Three patient-centricity factors in neurotech device development

Neurological disorders are among the most frightening illnesses we face, yet there are very few effective disease-modifying therapies available. For some neurological issues, treatment involves lifestyle changes, physiotherapy, and pain management, with medication to prevent or slow worsening of the condition, though there is no cure.

In response to this, the emergent sector of neurotech has witnessed a convergence of therapy and technology to improve the diagnosis, treatment, monitoring, and management of patients with neurological disorders. Despite the advancements in neurotech evolving at a rapid pace, the sector has been hampered by suboptimal care pathways lacking adequate infrastructure, as well as ill-defined approaches to reimbursement that struggle to support innovation. New companies entering the sector must differentiate themselves to achieve commercial success, adoption in healthcare systems, and, above all, optimal patient outcomes.

We have identified three key factors that organizations developing neurotech should consider to build meaningful and commercially resilient solutions.

1. Address heterogeneity

Heterogeneity is an inherent characteristic of neurological diseases. The vast inter-patient differences in disease presentation, symptoms, cause, and progression make diagnostic decisions, prognosis, and treatment difficult. Differences observed between patient populations are also exacerbated by a variety of genetic and environmental factors including, lifestyle, disease state, age, overall health, and genetic versus sporadic presentations of the disorder.

The heterogeneity of neurological disease is a key challenge to disease understanding and treatment development. However, compiling data directly from the patient can offer two key benefits. First, insights from data and information collected can be fed into product development to better adapt the product to heterogenous patients. And second, the rich patient data gathered from pilot studies provide a better understanding of neurological diseases. This data can inform clinical research, care, and diagnostic tools. Specifically, patient data could be built into clinical claims and potentially facilitate regulatory approval for organizations developing neurotech.

Currently, patient experience data are used in the form of patient-reported outcomes (PROs) and other types of clinical outcome assessments (COAs) but are often used as secondary or further exploratory endpoints. Importantly, recent advancements to the PFDD (patient-focused drug development) guidance emphasize a shift to adding greater weight to the patient voice. This change, which highlights the value of listening to and incorporating the patient voice, aims to create a more robust and systematic approach to obtaining qualitative patient experience data.

2. Fill specific unmet needs

In many cases, patients living with neurological disorders report unmet healthcare. A study found that almost 20% of individuals living with epilepsy were more likely to report that they had unmet healthcare needs compared to the general population. This shared frustration has brought together communities and patient advocacy forums and has led to the development of several patient-led ventures to accelerate change.

One example is My Moves Matter (MMM), a patient-founded startup to support peri-menopausal women with young onset Parkinson’s disease who have identified changes in their symptoms and medicinal efficacy during fluctuations in their menstrual cycles. MMM provides a solution to a patient group whose requirements are not well understood or even documented. Capturing data this way can progress the clinical understanding of the disease and ultimately lead to better care, therapies, and patient outcomes in the future. 

Neurotech companies can learn a lot from the patient voice, and in this case, incorporating the patient voice can drive human-led product development, ultimately creating an improved, tailored solution that adequately fills a gap in needs. Another company, Charco Neurotech, has iterated its non-invasive wearable medical device for people with Parkinson’s from the currently available CUE1 device to the in-development, next generation CUE2 device based on patient feedback. Similarly, Cumulus Neuroscience has placed users at the center of its early-stage design of EEG headsets for CNS clinical trials to increase the likelihood of long-term engagement from all users and stakeholders.

3. Increase understanding of conditions and alleviate stigma

Stigma toward people with neurological disorders presents serious consequences for the impacted individuals, such as social exclusion, workplace discrimination, and increased difficulties in the recovery process. A study by European Federation of Neurological Associations found that as many as 92% of those living with a neurological disorder feel affected by stigma.

Some of key contributors to stigma are lack of knowledge, misunderstandings, and myths in disease presentation and progression. A report published by Sue Ryder, a British palliative, neurological, and bereavement support charity, revealed 67% of the public had little to no knowledge of neurological disorders, and 45% were unable to name even one condition. Listening to patient voices is critical to improving awareness and alleviating this stigma.

The patient voice arms neurotech developers as it provides them with invaluable sources of qualitative information. This can be used in improving care solutions, which directly reduces the disease burden on the patient as well as feelings of discomfort and self-consciousness attributed to their neurological disorder.

Neurotech companies can also leverage their platforms to build their products’ reputations via patient engagement and communication channels, such as disease forums, patient advocacy groups, and blogs. Through these mediums, the sharing of patient experiences with their disease and its management can enhance understanding of the disease for patients, caregivers, and wider society.

In response, some neurotech companies are moving from purely product-based commercial models to deliberately combined product and service models, which ensure direct and continuous patient touchpoints. This constant feedback informs future product and service development and aims to maximize patient outcomes.

However, this combined product and service approach requires fresh commercial engagement from healthcare systems, which need to be willing to move beyond fee-for-product and recognize the value in a fee-for-service model. This delivers first-hand insights and continuous improvement. Healthcare systems will need to be open to novel reimbursement pathways and ultimately build a healthcare system that values and helps to scale innovative neurotech solutions.

Conclusion

Success for neurotech innovators relies not only on devising innovative new products and services but also on building a business model designed to capture the patient voice and incorporate it into product development. The potential for value outcomes is great; patient voices will directly benefit patient outcomes through building richer disease data sets, which can contribute to clinical claims, regulatory change, disruption of traditional clinical treatment pathways, and improved early diagnosis, as well as alleviating stigma attached to neurological disease.

Read the Med Device Online article