Medical Device Development: 8 Costly Mistake
Successfully taking a medical device to market involves meeting specific Food and Drug Administration (FDA) regulations and accurately documenting the development process. If these regulations are not met, the medical device development team will be saddled with the responsibility of troubleshooting the entire process and in extreme cases, starting from scratch. To avoid costly recalls and having to go back to the drawing board, here are eight mistakes to look out for and timely tips to avoid them.
1. Failing to Conduct a Comprehensive Design Review
The excitement that comes with discovering and producing an innovative idea is infectious and can lead to rushing the design process. A thorough design review must take into consideration the device idea, the materials, manufacturing tools, and the cost analysis required to manufacture a functional product.
Ignoring any facet of the design review stage may increase production costs or reduce the efficacy of the end product. For example, making design changes to specific components without calculating their effects on the capabilities of medical devices results in incompatibility.
Tip: A comprehensive ideation stage with a flexible blueprint or review is required to avoid additional costs, failure, and time wastage. Flexibility ensures changes to the initial idea are accounted for throughout the production stage.
2. Overlooking the Human Factor Angle
Class II and III devices are likely to be used in close proximity to patients; hence, how patients will interact with these devices is a crucial consideration. High-performing medical devices should guarantee ease of use for healthcare professionals and should provide some level of comfort to the patient. For example, oxygen masks should be accessible and easily handled by healthcare professionals and fit the facial features of patients.
Tip: Conduct extensive market research to gain insight into the pain points of prospective end-users. This will help with integrating optimized features within the medical device.
3. Skipping the Alpha & Beta Development Phase
In a rush to go to market or leverage first-mover advantage, medical device manufacturers may make a functional prototype, test it, and believe it is ready for mass production. The FDA recommends incorporating an alpha and beta development phase to ensure comprehensive testing is done. The alpha stage involves creating a functional prototype and testing it, and beta development involve correcting mistakes to develop the final beta product.
Tip: Incorporating FDA recommendations throughout the medical device development process will eliminate many of the mistakes you are likely to make. It is, therefore, recommended to create a comprehensive development timeline that will include a testing schedule for the alpha and beta prototypes and all other FDA recommendations.
4. Taking Testing and Validation Lightly
Validating medical device products and documenting how they intend to function under diverse scenarios is crucial to the development process. For medical devices, testing is done through simulations and trial runs with patients. A comprehensive test will showcase every angle of the device’s applicability. For example, materials that may come in contact with human skin must be tested on different skin types to ensure biocompatibility. Also, medical devices that integrate electronic components must meet the RF transparency requirements to ensure safety.
Tip: Utilize simulation modeling software and standardized testing environments to ensure the medical device will perform as intended. Simulation modeling can conduct thermal, electronic, and mechanical tests of the different device components.
5. Improper Product Documentation
Accurate documentation is one of the requirements a medical device must have to receive certification. The documentation is expected to capture the diverse aspects of using the device from unboxing and configuration to delivering patient care. Regulatory documentation also includes documents specifying the materials and production process utilized in medical device development.
Poor documentation policies will lead to delays in going to market and a costly, time-consuming re-documentation process.
Tip: To achieve accurate documentation, medical device manufacturers should borrow the concept of integrated documentation common with IT DevOps teams. This process involves integrating a documentation framework right from the ideation phase. Integrated documentation ensures every document associated with the medical device can be produced if required.
6. Ignoring Component Shelf Life and Storage Instructions
As a follow-up on the need for proper documentation, overlooking storage instructions and advisable shelf life for certain medical devices will reduce their chances for certification. In scenarios where specific storage instructions are required such as for defibrillators or surgery kits, product documentation must provide clear guidance for its management system. The management system ensures the medical devices are properly kept before use to eliminate unexpected damages.
Tip: Include an integrated documentation process into the system. This provides windows for including product management system documents before going to market.
7. Ignoring Impending Regulations
Updates to regulatory policies are an integral part of the healthcare industry. With more knowledge of human anatomy, comes the need to improve the healthcare services and medical devices used to support patient care. Hence, it is likely that the regulations you follow now may be updated in the future. Taking into consideration impending regulation will ensure you avoid the costly process of re-documentation.
Tip: Conduct extensive market and policy research covering future use cases for the medical device. This will help provide insight into relevant impending regulations. This insight creates the foundation for future documentation updates.
8. Ignoring Secondary Market Regulations
Although you may intend to focus on selling your product within a specified geographic location, its success may call for further expansion. For that reason, it is important to consider various markets and their regulation for product commercialization during the ideation phase. FDA and EU MDR regulations are somewhat similar, so no extraordinary changes may be required, but staying prepared will ensure the medical device gets to its secondary market quicker.
Tip: Conduct research on the available regulations on medical device development within potential secondary markets during the manufacturing process.
Consult with the Experts on Medical Device Development
Working with the experts in medical device manufacturing helps to ensure every step of the development process is accurate. Your first foray into medical device development may seem daunting, but experienced contract manufacturers have gone through these steps many times. Choosing to consult or outsource your medical device development process to experienced hands will save costs, ensure accuracy, and eliminate the eight costly mistakes outlined here. To learn more, speak to the experts at ACHB.