7 Emerging Development and Design Trends in the Medtech Industry

Today, MedTech companies are required to design and develop medical devices and products that comply with Good Design Practices keeping in mind the following aspects: usability, better quality, and patient safety. The industry as a whole is also facing a severe resource crunch, especially in the post-Covid world, requiring the companies to

• Provide cutting-edge solutions at lower costs
• Shorten the time to develop
• Improve operational efficiency
• Maximize procedural success
• Identify and mitigate risks
• Manage design change efficiently

This requires a concurrent product development strategy wherein quality and safety become important aspects to consider right from the design stage. In the case of a new medical device being developed, a minimally viable product (MVP) is designed with a scalable architecture for future updates and adding of features without delaying releases.

This requires an approach wherein the process of design controls; requirements documentation and traceability; and product risk management becomes a focus right at the start.

Product managers and engineering leaders we spoke to at ComplianceQuest say that “the only way to gain a competitive advantage in today’s landscape is to have an uncompromising approach towards quality and safety – right from the design and development stage.”

Key Trends in Medical Device Design and Development

Digital transformation and industry 4.0 technologies have disrupted how businesses function across sectors. In the MedTech industry, there is now greater use of technologies like AI, advanced analytics, and IoT-enabled sensors to capture data.

While there’s rapid innovation on one side, there’s also increasing scrutiny and evolving regulatory requirements to tackle.

Some of the key emerging trends include –

Trend #1 – Changing User Preferences: Customer is always king. But technology has again put the user in the center, even for medical devices that originally needed the expertise to operate. Today, devices traditionally managed by physicians and/or surgeons are being operated by nurses and medical technicians. Therefore, the user interfaces are undergoing a sea change, becoming intuitive and simpler to operate. Some devices also need customization based on patient needs, which need to be factored in during the design and development process.

Trend #2 – Sensors and Embedded Devices: IoT is being leveraged to enable the real-time monitoring of patients remotely. Wearable devices monitor vital parameters and alert in case of any alarming signs.

Trend #3 – Telemedicine: Remote consultation with medical professionals can be a blessing for those living in remote locations and finding the commute taxing. Being able to consult a professional from the comfort of their home or hospital bed makes for greater efficiency without compromising on the quality of consultation. Covid further boosted this due to the lockdowns and the need for social distancing.

Trend #4 – Ensuring Security: Healthcare is a sensitive issue and needs highly secure devices. Since access to data in the wrong hands can lead to several problems including with the regulatory bodies, design must incorporate security as integral to development.

Trend #5 – Gene and Cell Therapy: This is gaining popularity to address rare or incurable diseases to improve outcomes but is highly challenging due to the highly personalized nature of the process and the challenge in designing, developing, and delivering them. They require several factors such as Chain of Custody and risks to be managed efficiently.

Trend #6 – Analytics & AI: The use of sensors and telemedicine is generating lots of data that can be useful in feedback and continuous improvement of the products. Therefore, a robust reporting and analytics capability is an essential part of device design and development. Additionally, we’re seeing AI models being deployed into MedTech products, to enable doctors and other healthcare professionals to use data better and garner insights.

Trend #7 – Predicting Trends: Along with feedback about the device’s performance, the manufacturers also need data to predict trends and be prepared with strategies to meet these trends. Access to big data – along with the device data – becomes important to know what tomorrow brings.

Automating Design and Development to Meet the Changing Needs of the MedTech Sector

As regulations, user needs, and industry trends change, device manufacturers also need to be able to keep pace to remain relevant. Earlier, the design and development of a product took time. Today, the product development lifecycle has to be shortened without compromising on quality and performance. Product design, development, and security have to be closely aligned and integrated so that there are no delays or surprises. The process needs to include requirements traceability and enable identifying and managing risks.

ComplianceQuest Product Design and Development Solution empowers MedTech companies with features for Design Controls, Requirements Traceability and Risk Management.

• Design Controls: It provides complete visibility into the product design process, making it easy to collaborate and design high-quality products, all the while guaranteeing compliant and comprehensive documentation.
• End-to-end Design Project Management: It is customizable and allows design leaders to design projects, track actions, deliverables, and timelines, and provide visibility to all relevant team members. Assign actions to team members and follow up on them to make sure they are completed on time. It’s also easy to keep track of all deliverables during all stages of the design lifecycle with advanced list views and Gantt charts that ensure each component receives the attention it needs.
• Improve Compliance and Documentation: Healthcare is a highly regulated industry with lots of documentation requirements. The CQ solution facilitates documentation right from the time of requirements to outputs, reviews, and changes, including approvals, and revisions, with built-in revision control for design files. This ensures compliance with regulatory and quality standards such as 21 CFR 820.30 and ISO 13485.
• Requirements Traceability and Risk Management: Provides the needed visibility to track and manage all design inputs, outputs, validations and verifications along with integrated management of product risks. Embedded product risk management helps to assess and document all product-related risks and link them to specific parts or requirements, then document and implement the appropriate risk controls along with residual risk assessment for full compliance. In addition to serving as a single source of truth for all teams, CQ’s RTM and Product Risks documents are living documents that are always up to date. Changes in requirements are instantly flagged to make sure that no step is missed and that all regulatory and quality standards are met.

To know more about CQ’s Product Design and Development Solution, visit: https://www.compliancequest.com/requirements-traceability/