Tag Archives: combination products

Improving Paediatric oral medicine delivery – workshop

Workshop on Improving the Administration of Paediatric Oral Liquid Medicines using Dosing Syringes and Enteral Accessories

11th September 2018, London, United Kingdom

The workshop is likely to be of interest to many of our readers, so here’s information provided by the organisers:

The European Paediatric Initiative (EuPFI) is inviting expressions of interest in a workshop organised to identify and discuss challenges and potential improvements in the development, control and utilization of oral dosing syringes and enteral accessories for paediatric liquid medicines.

The workshop which will be held at University College London (UCL) School of Pharmacy premises in London, is a crucial step to find the optimal path towards correct dosing to all paediatric patients using these oral administration devices. A broad range of stakeholders, including patients/caregivers, healthcare professionals and representatives from the pharmaceutical industry, drug delivery device suppliers and academia, are invited to the workshop to share current practices and issues regarding the development and handling of oral dosing syringes and enteral accessories, to facilitate awareness and identify areas for improvement. Representatives from national competent authorities, EU institutions and other stakeholders will also attend.

Completed forms for expression of interest to attend the workshop should be submitted by 20th July 2018.

Places are limited and will be allocated to ensure a fair representation of all stakeholder groups and organisations, and so please do not book travel arrangements until your attendance has been confirmed.

Further details are available at http://www.eupfi.org/devices-workshop/

We have submitted our expression of interest in attending, and hope to see you at the workshop.

Medical Device Development – How to get the best possible return on your investment

Bringing a medical device to market requires significant investment of time, money and resources.

In our experience, the precise amounts of all three needed to successfully complete development, industrialisation and launch varies, depending on the nature, complexity and risk associated with the product.

It is not unusual for a low to moderate risk device to take 3-4 years to reach the market, supported by development investment of up to around $30million. As the device risk and/or complexity increases, so does the investment; by comparison, a complex, high risk device may take upwards of 6 years and $90 million to bring to market. There are no guarantees, of course, that the device will ever make it to the market or, if it does, that it will be commercially successful but for those that are, the rewards can be significant.

So the medical device development process can often be a perfect storm —high risks, high costs, lengthy development timelines that can eat into the revenue generation window, and potentially relatively modest returns—has created a difficult environment for medical device innovation. If you’re in this challenging environment, you’ll want to focus on strong management of process to mitigate risks and minimise time and investment, whilst ensuring your development roadmap doesn’t cut any corners.

In our experience, gained from over 25 years in device development, you stand the best chance of success if you focus on three critical factors;

  • Mitigating Risks
  • Controlling spend
  • Optimising project timescales

Mitigating Risks

To mitigate risks, first there has to be an understanding of the potential risks in the development process and secondly a plan to minimise their impact and mitigate them as far as is practical and cost effective.

Controlling Spend

Controlling spending is not just about spending wisely and getting best value, but also about making informed investment decisions (based on sound data and experience) to reduce risk by investing proactively in key areas. Sometimes, money spent in the right areas early on in the development process can save significant sums later on – the cost of quality effect.

Optimising project timescales

Optimising project timelines involves identifying key decision points and ensuring you have the data you need to make robust decisions when and where they’re needed, preventing unnecessary work or racing down a flawed development path. Creating the least impact on project timescales steps back from the fallacy of planning a “best case” project timeline, which almost inevitably falls apart at the first hurdle and ends up costing far more than budgeted and taking years longer to deliver (if at all). Instead, it looks in detail at the individual project elements and avoids the temptation of cutting corners to create a more robust, realistic, affordable and achievable plan for development through to launch and beyond.

That’s a lot to consider, no matter what development stage you’re at.

How to ensure medical device development goes smoothly

To ensure things go as smoothly as possible, when we’re brought into a project to deliver a specific piece of work we offer clients the option of a scoping day, assessing collaboration prerequisites and risk factors in a pre-collaboration checklist.

This builds the foundation for a successful working relationship, with no surprises, and enables us to help you avoid the pitfalls that can stop, stall or even derail a project completely.

