IEC 62304 | How to Overcome the Challenges in Medical Device Manufacturing?
Article Context:
A functional safety standard called IEC 62304 addresses the secure development and upkeep of medical device software. It offers procedures, activities, and tasks to assure safety.
From the outset development of IEC 62304 software development template, safety must be ensured. Patient safety is especially important which cannot be fully ensured by product testing. Additionally, including safety in your procedures early on will save time and budgets afterwards. IEC 62304 latest version consists of all the important aspects of medical device manufacturing.The IEC 62304 classification of software safety dictates the safety-related procedures you must follow. This affects every stage of the software development lifecycle, including requirements gathering, coding, release, and maintenance. IEC 62304 compliance is important to make sure that safety is ensured.
How to Overcome the Challenges in Medical Device Manufacturing?
The development of medical technologies is quickly becoming a crucial component of the medical sector and the production of medical devices to cover the IEC 62304 checklist. Medical device production is aided by the quick speed of technological advancement and its advantages. Like other manufacturing processes, the production of medical equipment calls for intricate and effective phases. However, there are a number of difficulties in producing these medical devices. These difficulties can occasionally be made worse by manufacturing errors. In either case, all manufacturers and other industry participants must understand these difficulties and how to deal with them. You need to know the checklist of IEC 62304 2006 for that.
High Cost in Design and Development
A crucial stage in the production of medical devices is product design and development. The cost of this stage is the main difficulty according to the IEC 62304 latest version. To bring the device concept from design to actual manifestation, a significant amount of budget is needed. However, this expense can be controlled and decreased to simplify marketing and boost ROI.
By laying a strong basis for the design project with succinct and explicit specifications, you may lower the excessive cost of design and development. The necessity to place a strong emphasis on user needs and increased ROI must be better understood by manufacturers.
Complex Partnership in Technological Aspect
Manufacturing of medical devices combines both the medical and technological sectors. It can be very difficult to strike the correct balance between the two businesses. Additionally, it could be challenging to locate the ideal alliance for functional and financial requirements. Bringing together two businesses from different industries presents challenges due to dissimilar systems, cultures, and communication methods as per IEC 62304 compliance.
Medical device producers can benefit from medical solutions to encourage more effective collaboration with tech firms. Additionally, compared to tech start-ups, it is simpler to enter the market by concentrating on collaborations with high-tech enterprises. Finding and modelling only IT companies with comparable objectives will make commercialising ideas easier. Additionally, employing MES (Manufacturing Execution System) in conjunction with partnerships and acquisitions can promote visibility, teamwork, analytics, and coordinate manufacturing throughout the entire partner ecosystem to follow IEC 62304 2006.
Global Regulations Issue
The medical device sector faces many difficulties because of international regulations and government policies including IEC 62304 checklist. For instance, every manufacturer must go beyond to comply with quality and regulatory inspections when there are numerous rules in place, such as MDR (Medical Device Regulation).
Manufacturers must first be aware of global standards for quality and legal obligations. They ought to concentrate on conformity and product quality as well. Similarly, to this, producers must maintain reliable data gathering and analytics throughout the production cycle, keeping in mind the quality benchmarks set by IEC 62304 software development template regulatory agencies.
Data Analytics Problem
Every production channel requires data to function properly. The enormous volume of data generated by businesses make medical devices present a significant difficulty. These facts are essential for formulating regulations, carrying out novel concepts, and raising ROI. In the medical manufacturing sector, each stage from data collection to analysis and result presentation can raise serious concerns. Intelligent data analytics presents a challenge that calls for calculated and exact actions. As per the IEC 62304 classification, there are many problems to address in this category.
Manufacturers could begin by focusing less on paper documents and more on measurements produced by the main value chain by using IEC 62304 medical device software. Additionally, standardised data across the board is essential for enhancing performance. Effective solutions to the issue of intelligent data analytics include automating data collection procedures, developing flexible data formats, guaranteeing consistency in analysing product performance, and assessing operational data.
Value-based Pressure in Healthcare
Like every other industry, medical manufacturing wants to provide a sizable return on investment. They must, however, strike a balance between producing an excellent ROI and their value-based production method as per IEC 62304 latest version. Manufacturers are under pressure to prioritise patient outcomes and healthcare in their design.
Medical device producers can overcome this difficulty by focusing on production cost-effectiveness. Manufacturers must use cost-control strategies and outcome-based models that promote production flexibility. A value-based manufacturing process is unavoidable when considering the trends in the medical device business as per the IEC 62304 medical device software life cycle processes.
Speed in Product Innovation
When it comes to keeping up, manufacturers may have considerable difficulty due to the rapid improvements in medical technology according to IEC 62304 standard. A huge gap may need to be bridged between the increasing trends of wearable medical tech gadgets and expanding health demands in addition to the intense rivalry. To satisfy the fast market pace, intelligent product design, lower cost, better performance, and more solution offerings, medical device manufacturers must speed up product innovation.
