Patient engagement in the medical-device industry
Patient engagement in medical technology brings patients' practical needs into product development and communication. Smaller companies, limited resources and established working practices can make it difficult to turn support for engagement into routine activity.
Adoption and obstacles
Medical technology has adopted patient engagement more slowly than the pharmaceutical industry, partly because it consists largely of smaller niche companies, although some companies match large pharmaceutical firms in revenue. A medical-technology industry survey found that 60% of respondents valued patient perspectives but only 15% had fully integrated patient engagement initiatives. In a separate survey of medical-technology marketers, about 88% reported that their organisation lacked a fully resourced, centralised patient engagement function.
Valuing engagement does not mean that a company has the function, systems, knowledge or resources to implement it effectively. Smaller budgets can limit the resources available for a dedicated function. Other obstacles include cultural resistance, entrenched practices and concern about the complexity of engagement. Patients' diverse needs also have to be balanced with technical and regulatory requirements. Medical technology's natural agility and the contribution of medical writers and communicators can help overcome some of these challenges.
Product acceptance and usability
Without patient involvement, drug-device development can lose patients’ distinctive perspective and risk producing treatments that do not meet their needs, with lower uptake, adherence and health benefits. It can also affect a company's reputation for patient centricity.
Exubera, marketed by Pfizer, was the first inhaled insulin formulation approved by the FDA in 2006 for type 1 or type 2 diabetes. Its device was bulky, and preparing a dose required patients to consult a complex chart and make conversions. About seven years later, Afrezza from MannKind was available in the United States with a more compact, discreet device and dosing in simple units, allowing quick administration.
Patient input during a combination product's lifecycle
For drug-delivery combination products, patient engagement can add value at concept development, design and testing, and education and training; these are examples rather than an exhaustive list.
| Stage | Patient contribution |
|---|---|
| Concept development | Firsthand experience of daily challenges can identify practical needs and gaps and direct research and clinical trials towards them. |
| Design and testing | Patient involvement can help make devices intuitive and user-friendly; prototype feedback can identify usability problems and improve functionality, while human factors studies provide data on performance in everyday settings. |
| Education and training | Patients can help make materials clear, accessible and relevant to diverse user groups and identify common questions and concerns, facilitating smoother adoption and potentially better compliance. |
Medical writers' contribution
Medical writers can champion patient voices by advocating for involvement and developing clear, patient-focused materials. Discussing the benefits can increase the patient voice where lack of awareness or cultural resistance limits engagement. Involving patients in development can help align treatments with their needs and improve real-world adoption and adherence. It can demonstrate patient centricity, increase trust in a company and the wider industry and differentiate companies whose products patients trust.
Patient involvement can reduce recruitment time and increase trial success in clinical trials and device testing, bringing economic benefits. Involving patients in scientific communication can also increase its reach and quality. Engagement throughout the medical-device lifecycle can strengthen trust and transparency, which support successful adoption.