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It’s impossible to underestimate the role of software technology in healthcare. It assists in real-time patient monitoring, prevents the development of crises, keeps track of patients, monitors equipment status, and many other areas. The end-user and their needs are the center of these technologies.
This understanding should be vital in designing a healthcare product, as well as following standards and regulations and keeping up with rapidly changing industry trends. This is what we explore in this article, along with the challenges that the company developing such a product may face.
Product design in healthcare is the process of creating a product that meets the needs and requirements of the healthcare industry. Its goal is to improve patient outcomes and enhance the quality of care. This field combines principles of design, engineering, and healthcare.
Among the most prominent examples of such product design are medical devices (wearable health monitors, diagnostic equipment, and infusion pumps) and healthcare software (electronic health record systems, telemedicine platforms, and different health apps). They aim to create solutions that improve patient care, clinical outcomes, and overall efficiency in the healthcare institution.
When balancing the benefits and challenges of product design, the healthcare field requires a cautious approach. Successful design requires collaboration between designers, engineers, healthcare professionals, and regulatory experts. Among the most prominent benefits of are:
Improved patient outcomes. Well-designed healthcare products can improve patient outcomes by addressing specific healthcare needs. For example, devices that enhance monitoring or treatment adherence can contribute to better health management.
Enhanced user experience. User-centered design principles can result in healthcare products that are more intuitive, user-friendly, and tailored to the needs of both healthcare professionals and patients. A positive user experience can lead to increased adoption and compliance.
Increased efficiency in healthcare delivery. Innovative product designs streamline healthcare processes and reduce time and resource burdens. Among such solutions are systems that automate routine tasks, optimise workflow, and contribute to more efficient healthcare delivery systems.
Speaking of the main challenges, it’s important to note the following:
Stringent regulatory compliance. Following the regulatory standards and obtaining certifications is a significant challenge. The process can be time-consuming and complex. It also requires frequent updates and makes it challenging to launch products on time.
Interoperability issues. Achieving seamless integration with existing healthcare systems and smooth interoperability is usually challenging. Lack of standardisation can hinder effective communication between different parts of the system.
Data security and privacy concerns. Healthcare products involve storing and management of sensitive patient data. Ensuring data security and maintaining patient privacy is challenging, especially with the increasing frequency and sophistication of cybersecurity threats.
Insufficient user research. It’s vital to pay attention to aspects such as ethical, cultural, and language peculiarities. While conducting user research, consider who will mostly use the product — healthcare providers or receivers.
Product design in healthcare is vital for creating solutions, prioritising patients and improving clinical outcomes. Also, they optimise workflows, drive innovation, and ensure the safety and compliance of healthcare products. These are the areas where it shines:
Enhanced patient experience. Thoughtful product design results in products prioritising patient needs and experiences. Whether it’s a medical device or a healthcare app, these contribute to a more positive and comfortable healthcare experience, resulting in better patient satisfaction and engagement.
Improved clinical outcomes. Well-designed healthcare products provide more accurate diagnoses, effective treatments, and better clinical outcomes. Innovation in product design plays a critical role in advancing medical technologies. Ultimately, it benefits patient health.
Efficiency and workflow optimisation. Efficiently designed healthcare products streamline workflows for healthcare professionals. User-friendly interfaces, intuitive designs, and interoperability contribute to smooth processes. This reduces the time and effort required for tasks and enhances the overall efficiency of healthcare delivery.
Innovation and adaptability. Product design drives innovation in the industry. It fosters the development of new solutions to address emerging challenges. Telemedicine platforms and wearable devices enable healthcare systems to adapt to changing patient needs, tech advancements, and industry trends.
Safety and regulatory compliance. Meticulous medical product design processes ensure that products meet safety standards and regulatory requirements. Following these standards is crucial for patient safety. They also prevent introducing potentially harmful or ineffective products into the market.
Transform your healthcare vision into reality. Let’s discuss your design needs.
Designing and developing a healthcare product involves a systematic approach and includes the following steps:
1. Defining the problem and identifying user needs. Understand the healthcare problem or need your product will address. Research existing solutions, user experiences, and industry trends. Engage with healthcare professionals, patients, and other stakeholders to identify their needs, challenges, and expectations.
