Medical Products

We assist from concept to launch—evaluating user requirements, studying competitive patents, finding patent opportunities, handling regulatory compliance issues, selecting approved materials and processes for manufacturing, processing documentation for FDA submissions, and designing the Product Brand Language.

Cross-disciplinary project teams pull from our seven in-house disciplines: design and innovation strategy, user research, industrial design, interaction design, mechanical engineering, electrical engineering, and software engineering.

Our consumer and commercial work enhances our larger understanding of user needs, materials, and processes, along with design trends and emerging technology.

With more products featuring digital interfaces, design doesn’t end with the physical product. Our interaction designers and electrical engineers are often part of the project team. Their contributions may include user interface architecture and visual design for embedded touchscreens as well as the underlying electronics hardware and firmware.

The development of mobile apps as companions to medical devices often comes into play. (Learn more about our integrated Digital-Physical Design expertise.)

Human factors and usability engineering not only help maximize the ease of use, efficiency, and user satisfaction of any product, but they are FDA-required components of medical device design.

Medical device designers must conduct human factors validation testing to demonstrate that the intended users of a device can use the product to perform the intended uses in the intended use environment.

This effort is commonly referred to as usability engineering, and the goal is to ensure that the device has been optimized to eliminate, or reduce to the furthest extent possible, use errors that could cause harm to a patient.

Delve employs a wide array of user research techniques to help clients navigate through the human factors regulatory process, from initial product design to final validation testing.

We have extensive experience executing user research aligned with regulatory guidance and are well-versed in standards requirements, including

• FDA Guidance 1757: Applying Human Factors and Usability Engineering to Medical Devices
• AAMI/ANSI HE75:2009 Human Factors Engineering—Design of Medical Devices
• AAMI/ANSI/IEC 62366-1:2015, CE marking (Europe)
• Medical Devices Directive 93/42 EEC (Europe)

Formative Testing

Formative studies are typically conducted to help inform the design refinement of product concepts and prototypes.

They will typically include evaluations with representative users to answer design questions, identify strengths, probe for weaknesses, and detect potential use errors that may occur while using a product.

Conducting formative testing early and regularly throughout the design process can help medical device companies save time and money before final products or prototypes have been created.

Formative testing can be done in a wide variety of forms, including qualitative interviews, quantitative testing of one or more prototypes, and statistical analysis of observational data across multiple usability studies to investigate improvements in safety and usability over time.

Delve helps clients define the optimal formative testing plan to align with their product, development plans, and regulatory pathway. Then, our researchers efficiently and effectively execute the studies, providing clients with the timely answers needed to assess if a product is safe and effective.

For those who plan to sell their product across international markets, Delve collaborates with national and international partners to help clients connect to relevant users across the globe.

Human Factors Validation Testing

Human Factors Validation Testing, also called “Summative Testing” or “Simulated Use Validation Testing,” is required by some regulatory bodies—specifically the FDA—to demonstrate that the production-ready product can be used by the intended users, for the intended uses, and under the expected use conditions, without causing harm or degrading medical treatment.

A minimum of 15 users per user group (i.e., a set of users with distinct characteristics) must use the final product to perform critical tasks (i.e., tasks that could lead to medical harm) in a representative use environment.

Delve's team of human factors experts can help companies execute all stages of validation testing, from defining the user groups, uses, and use environments, to creating a risk analysis, to conducting the simulated-use validation testing.

European Medical Devices Regulation (MDR)

Medical device manufacturers who have a device with a CE mark or who are looking to submit a CE Marking Technical File need to ensure they are up to date with the new EU Medical Devices Regulation (MDR), which went into effect May, 2020.

The new EU MDR regulations will place greater scrutiny on the history of the research that has been conducted to ensure the “safety and health” of users and patients, as well as on the information to be included with your product [instructions for use (IFU), implant card, labeling, etc.].

This new regulation is four times longer than its predecessor, the Medical Device Directive (MDD). To meet these new requirements, additional labeling and IFU comprehension studies and usability studies may be necessary.

A gap analysis of your Design Dossier may be an ideal starting point to identify the needs to be addressed. Read more about how the new MDR relates to human factors and usability.

Usability Engineering for Risk Management

To ensure that a device has been designed such that critical tasks can be performed safely and effectively, medical device manufacturers must conduct a risk analysis to identify the risks associated with device use and the measures that have been implemented to reduce those risks.

A well-crafted usability engineering plan ensures that user research efforts directly consider the use tasks identified as critical by risk management efforts.

Delve has considerable experience working with companies to create risk analyses, including defining the tasks necessary to safely and effectively use the product, identifying potential use errors and the associated clinical consequences, and assigning severity levels (highlighting critical tasks that must undergo validation testing).

Ethnographic Research

Products for which development is informed by user research are safer, make fewer cognitive and physical demands on users, are easier to learn, and simpler to use.

More and more often, companies are realizing the potential return on investment of early integration of user research-driven insights and human factors into their product experience design process.

This early-stage research often takes the form of ethnographic research or contextual inquiry.

We routinely go into the field to observe surgeons, healthcare consumers, patients, and other users in a broad range of contexts from homes to hospitals — and in U.S. to overseas markets.

Our researchers identify design opportunities informed by the real-world eco-systems where the products are expected to perform.

When we can’t be there, we use current and emerging technology to gather and analyze data.

Go to Design & User Research to learn more about our generative research methods (ethnography and observation, interviews, benchmarking, and competitive analyses) and evaluative research methods (human factors evaluation, simulated use, and comparative testing).

Medical devices deliver some of our toughest development challenges.

Our robust team of mechanical and electrical engineers use advanced tools to design medical products with complex mechanical and electromechanical systems.

Our highly experienced and skilled team of degreed engineers is equally proficient leveraging hand calculations as they are the most advanced CAD-based analysis tools.

These help us identify and solve for issues in the early stages of the design process — and shave precious time off of project schedules.

Prototyping and Testing

As described in Engineering Analysis and Optimization, we build and test prototypes to put all design options through their paces both virtually and physically.

We’re frequently developing proof of principal models and building subsystems to remove risk from the process.

With the tools in our engineering lab, we have the ability to simulate, test, and optimize for many factors.

Ultimately, our engineers will conduct failure mode and effects analysis (FMEA) with advanced CAD tools to determine design performance.

This rigorous testing proves that each medical product meets the safety standards put in place by various governing bodies, such as the FDA, CSA, CE, and UL.

Getting To Production Ready

We work in parallel with client and production partners to make sure everything is ready to roll into efficient production.

This process consists of: material and processes specification, vendor selection, detailed part design, software fine-tuning and testing, failure mode analysis, tolerance analysis, additional expert reviews to ensure compliance and effective manufacturing, and building and testing a beta prototype.

Though we’re capable of managing production, more typically we act as a consultant to the process and address opportunities for improvements as they arise.