A Definitive Guide to Medical Device Design and Development
White Paper
A Definitive Guide to
Medical Device Design and Development
An effective medical device design addresses healthcare regulatory compliances,
solution specifications, and deliver functionalities that satisfy end users’ needs.
This white paper provides a comprehensive guide for Medtech professionals to
design and develop effective medical devices.
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A Definitive Guide to Medical Device Design and Development
Contents
3
P.
Why is Medical Device Design
Important?
P.
How to Design and Develop a
Medical Device
8
P.
P.
Product Ideation and
Conceptualization
11
P.
Design Control Regulations
12
Testing – Verification and
Validation
5
P.
10
P.
Addressing Regulation and
Compliance Need
3
P.
Design Control Process
15
17
P.
Risk Management Procedures
P.
Conclusion
18
About eInfochips
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A Definitive Guide to Medical Device Design and Development
Designing a medical device that adds value to 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.
Hence, it seeks a holistic approach to design a medical device rather than being an isolated part
of the complete process. It requires precision in every stage — right from product ideation to
compliance, designing, testing and marketing of the product.
Why is Medical Device Design Important?
Design and development of a medical device is the most crucial phase for its success. A looselydefined and designed product cannot comply with the regulatory needs and make it to market.
Or just in case, even if it passes the compliance, it will fail to deliver the defined functionality and
benefits, according to the market needs and suffer from lesser market adoption compared to welldesigned products.
Studying multiple Medtech projects, including allergic drug vending machine, software controlled
insulin pump, endoscopy device miniaturization and many more, we understand that medical
device development is more than just conceptualizing a solution, developing a prototype and
mass manufacturing to sell.
How to Design and Develop a Medical Device
It takes a significant amount of effort to deliver the right healthcare solution that meets customer
demands.
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.
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A Definitive Guide to Medical Device Design and Development
Considering these, here’s a comprehensive guide to designing and developing effective medical
devices for Medtech professionals.
Here’s a definitive medical device design guide to successfully design and develop Medtech
solutions and medical devices that address the needs of customers as well as serve the
compliance needs.
Here is the index for the same:
•
Product Ideation and Conceptualization
•
Addressing Regulation and Compliance need
•
Design control regulations
•
Testing – Verification and Validation
•
Risk management procedures
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A Definitive Guide to Medical Device Design and Development
Product Ideation and Conceptualization
Like other industries, Medtech innovation starts with analyzing 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.
These needs either could be “Vitamins” or “Pain Killers”.
Let us understand what are Vitamins and Pain Killers in terms of product development:
It’s not obvious that a device must address a particular problem, a device might also be a
solution that aids convenience on a routine lifestyle or situation.
For example: A device like health tracker tracks steps taken, calories burned or even
monitors one’s sleeping habit. In this case, it doesn’t deliver a solution, but gives you a fair
idea about your daily routine, which helps you to improve health or lifestyle. This kind of
solution is termed as Vitamins while a device that addresses a problem such an Insulin Pump
is a Pain Killer.
Ideally, product ideation and conceptualization start with the following steps:
Step 1: Identification of Need
Identifying the need with demand is a primary step for creating a medical device offering, apart
from being compliance-ready.
The success of this depends very much on two things:
1. The gap between the need of target market and what Medtech developer perceives as the
need; the lesser the gap, the better inputs for product definition
2. A strong product definition extracted by analyzing the market needs
(Hint: Medical device product definition is about defining design and desired performance with a
specific need.)
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A Definitive Guide to Medical Device Design and Development
Step 2: Device Classification
Once you are done with the product definition and idea, you need to consider procedures like
FDA defined classification and intellectual property rights.
Medical device classification is based on the risk associated with the use and enforced by law.
Also, you need to look for any pre-existing Intellectual Property on the proposed idea or similar;
it might actually disallow you to use the mechanism or technology.
To carry out complete discovery phase, a strong 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 in-house team, a
consultant or a medical device engineering company.
Whatever option you choose, the team needs to be experts in the following areas:
• Engineering and design
• Human factors and usability engineering
• Clinical and scientific knowledge of medical industry
• Regulatory affairs and quality assurance
• Intellectual property law
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A Definitive Guide to Medical Device Design and Development
Step 3: Transition to Discovery Phase
The next step is to transmit the idea into the discovery phase. This phase consists of initial
designing, prototyping, PoCs, and iteration driven redesign.
Once you successfully complete the product conceptualization and discovery phase, you may
proceed further for FDA approval and commercialization.
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A Definitive Guide to Medical Device Design and Development
Addressing Regulation and Compliance Need
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 a biomedical materials, tools, and equipment.
These medical device standards allow institutions in the medical device field such as product
manufacturers, laboratories, and others to inspect and assess such equipment and devices to
ensure standard quality and usability.
International Electrotechnical Commission (IEC)
The International Electrotechnical Commission (IEC) published first of its kind medical devices
standard in 1970, IEC 60601-1. IEC 60601-1, Medical electrical equipment – Part 1: Is the
internationally recognized standard which addresses general requirements for medical electrical
equipment and devices covering standards for basic safety and essential performance.
