Prototyping is an important step in medical manufacturing
An optimized prototyping process can improve medical manufacturing in nearly every field. Manufacturers can save money, ensure compliance, produce better-selling products, and most importantly, save lives. Medical manufacturing cannot ignore these benefits.
Prototypes are useful resources in any field. They are critical in medical manufacturing as responsibilities, costs and standards increase in the healthcare industry.
For most medical device innovators, prototyping is one of the most exciting times in product development. It was very satisfying and fun to see early design images and specs physically come to life. But if the team is financially constrained and interested in capital efficiency processes, that excitement breeds the temptation to bypass multiple elements that must precede prototyping.
Clinicians follow very specific processes when preparing for surgery; imaging, preoperative planning, team and operating room scheduling, cleanup, etc. Likewise, engineers should not build without a plan, strategy, and flowchart. In order to maintain a capital efficient and flexible process, innovators have the best chance of reaching their intended destination in the shortest time possible.
Understand the prototyping stages of medical products
Having a common understanding of the functional utility of each stage of prototyping 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 invested in developing them. For many medical device startups, the founders are not experienced product developers or understand the process.
proof of concept stage
Proof of Concept (PoC) prototypes are benchtop physical models and breadboards. They are used to evaluate the feasibility of the performance of a subsystem or technical component. For example, a pipe clamp design can be evaluated for pressure or flow control capabilities, or a dc-dc converter can be evaluated for load heating, noise, and line/load regulation.
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 assessments and feasibility reports aid in component selection and specification development and are part of the Device Design History File (DHF).
PoC prototyping is 40% to 80% stable in the final design. The PoC prototype phase should be completed within a few months. The development of PoC prototypes can be used to complement and refine the User Requirements Specification (URS), Project Development Plan (PDP) and Hazardous Situation List (HSL) as part of the risk management process.
An Alpha prototype is an initial attempt to design and manufacture a product to meet a Product Requirements Specification (PRS). It was also the first attempt to make a prototype that looked and worked like the final product.
The iterative process of designing and building the Alpha prototype will guide the next phase. Alpha can be built with 3D printed housings and components for physical fit and performance evaluation. It will feature an initial PCB and enclosure design for in-house testing and evaluation for performance, safety, EMC, usability and appearance. Alpha development was expensive compared to previous stages and took months to iterate and refine the design.
Alpha design and testing is critical to understanding the limitations of the product and improving the design. The Alpha prototyping phase will involve the development of hardware and software design specifications that define performance specifications and incorporate security mitigations for hazards identified in the HSL.
By the end of the Alpha prototype development phase, the device requirements, risk management, regulatory strategy, and V&V plan should be well-defined enough for a pre-submission meeting with the FDA on the product and expected regulatory strategy. The pre-chapter meeting will provide FDA input, ideally agreeing that the chosen regulatory pathway and testing plan are acceptable. It’s best to get FDA feedback on any flaws before starting beta prototype development.
Beta prototype optimization phase
Beta prototyping combines the design improvements found in Alpha development and implements them into production tools, molds, PCBs, subassemblies, enclosures, GUI designs, and more. Test plans and validation protocols are prepared. The software is improved and ready for the first version. Documentation has been updated and is ready for publication of the Device Master Record (DMR). Draft production testing and assembly protocols.
Beta prototypes are assembled and tested according to production procedures, and risk mitigation measures are documented in a risk management report. Beta prototypes are ready for validation and preliminary validation testing, safety and EMC testing, and performance testing to verify compliance with the PRS.
After the beta prototype is assembled, improvements will be required, and these improvements should be controlled by configuration to reflect the reason for the changes and how they enable the beta prototype to overcome any deficiencies that meet specifications and standards. Beta prototyping will involve the development of hardware and software verification specifications to ensure that the product meets the design requirements.
Trial production stage
The pre-production phase is the phase where improvements from beta prototype verification and validation testing are incorporated into the design and production process. Documentation for DMR and RMR has been updated. Design transfer to manufacturing and implementation of the quality management system is done for pilot production.
These units can be used for summative usability testing and clinical trials and are suitable for first-time market launch. The design and production process are relatively stable. Submission to the FDA for regulatory release to market is completed at this stage, based on the timing of validation and confirmation testing.
