While doctors and nurses are often the face of healthcare, behind the scenes, there’s a field that plays a vital role in advancing patient care: medical device design. This innovative discipline combines engineering, creativity, and medical knowledge to develop the tools and equipment healthcare professionals rely on every day to diagnose, treat, and monitor patients.
This post will break down what medical device design is and the key stages of the development process, from napkin sketch to FDA approval. Whether you’re a healthcare professional, an aspiring designer, or simply curious about the technology behind modern medicine, we’ll peel back the curtain on this fascinating intersection of healthcare and engineering.
What Is Medical Device Design?
Medical device design is the process of conceptualizing, developing, and refining diagnostic equipment, preventative devices, or instruments used to monitor or treat medical conditions. Medical devices range from simple tools like bandages to complex implantable devices like pacemakers.
Some popular types of medical products include:
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- Diagnostic devices: Used to detect or monitor medical conditions (e.g., X-ray machines, blood glucose meters, pregnancy tests)
- Therapeutic devices: Designed to treat or manage medical conditions (e.g., insulin pumps, pacemakers, inhalers)
- Life-supporting or life-sustaining devices: Essential for sustaining life or supporting vital functions (e.g., ventilators, dialysis machines, heart-lung machines)
- Surgical devices: Instruments or tools for performing surgical procedures (e.g., scalpels, laparoscopic instruments, electrocautery devices)
- Implantable devices: Surgically inserted into the body to replace, support, or enhance biological structures (e.g., artificial joints, stents, cochlear implants)
- Monitoring devices: Track vital signs and other health parameters (e.g., blood pressure monitors, ECG machines, wearable fitness trackers)
- Assistive devices: Designed to aid individuals with disabilities (e.g., mobility scooters, hearing aids, screen readers)
Different types of medical devices are classified based on their function, intended use, and the risk they pose to patients. In the United States, the FDA categorizes medical devices into three classes: Class I (low risk), Class II (moderate risk), and Class III (high risk). This classification system determines the level of regulatory control and the approval process required for each device, with Class III devices undergoing the most stringent review before market authorization.
Stages of Medical Device Development
Medical device development is the process of transforming a concept into a commercially viable medical product. It’s a structured process that typically involves several distinct stages.
1. Concept and Ideation
The initial stage of medical device product development begins with identifying an unmet medical need. This could stem from clinical observations, patient feedback, or gaps in existing healthcare practices. For example, a surgeon might struggle with a specific instrument, or a patient might find a particular medical procedure too invasive or uncomfortable. By pinpointing a specific issue, designers can target their efforts toward creating a meaningful solution through creativity and critical thinking.
Once they’ve identified the need, the next step is to generate ideas. This involves brainstorming sessions where no idea is too far-fetched. The goal is to explore a wide range of possibilities without immediate judgment.
For example, imagine the identified need is helping individuals who suffer from a distorted sense of smell. Some brainstorming ideas might include a scent-neutralizing nasal spray, a smart air purifier that filters out specific odors, or an olfactory retraining app.
After brainstorming, it’s time to evaluate the feasibility of these concepts. This analysis considers technological capabilities, potential manufacturing processes, and initial regulatory considerations. Designers ask questions like:
- Can this idea be turned into a functional device?
- Is it cost-effective to produce?
- Will it comply with regulatory standards?
The outcome is a clear, well-defined concept that lays the foundation for subsequent development stages.
2. Design and Development
Once a viable concept is in place, the design and development phase begins. This involves detailed design and engineering to transform the initial idea into a functional prototype. Engineers work closely with designers and clinicians to create detailed design specifications, focusing on functionality and usability.
Medical device prototyping is a crucial part of design and development. Initial prototypes are developed and subjected to rigorous testing to evaluate their performance, safety, and durability.
For example, a prototype of a new insulin pump might be tested in a simulated environment to ensure it delivers the correct dosage, is resistant to water and impact, and maintains its functionality over extended periods. The goal is to identify potential issues early in development and refine the design accordingly.
This phase also includes the development of manufacturing processes. Engineers design the methods that will be used to produce the device, ensuring they are efficient, scalable, and capable of maintaining high-quality standards.
For instance, they may develop precise molding techniques for plastic components, optimize robotic assembly lines, or implement rigorous quality control checks at each stage of production. This preparation is essential for the next stage, where the device will undergo more extensive testing and regulatory scrutiny.
3. Verification and Validation
The goal of the verification and validation (V&V) stage is to ensure the medical device is safe, effective, and compliant with all regulatory standards. Verification confirms that the design meets the initial specifications and requirements, while validation shows that the final product meets the intended uses and user needs.
