Lots of hard work and expertise goes into designing and developing medical diagnostic devices. Every stage of the process takes precision, attention to detail, and dedication to the extensive procedures and regulations of the healthcare sector. That’s why medical device development teams must implement a multifaceted approach that addresses idea feasibility, compliance standards, optimized design, and thorough testing and quality assurance. Medical device experts will help you navigate each step of the process—from conceptualizing your idea to putting your product on the market—keeping time, costs, and complications in mind. Since the development team you choose plays such a critical role in the success of your product, you must find a partner you can trust every step of the way. Learn more about how Gener8 and its partners help clients achieve success with this guide to the steps we take to design and create medical diagnostic devices.

Product Conceptualization

Before the development phase begins, medical device design experts must turn a product idea from a vague concept into a feasible design. This, of course, begins with the concept itself. Product ideas seek to meet a market need or improve upon previous solutions to market needs. This problem-solution mindset helps developers turn an idea into a design. During the product conceptualization stage, developers establish their goals for the product and create a strategy to meet them. This means defining the product and the opportunity it presents in the market, identifying product classifications and requirements, and laying out user needs. With these targets in sight, developers can begin turning the product concept into an array of potential designs and prototypes. These quick concepts are the first steps to nailing down a design that meets client and end-user needs through functionality, safety, and attractive design. With a few potential solutions in hand, developers can then present and analyze each concept to decide which design best fulfills all the product requirements.

Navigating Regulations and Compliance

Industry regulations and compliance standards inform every step we take to design and create medical diagnostic devices. Your product won’t make it to market unless it meets every requirement. While verification, validation, and other quality assurance measures test your product in the final stages of development, addressing compliance throughout the entire process helps create a safe, reliable, and effective design from the start. Two organizations play a central role in international medical device standards: the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC).

International Organization for Standardization

The International Organization for Standardization provides specifications for a myriad of industries, including medical device design. Across the world, organizations use ISO 13485 and ISO 14971 as standards for medical device quality management. ISO 13485 outlines quality management system requirements. This set of specifications allows companies to demonstrate their ability to produce devices that meet the requirements of both their customers and any relevant regulations. ISO 14971 revolves around risk management and how it applies to medical devices. Development teams must have a set of risk management procedures that adhere to ISO 14971 guidelines. With the processes that ISO 14971 sets forth, developers can better identify hazards, evaluate and control risks, and analyze the effectiveness of current risk management procedures. Gener8 is also certified to ISO 9001 standards, which outline general quality management system criteria for any company, regardless of industry or size.

International Electrotechnical Commission

The International Electrotechnical Commission first published its set of medical devices standards—IEC 60601-1—in 1970. Over the years, these guidelines have undergone multiple revisions to adapt to evolving technology in the healthcare sector. IEC 60601 establishes an internationally recognized set of standards for medical electrical equipment and devices. These general requirements address needs such as safety and performance. The most recent iteration of IEC 60601, published in 2012, also addresses human factor considerations, usability and commands, software in medical devices, and more up-to-date specifications for both electrical and mechanical hazards.

A successful medical device development partner will offer experts who know their way around these internationally recognized standards. With these regulations and requirements in mind, developers can take a detailed, compliant, and thoughtful approach to every project they begin.

Design and Development

Once the development team has a feasible product concept that meets both user and industry needs, development can begin. The initial development stages consist of creating and testing rapid prototypes against the previously defined product requirements. This step also includes the material selection process, during which experts select components and materials that offer the best durability, precision, and functionality for your device. The mechanical engineering of diagnostic device design involves multiple iterations of the product. That’s why development teams must have efficient procedures for rapid prototyping, testing, and altering the design.

Once the prototype design meets compliance regulations, functionality requirements, and user needs, developers can begin perfecting the design as a production-quality device. The development team will invest in the tools, software, and materials necessary to create and revise beta units. As the development team molds and assembles these fully functional devices, they will continue to test each unit against the product requirements. Thus, the design continues to go through multiple iterations.

Verification and Validation

After the development phase comes the quality assurance phase. Much of this stage involves design verification and validation. These two processes ensure that a device is safe, effective, and relevant to its users and market. Verification is an internal process that asks whether the team designed the device correctly. The verification process ensures that a device meets all requirements and that the design input matches the design output. If the device meets all relevant specifications—such as speed, portability, or weight—as well as compliance standards and industry regulations, then it passes verification.

Validation, on the other hand, is an external process that ensures the device benefits its target users. The process of validation ties your device back to the initial market need that inspired its conception. Validation also helps put the device into a real-world setting.

Once a device makes it through verification and validation successfully, it’s ready for manufacturing and market release. The process of designing and creating a medical diagnostic device is extensive. An idea might go through countless iterations and revisions before it’s even ready to enter the verification and validation stage. However, the work that expert development teams put in throughout the process ensures that your idea becomes a successful product that benefits you and your end users.