Springboard’s Tom Oakley summarises Connected Drug Delivery Devices in the introduction to the latest OnDrugDelivery magazine issue.
For more information, please contact Tom Oakley.
Let us suppose you need a new product developed. You have 3 choices:
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.
A new article in the popular Business Weekly magazine explains how demand for Springboard’s device development expertise from multinational clients has fuelled growth.
“Most of us understand that innovation is enormously important. It’s the only insurance against irrelevance”
“Innovation requires the ability to collaborate and share ideas”
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!
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…
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:
Typically, you can optimise a project for any 2 of the above.
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:
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…
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:
Here is a list of common pitfalls to watch for:
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.
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’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.
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.
Injecting a large volume requires either:
In addition, many injection devices are limited to 1 mL volume because:
Increasing the concentration of the drug in the liquid increases the formulation viscosity, which cannot become too great because:
There are various autoinjector technologies which do not contain a glass syringe, such as:
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 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:
There too many bolus injectors in development to list here but some examples are:
West has launched the Smart Dose injector for Amgen’s Repatha drug. The device is based on the Crystal Zenith plastic cartridge.
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.
SteadyMed is developing the ‘PatchPump’ platform which uses an expanding battery to force drug out of a flexible primary drug container.
Sensile Medical has various formats of pump based around its core micropump technology.
Ypsomed is promoting its YpsoDose concept based on 5 mL or 10 mL prefilled glass cartridges.
Bespak has created a prototype demonstrator of a HFA gas-powered bolus injector, called 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.
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 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.
Until now, Springboard has been fortunate enough to be based at the excellent St. John’s Innovation Centre in the heart of one of the world’s most important technology development clusters.
Springboard works for multinational clients around the world but our location in Cambridge, UK, is important because:
We have grown our team and our lab facilities based on strong demand over the years, and we are now at the point when we need to move to new premises.
Therefore, we are very excited to announce that we will be moving to the Jeffreys Building (next door!).
The move will allow us to:
We’re thrilled about the opportunities it gives us to deliver more and better projects to our clients over the coming years.
If you would like to know more about anything to do with Springboard, please do not hesitate to contact Tom Oakley.
When Edmund Hillary and Tenzing Norgay climbed Everest for the first time in 1953, they didn’t just take a giant leap for the top. Rather, they conquered the 8000 meter giant in a series of 10 centimetre steps with manageable milestones along the way.
An R&D analogy is a company who had spent years developing a new biopsy product in which a rotating blade advanced over a needle used as an anchor. The samples were small and unreliable, so customers were losing confidence. They had tried a bigger motor, sharper blade, different shape, but to no avail. Generation 4 was on the market but still too few customers.
Instead of leaping immediately for a whole new design, we broke the challenge down into a series of steps. How strong is the anchor force? How big is the cutting force? Which is larger? These could be measured simply on a standard piece of laboratory apparatus called a tensometer. When the graph was plotted, we could see that the cutting force was far greater than the anchor force, so the device was just recoiling every time it fired.
So the next steps were: how can I make the cutting force smaller? How can I make the anchor force larger?
Breaking down the problem into steps like this means you then spend your time solving the right problem. It might feel that pausing to do a sequence of scientific experiments adds time compared to aiming straight for the whole answer, but in reality it is often possible to find a much quicker route to success. If every step is in the right direction, you’ll arrive at the answer. But if you spend time solving the wrong problem, no matter how elegantly, you get nowhere.
This is an approach we’ve done for our clients many times over, and the savings can often be measured in years.
Please contact Keith Turner if you think we could help you or if you would like to be alerted to the next strategy.
There’s a great quote by Thomas Edison when asked if he felt like a failure because of all his failed attempts to invent the electric light bulb. “Young man, why would I feel like a failure? And why would I ever give up? I now know definitively over 9,000 ways that an electric light bulb will not work. Success is almost in my grasp.”
And not one of those 9,000 prototypes was made on a production line.
A situation that our clients commonly find themselves in goes a bit like this. “Yes, I know it’s not quite working yet but time is running out before the product launch next April and so we have to commission the tooling now. Management aren’t willing to let the launch date slip.”
It brings to mind a medical project in which the disposable part had been pushed through to injection moulding. The trouble was that revisions to the design were still being made. It was possible to modify the tool, but each time that happened, it took six weeks to get the next parts released before they could be tested.
Earlier in the same project, we had been prototyping the disposable component on our CNC mill. You could do a test, modify the CAD, set the mill running overnight and test the next iteration the next day.
Short development cycles demand flexibility, and for this it helps to delay tooling until you know the design works in all respects except for those specifically dependent on tooled properties. Even if you need 100 parts for a clinical evaluation, perhaps they can be machined? It might cost $10,000 and some planning ahead in validation, but that’s child’s play compared with a 12 month delay to a multi-million dollar programme.
There’s a whole suite of prototyping methods available today, such as additive methods (SLA, 3D printing, SLS, vacuum casting…) and subtractive methods (machining, laser cutting, EDM…), not to mention various ways of sealing, bending and so on.
In the next article we look at how to break down a daunting, complex problem into a series of manageable steps.
Please contact Keith Turner if you think we could help you or if you would like to be alerted to the next strategy.
We know how it feels. You have a passion for engineering and science from an early age. You want to use your brain power and creativity to make a positive and exciting contribution to the world. You work hard for years through your education culminating in a top degree or doctorate from one of the best universities. You should find a job which recognises and rewards that passion. Shouldn’t you?
We remember what it was like ourselves, and we asked our staff of top engineers and scientists what they looked for in their ideal job…
Most talented engineers and scientists want to their abilities for worthwhile and productive causes. We want to solve problems, not cause them. That’s why Springboard has an ethical policy which means we won’t work on things which cause more harm than good like weapons. Our staff take great satisfaction that they will be proud of what they have achieved.
There is huge diversity in the range of products and problems that Springboard is asked to work on. If we specialise at all, it is in doing things well!
You would find the variety thrilling, challenging and rewarding all at the same time.
Excellent people want, and deserve, excellent opportunities. That is why we at Springboard spend a lot of time mentoring each other in good practice, new techniques or just interesting ways of thinking about things. We also give a personal training budget to spend on what you think is most important for your development.
There are many jobs out there where you can work your socks off and still not make much impact in the real world. It is different at Springboard: all of the devices we design are on their path to production where they can then make a real difference to peoples’ lives – and you might get to say, “I did that!”
In summary, we understand what you are looking for because we are looking for the same things, and we built a company with that in mind. You will not be surprised to find that some of the most important elements that people look for in a job are the same as the key motivations for starting Springboard.
If you are a bright and passionate engineer or scientist looking for a truly rewarding job, please get in touch.