Medical Device Development

Improve health outcomes by developing complex, highly engineered medical equipment that meets the highest standards of performance, safety, and availability.

What is medical device development?

Medical device development is the development of special-purpose appliances, implants, or other instruments designed to improve health outcomes. Some medical devices, such as pacemakers or insulin pumps, combine hardware with embedded software that continuously monitors and controls the device. Medical device development has improved the quality of life of millions of patients and is one of the most complex and rewarding areas of scientific discovery today.

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What are the five phases of medical device development?

Phase 1: Initiation and Risk Analysis

The first step in developing a medical device is identifying a medical need that isn’t being met. The creators begin to develop and assess the feasibility of the device, known as a “proof of concept”. Devices are designed according to their classification. There are three types of classification for medical devices that range from the least amount of risk to the most.

Phase 2: Conceptualization and Feasibility

In the next step in development, a prototype of the device is built. This is an early version of the designed product. The prototype needs to undergo rigorous testing before it can move on to the next phase. This phase is to ensure that the device will work when tested on human subjects and reduce the risk and potential for harm.

Phase 3: Design and Development/ Verification and Validation

Depending on the level of risk of the device, the pathway to approval becomes more rigorous. Class 1 devices don’t need pre-market approval, whereas Class 2 and 3 devices do. Regulatory control is the most stringent for Class 3 devices.

Phase 4: Final Validation and Product Launch Preparation

Once a device has passed the validation process and enough information on a device’s safety has been gathered, they can begin the application to market the device to the public.

Phase 5: Product launch and Post-Launch Assessment

Monitoring after the device has been introduced to the public is essential to keeping the public safe from harm. There are continuous manufacturer inspections, companies are mandated to report any problems, and the FDA will soon begin monitoring these devices in real time.

Phase 1: Initiation and Risk Analysis The first step in developing a medical device is identifying a medical need that isn’t being met. The creators begin to develop and assess the feasibility of the device, known as a “proof of concept”. Devices are designed according to their classification. There are three types of classification for medical devices that range from the least amount of risk to the most. Phase 2: Conceptualization and Feasibility In the next step in development, a prototype of the device is built. This is an early version of the designed product. The prototype needs to undergo rigorous testing before it can move on to the next phase. This phase is to ensure that the device will work when tested on human subjects and reduce the risk and potential for harm. Phase 3: Design and Development/ Verification and Validation Depending on the level of risk of the device, the pathway to approval becomes more rigorous. Class 1 devices don’t need pre-market approval, whereas Class 2 and 3 devices do. Regulatory control is the most stringent for Class 3 devices. Phase 4: Final Validation and Product Launch Preparation Once a device has passed the validation process and enough information on a device’s safety has been gathered, they can begin the application to market the device to the public. Phase 5: Product launch and Post-Launch Assessment Monitoring after the device has been introduced to the public is essential to keeping the public safe from harm. There are continuous manufacturer inspections, companies are mandated to report any problems, and the FDA will soon begin monitoring these devices in real time.

What are medical device development best practices?

Integrated Product Delivery

Align medical device hardware, software, and service teams. A single pane of glass solution lets teams collaborate, manage change, channel feedback into design decisions, and focus on quality.

Shared Requirements Management

Highly engineered medical products can have thousands of discrete requirements. A shared requirements management platform allows teams to specify and manage requirements using compliant approval processes.

Collaborative CAPA and FMEA Management

Adopt a whole-team approach that provides transparent access to risks, hazards, failure modes, corrective and preventive actions (CAPA), and other risk-relevant data in a central repository. Integrate FMEA analyses into daily workflows and monitor progress. Prepare for audits with dashboards and reports that demonstrate compliance with ISO 14971, IEC 60812, and other relevant standards.

Reuse

Engineering efficiency climbs sharply when teams share common libraries of information organized by logical groupings. Version-control, branch, and merge information as needed to jumpstart new projects.

Automated Risk Management Workflows

Define and enforce tailor-made processes to automate the risk management lifecycle, embedding risk assessment in daily design and development processes. Custom workflows guarantee that no team members can deviate from established procedures, and accelerate company-wide response to escalations.

Medical device classifications

The FDA separates medical devices into three classes based on their risk level to consumers.

Class I

A medical device class refers to the amount of risk involved to the patient. Medical devices, such as bandages, oxygen masks, tongue depressors, and even basic surgical tools, are considered lowest risk under Class I but still have general controls set forth by the Food and Drug Administration (FDA) to maintain quality and safety for consumers.

The general controls consider:

  • Good manufacturing practices
  • Standards and reporting adverse events to FDA
  • Registration
  • General recordkeeping requirements

These FDA controls ensure that devices are still safe and effective once they’ve gone to market. If the device is considered generic enough to be exempted from FDA clearance for US marketing, such as stethoscopes and bedpans, there is no need for pre-market approval. These devices must be listed by the FDA and their establishments registered. Class I comprises 47% of devices and 95% of those devices do not have to go through the regulatory process.

