How to Boost New Product Introductions in Medical Device Industry With MDM

Most regulators require manufacturers to maintain detailed logs about the design plan, requirements, and changes made at any point. They also expect these logs to be well-organized, updated, secure, and easily accessible on a single platform. That’s why everything from the product ideation and analysis phase must be documented accurately using an MDM solution, along with proper contexts, such as definitions, standards, test plans and results, decisions made, and approver signoffs. This helps with medical device regulatory affairs, maintains every stakeholder on the same page, and serves as a reference for future product development cycles.

For instance, if a company specializing in cardiovascular monitoring devices is launching a new product for valve monitoring, the research done regarding markets, customers, competitors, and regulations will be helpful for all subsequent device launches.

Regulations and standards exist to assign accountability and provide the rationale behind decisions made, especially regarding changes to the product design, valuation, launch timeline, or costs.

Capturing all data related to change management and maintaining all versions of the changes made is essential for traceability, design control, and proper information flow. All stakeholders are well-informed of changes made at any point in time. MDM solutions are also equipped with change request and approval mechanisms to ensure proper approval and sign-offs, crucial for proper data flow and regulatory purposes.

BoM-related change management is vital to avoid incorrect purchase orders being issued to suppliers and receiving obsolete parts. BoM (Bill of Materials) is a list of raw materials, parts, components, along with their respective quantities, and inefficient data capture processes can lead to expensive procurement errors and quality issues.

For a highly regulated industry, medical devices compliance with FDA, MDR, TGA, and other global agency regulations is one of the most challenging aspects of NPI. For instance, the FDA’s CDRH assigns classes for medical devices depending on the category, and manufacturers must prepare their submissions for clearance. While Class II devices might require only a 510(k) submission and clearance from the FDA to initiate marketing, the most rigorously controlled Class III devices require pre-market approval (PMA) and clinical trials.

Just like the FDA, the EU’s MDR also assigns classifications and expects manufacturers to set up a quality management system and maintain all project-related documentation constantly updated. Companies can configure their MDM platforms to meet the audit requirements by monitoring design versions, audit trails, changelogs, quality checks, and security standards. Moreover, MDMs can be central to source, manage, and publish compliance data (such as UDI and EU MDR information) to the regulatory databases and GS1 data pools.

The evolution of technologies such as CAD, which provides a realistic rendering of the product being designed, has made prototyping more effortless. More recently, a shift toward 3D printing has made it possible to use plastic and metal to create realistic prototypes. However, despite the advancements in prototyping, monitoring the entire process is essential to ensure quality control, avoid design flaws, and minimize cost overruns.

Tracking the entire prototyping process using an MDM solution can help vet the design process and reduce the likelihood of defective products getting cleared. It also facilitates the auditing process.

Medical device companies rely on a vast and intricate network of partners such as contract manufacturers, distributors, consultants, hospitals, and laboratories. The quality of suppliers directly impacts the quality of the end product, which makes vetting the list of suppliers and fostering a relationship with them essential for the NPI process.

Inefficient processes can decrease the overall product quality, lead to a loss of intellectual property, and increase time-to-market significantly. Moreover, compliance requires medical device companies to audit and run quality checks on their suppliers. Maintaining all the supplier information, their approval status, their pricing, quality of the supplies, response and delivery time, and audits on a single platform simplify supplier management processes.

After completing all quality checks on the prototype, the next step is to design the product. The entire process involves constant quality checks to mitigate the risk of failure and delays in product launches. Additionally, regulators like FDA require the whole design process to be documented for complete traceability. Production begins once the design has been finalized. A core aspect of NPI is to keep all the stakeholders, reviewers and approvers in the loop since the ideation phase by sharing all the relevant information through the MDM platform.

The manufacturer is already aware of the entire product development history, streamlining the whole manufacturing process and reducing the risks of failure.

Despite running simulations and extensive clinical trials, it’s impossible to directly observe the real-world performance of most medical devices. That’s why the FDA requires devices categorized as Class II or Class III to monitor the performance of their devices once they hit the market through its MedWatch portal.

This is called post-market surveillance (PMS), and device companies must report any risks, failures, or incidents using MedWatch. Configuring MDM platforms to automatically record patient feedback and complaints and sharing it transparently with the right stakeholders is vital for effective post-launch surveillance of the real-world safety and effectiveness of the product.

The medical device industry is a competitive, challenging environment with increasingly complex regulatory hurdles and rapidly evolving technologies. Moreover, the industry’s drowning in an ocean of data and extracting value while ensuring quality standards in real-time isn’t possible without sound data management practices, tools, and processes.