MEDical Device design Consulting

A Top Medical Device Development Company

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.

Medical Device Design and Engineering
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.

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.

Medical Device Product Roadmap Development
Understanding the needs of the end users of the medical devices we develop is essential to creating a successful product.  Also critical is understanding how the medical device will fit into the existing market. During the research phase of our medical device development, Speck’s team of researchers coordinates with our industrial designers and engineers to answer key questions about the medical product.

Research and human-centered design thinking are two of our strong points at Speck Design.  Our research implements various methodologies, including online surveys, one-on-one interviews, and ethnographic observations.
Medical Device Definition
Part of our medical device product development is defining its end users, their needs, the needs of all stakeholders and regulatory bodies.  Our approach is human-centered in nature.  We work to design the end-user experience around our medical products. This creates an emotional connection between the user and the product. Regarding stakeholders, the medical device definition aligns goals with regulatory compliance and budget control.  For us, a successful medical device works to improve the lives of patients and caregivers, functions within the initial design parameters, is approved by a regulatory authority, and is preferred by clinical healthcare providers or as a personal medical device.
Medical Device Engineering
As a medical device engineering company in Silicon Valley, we have teams and equipment dedicated to prototyping, testing, and developing medical products.  This allows us to deliver innovative designs to market quicker, but it also gives us greater control over the entire process from the design and development process to launch.  Through our phased approach to medical device engineering, we offer efficient, systematic, and proven services to deliver viable products to market successfully.  The outside partners we utilize are thoroughly vetted long-term associates who have proven to be subject matter experts in their respective fields: three examples of partner fields here. (manufacturing?)

Medical Device Development and Verification

Medical devices are unique and, in some ways challenging for engineering firms. Developing them requires extensive experience in electrical engineering, industrial engineering, mechanical engineering, and industrial design.  However, they also need a firm understanding and proficiency in user research, human-centered design, prototyping, road mapping, and regulatory certification.  Speck Design has decades of experience developing medical products for various uses such as drug delivery devices, handheld surgical devices, patient monitoring devices, home health care devices, and diagnostic medical devices.

This means our teams of engineers and industrial designers can identify and solve issues early on.  It also means we understand the human aspects that must be applied when developing medical products. Finally, our team is prepared to develop medical devices to be verified in compliance and certification (including FDA certification).
Medical Device Roadmapping
Technological road mapping is a framework used in developing many products, including medical devices.  It is a process that involves preliminary activities, development activities, and follow-up activities.

Medical device road map preliminary activities: outline essential requirements, define the scope, develop boundaries under the initial vision.

Medical device road map development activities:  develop critical system requirements, flush out technology drivers, target project advancements.

Medical device road map follow-up activities verify medical product success and make design improvements.
Medical Device Proof of Concept
Proof of concept (POC) is essential for medical device development.  It is a methodology in which our medical product development teams share progress emerging technologies (as defined by the roadmap), and, most importantly, provide our clients with a tangible concept. It is a critical activity for testing designs, assumptions, and technologies.  It should show basic functionality and verify that the medical device development concepts and theories can be achieved on a fundamental level.  This may include failure mode and effects analysis (FMEA) for meeting safety standards by various governing bodies: FDA, CE CSA, UL.

Prototyping Medical Devices

In medical device development, early prototyping is a cost-efficient and time-efficient way of creating a tangible proof of concept for verification and validation.

The interaction between the end-user and the medical device beta prototype is essential for making improvements to the industrial design of the medical device (the look and feel) and the medical product’s industrial engineering design (its function).  These prototypes and the resulting feedback inform our estimated production model timeline and costs as we move forward. This is also one of the most powerful interactions in the human-centered design process.  This is the point at which we can observe the interaction between a human and a medical device and hone in on critical end-user issues that may still need to be solved.
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Quality Systems for Medical Devices

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.

Quality System: “A set of processes and procedures you define and implement to describe how your company addresses medical device regulations, including design controls.”  

FDA defines the rules in 21 CFR Part 820. These regulations are required if a medical device is for the U.S. market. European requirements are a little different. Over there, a quality system be established to meet the medical device regulations (and/or IVD regulations). For this reason, many medical device companies decide to implement a quality system and have it certified to ISO 13485:2016 to fulfill EU requirements.

These are the medical device quality systems that must be put in place before clinical trials:

Design Controls
Risk Management
Document Control & Records Management
Supplier Management  

Medical Device Design Controls
It is essential to design and develop safe medical devices. The FDA, European Commission, Health Canada, and all other regulatory bodies throughout the world will want some assurances that a medical device is safe before it is brought to market. This is the essence of design controls.: proof that a medical device is a safe product that meets user needs and requirements. Our team of experts work closely with our clients to help them meet all requirements by regulatory bodies.
Medical Device Traceability
An industry best practice is the construction of a traceability matrix. This shows linkages and relationship between user needs, design inputs, design outputs, drelationships, and medical product design validation. Building and maintaining your traceability matrix using Excel or Google Docs can be a reasonably straightforward task during the initial months of product development. Once a medical device project progresses, using these general-purpose tools takes days, if not weeks, to properly update and maintain your traceability matrix.

Our medical device development experts have extensive experience planning for these complexities and setting up a system early to ensure that this effort is both efficient and correct.
Medical Device Risk Management
Our team of experts is thorough with defining and documenting user needs, design inputs, Design Outputs, Design Verification, Design Validation, and Design Reviews.

Before clinical use, a medical product must be found to be safe, and/or it must be determined that the medical benefits outweigh the risks (which should be documented in a risk/benefit analysis). We do this through our risk management process.

Our Risk Management process includes:

Risk Management Planning
Risk Analysis
Risk Evaluation
Risk Controls
Overall Residual Risk Acceptability
Risk Management Review
Production & Post-Production Information
Design Controls with Risk Management.

Our risk management process lives throughout our entire product life cycle.
Medical Device Document Control & Records Management
Document control isn’t a single procedure, it is an ongoing process that extends through a medical product's lifecycle, influencing processes at every stage. The better organized this process, the easier it is to leverage the five advantages of an effective document management system. At Speck Design, we have experienced team members that can set up or work with your internal document control systems or records management systems to ensure a smooth process that meets all requirements.

Medical Product Supplier Management  

We have an internal team of individuals focused on managing, finding, and cultivating relationships with suppliers. We have spent years creating supplier relationships that allow us to start each project with relationships and knowledge already built.

Our supplier management follows a few fundamental principles:
Doing appropriate research before adding them.
Communicating early, clearly, and often.
Make sure the part meets your specifications before finalizing the supplier relationship.
Building a relationship of trust and respect.

The quality of one’s supplies and supplier relationships have a direct relationship with the outcomes of a medical device.
Medical Device Manufacturing
The research and development phases of medical devices are the lead-up to the actual manufacturing.  It is called Design for Manufacturing, and this is our specialty here at Speck Design.  We understand every choice we make along the way impacts the eventual manufacturing itself.  We have relationships across the globe and in the US with medical device manufacturers.  This allows us to provide added value in the form of a vetted medical device manufacturing network.  It includes our ability to provide companies:

Reliable medical device manufacturers
Cost-effective medical device manufacturers
Sustainable medical device manufacturers
Large or small-batch medical device manufacturers
FDA compliant medical device manufacturers

Manufacturing partners are critical to any medical device venture and can impact the future success of these types of products.  This makes our ability to safely streamline the manufacturing portion of medical device development an excellent value add of Speck Design.
Featured Medical Device Design and Engineering Projects