- Understand the prototype stages of a medical product
- Proof-of-Concept Phase
- Alpha Phase
- Test Prototype Optimization Phase
- Pre-Production Phase
- Mature Product Release
- Five Ways to Reduce Risk for Medical Device Companies
- Improving patient safety
- Reduce Costs
- Ensure compliance
- Optimizing product design
- Advances in Medical Device Prototyping
An optimized prototyping process can improve medical manufacturing in virtually any field. Manufacturers can save money, ensure compliance, produce better-selling products, and, most importantly, save lives. Manufacturing cannot afford to ignore these benefits.
Prototypes are a useful resource in any field. As responsibilities, costs, and standards increase in the healthcare industry, they are critical in medical manufacturing.
Understand the prototype stages of a medical product
A common understanding of the functional utility of each prototype stage is critical to managing the expectations of everyone involved in the project, from designers to executives and investors.
Prototypes at each stage of development have a utility that needs to be understood to justify the cost and time spent developing them. For many medical device startups, the founders have not experienced product developers and do not understand the process.
Proof-of-Concept Phase
Proof-of-concept (POC) prototypes are desktop physical models and breadboards. They are used to assess the feasibility of subsystem or technology component performance. For example, a tube clamp design’s pressure or flow control capability can be evaluated, or the load heating, noise, and line/load regulation of a DC-DC converter can be assessed.
PoC prototypes are used to evaluate the usability of user interfaces, such as the operability of an active graphical user interface (GUI) model or the ease of loading a piping kit onto a pump panel model. These evaluations and feasibility reports aid in component selection and specification development and are part of the Device Design History File (DHF).
Prototype PoCs have 40% to 80% stability in the final design. The prototype phase of proof-of-concept should be completed within a few months. As part of the risk management process, the development of the prototype PoC can be used to supplement and improve the User Requirements Specification (URS), Project Development Plan (PDP), and Hazardous Situation List (HSL).
Alpha Phase
Alpha is the initial attempt to design and manufacture a product to meet the Product Requirements Specification (PRS). It is also the first attempt to build a prototype that looks and works like the final product.
The iterative process of designing and building the Alpha prototype will guide the next phase. Alpha can be physically matched and performance evaluated using 3D-printed enclosures and components. It will use the initial PCB and enclosure design for internal testing and evaluate performance, safety, EMC, usability, and appearance. Compared to the previous phase, Alpha development is very costly and requires several months of iterative design refinement.
Alpha design and testing are essential to understand product limitations and improving the design. The Alpha prototyping phase will involve the development of hardware and software design specifications that define performance specifications and incorporate safety mitigation measures for hazards identified in the HSL.
At the end of the Alpha Prototyping phase, the device requirements, risk management, regulatory strategy, and V&V plan should be sufficiently clear to allow for a pre-submission meeting with FDA regarding the product and anticipated regulatory strategy. The prior meeting will provide FDA input and ideally agree that the chosen regulatory approach and test plan are acceptable. It is desirable to obtain feedback from the FDA on any deficiencies before beginning beta prototype development.
Test Prototype Optimization Phase
The beta design incorporates design improvements identified in Alpha development and implements them into production tooling, PCBs, subassemblies, enclosures, GUI design, etc. Test plans and validation protocols are prepared. The software has been improved and is ready for the first release. Documentation has been updated, and the Device Master Record (DMR) is ready for release. Production test and assembly protocols are drafted.
Probe types are assembled and tested according to production procedures, and risk mitigation measures are documented in the Risk Management Report. Prototype types are ready for verification and initial validation testing, safety, and EMC testing, and performance testing to verify PRS compliance.
After the beta prototype is assembled, improvements are required. The configuration should control these improvements to reflect the reasons for the changes and how they enable the beta prototype to overcome any compliance deficiencies with the specification and standards. Prototyping will involve the development of hardware and software verification specifications to ensure that the product meets the design requirements.
Pre-Production Phase
The pre-production phase incorporates improvements from Beta prototype validation and verification testing into the design and production process. Documentation for DMR and RMR is updated. Complete design transfer to manufacturing and QMS implementation for pilot production.
These units are ready for summative usability testing and clinical trials and are suitable for the first time to market. Design and manufacturing processes are relatively stable. Depending on the timing of verification and validation trials, marketing surveillance should be submitted to the FDA at this stage.