The IEC 60601-1 has undergone many revisions time to time over the years in order to remain
adaptive and up-to-date with newer medical technologies. The latest set of changes was
introduced with the 2012 publication of Amendment 1 to IEC 60601-1.
This standard includes the requirements for essential performance, commands usability
engineering evaluations and human factor consideration, and mandates the adoption of a formal
development life cycle process for software.
It also specifies new as well as revised technical specifications for electrical and mechanical
hazards, also new product labeling and documentation requirements.
International Organization for Standardization
The International Organization for Standardization also have specifications for medical device
standards. ISO 13485 and ISO 14971 are widely used standards across the world for medical
device quality management.
Other than these international standards, there are certain standards which are region specific and
all of them are adopted from international standards with little modification and limitation.
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A Definitive Guide to Medical Device Design and Development
1. If you are manufacturing or selling medical devices in the US, the medical device will be
regulated by the Food and Drug Administration (FDA).
American National Standards Institute (ANSI) is the representative of ISO standards in the
US. There are two more similar organizations: Association for the Advancement of Medical
Instrumentation (AAMI) and the American Society for Quality (ASQ) that defines standards for
the US.
If you have designed a device considering ISO standards, there is a possibility that the FDA may
not approve the device. As FDA has its own set of procedures for risk management derived from
both international and regional standards, which includes:
•
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 additions and modifications from the referred
international standard.)
In case of quality management standard, it does not follow the international or regional version
of ISO 13485 standard. This is because FDA has different guidelines for quality management in
medical devices for the US market.
2. For the European Union, the European Committee for Standardization (CEN) is the
standardization adopted from ISO and the European Committee for Electrotechnical
Standardization (CENELEC) is the regional standard inspired by IEC.
CEN is a bit modified as per requirement from ISO and written with “EN” prefix. For e.g.:
•
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
National members adopt these standards from EU while adding their own prefix. For Switzerland,
Swiss Standards publishes standard with “SN” as prefix such as SN EN ISO 13485:2012 and SN
EN ISO 14971:2012.
3. For Canada, Canadian Standards Authority (CSA) is the representative organization for ISO.
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A Definitive Guide to Medical Device Design and Development
Design Control Regulations
Medical device manufacturers need to follow Design Control guidelines since the regulatory
bodies like FDA, European Commission, Health Canada, and others want to ensure that the
medical devices are safe for potential users before manufacturers start to market the devices.
As said earlier, the FDA doesn’t follow ISO 13485 as it has different requirements for quality
management. Design controls are defined under FDA 21 CFR 820.30 which has a similar intent to
section 7.3 Design and Development described under the guidelines for ISO 13485.
Additionally, FDA incorporates Current Good Manufacturing Practice (CGMP) requirements into
the quality system regulation with an aim to follow good quality practices for medical devices
designs. The regulation provides a framework to implement the design control to a wide variety
of devices. The framework delivers flexibility for both regulatory compliances as well as internal
design and development process.
To successfully implement design control of medical devices, professionals with both technical and
non-technical background, such as business administration, life science, engineering, computer
science, and the arts are required.
Design controls guideline is a quality system approach that covers the entire life of medical device
starting from design, production, distribution, use, maintenance, and obsolescence.
Here is the index for Design Control clause of the FDA.
• SECTION A. GENERAL
• SECTION B. DESIGN AND DEVELOPMENT PLANNING
• SECTION C. DESIGN INPUT
• SECTION D. DESIGN OUTPUT
• SECTION E. DESIGN REVIEW
• SECTION F. DESIGN VERIFICATION
• SECTION G. DESIGN VALIDATION
• SECTION H. DESIGN TRANSFER
• SECTION I. DESIGN CHANGES
• SECTION J. DESIGN HISTORY FILE (DHF)
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A Definitive Guide to Medical Device Design and Development
Design Control Process
Initial phase from which Design Control starts is Design Input development and approval, which
consists of device design and manufacturing processes to be carried out in the production phase.
Design control is a holistic approach and doesn’t end with transferring the design to the
production phase, once the design is finalized. It also impacts manufacturing processes according
to the changes in the design phase or even post-production feedback.
It is an ongoing process to develop a product that is usable for a user and thus for the enhanced
product, it considers revolutionary changes from usage pattern as well as analyzing failed
products.
The image below depicts how Design Control can be performed in the waterfall design process.
Step 1 (User Needs)
Requirements are defined considering the market need and the device is designed to address
that need. After series of evolution, the medical device design is finalized and transferred to
production for manufacturing. There is a need of feedback during each and every step of this
process.
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A Definitive Guide to Medical Device Design and Development
Step 2 (Design Input)
This is an iterative process. When an organization decides to address the particular need, they
review and test the acceptability of design input derived from the need. At that point, the iterative
process of converting requirements into device design starts.
Step 3 (Design Process)
These design inputs are converted into design output by converting those requirements into highlevel specifications (which are Design Output).
