Key Aspects Of Medical Device Design

Medical device design makes these devices functional, convenient and aesthetic, meeting user needs, design controls and risk management requirements.

Medical device industry is really lucrative and much-in-demand, the market for medical devices is vast and commercially attractive. To avoid many traps and pitfalls this market is rife with, you need a team that brings together engineering expertise, understanding of healthcare regulations and patient needs, and profound knowledge of manufacturing and engineering processes.

A good example can be the case of EEG device developed by AJProTech for the biohacking company 40 Years of Zen. This amazing success story started, when Dave Asprey, the trailblazer in the area of biohacking and the founder of 40 Years of Zen, got flabbergasted by the statistics that each year 1 in 4 individuals suffers from a mental health disorder, being overcome by the rapidly changing world. This suggested him an idea of a device that would help users harmonize their mental activity. The gadget has  electroencephalography (EEG) sensors that capture electrical activity of the brain and pass it to a computer, so that people can better understand and regulate their mental states.

So, Dave Asprey offered AJProTech to create such state-of-the-art design for his company. Indeed, we have enough capabilities to cover the whole development cycle, from prototyping and testing to product launch and strategic marketing, and we speedily delivered an unparalleled solution.  

HOW TO DESIGN AND DEVELOP A MEDICAL DEVICE?

Study our medical device design guide, and you will know how to create healthcare apparatuses that address both customer needs and compliance requirements.

The five key milestones of medical appliance design process are user needs, design controls, risk management, prototyping, and testing. 

An apt illustration of this point could be the story of the Lung Health Analyser design. The starting point was March 2020, when the covid pandemic broke out, hospitals were crammed, and a clear need was identified for patients to have an alternative method to check their lungs without going to the doctor.

By combining design, engineering, and rapid prototyping, we developed a technically feasible solution in a short time. 

The product is designed in the form of a neat user-friendly vest with 32 digital PC-connected stethoscopes that are pressed against the patient’s body. 

For prompt prototyping, we used 3D printing and CNC machining. 

The device outputs are analyzed by Machine Learning algorithms for assisted or automated diagnosis of different respiratory conditions. The product efficiency was confirmed by clinical trials.

User Needs and Requirements

The starting point of industrial design is identification of user needs and requirements to make sure your product is safe, efficacious and user-friendly. Medical device designers gather information about user “pain” via user surveys, interviews and observation. 

Design Controls

Design controls are risk management procedures that ensure that the product is fit for the intended purpose.

The framework for these procedures is set by design control guidelines adopted by the FDA, the European Commission or other regulators. The guidelines comprise the following key elements:

1. User needs: how the product is to be used. On the basis of this information device design starts.
2. Design inputs: measurable parameters that characterize the appliance functionality, safety and performance.
3. Design outputs: project deliverables, that is documents, e.g. drawings, design specifications, manufacturing instructions, etc. 
4. Design verification and validation: Design verification ensures that the design output is coherently in line with the design input, without any glitches, while design validation confirms that the final product consistently meets user needs.

To facilitate the approval process, standard-compliant verification and validation procedures should be used.

• Design reviews: To make sure that the device is safe and that design control parameters are properly implemented, each stage of the design process is reviewed. As soon as the final design is ready, it goes to production for medical device manufacturing.

Medical Product Design

As a result of design, a medical product acquires its unique aesthetic appearance, falling within the brand identity, its unparallel functionality and reliable usability. Working with medical products, designers should also bear in mind the product manufacturing process, packaging, and disposal.

Medical Device Prototyping

Medical device prototyping is making a three-dimensional model, physical or digital, of the product concept.

Potential purposes of prototyping include enhancement of the product design, assessment of the product performance and safety, detection and correction of existing design defects.

Medical device companies utilize several types of prototypes:

1. Duct Tape Prototypes are not meant for thorough testing or demonstration but rather for initial experimentation to see if a basic idea is feasible or to communicate basic concepts to a team.
2. Proof of Concept (PoC) Prototypes focuse on validating ideas or technologies
3. Work-like prototypes are used to test and refine the operation of the product before moving on to looks-like prototypes or full production.
4. Pilot Prototypes are intended for verification and validation. The resulting data are submitted to the FDA or other regulators to confirm that the product is safe and efficient. 

Prototyping is key to the future successful operation of the medical appliance. 

Regulatory Compliance

For medical devices, regulatory compliance may be even more crucial than for other products, because it guarantees that the medical device is safe and effective.

Across the world, medical devices are regulated by the International Electrotechnical Commission (IEC) and the International Organization for Standardization.