Mature Product Release
Mature products incorporate user feedback and production monitoring improvements. The design process is stable with a high yield combined with cost-saving measures. Post-sales monitoring of the product is based on complaints, user requests, and feedback from the manufacturing experience. Feedback may lead to initiating a CAPA program to resolve any issues.
Medical device companies must overcome many significant challenges when introducing new products. In addition to the high cost of the entire product design development process and manufacturing process, device manufacturers must ensure compliance with the specific regulations of the markets where they plan to sell medical devices.
Prototypes help increase profits, reduce risk, and even save lives.
Five Ways to Reduce Risk for Medical Device Companies
Modern technology has made the healthcare industry better. New devices can improve patient care and save lives, providing opportunities and greater responsibility for manufacturers. Manufacturing may be lucrative, but it must also meet a higher standard.
Given this dynamic situation, prototyping is a necessity. While prototyping is a standard practice in all manufacturing areas, it has a unique importance in the medical field. It can increase profits, reduce risk, and even save lives.
Improving patient safety
The primary purpose of medical device prototyping is to improve safety. If a manufacturer rushes to produce a product, it may pose risks that even the company is unaware of. Creating and testing prototypes first can help highlight these potential hazards so that manufacturers can fix them.
More thorough prototyping will help reduce these risks. As you create and test new prototypes, you will discover issues you may not have considered. The design can then be improved at each stage to create a safer final product.
Reduce Costs
Prototype medical devices can also reduce production costs. At first, they seem counterintuitive because the process will increase time to market, and redesigning will “waste” materials. You may not realize that prototypes reveal the best way to produce, not just design flaws.
When building a new prototype, you will find out if some production methods are more efficient or economical than others. The original design may not be cost-effective in manufacturing. If so, prototyping will reveal this. Just as you tweak and improve the design of a product, so does its manufacturing process.
Outsourcing production – often the most cost-effective option – can minimize manufacturing costs. You can find the best way to design and manufacture your product without using in-house equipment or resources.
Ensure compliance
Every industry has standards that products must meet, but the medical industry has more standards than most. The FDA has at least seven regulatory requirements that apply to medical devices. Failure to meet these requirements can result in large fines or even legal action, so compliance is critical.
Prototyping makes the compliance process smoother. The prototype can reveal potential FDA violations so that they can be addressed before the manufacturer increases production. Likewise, you can submit new versions to regulatory agencies to ensure they are compliant when creating final designs.
Manufacturers that provide services to multiple countries must comply with various regulatory agencies. Prototyping allows them to design variants that meet the needs of each region. Through this process, they can discover how to make a single product that meets the standards of many countries.
Optimizing product design
Medical device issues are taken seriously, but not every issue raises health and safety concerns. The prototyping process will reveal a large number of these smaller product defects and provide manufacturers with the opportunity to correct them. While these may seem trivial, addressing these issues will help create the best products possible. The medical device market is huge and still growing. In such a thriving market, it is easy for some products to fall behind many competitors. Small design choices that improve ease of use or comfort in a highly competitive industry can have a major impact.
When you prototype a product, you can improve those smaller details for every more serious problem you solve. When the design is complete, it is safer and more appealing to the end user.
Advances in Medical Device Prototyping
Several advances over the past few years have made prototyping more efficient and effective. 3D printing has the potential to revolutionize the medical device industry. You can produce a prototype from a design in a matter of hours, saving time and money.
Saving time for the mass production of models will allow the prototype phase to be completed faster. There will be more time to edit the design, and the product can be brought to market faster.
Technologies such as 3D printing and CNC machining have taken rapid prototyping to a new level. Some companies deliver prototypes in a week or less, whereas this process took months in the past. As these manufacturing technologies improve, they can deliver products faster.
Machine learning algorithms can model possible scenarios for product use. Likewise, they can analyze past data to suggest the fastest or most cost-effective way to manufacture a product. These algorithms can shorten the prototyping and testing phases.
Suppose you have the idea of developing a new medical device to improve your quality of life. In that case, your responsibility as a device manufacturer is to develop the highest quality product possible. This means that the resources that contribute to the process should be qualified and able to achieve that result. Many design and development firms specialize in these services, helping companies turn their great ideas into functional, compliant, commercially viable products. elimold can be a reliable, competent partner to help you find this specialty.