboard is its open innovation culture. Springboard can provide a fully self-sufficient team to a project but welcomes input from clients either through brainstorming sessions or weekly updates.  This approach enables the client to retain control of the concept while giving Springboard full rein to suggest enhancements.  “They don’t have to hand-hold us but they get to contribute; we believe in a highly collaborative approach”.

Springboard is also renowned for its highly ethical approach to projects. Its mantra is to work on innovation that are technically challenging but also ethical and worthwhile.  Staff like to be able to say that they are working on a project that will certainly improve peoples’ lives and might, for example, lead to a cure for cancer.  This approach is helping the business recruit the highest calibre of engineers and scientists; the ongoing recruitment process is also enhanced by Springboard’s outreach activities with schools, colleges and Cambridge University.

If you would like to know more, please get in touch.

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.

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.

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.

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.