The multidisciplinary challenge of bringing medical wearables to market

Here, I outline the key considerations shaping the development of medical wearables today and how early, multidisciplinary collaboration can accelerate devices from concept to commercial readiness.

Biocompatibility and materials selection for medical wearables

Medical wearables must perform reliably in direct contact with the body, so materials science plays a defining role in device performance, comfort, and long-term safety. Early materials selection enables teams to design with real-world conditions in mind, rather than retrofitting the device later. 

Components must be: 

• Skin-safe and biocompatible. 

• Resistant to sweat, movement, humidity, and temperature changes. 

• Durable for extended wear periods. 

• Suitable for cost-effective and scalable manufacturing. 

Addressing materials needs at the start helps reduce problems such as poor adhesion or skin irritation that often surface during user trials. By shaping technical choices early, materials scientists ensure that user needs, clinical requirements, and manufacturing constraints inform the design process from day one. 

We worked with NeoBand to develop a wearable temperature monitoring band for babies that require emergency transport. Our expertise in materials and formulation were key for the success of this life-changing innovation. 

Engineering wearables for real-world performance

Once the right materials are identified, engineering decisions determine whether a wearable functions effectively in real-world environments. Devices must strike a balance between comfort and performance, as well as innovation and manufacturability. This involves integrating hardware, electronics, and user experience considerations into a single, coherent design. 

Successful wearable devices depend on: 

• Battery life and ultra-low-power processing. 

• Sensor accuracy during movement. 

• Wireless communication and reliable data transfer. 

• Washability and long-term durability. 

• Manufacturability at scale. 

• Circularity and sustainability. 

• User-centred design principles. 

Technically impressive devices that are difficult to manufacture, maintain, or wear rarely progress to market. Co-design approaches are therefore essential. Bringing together designers, engineers, manufacturers, clinicians, and end-users helps ensure that prototypes are practical, scalable, and ready for use in both clinical and commercial environments. 

Six emerging technologies shaping next-generation wearables

Emerging technologies continue to shape the future of wearable innovation. Understanding these trends early helps teams plan for evolving clinical expectations and new market opportunities. 

1. AI and edge processing

Ultra-low-power processors increasingly allow AI-driven analytics to run directly on devices. This improves response times, supports continuous monitoring, and enhances data security by reducing reliance on cloud transfer. 

2. Smart wound care

Printed sensors, hybrid electronics, and new skin-compatible materials are enabling wound dressings that can monitor healing conditions in real time. Future versions may integrate therapeutic functions, creating intelligent wound-care systems. 

3. In silico modelling

Multiphysics and multi-modal simulations offer valuable ways to evaluate device performance and human interaction before physical prototypes are made. Regulatory pathways are evolving, but modelling can reduce development cycles and risk. 

4. Minimally invasive wearables

Microneedle systems are emerging for biomarker sampling and drug delivery. When combined with microfluidics and multi-modal sensing, they could support closed-loop treatment in home-based settings. 

5. Energy harvesting and wireless power transfer

Advances in transcutaneous and wireless energy technologies may reduce reliance on large batteries, enabling longer-term device operation. 

6. Ubiquitous wearables and smart garments

Progress in printed, flexible, and stretchable electronics is enabling longer wear times and discreet physiological monitoring, supporting next-generation smart garments and ​“invisible” sensors. 

Together, these emerging technologies demonstrate the pace of innovation in the sector. They also highlight the need for multidisciplinary thinking, since each technology creates new materials, engineering, clinical, and regulatory considerations. 

Regulatory and clinical pathways for wearable devices

Regulatory and clinical planning must begin early, as requirements influence every stage of device development. Integrating regulatory strategy from the start helps reduce redesign, ensures compliance and reduces the risk of failed submissions. 

Common challenges include: 

• Selecting the correct Notified Body or regulatory pathway. 

• Submitting incomplete technical documentation. 

• Misclassifying the device under EU MDR, IVDR, or FDA requirements. 

• Insufficient evidence of Quality Management System (QMS) utilisation. 

In the EU, regulatory review can take 18 months or more, depending on device type and evidence requirements. Establishing an appropriate QMS early and ongoing regulatory support helps teams build a robust, auditable foundation for market approval. 

User-centred design in medical wearable development

Clinical accuracy alone does not guarantee commercial success. Devices must be intuitive, comfortable, and trusted by their users. User-centred design ensures that the wearable genuinely fits into patients’ lifestyles and clinical workflows. 

Structured user-testing cycles help refine: 

• Size and comfort. 

• Interface design.

• Ease of application and removal. 

• Integration into daily routines. 

Involving patients, caregivers, and clinicians throughout development ensures that wearability, usability, and trust are prioritised from the start, reducing the risk of abandonment and creating devices that better support real-world uptake. 

Multidisciplinary collaboration: the foundation of successful wearable development

Wearable device development is inherently multidisciplinary. Integrated working enables teams to resolve challenges that span biology, engineering, and clinical applications. 

Collaboration enables:

• Early identification of cross-cutting issues. 

• Faster iteration cycles. 

• Reduced technical and regulatory risk. 

• Clearer communication of requirements. 

• Stronger product architectures. 

CPI sees these benefits first-hand. Through shared laboratories, integrated project teams, and coordinated innovation programmes, CPI helps organisations of all sizes move efficiently from concept to commercial readiness. 

Funding and investment for MedTech wearable innovation

Developing medical wearables is a resource-intensive process, and many start-ups and scale-ups face significant financial and strategic challenges. Sound funding strategies support technical progress and reduce barriers to investment. 

Key challenges include: 

• Managing cash flow during long development cycles. 

• Navigating regulatory uncertainty. 

• Securing investment for high-cost R&D programmes. 

• Demonstrating early clinical evidence to reduce investor risk. 

Combining non-dilutive funding with strategic investment planning can help organisations progress more predictably. CPI supports companies with grant writing, investor readiness, and technical de-risking to strengthen commercial narratives and build confidence with investors. 

Accelerating progress through integrated development

Medical wearable development requires coordinated expertise across scientific, engineering, clinical, design, regulatory, and commercial domains. Many challenges arise not from technical limitations but from fragmented workflows and siloed teams. 

A collaborative, multidisciplinary approach supports: 

• Faster and more reliable development. 

• Reduced rework and technical risk. 

• Improved user experience. 

• Stronger regulatory and clinical readiness. 

• Accelerated pathways to market. 

If you’re developing a medical wearable and want to accelerate your route to market, contact CPI to explore how our multidisciplinary teams can support materials development, device engineering, regulatory strategy, and clinical readiness. Let’s innovate together.