Taken from our lunch & learn series of talks, this blog will also discuss the criteria and requirements used to evaluate most medical device applications. We will also touch on how to ask the right questions to stakeholders so you get the best information to properly develop and market your device.
Why the right medical device is so important within the drug development process?
In the long run, the development effort of a device is tiny. Especially when compared to the huge cost and time it takes for a large drug development. However, this still means that your chosen drug has to be administered with the right device in order to meet the requirements of holding and delivering the therapy.
Simply put, if a device doesn’t work properly or refuses to function technically when delivering a therapeutic agent, people can’t use it. As such, it is key to never underestimate the importance of the device within the drug administration process.
So what makes the ‘right’ device for drug delivery innovations?
It is important to remember that what makes the ‘right device’ for one company, may be completely different from what makes the ‘correct’ device for another.
For example, at one company, their team might focus on the commercial factor that gets them to market or clinic the quickest. For another, their priority could be focusing on a device which has superior technical performance, or one that offers the optimal user experience.
It’s important to look at each device individually. But in an ideal world, you’d want a perfect blend of all three: User, Technical and Commercial.
However, this can be difficult to achieve when you’ve got different people on the team with different objectives.
We’ll explore how you can streamline these views into the early stages of innovation further on in the blog.
Should you develop or license your medical device?
When it comes to the delivery of therapeutic agents, you have two options at the beginning of development:
- create your own from scratch
- license an existing technology or an early-stage project from somebody else
There are many good reasons why you’d want to develop your own device. But if there’s something available (either on or near market) that you could license, this can save you time, cost and is less risky in comparison to ground-up development.
As its one of the most popular methods, licensing is the route this blog will focus on.
How do you decide which drug delivery technology is right for your therapy?
This is where it helps to have an ‘ADEA’ of what to do:
Align, Define, Explore and Assess.
These are four steps that medical device developers might take to help identify promising technologies for a chosen therapy.
Our team of front end innovation consultants use these to gain insights, contextual clues and get feedback on early ideas.
Step one: align
If you have any key strategic questions, make sure to align these with stakeholders from the start.
At Team Consulting, we believe it’s important to share knowledge internally in order to gain consensus and outline project goals from the start. This will prevent the risk of disagreements later on in the programme.
To do this, hold a strategic workshop right at the start of the project. This can bring your team together across a number of possible scenarios.
Workshopping drug delivery systems across sectors
This workshop should be attended by a diverse mix of stakeholders from across the business, whether that’s formulation, clinical, devices, or commercial. It’s a forum for people to share their own views and develop a shared goal, which is important for any project. Plus, it’s a good opportunity for busy people located around the globe to get together and work as a team!
At Team Consulting, we are able to conduct workshops with people from the same company across a number of countries – even organising workshops with up to 40 people in 10 different locations!
This shows that even if you aren’t able to meet face-to-face, our front-end innovation team have found that remote workshops using video conferencing or remote collaborative tools, can work just as well.
Choosing your goals and objectives
During your workshop, everyone should decide on the overall objective your therapy hopes to achieve (aided by your device). This also makes sure that knowledge is shared between different skill sets. It also ensures that everyone understands the aspirations or constraints from each viewpoint.
Then, any knowledge gaps should be identified – leading to a research plan being put in place to address them.
Step two: define
As mentioned before, your team should define the medical device requirements with a diverse stakeholder group – taking into account user, technical and commercial factors. From a commercial angle, perhaps you are aiming for a market launch no later than a determined time or from a user perspective, it might be important to consider a device suitable for use by patients with certain conditions. You might also be looking at a device through a technical lens, aiming to find something that delivers a drug or volume of payload within a set timeframe.
You’ll need to discuss and capture these requirements as part of your overall product development, defining your user requirements specification and product requirement specification before settling on a solid design output. It can be useful to have an independent facilitator to help with this.
Determine which requirements are a priority for your medicinal product
Once you have captured a list of requirements, it’s good to know which ones are the priority. These are the ones that are essential in addressing the device, before moving on to the ‘nice to haves’ – becoming a way to score and assess medical devices further on in the process.
After the workshop, this criteria can then be defined to score and assess medical devices further on in the process. This is a detailed step that might not need to happen in every case, but it can ensure that all technologies are assessed fairly and equally.
Following this second step, you should have gathered technical, commercial and user requirements for a diverse mix of stakeholders.
Step three: explore
The third step is one of the easiest, as this is where the outstanding options for drug delivery systems are fully explored.
Some data sources where relevant information can be found include:
- consultations with device experts
- attending conferences
- looking at articles and journals from the medical industry
- consulting company websites
- potentially starting initial supplier conversations
Once this information has been gathered, we recommend creating a spreadsheet full of details about each of the devices. It could also be beneficial to create a pro forma template. This should be done for the initial longlist of therapy delivery systems that are being considered.
At the end of this third step, the landscape of possible drug delivery systems has been explored. All the relevant information and data will have been captured for each device and presented in a way that makes it easy to compare your options.
Step four: assess
In the fourth and final step, the technologies should be assessed against the requirements outlined in step two, ‘define’. Using a scoring and selection matrix, an additional column can now be added to hold a ‘weighted score’. This allows you to give an overall ranking for each device.
These numbers will allow you to quickly assess the devices and identify which ones best meet your shortlisted needs. Then you will have systematically scored and assessed the technologies against one another in a fair and equal manner.
So what happens next?
The four steps outlined in this blog navigate the early part of the device selection process and what you need to do to then shortlisting drug delivery systems. Following this, it is likely that further research is required to ensure your device meets the needs of end-users and that it complies with regulations. This may lead to design modifications and other changes throughout your development programme.
Once a shortlist of candidate devices has been determined, what usually follows is:
- supplier assessment
- design modifications and performance testing
- market research and usability testing
- commercial and regulatory processes
Your development team can then make the final device selection.
FAQs
If I’m choosing an existing device for my therapy, are there many options to pick from?
Typically, the breadth of options on offer depends on the therapeutic applications in question and how far you are in the development process. For example, those looking to use an autoinjector for treatment might have broad categories to explore as they are used to administer a number of therapies. But if you are focusing on wearable injectors, you may have fewer options.
This shows the importance of defining those requirements early on in the development journey. They can help stakeholders narrow down their search, prioritising devices that meet the criteria and selecting two or three solid candidates at the end of the process.
Does it matter if you don’t have all the information needed to assess drug delivery devices?
The steps outlined in this blog are a very early stage activity – meaning that information can be refined and gathered as people work through the process. As people start to determine which device will work best for their project, knowledge gaps will be found and acted on – so overall exploratory research can still be navigated through research or even competitor landscaping.
Even if you do not have all the information needed to fully assess the devices, you can always use existing research to help you figure out the rest. It just means that the stakeholders may have to consider a long list of candidates until more information is available.
