MEDical Device design Consulting

Medical Device Innovation

Speck Design is a top medical device design company and engineering company. We offer end-to-end design services for the development of medical products and have extensive experience researching, prototyping, designing, and bringing new medical devices to market. We also have expertise in reimagining existing medical devices for new or improved usage.

research

Conducting various research methods such as user research, ethnographic research, and concept research are imperative to medical technology development.

Experience Design

Due to the importance of the devices in the life and well-being of patients, it is essential to ensure a superior user experience (UX) in the designing and development of medical devices. A suitable user experience will guarantee safety and usability and decrease errors.

Human factors

The goal of human factors for medical devices is to design medical products that users can operate safely in real-world situations, leading to increased worker productivity and improved performance at the point of care.

engineering & Design

The complexity of medical device creation presents specific challenges that require an integrated engineering and design team to work together to create a successful product.

Verification & Validation

Verification and validation of medical devices in our design process ensures that the device is aligned with the need of targeted users and delivers the intended solution while meeting regulatory standards.

Quality systems

When creating a successful medical product, additional steps are needed to set up and maintain quality systems to meet regulatory requirements. We have extensive experience setting up quality systems for medical devices.

Medical Design Development Process

As a medical device product development and engineering company, we prioritize functional design that emphasizes intuitive creativity and calculated scientific decision-making. We’re committed to creating impactful products and medical devices that define their markets and industries and create new intellectual property. Our highly collaborative environment allows Speck’s designers and engineers to find innovative solutions that consider and define product form and function, usability, physical ergonomics, marketing, brand development, sustainability, and sales.

10% of Electrical Medical Devices Pass the Required Standards on the First Submission. Companies Speck Assists' Success Rate is over 72%

Our teams work to offer medical device design and development services, including industrial design, mechanical and electrical engineering, and setting up, running, and maintaining medical quality systems. Our approach is always human-centric, applying our human-centered design-thinking to the process to come up with creative, empathetic solutions in medical device design, product engineering, regulatory compliance, user research, and more. Throughout the last 25+ years, we have done design, engineering, and development across a vast set of medical devices and categories, including:

‍
- Drug delivery devices
- Handheld surgical devices
- Patient monitoring devices
- Diagnostic medical devices
- Digital interface design for medical devices
- Medical device user research
- Home health care devices

As a top medical device design firm our work also includes life sciences projects such as product definition, technology roadmap discovery, future concept development, interface design, user research design, usability testing, engineering development and verification, design for CLIA certification, proof of concept prototyping, beta prototyping, ISO 13485 certified, FDA compliance, and intellectual property support.