An Ultimate Guide To Medical Device Prototyping

Medical device prototyping must meet certain criteria, and rules of healthcare, and be user-friendly. Because, medical devices are intended to diagnose, cure, or mitigate diseases, conditions, or abnormalities without the use of chemical action or metabolism. Small mistakes in design can lead to life-threatening consequences.

The FDA categorizes medical device designs into three categories of distinct risk levels. Class I consists of minimal-risk products such as bandages and face masks for which users register themselves. Class II includes devices that are moderately to highly risky, including syringes and electric wheelchairs, which account for more than 40% of the medical device market. Class III devices are for high-risk and surgically implanted devices such as pacemakers and implants. The degree of regulation increases with the risk of the device and becomes more costly and time-consuming. The classification system is based on the level of risk which is why development should be adapted to each of them. 

Continue reading to discover the key aspects and procedures of medical device development.

Importance of Prototyping to Medical Device Development

Development of Medical Device Prototyping

Prototyping means moving from concept to reality, from idea to a certain type of product. It allows for a consecutive modification until all the requirements of the medical device are met. In addition, the process is imperative to show the feasibility to the investors and attract funds for the development. (Read more about prototype outsourcing)

Prototyping is safer and more usable because it can be tested in iterations. Thanks to the process, many design weaknesses can be detected at the early stage and it allows prototype companies to minimize the risks when large quantities of the product are produced. It can be used on real people in real situations, allowing designers to incorporate feedback into their prototypes. These help inform the device to be compliant with regulatory requirements and acceptability to users.

Choosing the Right Material and Medical Manufacturing Technique

Right Material Selection For Prototyping

The choice of materials in medical device prototyping is critical. Decisions about safety, performance, and development costs must be made in the right manner. Some of these properties such as strength, flexibility, and biocompatibility must meet the device specifications. Failure or adverse patient effects may occur if unsuitable material is employed to design a prototype. By considering these aspects during the prototyping stage, much effort is provided for testing as well as for the overall product development.

Stages of Custom Medical Device Prototyping

Stages of Medical Device Prototyping

The custom medical device prototyping process entails several clearly defined steps, ranging from concept demonstration to pilot production. All of them reduce the development time, guarantee compliance with the requirements of the legislation, and increase the readiness degree for the market. This special concern of frequent and rigorous testing and refining marks all stages of development to facilitate the creation of intricate and durable medical gadgets.

Proof of Concept

The initial phase affirms the device conception at the center of the idea. It confirms that it is a realistic idea for further improvement and development. In this stage, theoretical concepts are applied to determine that they are functional as intended.

Alpha Prototype

The alpha prototype also presents a functional form of the device. In this case, its goal is to assess key functionalities and collect preliminary users’ opinions. Still, many technical and functional issues are diagnosed and solved, which will be crucial for further development.

Beta Prototype

In the beta stage, material, software, and interfaces are fine-tuned. It gets to a stage where testing can be done properly as the product gets closer to the final form. Incremental modifications are made by more specific details of the user’s interaction with the interface.

Pilot Prototype

The pilot prototype is by far the closest to the final product both in terms of design and performance. It is used for pre-commercial testing to check legal requirements. This stage re-affirms measures of quality and sets the device for the market.

Types of Medical Prototypes and Their Importance

Each prototype type has its own unique and valid use. Prototypes range from mock-ups to prove that a design is possible to refined mock-ups designed to resemble the finished product closely; they are crucial to communication. Understanding each type is crucial to applying it correctly along the development life cycle.

Specifically, early-stage visual prototypes are used to gain stakeholder buy-in by presenting some ideas. Functional prototypes allow the examination of the usability and regulatory conformity of the product by the actual users.

Techniques of Rapid Medical Device Prototyping

The rapid prototyping techniques can be categorized based on the hierarchal or integrated approach and device complexity. This means selecting the best method to accurately replicate functionalities and user interfaces. Below are common techniques used in medical device prototyping:

1. 3D Printing

3D Printing For Medical Devices

3D printing involves building up materials layer by layer to develop designs featured in the digital models. It provides high flexibility, especially for designing and manufacturing complex, unique designs. It is particularly helpful for manufacturing prototyped geometries that cannot be made using conventional manufacturing techniques.

2. Plastic Injection Molding

Medical Device Injection Molding

Components are produced efficiently by injecting molten plastic into molds. It is suitable for generating identical and accurate plastic prototype in bulk quantities. Prototype molds also allow for the production of small quantities at considerably cheaper and faster rates.

3. CNC Machining

Medical Device CNC Machining

CNC machining employs sophisticated tools by computer-controlled to carve solid blocks. It is especially suited for the high accuracy and repeatability needed in prototype manufacturing with a small tolerance range. So, CNC prototyping finds application with high-stiffness materials such as metals, and high-rigidity plastics.

