The Impact Of Change On Medical Devices
Medical technology and medical device companies have a great impact on the healthcare sector. To pursue change to any technology is to keep evolving the needs of the world. Unlike others, medical device company has to make changes to their device constantly.
The advancement in technology or process allows to provide patient’s better care and condition of life. The change to the medical device is always expected to be good and follow the mandatory regulatory norms, where the ultimate purpose of safety, improved quality and cost-effectiveness should be served.
The changes to medical devices can be driven by various factors:
- To update specific processes or product
- To increase the quality and safety of the product
- To make the post-market changes due to user/regulatory complaints
- To ease the usage of the product
- To upgrade the technology and many more…
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When we talk about the change to the medical device here, we say about device change or the changes made to the medical device. These changes are classified based on the criticality. A change refers to the SIGNIFICANT when it involves the design change or the change in the intended purpose of the medical device.
Examples
Change in shape of the knife to improve its performance during surgery. Change in the intended purpose of the software as if it is designed just for detection of the problem, changing this to fixing the problem. The changes can be classified as major, minor, or critical depending on its impact on the system. The major change is when there is a change in design, raw material, or technology according to need. E.g., change within the raw material redesigning the device, or changing the technology.
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Minor modifications, such as administrative changes in the workplace, have little effect on the product. Critical change necessitates extensive planning, documentation updates, and substantial capital. Changes in design affect form, fit, and function (FFF). The form-fit function is associated with device design and is defined as the “physical, functional, and performance criteria or characteristics of the entire assembly or the components that give a unique identity to a device and have an impact on change.”
During the design change process, the manufacturer must closely monitor whether the new alteration or trade-in part meets the medical device’s form-matching requirements. When changing any design or process, the maker should consider FFF criteria. The form determines the device’s appearance. A device’s physical characteristics, such as shape, size, dimensions, color, and visual aspects, are unique to that object. For example, we can explain a spacer or the inhaler’s plastic tube, which has one mouthpiece at the end.
Fit refers to an item’s capacity to interconnect with other components or form an essential part of an assembly. For example, we want our spacer or plastic tube to fit perfectly into the finished product. Function refers to the action or function that the item will carry out, resulting in the device’s existence. For example, a spacer lengthens the time it takes for drugs to enter the lungs, which is beneficial for children.
If we make any changes to improve the device’s performance, the change assessment team must examine the proposed change and determine its impact on FFF. When there is a significant change to the medical device, change and design control management is required.
Change And Design Control Management
The need of change and control management is to meet the regulatory requirements of the FDA and other governing bodies. It is an effective way to create a safe product and satisfy the patient/user needs. It is the best practice in developing the best product. Change and design control management helps us to learn to be successful in developing products that meet the customer’s needs.
Innovative Medical Device
The above cycle well describes the steps to develop and deliver your innovation (innovative medical device). FDA and other regulatory bodies maintain a systemic approach to control changes to products.
Steps Involved In Change Management
- Identify the need for change e.g. One of the case studies gives the example of a change in the catheter logo from one side to another.
- Justification for the change made e.g. Though the change in position of the catheter logo made the marketing department unhappy, was insignificant but analysis suggested that it could impact the device’s safety and efficacy.
- To review the change. Here, it means the technical reviewing the proposed change.
- To Approve the change
- To document all the steps. It is the most important step to change made to medical device
- Communicate the change to the respective personnel
- To implement the change
- To evaluate the change
The figure describes the art of design change inputs and validation for the same.
Impact Of Change On Medical Device
Here we discuss the key modifications made to medical devices and how they work or are utilized. Making adjustments to medical devices is an important element of the design process for improving your product and making it a tremendous success.
The transition to medical devices has had a significant impact on cost development. The biological safety evaluation is the parameter taken into account when making adjustments to the medical equipment. The alteration affects both the inside and outside of the machine. The exchange’s responsibility has been extended to the impact assessment group, which includes the technical groups of R&D, QA, regulatory affairs, validation, marketing, engineering, quality controls, risk management, and environmental safety.
