Transformation Towards Human-Centered Medical Devices: Service Design for Product Management

Part I

Introduction

Why do we need another book on service design?

Along with business and technology considerations, innovation should factor in human behavior, needs, and preferences. Human-centered design thinking – especially when it includes research based on direct observation – will capture unexpected insights and produce innovation that more precisely reflects what consumers want.

Tim Brown: Design Thinking

Harvard Business Review 2008

In the above quotation, Tim Brown summarizes the human-centered design approach, the ideology behind service design. Combining this mindset with the framework of (IVD) medical device standards and regulations increases the likelihood that the developed medical devices are safe and clinically relevant as well as meet customer demand and expectations. Standards and regulations stress the importance of focusing on the user but, naturally, do not offer practical tools to achieve this. Medical device products are more than goods. As a practical, human-centered, and holistic approach, service design can complete the medical device manufacturer’s toolbox for designing the aspect of service and experience. Service design may help close the distance between the product manager and the customer and help co-create added value.

Over recent decades, service design has shown its versatility, serving a range of purposes from organizational strategy to product and service development. The master’s thesis research this handbook is based on concluded that service design remains underutilized by medical device and IVD medical device manufacturers and that industry-specific service design content is needed to increase awareness in the industry. Service design has increasingly been adopted by organizations across various industries, including companies involved in emerging technologies. It’s time for medical devices to follow suit.

Numerous case studies have highlighted service design's potential to optimize healthcare operations and patient experience in hospitals and other caregiving settings. On the other hand, there is little evidence of medical device manufacturers using service design.

In the worst case, medical device manufacturers lack systematic user involvement and needs-driven product development, which leads to innovations that are predominantly product- or technology-driven. A culture of training the user on poorly designed products instead of developing the products to fit the user’s cultural context or capabilities has been observed in the medical device industry. A medical device product manager is often responsible for translating the voice of the customer to the rest of the development team. Co-creation with the medical device user may not be straightforward, but it’s often vital or at least worth the effort. This book aims to provide practical resources to improve user involvement in all types of product management projects, including product development.

Based on academic literature, involving the user in product development brings multiple benefits for both the user and the manufacturer. However, literature also suggests manufacturers face challenges with involving the user.

Benefits of user involvement

increases product safety

improves the health of patients

provides access to user experiences and ideas

improves usability and understanding of the user’s cultural context

improves clinical effectivity

helps to meet user needs and clear clinical needs

ensures that the correct device is developed

Challenges of and attitudes towards user involvement

manufacturers do not always perceive end users (especially patients) as a key success factor

lack of resources and the perception that human-centered methods are too resource intensive

may commence a time-consuming ethical approval process

lack of use and/or understanding of formal user research methods

product development processes failed to provide the necessary guidance and support for the establishment and enforcement of the use of rich and valid user insights

The service design tools, thinking and process may open new ways to do product management. They lighten the product manager’s load of communication, administrative, and development tasks. Service design a good approach for strategy, troubleshooting, and (user) research. Like one co-creator of this handbook said:

"It's not a new idea to base product development on the voice of the

customer, but it's great to have a process for that."

Service design benefits both external customers and the organization's employees. The advantages of service design become most evident when it’s implemented throughout the organization. Medical device product management and related functions can be a viable path to introduce the service design approach in a medical device manufacturing organization.

For organizations, service design may provide

deep exploration of competitive advantages and market demand

transition from innovation to creating value for profitability

attraction and retention of a new generation of talents

a way to dispel organizational silos.

To conclude, this book aims to inspire the reader to increase user involvement through design thinking and service design. It explains why, where, and how a medical device product manager or manufacturer can use service