2. Conceptualization and ideation. Brainstorm to generate ideas and concepts that address the identified problems. Consider usability, feasibility, and innovation. Create rough prototypes or mockups to visualise and test your concepts. These might be paper sketches, wireframes, or digital prototypes.
3. User-centered design. Create user personas to represent the characteristics and needs of your target audience. Apply user journey mapping to understand the end-to-end experience of interacting with your product.
4. Technical design and development. Develop detailed technical specifications and design documentation based on the chosen concept. Create functional prototypes to test the technical aspects of your design. Implement the design in an iterative fashion, continuously refining and improving based on feedback.
5. Regulatory compliance. Understand and comply with relevant healthcare regulations and standards. Prepare necessary documentation for regulatory submissions and approvals.
6. Testing and validation. Conduct usability testing with real users to identify and address design flaws. If applicable, conduct clinical trials to validate the efficacy and safety of the healthcare product.
7. Iterative refinement. Continuously gather feedback from users, healthcare professionals, and stakeholders. Use feedback to make iterative refinements to the product design and functionality.
8. Implementation and production. Once the design is finalised, scale up production processes for mass manufacturing or software deployment. Implement rigorous quality control processes to ensure consistency and reliability.
9. Deployment and launch. Plan and execute a strategic market entry, considering pricing, distribution, and marketing factors. Provide training materials and support resources for users and healthcare professionals.
10. Post-launch monitoring and updates. Continuously monitor the performance and user feedback after the product is launched. Provide regular updates to address issues, add new features, and ensure ongoing product relevance.
Foster collaboration between designers, engineers, healthcare professionals, and regulatory experts throughout the entire process.
Designing healthcare products requires careful consideration of user needs, regulatory compliance, and the unique challenges of the healthcare industry. Here are five main tips to guide the design process:
1. Build your design around the user. Prioritise the needs and experiences of end-users. These are healthcare professionals, patients, and caregivers. Understand their workflows, preferences, and pain points to create a product that is intuitive, efficient, and aligned with user expectations.
2. Follow regulatory standards. Stay informed about those regulations applicable to medical devices and health technologies. This includes obtaining necessary certifications and approvals to ensure the safety and legality of the product.
3. Allow for interoperability. Ensure seamless integration with existing healthcare systems and technologies. Compatibility with diverse devices and software enhances the product’s utility and facilitates data exchange across different platforms.
4. Focus on security and privacy. Implement robust security measures to protect sensitive patient data. Prioritise data privacy and confidentiality to comply with healthcare regulations and build user trust. Consider encryption, access controls, and other security features.
5. Emphasize usability and accessibility. Make your product user-friendly for users with varying levels of technological proficiency. Ensure that the design accommodates users with different abilities and considers factors such as font size, color contrast, and navigation simplicity.
6. Ethical considerations. Be mindful of ethical concerns, especially when dealing with sensitive health information. Prioritise transparency and user consent in data collection and usage.
7. Consider scalability and future-proofing. Design the product with future advancements in mind. Allow for updates and adaptations to keep pace with evolving healthcare needs and technologies.
Medical product design and development are subject to various standards and regulations. They ensure the safety, efficacy, and quality of medical devices and health technologies. The specific standards and regulations can vary by region, but several international standards and regulatory frameworks are commonly referenced. Here are the key ones:
ISO 13485 – Medical devices – Quality management systems – Requirements for regulatory purposes.
An international standard that specifies requirements for a quality management system in the design, development, production, installation, and servicing of medical devices.
ISO 14971 – Medical devices – Application of risk management to medical devices.
Provides a framework for risk management in the design and development of medical devices, helping to identify, assess, and control risks throughout the product lifecycle.
ISO 62366 – Medical devices – Application of usability engineering to medical devices.
Focuses on usability engineering processes to enhance the safety and effectiveness of medical devices by addressing user interactions and user interface design.
IEC 60601 – Medical electrical equipment.
A series of international standards specifying general safety and essential performance requirements for medical electrical equipment.
IEC 62304 – Medical device software – Software life cycle processes.
