Question

does anyone have any advice on device design and where to even start when it comes to designing a device? I'm interested in medical device design and I have a meeting with my professor tomorrow and have no idea what to do or say.

Answer 1

Hey buddy goodmorning

I will give a little brief summary about it, just read it ?

As per your topic as the name suggests, refers to the design of medical devices.

Here is the index for the same how to start your medical devices design.

• Product Ideation and Conceptualization
• Addressing Regulation and Compliance need
• Design control regulations
• Testing – Verification and Validation
• Risk management procedures

Let’s get going.

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 an 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 for 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.)

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 an in-house team, a consultant or a company to get help with medical device engineering.

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

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.

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.

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.)

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.

Like I 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 design. 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.

Medical Device 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.

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 high-level 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 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.

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.

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.

All the best my friend ❤

Must upvote