4. Interactive Prototyping

Custom Iterative Prototyping

The iterative technique is helpful for digital prototypes since it enables the different design elements to be engaged by various stakeholders. Low-fidelity and high-fidelity interactive prototypes help to define user interfaces by mimicking interactions and sequences of operations on a screen.

Challenges in Medical Device Prototyping

Prototyping of medical devices cannot be considered a simple process. To achieve accuracy, and detailed prototypes, there is a need for interdisciplinary coordination to ensure the final prototype fits the testing requirements. 

1. Planning Tests

It starts with clear objectives that are derived from device specifications and legislative requirements. Having set pass/fail criteria makes the evaluation process more organized.

2. Types of Testing

Original samples are subjected to functional, usability, and reliability tests. Acceptance tests prove that the device is functional, and serves its purpose. Usability evaluations are majorly concerned with ergonomics and hazards during usage. Reliability tests are employed to check how long the product holds up in normal use and conditions it is unlikely to face.

3. Regulatory Validation

Results of tests carried out are aggregated to provide evidence that a particular aspect meets the required norms. Documentation is critical in most regulatory submissions and device approval.

4. Iterative Refinement

The test results indicate changes and modified prototypes are tested again. Such an iterative process assures that the device has attained all the safety and performance requirements for the market before the release.

Key Steps in Prototype Testing for Medical Devices

Prototype testing guarantees the design functionality, the safety of the end product, and its compliance with the existing regulations. It is the critical stage for the confirmation and validation of medical devices. So, it must be understood that even partial prototypes need to satisfy the verification requirements of continuing development.

1. Planning Tests

It starts with clear objectives that are derived from device specifications and legislative requirements. Having set pass/fail criteria makes the evaluation process more organized.

2. Types of Testing

Original samples are subjected to functional, usability, and reliability tests. Acceptance tests prove that the device is functional, and serves its purpose. Usability evaluations are majorly concerned with ergonomics and hazards during usage. Reliability tests are employed to check how long the product holds up in normal use and conditions it is unlikely to face.

3. Regulatory Validation

Results of tests carried out are aggregated to provide evidence that a particular aspect meets the required norms. Documentation is critical in most regulatory submissions and device approval.

4. Iterative Refinement

The test results indicate changes and modified prototypes are tested again. Such an iterative process assures that the device has attained all the safety and performance requirements for the market before the release.

Managing Innovation Through Medical Prototyping

Innovative Medical Prototyping

Prototyping has a key role in the development of medical technology. Innovation is encouraged, device performance is optimized, and, as a result, the patient’s condition is positively affected. The process helps to guarantee compliance with the high standards of the industry while minimizing the time required to develop the design and expenditures.

Prototyping is useful in making improvements on the designs and optimizing the manufacturing processes that make it possible to launch revolutionary devices into the market. Still today, it serves as a fundamental principle for the development of medical devices as safe, performing, and innovative products.

Examples of Medical Device Prototyping

The section highlights various types of prototypes used in the development of medical devices.

Wearable Monitoring Devices

Wearable Monitoring Device

Wearable health technology (WHT) is an emerging field and gaining popularity worldwide. Creating a cardiac monitoring prototype needed the input of the best cardiologists out there. This guaranteed reliability and relevance to the actual solving of problems in different fields. Thus, prolean’s endeavors yielded the development of the next generation of wearables that are patient-centered. The result helped improve the ability to monitor patients’ health to a great extent.

Surgical Instruments & Tools

Surgical Instruments & Tools

Surgical tools must be designed with knowledge of the medical procedures. One project aimed to create a minimally invasive surgical instrument to improve patient outcomes. The team focused on usability, making the prototype more ergonomic at each stage. The final tool introduced new features. Multiple inputs shaped the design to meet surgical requirements. This success highlights the importance of progressive prototyping.

Implantable Devices

Implantable Device

Designing implantable devices entails having to meet high safety measures. Neural implant is a combination of research, designing, and strict experimentation to come up with a good product. Every developed prototype aimed at improving the therapeutic value of the invention. Because the final result was to help progress neuro-therapeutic strategies. 

Prolean Tech’s Expertise in Medical Product Design and Manufacturing

Prolean Tech is skilled in front-knit design processes and back-knit prototyping services. We fashion our medical device prototyping to be affordable, reliable, and effective in meeting the needs of the market. Acquiring more experience in design for manufacturability results in a reduced level of complexity and better effectiveness. It also decreases the costs and quality problems of the manufacturers but it also helps the sustainability processes.

As your R&D team’s strategic partner, Prolean Tech reduces the time it takes to transform your idea into a reality. We define well-articulated and precise objectives that can enable improvement in the dematerialization of processes. Our teamwork approach gives faster results and reasonable solutions to our worthy clients and helps you introduce new medical devices in the market more efficiently.