Outlines software development lifecycle processes for medical device software, covering design, maintenance, and risk management.
Besides those mentioned above, there are different lists of standards in the U.S., Europe, Canada, Japan, China, etc.
Ongoing technological advancements and evolving healthcare needs shape the future of medical product design. These are a few of many trends that are likely to influence its trajectory:
1. Digital health and telemedicine. Integrating digital technologies, including telemedicine platforms, remote patient monitoring, and health apps, will continue to play a significant role. Designers will focus on creating seamless, user-friendly interfaces for virtual healthcare delivery.
2. Wearable health technologies. Wearable devices for health monitoring, such as smartwatches and fitness trackers, will become more sophisticated. Future designs may incorporate advanced sensors, real-time data analysis, and enhanced user experiences to encourage continuous health tracking.
3. Artificial Intelligence (AI) and Machine Learning. AI and machine learning will be integrated into product design to improve diagnostics, treatment planning, and personalised medicine. Designers will need to create intuitive interfaces that enable healthcare professionals to interact effectively with AI-driven tools.
Furthermore, this could help to eliminate the middlemen’s involvement, which is incredibly money-consuming. A recent U.S. report on medicare spending on drugs found that 70% of spend goes to middlemen (primarily PBMs, wholesalers, and pharmacies) and only 30% to the pharmaceutical companies developing medicines. Similar dynamics exist in every other vertical: hospital care, medical equipment, and insurance. AI could eliminate these inefficiencies, from automating repetitive human jobs to exploring new and better business models for providing care.
4. Human augmentation and robotics. Using robotics and human augmentation technologies in healthcare will impact product design. This includes exoskeletons, robotic surgery systems, and assistive devices. Designers will focus on optimising user interfaces for collaborative work between humans and machines.
5. Precision Medicine. Advances in genomic and personalised medicine will influence products. They will be designed to support the delivery of precision medicine, including diagnostics, targeted therapies, and treatment plans tailored to individual patient profiles.
6. Blockchain for healthcare. Using blockchain technology for secure and transparent health data management will impact product design. Designers must create interfaces that ensure user-friendly interactions with blockchain-based healthcare systems.
7. Augmented and Virtual Reality (AR/VR). AR and VR technologies will be broadly used in medical training, patient education, and therapeutic interventions. Designers will focus on creating immersive and effective user experiences.
8. Sustainability and eco-friendly designs. There will be a growing emphasis on sustainability. This includes eco-friendly materials, energy-efficient devices, and designs that minimise environmental impact throughout the product lifecycle.
The future of healthcare product design looks highly diverse and promising, with rapidly changing and expanding patient and healthcare organisation demands. This implies there will always be room for new solutions in the technology market.
In the working process, it is crucial to ensure the product’s compliance with respective requirements and regulations, align with the needs and problems of end-users, and provide the product with the capability for updates and improvements.
The healthcare field itself is incredibly demanding. The same can be said about the design and development of healthcare products. There are strict demands and regulations, as well as plenty of space for creativity. It’s a very dynamic sphere, and chances to succeed rely on the tech partner you work with.
Blackthorn Vision is a company with years and years of experience in product design for the healthcare area. Our teams developed health-tracking apps, fitness programs, and diagnostic software. We keep an eye on industry development and ensure the use of the newest technologies and application of the latest trends.
If you have an idea in your mind and want to implement it — contact us. Also, drop us a line if you need consulting, improvement of your existing system, or if you have more questions about healthcare product design.
Medical product design is creating the concept, developing, and refining healthcare solutions. Their mission is to meet the needs of patients, healthcare professionals, and the healthcare system as a whole.
Medical product design includes creating medical devices, software applications, and technologies. It requires a thorough understanding of user needs, rigorous testing, and following the quality standards. The final result is a safe, effective, and innovative healthcare product.
An excellent example of great design is smartwatches with sensors that monitor physical activity, heartbeat, and related trends. Also, wearable devices that monitor sugar levels, smart knee wraps that assist in rehabilitation, dental diagnostic software, home workout apps, etc. The programs healthcare institutions use to store and analyse patients’ data, find trends, and manage healthcare processes are also worth mentioning.
