Want to talk to us about medical devices?
TTP has been working with clients to design and develop medical devices for over 30 years. Our multi-disciplinary team has completed numerous parenteral developments for pharma companies. Projects routinely cover front-end innovation and product definition through to industrialisation support.
Looking ahead, it won’t be about the drug or even the combination of drug and device: with the introduction of value-based healthcare the way in which therapies are evaluated will change. TTP understands this complexity and we work with our clients to engineer outcomes.
Poor medication adherence can have a serious impact on both patient outcomes and the bottom line for the pharmaceuticals industry. One difficulty in improving adherence is that it can take twelve months of patient testing to get feedback on a novel device design.
TTP set itself the challenge of coming up with a way to predict adherence and has now developed a deterministic model for this purpose. This model helps to: identify reasons for poor adherence; rank device design features; input to cost-benefit decisions; and structure discussions and brainstorms. Once the model has calculated an adherence score, TTP have also developed a design toolkit to guide discussions on improvement options.
As connectivity becomes a central element of healthcare, TTP is working with its clients to overcome the challenges and deliver meaningful and valuable solutions to the markets. A common early decision is whether to add sensing/connectivity to an existing device or integrate it in a new device (with many intermediate options possible). From navigating healthcare economics and driving patient engagement, to addressing data security and developing ultra-low power devices, TTP has been at the forefront of development for 30 years.
The pain associated with injecting a drug is often pushed off pharma companies’ priority lists during drug development by other, much-discussed challenges. It is rarely missing from users’ priority lists. Further, absence of pain is a key driver in decision making: reducing pain is expected to materially improve adherence in many cases.
But pain is complicated, and VAS pain testing requires a largely developed device. TTP has developed capabilities linking biomechanical modelling of key injection processes to an applied knowledge of the peripheral nervous system – device design choices can now be made not only to give the most consistent delivery, but also the most tolerable one for users.
Vials/PFS/OTS devices fulfil many market needs. But where they don’t, there is still a requirement for simple, bespoke, devices. TTP has an outline design for a simple autoinjector that can be made in 7 or 8 parts.
Many upcoming therapies can’t use existing delivery devices because of large volume and/or high viscosity and/or complex delivery profiles. Although needs appear disparate, “slow” is a common factor. TTP sees the potential for a new category of device ranging from simple mechanical to complex electromechanical.
TTP’s robust device design approach extends all the way from incorporating a deep understanding of the users through human factors to advancing engagement with manufacturing partners.
The core of our technical and design work is to avoid complexity with clever concepts; we support decision making with scientific models, and we anticipate manufacturability and reliability performance through probabilistic design. The latter goes beyond traditional tolerance analyses to predicting functional performance through mathematical models of the key mechanisms.
This approach has not only proven successful with our own designs but has also enabled TTP to support clients facing the scale-up problems that often arise with less robust device development styles.