Mark Tunkel, global category director, Services at Nemera, explores the factors that should be considered when developing a device strategy in the current technology landscape, and how a holistic approach can lead to better and more long-term decision making.
Key insights:
- It is critical to fully understand the patient journey as well any related clinical processes at the earliest stages of establishing the functional requirements and user needs for a new device application.
- The selected device and drug should be appropriate, safe and effective for the target population - optimising the patient experience to create competitive differentiation,.
- Clinical risks must be identified through conducting formative and summative usability testing for all aspects of the device and supporting assets.
An increasingly complex landscape for combination products
The complexities involved in selecting or developing the correct device for a combination product have never been more challenging. A convergence of trends, including significant growth in the global drug-development pipeline, the need for more complex delivery devices to address targeted applications and drug attributes, and increased migration of care from clinical to self-administration in home settings have driven demand for a wide range of solutions. This is coupled with a crowded competitive landscape in the biologics, biosimilars and generics segments, in which multiple competitors may be pursuing the same applications.
Pharma companies are under increased pressure to driven patient centricity, increase speed to market, reduce their risk, and create value for patients and other stakeholders across the landscape. Beyond the patient, this includes an ecosystem of stakeholders including providers, namely healthcare professionals, but also health systems; payers, to consider factors such as value-based care; and regulators, as the market for product introduction and the intended filing approach can impact device selection and development strategies. These factors then need to be considered within the available or emerging technology landscape.
All these factors lead to a need for developers to adopt a holistic approach to developing a device strategy, which is focused on the entire combination product that spans development stages and requires specialised expertise at every step of the process and balancing a variety of factors and influences that need to be considered. This leads to better near- and long-term decision making across the life cycle of drug products.
Integrating the voice of the patient into development
We believe at the earliest stages of establishing the functional requirements and user needs for a new device application, it is critical to fully understand the patient journey as well any related clinical processes.
Our team of design research utilises a method called applied ethnography to achieve this goal. This relies on interviews and in-context observations of practices, processes and experiences within the patient’s home or use environment. Potential use cases are looked at broadly beyond the administration event or complying with instructions for use. This starts from when a patient is diagnosed, to receiving their device, through the entire process of preparing, administering, and disposal and the times in between treatment to understand how the process changes over time and how frequency of administration may impact the patient experience.
It is equally important to gain an understanding of the experience of healthcare professionals to consider relevant settings in clinical environments. This is important in applications where care is being provided in both in home and clinical environments as well as a migration of care, such as an oncology ward, with significant support systems to an environment of self-administration where clinical personnel are not present and the burden of support falls to a family member or caregiver.
The outputs include patient journey maps, clinical process maps, an understanding of prioritised user needs and values, and pain points that can be leveraged toward improving the patient and provider experience.
This supports meeting needs holistically while making decisions around assessing the technology landscape to identify existing IP or platforms that may be fit for the intended purposes related to function and drug product attributes. This includes decisions around modality and variations within if considering existing IP platforms and may also lead to the development of a novel delivery system in which this foundation can be utilised to establish user needs and functional device requirements.
Surrounding the device for safe, effective and differentiated combination products
Once a technology or development project has been initiated its human factors and patient experience, activities must be integrated to ensure an efficient development process. The selected device, in combination with the drug, is appropriate, safe and effective for the target population. This also extends to optimising the patient experience to create competitive differentiation, and to ensure adherence and engagement with patients and clinical stakeholders. A good example of this approach might be the consideration of a biosimilar application where competitors are targeting the same reference drug and devices. Alternately, for NDAs and new device development programmes, the company needs to project what a future use case might look like and anticipate areas of risk to ensure that development is tailored to mitigate them. In both instances, the company needs to be sure that it is addressing the defined user groups populations and early use-related risk analysis activities to define the human factors and usability program.
Clinical risks must be identified through conducting formative and summative usability testing for all aspects of the device and supporting assets in alignment with the human factors programme definition, including the production of human factors engineering report documentation for use in for regulatory submissions. This process is linked to developing instructions for use, value-added packaging, as well as leveraging digital health related add-ons to support patient engagement/ adherence, as well as extend the value of a device platform. This can also be augmented by fit for purpose pre-clinical, clinical, and small series device supply to accelerate development timelines and defer capital expenses. It is crucial this is all completed holistically.
Benefits of partnering with an integrated service provider
Nemera’s integrated development, consulting, and manufacturing services allows customers to achieve the outcome of a successful regulatory submission and commercial launch of safe, effective, and differentiated combination products with a single partner applying an agile process across the device and combination product value chain. This will drive patient centricity, reduction of risk, and increased speed of market access. This approach can be applied to our IP platforms or with organic development and allow customers to focus on their core business.