The Ultimate Guide to Medical Device Design and Development: From Discovery and Concept to Design Controls, Navigating Medical Device Regulations, Risk Management, Quality Assurance, and More

Medical device design and development is a complex process rife with regulations, specifications, application requirements, and end user needs — all of which must be balanced and adhered to for a successful product. If your device lacks usability, market share will suffer, but if your device doesn’t meet regulatory guidelines, it won’t make it to the market at all. There’s much more that goes into designing, developing, and introducing a medical device to the market than simply coming up with an innovative idea, building your product, and offering it to the masses.
Medical device design
Thus, the job of a medical device developer is a multi-faceted one. Designers and developers must work collaboratively to carefully evaluate needs, functional requirements, specifications, and more, all while assuring quality and managing risk. We’ve put together this comprehensive guide on medical device and development to provide an analysis of the various steps and protocols necessary for successful device design, including:

Device Discovery and Concept

The idea for new medical devices, like most new product innovations, often stems from the discovery of an unmet market need — in this case, products that can help people better monitor and manage their health, aid providers in improving care delivery, or devices that enable better treatment administration. These needs aren’t always obvious to the target user, as common problems are often regarded as inconveniences that must be tolerated — until someone envisions a way to solve it. Suddenly, an inconvenience becomes a solvable dilemma.
However, many successful medical devices aren’t unique innovations. Sometimes, they’re improvements on established ideas; devices that can do what’s already been done but better, faster, or more accurately. Rather than focusing solely on bettering your competition or creating the next great innovation, you should pay attention to the market and focus on meeting needs. Identifying market need is merely the first step in a multi-faceted, complex process required to bring a medical device to the market, but it’s an imperative first step.
Product Development Process

Image via Compliance4All

Check out the following 10 resources for more insight on ideation and brainstorming medical device concepts:

Medical Device Regulations

Much of the medical device design, development, and testing process is driven by regulatory standards. In the U.S., medical devices are regulated by the FDA, and these standards are largely in line with the international medical device standards issued by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC). blood glucose meter
Regulations are further influenced by the International Medical Device Regulators Forum (IMDRF), an organization consisting of national regulatory authorities aiming for the international convergence of international regulations, standards, and practices. While much progress has been made in this area, ultimately, regulation is handled on a national basis, and therefore differences may exist from one country to another, posing challenges for medical device manufacturers. The good news is that many national regulatory authorities are active participants in the IMDRF, contributing to the development of ISO and IEC standards, providing greater consistency in the regulatory landscape. Finally, the World Health Organization (WHO) serves as the coordinating and directing authority for health under the United Nations, with WHO experts contributing to ISO and IEC committees as a Category A liaison.
Check out the following 12 resources for valuable insights and advice for navigating the complex regulatory landscape:

Design Controls

In the U.S., all medical device manufacturers must demonstrate compliance with the FDA’s Quality System Regulations (QSR), which apply to not only medical devices but also to other FDA-regulated products, including food, drugs, and biologics in addition to devices. Also known as the Good Manufacturing Practice (cGMP) requirements, the QSR were updated in 1990 to include design controls authorized by the Safe Medical Devices Act. In order to create consistent requirements for quality systems, the FDA opted to update the International Organization for Standards (ISO) 9001:1994 “Quality Systems–Model for Quality Assurance in Design, Development, Production, Installation, and Servicing,” eventually resulting in the ISO/CD 13485 “Quality Systems–Medical Devices–Supplementary Requirements to ISO 9001,” which officially went into effect on June 1, 1997.
Because of the broad spectrum of the medical device industry, it’s not practical for the FDA to prescribe how manufacturers should produce devices. Instead, the QSR serves as a framework for all manufacturers to follow, but manufacturers are tasked with following appropriate best practices, establishing suitable device requirements for safety and efficacy, and developing methods and procedures for design, production, and distribution of devices in line with the quality system requirements. In other words, the QSR outlines the end goal, but leaves creating the road map for getting there up to manufacturers.
Design Control Flowchart

Flowchart via

Design controls are the policies, processes, and procedures for managing design activities and evaluating quality and making adjustments for errors and shortcomings throughout the development process. Manufacturers are required to have their quality systems in place – defined and implemented – before they go to market. Design controls are one of four essential components of a quality system required by the FDA (more may apply depending on the type of device you’re manufacturing):

  1. Design controls
  2. Risk management
  3. Document control and records management
  4. Supplier management

Most medical device startups create their quality systems as they go, but all parts must be fully implemented before going to market. The design controls aspect focuses on ensuring that your medical device:

  • Is safe
  • Meets your defined requirements
  • Meets the needs of end users
  • Is suitable for its intended use

Check out the following 12 resources for more background and guidance on creating design controls:

Medical Device Testing

Safety is always a priority in product design, but in medical device design, it’s imperative to ensure that devices meet functionality, reliability, and safety goals. Medical devices run the gamut from simple health monitors to complex diagnostic and life-saving devices. In other words, patients’ lives can depend on the safety and efficacy of a single medical device. It’s a lot of weight on a medical device manufacturers’ shoulders — and that’s why continuous testing and iteration is one of the most vital components of medical device design and development.
Medical device testing flowchart

Image via RQMIS

It’s a best practice to define a test strategy in order to minimize testing costs and ensure that adequate testing is carried out throughout the development process. A test strategy offers numerous benefits including:

  • Controlling costs
  • Controlling the test period to avoid delays in getting the product to market
  • Accounting for all applicable standards
  • Anticipating the evaluation of material changes and future variants
  • Identifying success factors for exporting devices in advance

A testing strategy should include:

  • Target markets (geographical) and applicable standards for each region
  • The target date for putting the device on the market
  • Which versions of standards you’ll rely on
  • What laboratories you’ll contract with to conduct testing
  • The sequence of tests
  • Test results and conclusions

Medical device testing should validate and verify — to ensure that the needs of the end user are met and that the device does what it’s intended to do, as well as provide objective evidence that all requirements are satisfied. Again, the specific tests and evaluation design depends on the type of device being evaluated and the regulations, standards, and best practices that apply. While tests measure the validity of a device, testing methods should also be examined for validity, ensuring that the tests carried out are accurately measuring what they’re designed to measure. A test is worthless if it doesn’t provide an accurate picture of the target variable being tested (in this case, the specific functions of a device).
The following 9 resources provide more information on the various testing processes, procedures, and methodology for evaluating medical devices:

Risk Management

Every medical device manufacturer must have established risk management procedures in place, and those processes must be in compliance with ISO 14971, the internationally-accepted risk management standard for the medical device industry. ISO 14971 sets forth a process for manufacturers to:

  • Identify hazards associated with medical devices
  • Estimate and evaluate associated risks
  • Control identified risks
  • Monitor the effectiveness of risk-management controls

These requirements apply to all stages of medical device design and development, as well as the entire lifecycle of the device. An update to ISO 14971 is under development (ISO standards are reviewed, evaluated, and updated — if appropriate — every five years).
Risk management activities should be aligned with design control. In fact, there are risk management activities and outputs for every stage of design and development, illustrated in the chart below by Jackelyn Rodriguez in a paper for the Journal of GXP Compliance:
Design Control and Risk Management
The following 10 resources offer information and advice for effective risk management in the medical device industry:

Quality Assurance

ISO 13485 specifies that device manufacturers must establish a quality management system in order to demonstrate its ability to provide devices and services that “consistently meet customer and applicable regulatory requirements.” Quality assurance systems impact every phase of the device lifecycle including:

  • Design and development
  • Production
  • Storage and distribution
  • Installation
  • Servicing
  • Provision of related services and activities (such as technical support)

The requirements established by ISO 13485 apply to organizations of all sizes and also to suppliers and other third-party organizations that provide components or services throughout the entire product lifecycle. In fact, the manufacturer is responsible for meeting ISO 13485 requirements regardless of whether a particular component was manufactured directly by the company or outsourced to a third-party engineering or development organization. Therefore, it’s crucial for manufacturers to carefully evaluate and choose partners, contractors, suppliers, and any other third-party entity equipped to comply with these and other applicable regulations, as the manufacturer is ultimately responsible for compliance.
Quality Management System (QMS) Flowchart

Image via

A quality management system (QMS) is a comprehensive set of processes, procedures, responsibilities, and documents aimed at meeting target quality goals, applicable regulatory standards and best practices. A QMS then serves as a framework for coordinating a company’s overall activities for meeting both end user and regulatory requirements. It serves a variety of purposes including:

  • Waste reduction
  • Process improvement
  • Cost reduction
  • Identifying needs and opportunities for training
  • Engaging staff
  • Providing organization-wide direction

A robust QMS includes several critical elements including:

  • The company’s quality policy
  • Quality objectives
  • Procedures, manuals, and instructions
  • Internal processes
  • Data management
  • Customer satisfaction data
  • Quality analysis and areas for improvement

The following 13 resources include leading publications related to quality assurance and quality management as well as other valuable resources for establishing and maintaining a quality assurance program in accordance with applicable standards.

There’s a great deal of pre-planning, process management, and ongoing testing and validation that goes into the design and development of every medical device on the market. That’s why it’s imperative to find valued partners knowledgeable about the various regulations and standards related to medical devices as well as industry best practices that can help you seamlessly navigate the design and development process for compliant, safe, and effective medical devices that can impact — or even save — patients’ lives.

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