V&V typically includes clinical trials or evaluations. Here, the device undergoes rigorous testing in real-world scenarios to gather data on its performance, safety, and efficacy. This may involve collecting patient-reported outcomes, monitoring vital signs, assessing the device’s impact on quality of life, and comparing it to existing treatments or standards of care. The objective is to demonstrate that the device performs as intended under actual conditions. This process also includes risk analysis, where developers identify potential hazards and mitigation strategies.
Regulatory standards and guidelines play a significant role during this stage. The device must comply with various regulatory requirements, which are often stringent and detailed. The specific requirements vary depending on the target market, as different countries and regions have their own regulatory bodies and standards.
For example, medical devices intended for sale in the United States must meet FDA regulations, while those sold in Europe must obtain a CE mark, which is a license to sell within the European Union. Engineers and regulatory experts work together to ensure all aspects of the design and development process align with these standards.
The final step is compiling documentation to obtain regulatory approval to market and sell the medical device. In the U.S., the FDA requires either premarket approval (PMA) for higher-risk devices or 510(k) clearance for moderate-risk devices with substantial equivalence to existing products. Approval depends on providing clinical evidence, test reports, risk analysis, and other data showing the device is safe and effective for the intended uses.
4. Production and Scaling
Once the device passes V&V, it’s time to transition to full-scale production. This involves ensuring manufacturing processes are robust and scalable enough to produce the device efficiently and in large volumes.
The medical device development company will conduct small-scale production runs to validate processes before ramping up to higher volumes. This helps identify any issues to address and streamline the assembly line. Product samples are also tested again to ensure there are no deviations from the initial design.
Production teams implement stringent quality control measures to comply with Good Manufacturing Practices (GMP). This includes careful monitoring of the environment, equipment, packaging, storage, and distribution. Comprehensive documentation and standard operating procedures for each process are required. Products are closely inspected and tested at multiple points. Any non-conforming products are rejected to ensure patient safety.
Once the small-scale production runs are successful, the process scales by adding more resources and automation. However, quality cannot be compromised in favor of quantity. Additional quality checks are put in place to account for the higher output. This scaling process continues until the maximum production target is reached.
5. Post-Market Surveillance
The development journey doesn’t end with the product launch. Post-market surveillance is a continuous process of monitoring and improving the device’s performance in real-world settings.
This involves collecting feedback from healthcare professionals and patients, analyzing data on device usage and adverse events, and making necessary updates to ensure the device’s safety and effectiveness over time. Firms maintain regulatory compliance requirements through ongoing reporting and documentation.
As technology and clinical practice advance, the device may require updates to remain useful and safe. The manufacturer needs to plan for potential updates, recalls, and end-of-life strategies to properly phase out the device. An end-of-life plan helps ensure devices are replaced, serviced, or safely removed before they become obsolete or unsafe.
Key Considerations in Medical Product Design
Designing a successful medical device requires careful consideration of various factors that can significantly impact its performance, safety, and user acceptance.
- Target user focus: There is a natural tendency to develop a product that can do almost everything, with deep capability and often many, if not infinite, adjustments available. While it may not be what power users prefer, it’s important to simplify functionality to offer only what the majority of medical professionals or consumers will actually use.
- Safety and robustness: Incorporate both primary and redundant safety systems. Minimize or eliminate potential workarounds to prevent unintended use that could compromise safety. This can be as simple as designing a disposable unit to be unusable after the first time, thereby reducing the possibility of introducing potential contaminants into the system.
- Ergonomics: Conduct real-world testing with actual device form and size for hand-held devices. The StudioRed team once monitored multiple surgeries involving an arthroscopic wand and asked surgeons what they might suggest to improve or change. The common answer was, “It’s fine.” However, showing them mockups of various concepts they could hold and react to sparked detailed feedback.
- Sustainability: Disposability and eco-friendly design are valuable in medical device design. Doctors, nurses, technicians, and hospital buyers often respond to thoughtful medical equipment design solutions that consider these factors. Not only will this resonate in the sales cycle, but it will also likely become a point of pride for the hospital.
- Compliance: Consider the device’s target countries and ensure compliance with relevant standards (e.g., UL, FDA, FCC, CSA, CE, RoHS). A safety consultant usually counsels the team during component selection, development, and testing.
- Documentation: Maintain detailed design history files throughout the development process, including emails, specifications, research, testing reports, and design files. It’s important to keep files in chronological order to document the development process and rationale behind design choices.
The best medical device design companies maintain an internal copy of all file revisions. StudioRed has always followed this practice, and many clients return years later asking for a copy of the final design and engineering files.
Trusted Medical Device Design Solutions Since 1983
StudioRed has been a trusted name in medical device product design for over 40 years. Our expertise and dedication to excellence ensure that your medical device will meet all regulatory standards and user needs. Partner with us for your medical product design projects, and let’s bring your innovative ideas to life.
Contact StudioRed today to learn more about our medical device design services and how we can help you succeed.