Class II

Class II devices, which comprise 43% of all medical devices, including syringes, catheters, blood pressure cuffs, and some software used for diagnostic tools, have a higher level of risk than Class I, which requires additional regulation. For Class II devices, researchers and developers must complete premarket notification to show that their device is different than those already on the market and prove that the device is safe and effective through evidence from human clinical trials to gain premarket approval.

Due to the riskier nature of Class II devices, they are subject to special controls. These special controls involve:

  • Labeling requirements (information that must be included on a product label)
  • Device specific mandatory performance standards
  • Device specific testing requirements

Additionally, these devices are subject to the general controls for Class I.

Class III

Because Class III devices carry the greatest risk, Class III requires both premarket and postmarket surveillance. Only 10% of devices fall under Class III classification and include devices that usually sustain or support life or can be implanted into the human body, like heart implants or insulin pumps. Like Class II, Class III requires premarket approval, as well as general controls. The path to market requires stringent regulations and close monitoring throughout human clinical trials.

What are the challenges of medical device development?

Complexity

Highly engineered medical products can have thousands of requirements. Without the right toolset, simply finding the right information to work with can become a monumental task.

Highly engineered medical products can have thousands of requirements. Without the right toolset, simply finding the right information to work with can become a monumental task.

Regulatory

Products, as well as their development processes, are subject to stringent criteria and complex, market-specific, and ever-changing regulatory requirements.

Products, as well as their development processes, are subject to stringent criteria and complex, market-specific, and ever-changing regulatory requirements.

Security

Medical devices must be secure and inaccessible to bad actors and unauthorized personnel.

Medical devices must be secure and inaccessible to bad actors and unauthorized personnel.

Cost

In some markets, medical products must meet specific cost-benefit and performance targets in order to qualify for insurance acceptance.

In some markets, medical products must meet specific cost-benefit and performance targets in order to qualify for insurance acceptance.

Safety

Medical devices must be proven safe and effective for pre-market approval and must maintain that safety record throughout post-market surveillance.

Medical devices must be proven safe and effective for pre-market approval and must maintain that safety record throughout post-market surveillance.

Quality

Medical devices must meet the highest standards of safety quality. They typically require an auditable quality management system and demonstrable process maturity.

Medical devices must meet the highest standards of safety quality. They typically require an auditable quality management system and demonstrable process maturity.

Understanding risk management for medical devices

Risk analysis is required by the FDA to ensure patient safety. Researchers need to include risk analysis information with their application for a new medical device and must continue to prove its safety throughout the product lifecycle. This helps to prevent failure or hazards and keeps patients informed of the risk involved in using a medical device.

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Requirements, risk, and test management for medical device developers

Bring quality medical technology products to the market quickly and at optimal cost with Codebeamer. Adhere to the requirements of ISO 13485, IEC 82304-1, ISO 14971, IEC 60812, IEC 62304, ISO 60601, EU MDR, FDA Title 21 CFR, and more. Design for excellence and demonstrate regulatory compliance with minimal effort.

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Frequently asked questions

What is a medical device?

According to the Food and Drug Administration (FDA), the body that regulates medical devices in the United States, a medical device is “any instrument, machine, contrivance, implant, in vitro reagent that's intended to treat, cure, prevent, mitigate, diagnose disease in man.” Examples range from extremely simple tools, like tongue depressors or stethoscopes, to more complex devices like pacemakers or robotic surgical devices. Devices differ from pharmaceuticals because they don’t involve chemical activation or need to be metabolized or applied to the skin.

What are some examples of medical devices built with embedded software?

Examples of embedded systems in medical devices include defibrillators, blood pressure monitoring devices, digital flow pumps, heart monitoring machines, insulin and glucose monitors and pumps, surgical robots, pacemakers, CT and PET scanners, MRIs, mammography equipment, surgical navigation systems, and much more.

How is medical device software development unique?

Unlike other types of software development, medical devices systems typically:

  • Are extremely complex, requiring the integration of electrical, mechanical and software components and the collaboration of multiple requirements, design, development, and test stakeholders
  • Are subject to stringent and continuously evolving regulations in the markets they serve
  • Control parts that are not easily updated, and must operate flawlessly over the life of the device or patient
  • Are mission- and safety-critical, requiring the highest levels of quality, security, and reliability
  • Require real-time response, mandating a RTOS and programming language
  • Operate within a low power consumption environment
  • Must be manufactured to meet the highest standards of precision, cleanliness, and performance in or near the human body

What is the regulatory landscape for medical device development?

Medical devices are highly regulated in order to ensure their safety, performance, and reliability. Regulatory standards and guidelines govern not only the device quality, but also the rigor of processes used to develop and monitor them. The regulatory landscape for medical device manufacturers covers every aspect of product development, from pre-market surveillance and pre-market approval to ongoing post-market surveillance. By selecting an ALM platform with built-in support for medical device standards, organizations can streamline compliance and focus on innovation.