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by Jeremy Kooyman
Earlier this month ACI held their European Prefilled Syringes Summit in London. As part of Cambridge Design Partnership’s Drug Delivery team, I was invited to give a talk on Advanced Delivery Technologies and discussed some of the steps a pharmaceutical company could take to ensure that the next combination product they developed was a commercial success.
The pharmaceutical industry is currently experiencing an era of unprecedented public engagement and regulatory scrutiny. Companies like Turing, Valeant, and Mylan have caused consumers to become increasingly sensitive to the prices of their prescriptions. This is further compounded by large tech companies like IBM, Apple, Intel, Microsoft, and Google starting to make medtech and pharmaceutical business units – Google’s Verily in particular either has or has had collaborations with Johnson&Johnson, Medtronic, Biogen, GSK, Dexcom, Abbvie, Sanofi, Novartis, and Roche, suggesting that the previously reigning pharmaceutical companies could begin to change over time.
With the incumbent titans having their turf encroached upon by tech giants and voracious start-ups armed with new technology designed with a consumer in mind, we believe that the next generation of medical devices and combination products needs to be developed from a consumer perspective, rather than the traditional patient mind set, in order to be commercially successful. These industry shifts are creating customers who are demanding more from their products and there are a limited number of regulated medical products that exist which can meet these demands, exceeding the Regulator’s expectations of “Safe and Effective for use”. Of course, innovation within the boundaries of pharmaceutical development can be quite challenging from a drug delivery device perspective since the molecule will always be the focal point for development expenditure, and this is the crux of the issue I attempted to tackle with my talk.
Pharmaceutical development is driven from the molecule and this is inherent in the way new drugs are brought to the market.
Phase 1 and 2 trials determine safety and therapeutic effects of the drugs, and it’s not until phase 3 where the device is considered to be relevant to the development program.
Given the limited amount of time between a phase 2 trial completing and a phase 3 trial beginning, it is a rather challenging environment for device manufacturers. Still, this makes perfect business sense given the frequency of phase 1 & 2 trial failures, except that as we move towards new types of therapies like protein-based biologics, there’s an increased level of patient interaction with the delivery device due to drug development constraints like higher viscosities resulting in longer injection times. This makes the application of advanced delivery technologies like on-body delivery systems and wireless connectivity very appealing as they can provide solutions to these challenges, however this approach ignores the needs of the user and the patient who, as we discussed earlier, is starting to have higher expectations on their drug delivery devices.
This technology first development pathway is commercially low-risk but it’s also commercially low-reward as there’s a high chance that the product will fail to resonate with consumers. In the consumer space, this leads to a commercial failure and the product is often pulled from shelves within a year. It manifests differently in the pharmaceutical space, however, since new drugs are rarely pulled unless there’s a safety concern, patients who’re prescribed with the therapy become disengaged leading to reduced dosing compliance. This is a looming problem in the pharmaceutical space as talks around adherence and compliance-based insurance reimbursement start to loom in the wake of ever-expanding healthcare costs. We believe that there are three simple rules to combat this problem and none of them require modifications to the existing drug development framework:
1. The first rule of Advanced Delivery Technologies is: you don’t talk about Advanced Delivery Technologies!
In our experience, clients come to us with a technology driven product they’d like developed by our engineers which, upon gentle questioning, appears to not necessarily be addressing a burning problem with their target market. We like to encourage our clients to take a step back from their identified solution and make sure they’ve adequately identified the problem.
2. Find the Sweet Spot
As a business, you’re going to understand the realities of your market better than any consultancy, but how well do you know the stakeholder ecosystem surrounding that market? To find the sweet spot, there needs to be a balance between:
- Stakeholders (Buyers, Payers, Patients, Doctors, Service Providers, Benefits Managers etc.)
- Your Business (Success criteria, routes to market, business models, investment levels)
- The available technology (Materials, Mechanics, Sensors, Communications).
This often takes the form of ensuring that you’re addressing unmet needs of your stakeholders and making sure that they actually want what you wish to sell. But it is also balanced against your business requirements of investment levels and success criteria. Only when stakeholder and business needs are understood should you then look to technology.
3. Build the Minimum Loveable Product (MLP)
Unless you’re targeting an orphan drug or aiming to be first to market, minimum viable products don’t work in the long term. They can’t withstand competition, they create disengaged users, and can result in tangential ecosystems of products providing missing functionality to your device. As we argued above, your patients-now-customers have a consumer mind set, so whatever product you’re aiming to bring to market needs to have a clear definition of what “better” means. Maybe it’s simpler, faster, smaller, or often it’s something that makes the user happier. Your customers don’t care about the latest flashy technology, they care about managing their disease and they want a device that helps them with their daily lives.
Careful consideration of these three rules changes the role of stakeholders in existing drug development frameworks, from groups whose opinions are solicited and considered into partners in the process. Imagine performing a small phase of research work in parallel with early-stage drug development which consulted stakeholders beyond the business and explored issues like dosing volume, frequency, storage, and our favourite “How much does your existing therapy suck?”
This information can be used to guide both drug and device development by generating insights like; daily dosing frequency being tolerable if the injection pain was reduced. This could open up new paths and totally change the development direction – so rather than expending large amounts of money on the development of a drug with a higher concentration for less frequent injections, a company could target the drug delivery device to inject at a speed designed for the drug viscosity in order to reduce the injection pain. By the time the Design History File is being compiled, the regulator’s expectations of a patient centred development framework are easily reflected due to the stakeholder emphasis taken from the start of the drug’s development.
Innovation doesn’t require paradigm shifts, particularly in risk-adverse industries. Finding ways to identify new and lucrative markets within rigid regulatory and development frameworks is challenging but can be done as our clients will attest.
If you’d like to learn more about the research, design and development work we’re doing in the consumer, medical, and pharmaceutical spaces, email us at email@example.com or call +44 (0)1223 264428.
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