ISO 13485 Certified Medical Device Product Development
The sensitive nature of ISO 13485-certified medical device product development has generated many rules, regulations, and standards that restrict entry into the market. Hence, specific medical device product development processes vary from region to region and must be strictly followed by medical device manufacturers if the product is to reach its intended market.
Across the globe, these regulations are provided and overseen by specific regulatory organizations such as the Food and Drug Administration (FDA) in the United States, the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom, and the European Medical Device Regulation (MDR) in Europe. Despite the differences in regional regulations, some key stages in medical device product development are common to all. The following steps are meant to ensure the development process regarding Class I, Class II, and Class III medical devices is guided by fundamental safety and risk assessment procedures. The key stages are initiation, formulation, design, development, and validation.
Development of Class I, II, and III Medical Devices at ACHB
The type of medical device you intend to develop determines the length of your specific development process and the regulatory hurdles you’ll have to pass before marketing it and bringing it successfully to market. According to the FDA, medical devices fall under the following classifications:
Class I Medical Devices
This refers to generic devices such as scissors, oxygen masks, etc., that support healthcare delivery processes. Class I devices are not invasive in nature. They’re almost always iterations of existing devices rather than innovations.
Class II Medical Devices
Devices within this classification are generally used to provide supportive healthcare but are not implanted into patients. These devices — such as wheelchairs and pregnancy test kits — must be cleared by regulators before commercialization.
Class III Medical Devices
This refers to devices used to sustain life or that are implanted into patients. They come with considerable inherent risks and are heavily regulated to ensure the safety of patients. Examples of Class III devices include pacemakers, implanted defibrillators, replacement joints, etc.
The Medical Device Product Development Process at ACHB
While our internal medical device product development processes are not wholly unique, our team goes to great lengths to uncover all necessary details, weigh all options, and deliver comprehensive manufacturing solutions that optimize part design, production efficiency, and overall costs. From identifying possible risks at step one to integrating potential end-user feedback in step four, ACHB understands the critical nature of these devices and the importance of getting every single detail right, the first time.
Step One: Initiation Stage (Ideated & Risk Analysis)
The initiation stage begins with generating ideas for medical devices. These ideas could either be innovations or variations on existing products. The initiation stage becomes the driving force behind the development project, so intensive research is expected. During this stage, it’s a good idea to consider factors such as:
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Product Concept: Conduct an internal analysis of the medical device’s concept. The research should include clarification on the concept’s origin because innovations and variations of existing ideas are subject to different regulations. Your product’s functionality and application should also be outlined at a basic level. SWOT (strengths, weaknesses, opportunities, and threats) analysis can help pinpoint the strengths and weaknesses of the concept so you can fine-tune ideas.
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Target Market: Market research will inform you about the device’s commercial viability. Insight into the market’s requirements may then help you refine the concept.
Step Two: Formulation Stage (Prototyping & Validation)
A medical device prototype is the first physical representation of the product. The prototyping stage enables you as a development team to begin documenting the product creation process and deciding on the best manufacturing technique for the final product. The formulation stage is guided by factors that include:
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Mock-Up Development: Drawings and simple sketches are used to create rough representations of the product. Depending on your development team’s needs, they may create between two and five mock-ups.
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Feasibility Study: Study the mock-ups for further insight into the practicality of each idea. The feasibility study should be guided by market research, aesthetics, and functionality.
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Minimum Viable Product (MVP): The formulation stage ends when you choose and develop the MVP. The MVP is a representation of the product and its features. The focus at this stage is on aesthetics; functionality isn’t an important factor. An MVP is the basic frame of the product and can be produced using prototyping technologies such as 3D printing and molding techniques.
Step Three: Design & Product Development (Alpha/Beta Prototypes)
Coming up with an actual functional prototype is the design stage’s true meat and potatoes. Here, the materials are chosen, the manufacturing method is finalized, and any additional electronic components are integrated. You should use your anticipated manufacturing technique at this point to develop a functional prototype known as the Alpha prototype. The factors that make up this stage include:
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Materials Selection: Choose what the product is made of; the plastics, metals, and electronics that you expect to see in the final product all go into the Alpha prototype. With the materials in place, product prototyping can begin.
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Prototyping: Prototyping is an iterative process that often goes through multiple successive prototypes. The final iteration of the prototyping stage is the Beta prototype. The Beta prototype is the first physical product with all the features and components that will make up the end The Beta prototype gets shared with stakeholders and test groups to receive product feedback.
Step Four: Validation (Testing & Test Marketing)
Although the Beta prototype is functional, it still needs to be tested in earnest to validate whether it meets all requirements. Application testing involves using the product in real-world situations to determine its performance. If it is a Class II or III product, you may have to use simulation techniques to validate the product.
Information from comprehensive testing is further used to refine the product to create the actual end-use part. Once finalized, the product will receive no further design and development upgrades before hitting the market. At this stage, the factors to consider are:
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Integrating Feedback: This is the final point at which you can integrate feedback points into the product’s design before it goes to market. The final iteration of the beta prototype becomes the end-user.
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Product Documentation: Collate all necessary documentation during the validation stage so that your product is prepared for regulatory checks. With the correct certifications in place, your product will be ready for launch.
Efficient Medical Device Development Quotes
Successful medical device development takes into consideration all the above stages and classifications. Device manufacturers looking to take Class I, Class II, or Class III medical device products to market can increase their chances of success by partnering with industry-specific manufacturers, like ACHB, that have proven track records in developing devices across each classification category. If you need help along your medical device manufacturing journey, do not hesitate to speak to the experts today. Contact us to learn more about our ISO 13485-certified medical device development services.