Mature product launch
The mature product combines user feedback and improvements in production monitoring. The design and assembly process is stable and the yield is high, combined with cost saving measures. After-sales supervision of products is implemented based on complaints, user requirements and feedback from production experience. Feedback may lead to the initiation of a CAPA project to resolve any issues.
Medical device companies must overcome many significant challenges when bringing new products to market. In addition to the high costs throughout the product design and development process and manufacturing process, device manufacturers must ensure compliance with specific regulations in the markets in which they plan to sell medical devices.
Prototyping can help increase profits, reduce risk, and even save lives.
Five ways for medical device companies to reduce risks
Modern technology has made the medical industry better. New devices can improve patient care and save lives, offering manufacturers a world of opportunity and heightened responsibility. Medical manufacturing can be a lucrative industry, but it must also meet higher standards.
Given this dynamic, prototyping is a must. While creating prototypes is standard practice in all manufacturing fields, it is of unique importance in the medical field. It can improve profits, reduce risk, and even save lives.
Improve patient safety
The most critical purpose of medical device prototyping is to improve safety. If a manufacturer rushes to make a product, it can introduce risks that the company doesn’t even realize. Creating and testing prototypes first helps highlight these potential hazards so manufacturers can fix them.
More thorough prototyping can help reduce these risks. As you create and test new prototypes, you discover problems that you may not have considered. The design can then be refined at each stage, creating a safer end product.
Prototyping medical devices can also reduce production costs. At first, they may seem counterintuitive, as the process increases time-to-market and redesigns can “waste” material. What you might not realize is that prototypes reveal optimal production methods, not just design flaws.
As you build new prototypes, you’ll see if certain production methods are more efficient or affordable than others. The original design may not be cost-effective to manufacture, and if this is the case, the prototyping will reveal it. Just as you tweak and refine a product’s design, so can its manufacturing process.
Outsourcing prototype production—often the most cost-effective option—can minimize manufacturing costs. You can find the best way to design and produce your product without using in-house equipment or resources.
Every industry has standards that products must meet, but the medical industry has more standards than most. FDA has at least seven categories of regulatory requirements that apply to medical devices. Failure to meet these requirements can result in hefty fines and even legal action, so compliance is critical.
Prototyping makes the regulatory compliance process smoother. Testing prototypes can reveal potential FDA violations to address before manufacturers ramp up production. Likewise, you can submit new versions to regulators to ensure they meet standards when creating the final design.
Manufacturers serving multiple countries must comply with various regulatory agencies. Prototyping allows them to design variants that meet the requirements of each region. Through this process, they can discover how to manufacture a single product that meets multiple national standards.
Optimize product design
Problems with medical devices can be serious, but not every problem causes health and safety concerns. The prototyping process will reveal a large number of these smaller product defects and give manufacturers the opportunity to correct them. While these may seem trivial, addressing them helps create the best possible product. The medical device market is large and growing. In such a booming market, it’s easy for some products to lag behind numerous competitors. Small design choices that improve ease of use or comfort can make a big difference in a competitive industry.
As you prototype your product, you can refine these smaller details each time you solve a more serious problem. By the time the design is finalized, it will be both secure and more attractive to end users.
Advances in Medical Device Prototypes
Several advancements over the past few years have made prototyping a more efficient and effective process. 3D printing has the potential to revolutionize the medical device industry. You can create prototypes from designs in a few hours, saving a lot of time and money.
Saving time in mass-producing models will allow for faster completion of the prototyping stage. There will be more time to edit designs, and products can be brought to market sooner.
Technologies such as 3D printing and CNC machining have taken rapid prototyping to new heights. Some companies deliver prototypes in a week or less, a process that used to take months. As these manufacturing techniques improve, they will be able to deliver products faster.
Machine learning algorithms can model possible scenarios for product usage. Likewise, they can analyze past data to suggest the fastest or most cost-effective way to make a product. Using these algorithms can shorten the prototyping and testing phase.
If you have an idea for developing a new medical device with the aim of improving the quality of life, it is your responsibility as a device manufacturer to develop the highest quality product possible. This means that the resources that contribute to the process should be qualified and able to achieve this result. There are many design and development companies that specialize in these services to help companies turn their great ideas into functional, compliant and commercially viable products. Elimold can be a reliable and competent partner in helping you find this specialty.