Step 4 (Design Output)
Verification process confirms whether the specifications are satisfying requirements or not. And
the output becomes the input to revise the requirements and this process goes on until Design
Output is aligned with the Design Input.
Step 5 (Medical Device)
Once the final design is ready, it is transmitted to the production facility for mass manufacturing.
Design control regulation mandates Design History File (DHF), which illustrates the linkages and
relationships between all the Design Controls and help to trace all changes throughout the entire
product development process.
You can take a paper-based approach or a software-based approach, especially developed for
Design Control; your design history file must be traceable as well as accessible to all the team
members.
Testing – Verification and Validation
Every medical device must 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. This is why iterative testing with verification and validation of these medical devices becomes
imperative.
Verification and validation of medical devices in the design process aim to ensure that the device
is aligned with the need of targeted users and it delivers the intended solution. It also helps
ensure whether all the requirements are being satisfied or not. It helps to comply with regulation
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A Definitive Guide to Medical Device Design and Development
as well as designing the highest quality product and manufacturing processes.
Verification is internal to internal process, which evaluates whether a design output meets the
specified requirements, specification or regulation defined in the design input. Whereas validation
is internal to an external process, which evaluates if your product delivers benefits, according to
the need of targeted users or not.
Medical devices may consist of different technology shapes, sizes, and different level of
complexity. Verification and validation (V&V) activity is driven by regulatory environment and must
follow international standards.
Standardized V&V activities can streamline the manufacturing process as well as enhance approval
process. Additionally, automated testing, diagnostic techniques, and data collection tools can
enhance the V&V process.
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A Definitive Guide to Medical Device Design and Development
V&V being an iterative process consumes a lot of money, when planned poorly. A strongly-defined
test strategy can help you optimize cost as well as the test period to make the product market
ready on time.
The complexity of any testing strategy depends on technologies to be used and geographical
target markets. The test strategy should cover at least six parameters mentioned below:
• Targeted geographies and associated standards
• Time to market
• A standard to be followed with version
• Testing Labs – internal or independent labs
• Defining the sequence of tests
• Presenting the test result
Accordingly, tests used for verification and validation process also needs to be validated. This is
to ensure that you measure what you need to measure because a wrong test will deliver wrong
outputs of usability and functionality. Medtech companies need an effective and well documented
V&V, which complies with associated regulations.
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A Definitive Guide to Medical Device Design and Development
Risk Management Procedures
Risk management procedures for medical devices are enforced under internationally accepted
compliance standard ISO 149711:2007 Medical Devices – “Application of Risk Management to
Medical Devices”. Apart from this, risk management policies need to be incorporated across all
the stages of medical device design and development and should be also associated with design
control aspects as well.
Why is risk management procedure important?
Considering the complexity of medical device 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
How is Risk Management Procedure Followed?
The above image shows all the steps involved in the risk management process. 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.
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A Definitive Guide to Medical Device Design and Development
If the identified risk level is above the defined criteria, then it needs to be mitigated. The risk
level depends on many parameters such as the device, technologies or even company’s risk
acceptability policy.
Before finalizing a design, it is good practice to conduct a hazard analysis to get an idea about
the standard hazards associated with the device. Primary hazard analysis can be done easily by
considering major components and operational requirements such as raw materials and wastes,
hardware, monitoring and control systems, human-device interfaces and services; and then
identifying potential hazards associated.
There are certain hazards that must be evaluated:
•
Raw materials and wastes: toxicity, flammability, and reactivity of 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 prioritized 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 purpose.
During the prototype development phase, there is a need for detailed hazard and risk analysis.
There are two approaches for hazard analysis: Top-down and Bottom-up approaches.
• A hazard and operability (HAZOP) and Failure Mode Effects Analysis (FMEA) are analysis
techniques with a bottom-up approach. HAZOP is ideal for complex design, which involves
multiple step processes. While FMEA is ideal for devices having multiple mechanical components,
it is time-consuming.
• Fault tree analysis is a top-bottom approach to identifying top-level undesired output by
analyzing combination and a series of lower level events.
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A Definitive Guide to Medical Device Design and Development
Conclusion
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.
To stay in line with competition or decrease time-to-market, you may need help from an
experienced medical device engineering consultants or service providers.
If you want to explore more, here is the bonus research for you. We had asked 35 medical device
developers on what is the most critical factor to the success of their medical device design, read
here about what they think.
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A Definitive Guide to Medical Device Design and Development
About eInfochips
eInfochips is a product engineering and software R&D services company with over 20 years of
experience, 500+ product developments, and over 10M deployments in 130 countries across the
world. Today, 60% of our revenues come from Fortune 500 companies and 80% from solutions
around connected devices. From silicon to embedded systems to software, from deployment
to sustenance, we map the journey of our customers. We have the expertise and experience to
deliver complex, critical, and connected products across multiple domains, for projects as small as
a one-time app development to a complete turnkey product design. We continuously invest and
fuel innovations in the areas of Product Engineering, Device Lifecycle Management, IoT & Cloud
Frameworks, Intelligent Automation, and Video Management.
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