The market for medical devices is evolving, and manufacturers must learn to keep up. Efficiency, user involvement, and consistent research are excellent strategies to keep up with rapidly evolving product innovation. Companies can develop plans to hasten the development of new products and guarantee a closed-loop production system. The issue can be solved by fostering a collaborative environment for manufacturing by following IEC 62304 2015.
Time Constraint
The cliché, "time is money," is a constant in the creation of medical devices. A product's transition from a cost to a source of income happens faster the sooner it can be put on the market. You run a lower chance of having your product or technology usurped by a rival if you launch it faster. Additionally, many businesses today discover that the longer their time to market, the more difficulty they have locating the components and materials that were originally specified in the design. IEC 62304 standard has some specific checklist which must be followed as well.
You must be clear - upfront - about the issue you're trying to address, your target market, and the state of the device industry to decide the course and timescale your product will take. Get out there and speak with prospective customers to determine exactly what they need. Making that effort will ensure that the time and money spent creating your gadget will yield the highest possible return.
Getting all the Resources
How to best gain this knowledge is where the true issue lies. Many gadget makers try to manage a lot of the functions on their own. Owners naturally wear multiple hats, especially in smaller enterprises. But the truth is that no one person can wear them all, regardless of how big or small the business is. Additionally, in today's competitive labour market, where it is challenging to find, hire, train, and keep qualified staff, the issue of finding talent has grown. Also, the whole thing should match IEC 62304 checklist.
To make the best use of your limited budget, decide whether it makes sense for you to hire subject matter specialists in specific fields or to bring your product development needs in-house. Make sure those individuals will be able to engage freely with contracted subject matter experts in other areas if you can support bringing such services in-house. Additionally, consider bringing in the quality and legal training required to build a strong base on which your business can expand according to the IEC 62304 2015.
Differences between IEC 62304 and IEC 82304
| IEC 62304 | IEC 82304 |
|---|---|
| IEC 62304 defines the life cycle requirements for medical device software. The set of processes, activities, and tasks described in this standard establishes a common framework for medical device software life cycle processes. (Source:FDA) | One of the various standards that software as a medical device (SaMD) developers should follow is IEC 82304. It addresses the specifications for producers creating medical software products that are used without a specific hardware gadget. |
| According to the standard, health software is "software intended to be used specifically for maintaining or improving individual persons' health or the delivery of care." | IEC 82304, the worldwide standard for software lifecycle processes, is still not as well recognised as IEC 62304, yet another standard frequently used for SaMD. |
IEC 62304 FDA includes:
| IEC 82304 includes:
|
Conclusion
A large part of the rapid change in the medical device scene is attributable to modern technology, such as IoT devices as well as IEC 62304 medical device software. For product designers, these adjustments present both opportunities and difficulties. Medical device development has the potential for tremendous benefits, but some risks must be understood. With preparation and persistence, smart device makers may overcome many of the obstacles. A suitable team (internal and external) must be assembled, and efficiency creation management are crucial. Keep in mind these five obstacles as you move forward if your objective is to enter the medical device industry in the most economical and compliant way possible according to IEC 62304 standard.
FAQ's
What are the general requirements in IEC 62304?
IEC 62304 standard require the implementation of SDLC (Software Development Life Cycle) processes which include risk management, QMS (Quality Management System), resolving software related problems i.e., software safety classification, maintenance, configuration etc.
What Is IEC 62304 Software Safety Classification?
As part of Software Safety Classification, IEC 62304 standard identifies three safety classes for medical device software which are Class A, B and C. Class A concludes No injury or damage to health. Class B conclude Injury is possible, but not serious whereas Class C conclude death or severe injury.
When was IEC 62304 created?
IEC 62304 standard was published in the year 2006 by the IEC (International Electrotechnical Commission) and was amended in the year 2015 to provide enough clarify on how to deal with legacy software and apply risk-based approach for the safety classification of medical device software.
What is the difference between IEC 62304 and 60601?
Both the standards play a vital role and are important in the field of medical device software development
IEC 62304
- IEC 62304 is all about medical device software lifecycle processes.
- IEC 62304 standard is focused especially on software development and provides guidance on planning, developing, testing, and maintaining the medical device software.
IEC 60601
- IEC 60601 is about the security and safety requirements of electromedical equipment.
- IEC 60601 standard covers broader range of topics compared to 62304 including electromagnetic compatibility, electrical and mechanical safety.
What is the relationship between IEC 62304 and ISO 13485?
IEC 62304 standard should be applied in conjunction with ISO 13485 QMS (quality management system) standard, which offers a compliance framework for the medical device software lifecycle processes such as risk analysis, version control, maintenance of software and safe design.