Do you have a great concept that can create a successful medical device, and now you are looking for further steps to test and validate your idea and turn that into reality? We have good news for you. You can do so through medical device prototype development. But what is it, and how can it be the doorway for your successful medical device development?
In this detailed blog post, we will explore all about medical device prototype development. This blog will take you through the stages, tools and techniques, design dos & don’ts, and common challenges of medical device prototype development. At the end, we will understand how prototyping development is the doorway for turning your idea into reality.
A] What Is Medical Device Prototyping?
Medical device prototyping is an initial development process that involves creating a tangible design of a medical device to validate its feasibility. It allows investors to initially check the functionality and workability of the device ahead of going into full-fledged manufacturing. The medical device prototype offers a solid ground to test the device’s practicality with real users, make design changes, incorporate any feedback, and make it compliant-ready to get quick approvals. It is useful for checking the feasibility of medical devices, like implants, diagnostic tools, surgical instruments, wearables, etc., before mass manufacturing.
B] Key Stages in Medical Device Prototype Development
1. Concept Design & CAD Modelling
Concept design and CAD modelling are the foundation of medical device prototype development. It lays the initial foundation for designers to convert ideas into digital designs. This stage involves researching existing devices, identifying users’ needs, and creating a hand-drawn sketch to visualise the concept. Upon concept validation, the low-fidelity 3D design is generated through CAD (computer-aided design) software.
2. Proof-of-Concept (PoC)
It is a highly important stage where the concept is tested to validate its feasibility in a real-world scenario. It involves collecting all the proof and feedback to ensure the viability of the core idea. PoC allows stakeholders or investors to check the concept’s practicability physically and technically before moving to full-fledged prototype development, saving time and investment.
3. Alpha Prototype
Alpha prototyping is the initial step of prototyping. In this prototyping stage, the validated concept is turned into a tangible design for the first time. Though the Alpha prototype is not built for aesthetics, it is an early and minimally functional version of an approved concept for internal evaluation and further idea honing.
4. Beta Prototype
Beta prototyping is a nearly complete version of a validated concept that has virtually all features and functions that were intended. This prototyping stage doesn’t require frequent course correction, and it is available to get feedback from experts or the potential customer base. In short, the beta prototype is the refined version of the medical device with improved usability and safety.
5. Pre-Production Prototype
The pre-production prototype is a final model ready to get approved by the associate regulations and manufacturing validation. In this stage, designers ensure all the flaws and feedback have been addressed, and the product is ready to move to manufacturing validation and finally launch.
Prototype development is a crucial stage of the medical device development process. It requires the efforts of top designing minds and data-driven decision-making to bring an idea to life. That’s why every stakeholder or investor should ensure they select a trusted and highly skilled product design agency that not only transforms the idea into reality but also ensures the product is loved by the end users.
C] Tools and Techniques Used in Prototyping Medical Devices
1. Medical Device Rapid Prototyping
Rapid prototyping is the swift creation of a physical model using the CAD software’s data and 3D printing technologies, like FDM, SLA, and SLS. FDM (Fused Deposition Modelling) builds the parts layer by layer using thermoplastic filament. The SLA (stereolithography) process cures the liquid photopolymer resins into solid objects. And SLS (Selective Layer Sintering) fuses the powder material to reinforce the design.
2. CNC Machining
CNC machines are computer-controlled devices used to create high-precision components. In medical device prototyping, these computer-controlled machines precisely remove the excessive and redundant parts from the 3D models and make medical equipment prototypes aesthetically sound and user-friendly.
3. Silicone Molding
Silicone molding is used to create biocompatible and sterilisable 3D models from medical-grade silicone polymer. Silicone molding utilises 3D-printed patterns or manually crafted models to mold the soft part of medical devices or soft medical devices, like tubes, testing components, and wearables.
4. Injection Molding
Injection molding is a versatile technique used for high-volume prototype development. In this technique, the material is melted and injected into the mold cavity to form a desired part of the medical device or the device itself. This technique is widely used for short-run functional parts.
5. Electronics Integration
Electronic integration allows medical device prototypes to connect electronic parts, like sensors, PCBs, and other electronic components, to each other and make it a fully functional prototype. This is the last stage of prototyping and involves testing and debugging steps to ensure the prototype’s functionality before manufacturing validation.
D] Design Considerations in Medical Device Prototyping
When preparing for medical device prototyping, designers should ensure they use only biocompatible and sterilisable materials to mitigate harmful reactions and contamination issues. The designers should create a human centered design where ease of use and compatibility should be their top priority.
Regulations like the FDA (21 CFR 820) and standards like ISO 13485 have set a robust design control process to ensure device and patient safety. Designers should ensure they follow every rule, including ISO/FDA-compatible documentation and quality control to mitigate approval rigours.
E] Common Challenges in Prototype Development
Many challenges significantly hamper the process of prototype development, which are outlined below:
1. Unclear Requirements
Unclear requirements are a common challenge that significantly hampers prototype development. So, always ensure you organise a collaborative workshop to define the realistic and measurable requirements.
2. Budget and Time Constraints
High-fidelity and high-iterative design can increase the prototype development cost, whereas unrealistic deadlines can lead to rushed work. Therefore, always ensure you set realistic and achievable deadlines and build the low-fidelity prototype first to test the core concept.
3. Technical Feasibility Issues
Sometimes, overlooked design and manufacturing constraints lead to process issues in prototype development. That’s why investing in a good product design is highly essential to mitigate the outlined constraints later in the process. Consult an experienced product design company, like Criador Labs, to check the technical feasibility of the concept.
4. High-iterative Design
High-iterative design increases the investment and leads to unnecessary delays. So, make sure every flaw and feedback have been addressed in the Alpha and Beta phase of prototyping to save time and investment.
Conclusion
Medical device prototype development is a highly intricate process that requires careful attention and ample design checks to ensure a successful prototype development. It requires excellent design skills and data-driven decision-making to bring a concept into reality. So, consulting an experienced product design agency is extremely important to avoid the mistakes that you may come across if you don’t have an expert design team and a data-driven approach for medical device prototype development.
Criador Labs, a trusted and experienced medical device development company in India, houses a team of top designers who are known for their proficiency in designing prototypes for medical devices. We embrace data and modern technology-driven approaches to make your concept a successful reality. Contact us today and see your medical device prototype developed without going through a sea of frustration, worries, and sleepless nights. We are just a call away. Hurry up!
Abhishek Reddy Gujjala
Criador Labs is an innovative product design studio that is future-focused and renowned for turning bold ideas into exquisitely engineered products. With expertise in Medical Devices, Consumer Technology, and Industrial IoT (Internet of Things), we combine strategy, design, and usability to deliver tangible creative solutions. Founded by Abhishek Reddy Gujjala, an entrepreneur passionate about purposeful innovation, Criador Labs reflects his vision of creating meaningful products that solve real-world problems through thoughtful design.