The Cupboard of Shame

Many people like to be able to present a clean, well-ordered home when they are expecting visitors. Some even prefer to have their home “inspection ready” most, or all, of the time.

skeleton-closet_smallerThis goes for our work environment too, especially if these visitors are about to audit us. So it’s common during preparation for audits to tidy-up and clear out any junk or items that have accumulated for a variety of reasons. There’s nothing wrong with tidying up and audits are often a good prompt to do those annoying jobs that we have been putting off. Jobs like finding out how to dispose of some nasty chemical or how to recycle a load of plastic parts. However, as with tidying your home there can be a reluctance to throw some things away, even when you know you should, because at some point they may become useful or someone may ask for them.

A while ago, our team was supporting a client’s regulatory audit. The whole site was looking pretty good; tatty old labels and signs had been updated, benches were clean and everything was labeled to within an inch of its life, everything was looking spick and span. The site was ready.

On the first day of the audit the inspector asked to be shown around the site. The site tour included laboratories, manufacturing and packaging areas, the waste disposal area and the warehouse. The site tour was going well, people were looking happy and were able to answer the inspector’s questions satisfactorily. All was fine, until the “cupboard of shame” was discovered lurking at the back of the warehouse. Now of course the cupboard wasn’t really called that at the time, but thanks to the back-room team, the name stuck. The cupboard looked harmless enough, it was padlocked closed and was very small in size. However, when the inspector asked about the contents, signals started to be given off that something may be wrong. There was a lot of shuffling of feet and sidelong glances and it took a while to find someone who had a key.

Danger, Will Robinson!The padlock was unlocked, released and the cupboard doors swung open to reveal the contents; lots of “odds and sods” items, the stuff that really could have been disposed of long ago.

There were several boxes of a product from another site, no longer in production and years past its expiry date. There were end of reel labels and ”spare” plastic bottles, device components, plastic bags. A lot of the stuff had been kept just in case it may be useful, one day.

Now, the people who knew about the “cupboard of shame” weren’t doing anything malicious and genuinely had good intentions, they had even padlocked the door to restrict access. But none of that prevented the inspector’s discovery appearing as an observation in the final audit report.

red-light_smallerYou can bet that their “cupboard of shame” no longer exists after that unfortunate series of events.

Do you tidy up for every visit, or do you prefer to be “inspection ready” all the time?

Whichever your preference, what’s hidden in your “cupboard of shame”? You may welcome a fresh pair of hands helping to sort it out.

Three ways to smooth your path for device development

Medical Device Development routemap v5.0 narrow viewSpring of 2013 still seems recent, so I was surprised to realise that the route map for medical device development will shortly be 3 years old. If it were a child in the UK, we would be able to get 15 hours free childcare a week from this September.

Children learn and grow at an alarming rate, especially when you’re looking back over what seems like a very short time and realise that the baby you remember holding in your arms “yesterday” is now a teenager.

The route map too is growing up fast. It’s being used across the world, from Australia, through Asia to Europe and on to North America. Users have fed back great experiences. Uses ranging from a desktop aide mémoire, a teaching aid, through to a planning and design review tool!

There comes a time when a child learns new skills, and naturally integrates them into their daily lives and toolkit.

We’re proud to announce the launch of the route map for medical device development 5.0 today. Numerous user suggestions have been incorporated in this new version, along with two new tracks; Intellectual Property and Market Research.

The route map continues to help you in three ways, it;

  1. Describes the journey you’ll embark upon, from a device idea through to launch.
  2. Sets out the main activities for each of 9 disciplines, through four stages of product development.
  3. Identifies the points where there are major interactions between disciplines.

And here it is…

Click to open a pdf version you can download

Click to open a pdf version you can download

You may already see how this picture will be helpful, whether you’re working in medical devices, combination products, pharmaceuticals, aerospace, defence, electronics…..

Send me your thoughts on how you can use the route map, because having a straightforward, independent view is always valuable.