Change Impact Assessment
The impact of change should be reviewed in all available areas, including records and reasoning. For example, any alteration to an important medical equipment will affect its biocompatibility, safety, efficacy, and performance. The change impact assessment process generates a record of effect judgments and actions taken.
The risk-based strategy should be explored in this case, which entails examining both risk-associated and positive aspects. The risk-associated elements should be determined, and their severity and frequency allocated to define the risk level and ensure its acceptability. Change should focus on assessing the benefits of product availability, with minimum compliance. Risk assessment and management are essential to better the intended outcome of the change. Testing the repercussions of modifications, such as material changes, supplier changes, or material similarities, has a significant impact on medical device design. Updates to the risk paperwork are required.
Regulatory Requirements
The need for change control is outlined in the US FDA QSR (Quality System Regulation) (21 CFR part 820) and ISO 13485:2016. The manufacturers need to have comprehensive, descriptive documentation.
- US FDA 21 CFR Part 820.30 (i) outlines the design change where it describes
Each manufacturer shall establish and maintain procedures for identification, documentation, validation, or where appropriate verification, review, and approval of design changes before implementation.
- FDA 21CFR part 820.40 (b) outlines the document changes where it describes
Changes to documents must be reviewed and approved by an individual(s) from the same function or organization that did the original review and approval unless otherwise specified. Approved changes must be conveyed to the appropriate staff in a timely way. Each manufacturer must keep track of modifications to papers. Change records must include a description of the alternate, identification of the affected documents, the signature of the approving individual(s), the approval date, and when the exchange becomes effective.
- FDA CFR part 820.70(G) outlines the production and process change
(b) Production and process changes. Each manufacturer shall establish and maintain procedures for changes to a specification, method, process, or procedure. Such changes shall be verified or where appropriate validated according to § 820.75, before implementation and these activities shall be documented. Changes shall be approved following § 820.40.
ISO 13485:2026 Design and development changes
Many countries rely on ISO standards for quality control standards and ISO 13485:2016 sets out a series for design control requirements. ISO 13458:2016, Medical devices — Quality management systems — Requirements for regulatory purposes, section 7.3.9 (Control of design and development changes) states:
The organization shall document procedures to control design and development changes. The organization shall determine the significance of the change to function, performance, usability, safety, and applicable regulatory requirements for the medical device and its intended use. Design and development changes shall be identified. Before implementation, the changes shall be:
- reviewed
- verified
- validated, as appropriate
- approved
The review of design and development changes shall include an evaluation of the effect of the changes on constituent parts and products in the process or already delivered, inputs or outputs of risk management, and product realization processes. Records of changes, their review, and any necessary actions shall be maintained.
EU MDR
EU Medical Devices Regulation (MDR) provides new regulatory obligations for certain medical devices where such devices must comply with the MDR if a ‘significant change’ is made to their design or intended purpose and therefore it should undergo relevant MDR conformity assessment before placing to the EU market.
MDGC guidance
This provides the manufacturers the guidance on whether the change made to their device is a significant change or whether the change affects the indications, contraindications or clinical performance of the device.
According to MDR guidance, the changes are classified into five categories
- Intended purpose
- Design or performance specifications
- Ingredient or material
- Sterilization or packaging design with impact on sterilization
- Software
The notified bodies should assess any change made to medical devices and its impact.
Conclusion
The switch to medical devices is a perfect privilege since we make a difference in people’s lives by reducing pain, improving quality of life, and promoting responsibility. The safety of developing technologies is a challenge, and quality management is required, as is compliance with FDA and other regulatory standards to assure product safety.
Operon Strategists will help you examine the impact of changes in medical device management and regulatory standards, as well as support ISO 13485, CDSCO, and FDA 510(k). Contact us if you want additional information.
