Medical procedures are made easier and more effective by medical devices. This includes everything from catheters and tongue depressors to pacemakers and surgical lasers. However, the development and manufacturing of some medical devices and devices is one of the most difficult processes and requires precise specifications and high quality standards.
In this article, we clarify the medical device development process and analyze its phases and challenges. We also discuss considerations and tips for manufacturing medical products.
What is medical device development?
The development of a medical device into a marketable product is known as medical device development. It includes several steps that facilitate the transition of the product from its raw form to its usable form in the medical industry.
Medical device development engineers must follow the individual phases of medical device development. They must also adhere to strict legal regulations and carefully document their work to ensure quality standards and easy reproducibility.
Important steps in medical device development
Medical devices must be manufactured with high precision and care. This ensures that these products meet the diverse purposes for which they were designed. Therefore, the development life cycle of a medical device must pass through certain important phases. See how to create a medical device in phases.
Phase 1 – Ideation, conceptualization and risk analysis
This phase lasts about one to two months. Medical device development begins with careful planning, in-depth research and accurate documentation. For this process to be successful, it is important to consider opportunity and risk assessments, as these will also determine whether the project progresses or stagnates in later stages.
However, developing a medical device is difficult and requires careful consideration of its requirements. This data supports your risk analysis. A complete development strategy must be established for your medical device. However, the first phase of a medical device development strategy often includes the following steps, in order:
- Specify the use of the device or medical device;
- Find out if there are already products on the market that meet this need;
- Determine what makes the proposed product different from what the customer wants to ensure it is viable.
- The collected users should be used as input to the design process.
- Analyze the common user interactions that would occur with the product, be it a developed or existing gadget.
Phase 2 – Regulatory Compliance and Feedback Collection
This is one of the most important phases in medical device development and includes design and regulatory compliance. The formal risk assessment process and gathering regulatory and customer requirements become increasingly important in this second phase of medical device manufacturing. Now is the perfect time to proactively address threats and consider the needs of your consumers.
Customer feedback is extremely valuable. Therefore, it is important to actively collect them through surveys and interviews. Use these valuable insights in combination with market research and competitor analysis to design your product.
Phase 3 – Design development and validation
This is the development, verification and validation phase of the medical device design. The focus of Phase 3 is to control the production of the inputs and outputs of the medical device design. Medical device design criteria include various components such as product drawings, bill of materials (BOM), specifications, work instructions, and more.
Validating and confirming your design is an important part of the third phase of medical device development. During this phase, you must follow a consistent planning, design, review, and approval process. This method reduces the risk of errors and potential harm to end users while leaving an auditable record of actions taken.
At this stage it is important to answer questions such as:
- Manufacturing and quality plan and whether outsourcing is an option;
- What testing equipment would be needed;
- Test methods for validation and verification;
- The best way to meet customer needs.
Phase 4 – Manufacturing and Testing Phase
Teams of engineers, production personnel, quality assurance specialists, and regulatory experts must coordinate their efforts during this phase. It includes several crucial elements, from design for manufacturing (DFM) to quality control.
These teams work together to improve medical device design and ensure a smooth and effective manufacturing process. Therefore, DFM strives to optimize production processes, increase productivity, save costs and reduce the likelihood of manufacturing difficulties. You can accelerate the transition from prototype to mass production by applying DFM concepts throughout the design process.
Furthermore, materials with the required qualities and in compliance with legal requirements are carefully selected. Building a strong supply chain and finding reliable suppliers is essential to ensuring continued quality and availability of materials.
Phase 5 – Clinical trials and approvals
This is the clinical testing and approval phase, which typically lasts about 1 to 3 years. It is important to inform the medical authorities in your country before placing the device on the market. The approval process differs depending on the risk of the device. Class III devices are the most stringent and must undergo clinical testing before receiving a PMA (Premarket Approval).
Another aspect of Phase 5 is FDI. The IDE (Investigational Device Exemption) is the process by which clinical trials for medical devices can begin. Medical administrations can accept, reject, or accept with restrictions FDI. If the IDE is rejected, studies cannot begin until the deficiencies are corrected and updated data is submitted for approval.
Phase 6 – Commercialize the product
This is the final phase, which includes the introductory and post-marketing phases. It is important to highlight that the post-commercialization phase has no duration, as it is continuous.
Your products and quality management system (QMS) will be ready for market as soon as the FDA approves them. A reviewed and confirmed production schedule is critical to ensuring on-time delivery, staying within budget, and most importantly, producing safe, high-quality medical devices.
It is essential to continually ensure that your strategy complies with legal standards. Therefore, you must regularly inspect, audit and randomly check your production processes and QMS. These steps are an efficient way to identify and resolve issues caused by batch-to-batch variations.
Course and timeline for medical device development
Depending on the product, the development and approval of a new medical device can take several months or even years. The deadline generally depends on the class of the device.
Class I devices
Because of their low risk, the FDA can sometimes approve these devices within a week. These include electric toothbrushes, oxygen masks and tongue depressors. Most Class 1 non-invasive devices can self-register with the FDA.
Class II devices
Class 2 devices pose a medium risk. These include, for example, syringes, catheters and contact lenses. Manufacturers must compare their device with another approved device to demonstrate the product's efficacy and safety.
