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.

 

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.

Springboard is expanding to larger, custom-designed premises!

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:

  • It helps us to recruit very sought-after world-class device engineers and scientists; and
  • We have access to world-leading suppliers and equipment based locally.

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!).

Jeffreys BuildingThe move will allow us to:

  1. Design the layout so that we have our laboratories, offices and meeting rooms in the optimum sizes and positions;
  2. Double our laboratory space, giving us room for new equipment, and having larger machining, assembly, testing and metrology areas.
  3. Double our office space.
  4. Increase our meeting room count from 1 to 3.

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.

Strategies for faster R&D: Break it into manageable steps

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.

Everest

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.

Strategies for faster R&D: Save tooling for later

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.”

Lightbulb

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.

Strategies for faster R&D: Change one variable at a time

 

When the Wright brothers were trying to make their great aeronautical leap forward, they didn’t just throw feathers and motors at the problem to see what happened. Rather they tried to determine which of the three key challenges to mastering flight was most critical: wings, engines or control? Looking at the effect of changing one variable at a time helped them to determine that the critical weakness was in control, meaning that they could innovate in this aspect and set the way to their landmark achievement.

Wright brothers

It brings to mind a project where we were developing a cryosurgery probe to kill breast tumours by freezing. We had a functioning system that worked off a heavy gas cylinder but had recently made the exciting discovery that a simple 1 litre flask could be used to drive the probe directly from liquid nitrogen. This was easier to use, smaller, and cheaper, and so a sure-fire commercial advantage for our client. However, when we scaled our new technology up to full size it didn’t work. It wasn’t just slow, it was completely hopeless, and failed to get even remotely cool to the touch. Yet the only difference was the size.

But was it? The new flask was bigger, that’s true. But actually, the bung that sealed it was also a larger diameter. It was also deeper. And it was a different material. And the dip tube was longer to reach to the bottom of the larger flask.

On reflection, there was quite a lot different about the new system, and we had changed it all at once. This meant we didn’t know which thing we had to change to resolve the problem. There was a deadline approaching, and it was tempting to just jump to the end and try stuff in the hope it would work, but with planning we figured that we had a chance to solve the problem in two weeks by starting with the working miniature system and changing one feature per day until we had created the large system. 10 days, 10 features- surely one of those would be the key?

On day 1, we machined a new bung for the small flask out of the same material as we were using for the scaled-up system. It worked perfectly. On day 2 we scaled it up to the larger diameter- still great. On day 3 we extended the dip tube- still chugging along nicely. On day 4 we machined a deeper bung… nothing. A complete failure to freeze. It was now a simple deduction that the deep mass of rubber was sinking heat into our cryoprobe and preventing it from freezing. We added insulation around the tube as it passed through the bung and made ourselves a perfectly working full-size system. All in less than a week, which means we still had time to write the final report for our client who was visiting the next week.

This technique is widely used in science, and is particularly powerful when you have one prototype that you know works, but can’t figure out why another comes up short. If changing one variable at a time does not reveal the problem, there is probably one or more interactions between the variables. We can use techniques in a field of engineering called Design of Experiments to reveal them, but that is a subject for another day.

In the next article we look at how to speed up the development cycle by saving tooling until later.

Please contact Keith Turner if you think we could help you or if you would like to be alerted to the next strategy.

Strategies for faster R&D: High speed video

When the world’s fastest men competed for the 100m Olympic gold medal in Athens, 2004, four athletes crossed the line in a blur. But the event organisers didn’t just squint and pick a winner. Rather, they used high speed video to slow down the motion and changed the method of observation so that it became clear that the new champion was Justin Gatlin.

Olympics

It brings to mind a project I once worked on where we were trying to control air flows inside a dry powder inhaler. The powder kept ending up in the wrong place, and nobody knew why. We had tried different geometries, but to no avail. Finite element modelling hadn’t helped either.

