An effective medical device design addresses healthcare regulatory compliances, solution specifications, and delivers functionalities that satisfy end users’ needs.
A medical device industrial design that adds value to the end user and simultaneously captures profitable market share is really a tough job.
Is it because healthcare is a life-critical segment? Or is it because it involves complex procedures?
Apparently, both. In addition, it needs to be aligned with healthcare regulatory requirements, solution specifications, and should deliver functionalities to satisfy end user needs.
Design and development of a medical device are the most crucial phase for its success. A loosely-defined and designed medical device cannot comply with the regulatory needs and make it to market.
Being medical device developers and studying multiple MedTech projects, we understand that medical device development and design is more than just conceptualizing a solution, developing a prototype and mass manufacturing to sell.
How To Design And Develop A Medical Device?
A right healthcare solution demands everybody staying on the same page, with strong scope definition from end user’s need, collaborative efforts across the team, adherence to specification and requirements extracted from product definition, simultaneously mitigating risks and sticking to the best possible quality.
But, how can you successfully design a medical device? Here are the various steps to reach your goal.
Medical Device Ideation and Concept
Like other industries, MedTech innovation starts with analysing and identifying the market, the need of which is untapped or unmet or there is a more efficient way to address those particular needs. These needs could be anything that delivers a solution such as a new or better way of monitoring health, enhanced care delivery solutions, devices or technologies to deliver better administration or anything that supports health and a human life.
Ideally, product ideation and conceptualisation start with the following steps:
- Identification of Market Needs
- Device Classification – Medical device classification is based on the risk associated with the use and enforced by law.
- Discovery Phase – It consists of initial designing, prototyping, PoCs, and iteration-driven redesign.
To carry out the complete discovery phase, a strong medical device development team is crucial. This may be a pitfall if the team is not well experienced. In any case, you can decide to go with an experienced partner to get the help you need with medical device design.
The team needs to be experts in the following areas:
- Engineering and design
- Human factors and usability
- Deep knowledge and experience in the Healthcare field and its regulatory environment
Once you successfully complete the product conceptualisation and discovery phase, you may proceed further for CE or FDA approval and commercialisation.
Medical Design Regulations
In order to get into the market, the medical device needs to pass through certain regulatory compliances, subject to both regional and international standards. Medical device standards are helpful and enforced by law in specifying and evaluating the requirement for design and performance parameters for biomedical materials, tools, and equipment.
These medical device standards – such as IEC 60601-1, ISO 13485, FDA, EU MDR – allow institutions in the medical device field like product manufacturers, laboratories and others to inspect and assess such equipment and devices to ensure standard quality and usability.
Design Controls
Medical device manufacturers need to follow Design Control guidelines since the regulatory bodies like FDA, European Commission, and others want to ensure that the medical devices are safe for potential users before manufacturers start to market the devices.
The regulation provides a framework to implement the design control to a wide variety of devices.
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
Medical Device Testing And Validation
Safety is always a priority in product design, but in medical device design, it’s imperative to ensure that devices meet the functionality, usability and reliability objectives to get a successful share in the market. Apart from these, end users also look for effectiveness and safety of devices that they use to address a particular problem or condition, which are sometimes critical to life. That’s why continuous testing and iteration is one of the most vital components of medical device engineering and development.
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.
The complexity of any testing strategy depends on technologies to be used and geographical target markets.
MedTech companies need an effective and well documented V&V (Verification and Validation), which complies with associated regulations.
Risk Management
Considering the complexity of medical device industrial design, focused risk management practices help ensure usability, safety, and regulatory compliance. It is a process of identifying, controlling and preventing the failure that may cause hazards to users. It also mandates identifying associated risks. Upon reaching an unacceptable level of risk, it notifies developers to decrease at least up to an acceptable level.
The process starts with the identification of hazards and then associated risk is measured based on the consequences of hazards and their possibility of risk.
There are certain hazards that must be evaluated:
- Raw materials and wastes: toxicity, flammability, and reactivity of the material
- Environmental factors: sensitivity to temperature and humidity and more
- Mechanical or electronic hazards
- User device interface: hazards associated with human factors like ineffective delivery, drug administration, incorrect or incomplete information, control of life-sustaining operations
When multiple hazards are identified, they can be prioritised according to severity associated with them. Often, there is a scenario where you have insufficient information to identify hazards. In such cases, you may consider similar devices and their history for identification purposes.
Quality Assurance
ISO 13485 specifies that device manufacturers must establish a quality management system in order to demonstrate their 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:
- Medical device 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.
Conclusions
Every marketable medical device needs deep level engagement, considering the complexities involved due to the requirements, usage patterns, user experience, regulations, associated iterative process, technologies, material, and many more.
There’s a great deal of pre-planning, process management, and ongoing testing and validation that goes into the medical device design and development. That’s why it’s imperative to find valued partners knowledgeable about the regulatory environment 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.
In Creanova, you can find the experienced medical device development and design partner you are looking for. Thanks to our 2 decades exclusive experience in medical device design, development and ISO13485 certified contract manufacturing, we can support you to bring your product on the market, matching high aesthetics with improved usability, innovation and enhanced functioning.