However, the approval period may change depending on the type of device submitted. For example, the average approval time for anesthesia machines is 245 days. For toxicological devices, the approval period is shorter, around 163 days.
Class III devices
The most intrusive and dangerous devices are Class III devices. They represent approximately 10% of all medical devices, such as defibrillators, medical robots, cochlear implants and implanted prosthetics. Due to the increased risk, these devices undergo the most rigorous testing during the development phase to receive approval.
Medical bodies like the FDA require convincing scientific evidence that these products are safe and effective. Approval of Class III devices typically takes 243 days (or eight months) after submission. Note that this wait time has drastically decreased recently.
Benefits of Medical Device Prototyping
Developing medical device prototypes is important and useful because it facilitates the proper manufacturing of medical products. Here we discuss the benefits of this development in the medical industry.
Check product viability to reduce risks
Before committing to further development and investment, you can develop a prototype to determine the viability of the project, collecting feedback and finding suitable investors. For some projects, additional technical investigations may be required to confirm that conceptual ideas are viable before series production, as many projects will be very innovative.
Ensures regulatory compliance
Every company has requirements for products, but the medical industry has more requirements than others. Compliance with these requirements is essential, as failure to comply with these requirements can result in costly sanctions or even legal action.
Most importantly, medical device development facilitates regulatory compliance. Throughout the device development process, for example, prototyping can reveal potential FDA violations that must be addressed before manufacturers scale up production.
Validate and test
Prototypes can be produced, designed and tested to efficiently develop early-stage products and validate concepts. While some complicated and unusual projects may require multiple iterations of medical device prototyping to achieve the necessary advancement, medical device development helps streamline processes, thereby increasing the chances of success.
Medical device development challenges in prototyping and production
Medical device development is a dynamic, multifaceted process that involves a series of complex steps, from conception to market launch. Prototyping and production are important steps on this path, but they also bring with them some challenges.
Material selection
Choosing the material for the device is usually one of the first phases of the project. Medical devices often require allergy-free materials, such as medical plastics, which are also robust and can withstand constant washing or contact with chemicals. To transmit radio frequency (RF) signals, the material may also need to be transparent to RF.
Financial management
Balancing the need for high-quality materials and manufacturing processes with budget constraints is a constant challenge. Developers must optimize costs without compromising the safety and effectiveness of the medical device. Therefore, the transition from prototype to production requires careful financial planning to avoid cost overruns.
Iterative design
Prototyping often involves performing multiple iterations to refine and improve the design. The iterative nature of the design process can be time-consuming and impact project timelines and budgets. Rapid prototyping techniques can help speed up this phase, but finding a balance between speed and accuracy remains a challenge.
Regulatory challenges
It is crucial that all parties involved in the development of a medical device have a clear understanding of the product's regulatory requirements. Issues with regulations frequently arise during the production process.
Those involved must inform themselves about relevant federal laws and international standards. This familiarity provides them with a level of insight and helps prepare them for future related challenges.
Considerations and tips for medical device development
The development of medical devices is a demanding process, with no room for error, as human lives are at stake. If you want to develop or produce a medical device that meets and exceeds industry standards, you must consider several factors.
Data generation and storage
Does your product produce or use data? How is this information stored in it? How do individuals and other machines gain access to this data? Do they need to be encrypted if they aren't already? You may be working with a medical device developer to select the best and most secure method for collecting, storing, and distributing all the data generated by your product.
Testing usability
Conducting thorough usability testing with representative end users helps identify and resolve potential issues early in the prototype development process. This iterative approach improves the overall user experience and reduces the risk of usage-related errors.
User Security
Ultimately, the safety of a product must take precedence over all other aspects. If this is not the case, it becomes a burden and not worth it. Many of the amazing medical products currently in development are manufactured without considering this crucial factor, resulting in dangerous devices.
Cost and time
Many problems can arise during the development of medical devices, from sourcing materials to developing prototypes. It is important to carefully analyze these issues and create a realistic timetable and budget to make medical device development less expensive and time-consuming.
Design and development regulations as well as risk management for medical devices
Regulatory authorities such as the Food and Drug Administration (FDA), the European Medicines Agency (EMA) and other international bodies have developed a wide range of regulatory documents and risk management procedures. The aim is to ensure safety precautions at all stages of the development and production of medical devices.
An international non-governmental organization called the International Organization for Standardization (ISO) creates standards to ensure the effectiveness, efficiency and quality of goods, services and systems.
Standards for quality management systems (QMS) are set out in ISO 13485, which applies to both manufacturers and innovators of medical devices. This standard provides medical device manufacturers with guidance to ensure the highest level of product safety and quality.
Manufacturers use techniques such as HAZOP and FMEA to manage risk. HAZOP is a study performed to examine and evaluate current operations or processes to identify potential problems or hazards associated with the design of medical devices.
FMEA, on the other hand, is a structured method for checking the parts of a device. All possible errors are looked for and the risk of these errors is assessed.
Prototyping and production of medical devices with WayKen
Common questions
What is medical device research and development?
Medical device research and development covers several high-level topics, including competency monitoring and training, standards management, and document control. Verification and validation, risk management and ease of use also play an important role in medical device research and development.
Is FDA approval important for medical devices?
Yes, medical devices often need to be approved by medical bodies like the FDA. Before they are marketed and sold, the FDA reviews medical devices to ensure their effectiveness and safety.