“You can’t see what’s going on because it’s opaque”, people said. Well, true to a point, but with only a little effort it was easy to prototype transparent parts and set up a video camera at 2000 frames per second to visualise the particles. It was beautiful, and you could see each particle whirling about on its journey from the hopper to its final resting place stuck on the side wall. It soon became apparent that the problem started as the particles crossed a particular join in the moulding. This enabled us to focus our attention on that particular problem spot, and we soon found a leak. It was then a simple engineering job to seal the leak and recover the performance that was expected.

We have used high speed video on numerous projects at frame rates over 100,000 per second. Sophisticated techniques can be used to quantify stresses in moving parts and relate their behaviour to material properties. There are also more sophisticated variations, such as stroboscopes and particle image velocimetry, which uses pulsed lasers to visualise the movement of particles over tens of microseconds.

Have you ever had your prototype working, only to see it do something unexpected in its next iteration? In the next article, we look at a technique for staying at the best performance.

Please contact Keith Turner if you think we could help you or if you would like to be alerted to the next strategy.

What engineers and scientists look for in an ideal job

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…

Making a positive contribution to the world

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.

Variety is the spice of life

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.

Career development

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.

Keeping it real

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.

Strategies for faster R&D: Critical Observation

Nearly 200 years after its inception, Darwin’s theory of evolution still lives as one of science’s greatest breakthroughs. Yet Darwin made this monumental advance in understanding without the use of any computer, internet, or modelling software. He used direct, critical observation and a sceptical mind.

Darwins finches

It brings to mind an occasion when I was trying to work out why an ink-jet filter was blocking. The blue pigment sludge that built up on the filter over 30 minutes was causing the printhead to fail way short of its 100 day lifetime target. We had tried all the obvious things: bigger holes, shaking the mesh, scraping it clean, measuring the reduction in flow-rate, but all without success.

Because the pigment particles were only 1 micron across, we found it hard to work out what was going on. But is it really that difficult? There was a microscope on the bench next door and one of those swan lights that lets you change the illumination angle. With some new brackets and a special transparent cap, it was possible to set the filter up and running on the microscope and watch the particles. As they approached the mesh, some would stick to the wire material. Then the next would stick to the first particle, and another until long chains were formed that bridged the hole and it blocked. Then I tested a mesh with smaller holes and to my amazement, it actually took longer to block. As the particles approached the small holes, they sped up to get through the restriction, rather like a rapid in a river. All this extra speed caused them to dislodge other stuck particles and prevent blockage.

So the answer was to make the holes smaller, not bigger! And it was understood simply by looking very carefully.

In a modern lab there are all sorts of ways to help you look. Optical microscopes, electron microscopes, laser strobe systems are just a few of them.

In the next article, we look at one particularly useful way to assist critical observation.

Please contact Keith Turner if you think we could help you or if you would like to be alerted to the next strategy.

Strategies for faster R&D

Could you really cut R&D times by a factor of five?

Senior R&D managers are constantly under pressure to deliver their new innovations to the market. A plan with stage gates is agreed: proof of principle; detailed design; verification; validation; launch in 18 months from now. But it is frequent that five years later, despite everyone’s best efforts, the product still isn’t on the market. A new plan is in place to launch in 18 months from now.

Does this sound familiar? If it does, you are not alone. Executives want to reward those who can cut time to market yet many innovations get stuck in a cycle of insufficient performance, unexpected failures and unacceptable cost. Months turn into years.

At Springboard we employ strategies to reduce these timescales and we repeatedly find that five-year old problems can indeed be overcome in a year. The trick is not to deal with the string of problems more quickly, but to avoid them all together. In the coming months, we will be sharing some of these strategies through a series of blog articles. If you’d like an alert when the next article is released, contact Keith Turner and ask to be sent the link or connect on LinkedIn.

Springboard is a technical consultancy that solves difficult engineering and physics problems in short timescales, helping companies to get successful innovations to market more quickly.