As far back as 1970, the International Electrotechnical Commission (IEC) introduced the first standard for medical appliances: IEC 60601-1. Medical electrical equipment – Part 1: General requirements for basic safety and essential performance, which addressed general requirements for medical electrical equipment and devices in terms of electrical safety and performance. The IEC 60601-1 has been repeatedly revised and amended since then. 

Specifications for medical device standards are developed by the International Organization for Standardization. Medical device quality management is governed by the ISO 13485 and ISO 14971 standards.

Regulatory requirements may differ from country to country, though all of them originate from international standards. Thus, in the United States, the regulatory body for the whole medical industry is the Food and Drug Administration (FDA). A device designed considering ISO standards may not be approved by the FDA, since the FDA relies on its own risk management regulations, such as:

ISO 14971:2007, Medical devices – Application of risk management to medical devices (international standard.)

ANSI/AAMI/ISO 14971:2007 (R2010), Medical devices – Application of risk management to medical devices (A regional standard with some amendments to the above-mentioned international standard.)

The latter is prepared for the US by the American National Standards Institute (ANSI) on the basis of ISO standards together with the Association for the Advancement of Medical Instrumentation (AAMI). Apart from the ANSI and AAMI, US standards are also developed by the American Society for Quality (ASQ). 

In the European Union, medical device designers have to comply with the EU Medical Device Regulation (MDR) (2021). The platform for development of European standards is provided by the European Committee for Standardization (CEN). Standardization efforts in the electrotechnical area are supported by the European Committee for Electrotechnical Standardization (CENELEC).

Regulations produced by the CEN slightly differ from ISO and have the prefix “EN”, for instance:

EN ISO 13485:2012, Medical devices — Quality management systems — Requirements for regulatory purposes

EN ISO 14971:2012, Medical devices — Application of risk management to medical devices

How much does it Cost to Develop a Medical Device?

Each project is unique in its complexity and design needs – there is no one-size-fits all. To get a proper estimate, we encourage you to schedule a free 30-minute consultation with our team. We may give you an estimate of design cost and development timeframe right on the call: 

Does a Medical Device need FDA Approval?

The answer depends on the character of the product. Not all medical devices need FDA approval to come to market, but only those associated with higher risk. The FDA divides medical devices into three categories: Class I, Class II, and Class III, depending on the level of their risk for patients. The FDA does not request premarket review or clearance for Class I appliances, classifying them as low-risk. 

• Examples of CLASS 1 appliances include hospital beds, toothbrushes or oxygen masks. A typical requirement for such products is compliance with the Code of Federal Regulations 21 CFR Part 820 General Controls, however, some instruments may be exempt.
• CLASS 2 comprises devices with medium risk level, such as  syringes, sutures, pumps and contact lenses.  For such products,  the 510(k) pre-market approval process is needed, and the quality management system has conform to the provisions of 21 CFR Part 820: Special Controls (Design Controls).
• High-risk devices like breast implants, defibrillators or implanted prosthetics fall under  CLASS 3. The FDA requirements for such products are quite strict, including audit of their manufacturing facilities. Such instruments quality must be ensured by 21 CFR Part 820, often with mandatory clinical trials

FAQ

How AJPROTECH develops medical device designs?

We approach our projects using an agile and iterative process. A combination of design, engineering, and apt prototyping allows us to produce a reliable solution  fast. We use IoT, machine learning, MVPs and other cutting-edge methods and technologies. 

What are the stages of medical device design?

The stages are as follows:

• Need elicitation and concept elaboration. We have to discern the medical need, the customer requirements and build an initial design concept. 
• Design and Development. At this stage, detailed design blueprints are prepared.
• Prototyping. We create a 3D model of the device for evaluation and testing.
• Testing and Validation. The device is assessed, it undergoes performance tests, safety tests, usability tests and sometimes clinical trials.
• Risk Management. The company detects potential threats and develops processes for their mitigation.
• Regulatory Compliance. The device goes through the regulatory approval process to verify its compliance with FDA requirements, ISO standards, or other applicable provisions.
• Manufacturing. The device is placed into full production. Mass production must be without compromising the quality. 
• Post-Market Surveillance.  We continue monitoring the device safety and the performance within the scope of pharmacovigilance and sort out all potential issues.

 How long does it take to design a medical device?

Indeed, the design and development of a medical device typically takes one to two years. However, the exact timeline can vary based on several factors, including the complexity of the device, regulatory requirements, the level of innovation involved, availability of technology, and the need for extensive testing and validation. More straightforward devices might be developed quicker, while highly complex or innovative devices could take longer than two years. Additionally, factors such as company resources, efficiency of the project management, and collaboration with regulatory bodies can also influence the timeline.