How to Boost New Product Introductions in Medical Device Industry With MDM
Life Sciences | 9 min READ
    
The State of New Product Introductions (NPI) in Medical Device Industry
According to a McKinsey report, over 25% of the total business value for any organization is from new product launches. However, more than 50% of the new products launched fail to meet their revenue targets.
John Danese
John Danese

Industry Director

Life Sciences

Birlasoft

 
For a heavily regulated industry that must follow regulatory guidelines from bodies such as the FDA (in the US) and the MDR (in the EU), the product introduction process involves months of meticulous planning and documentation for compliance purposes. These companies invest billions in bringing a product from conceptualization to market. For instance, companies involve almost a quarter of their staff in the NPI process, and despite that, just 50% of their products meet all the success criteria. Additionally, 69% of new products are late to the market, and the average schedule overrun is 25%.
McKinsey states the hesitance of medical device manufacturers in embracing technologies such as automation, data management, and analytics to be a reason for delays and failures. The same report also mentions how the medical device industry has lagged in adopting comprehensive product development processes—thriving in a fast-paced, rapidly evolving market warrants the need for successful NPI processes with minimal waste, greater efficiency with higher margins.
NPI in Medical Device Industry and Data Management
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NPI (New Product Introduction) is a series of procedures that map everything from product ideation and design to its launch. It spans multiple internal divisions and third parties. Such product development lifecycles involve numerous stakeholders, such as R&D, product design, manufacturing, suppliers and contract manufacturers, compliance and legal, and more.
Each department uses separate systems, such as CAD, CAM, PLM, MES and spreadsheets to manage their information. This challenge is exacerbated with mergers and acquisitions, which bring in yet more systems and islands of master data. Conventional ERPs aren’t equipped to integrate such systems and merge their data on a single platform in a standardized format. Such systems are often ill-equipped to handle automated validations, quality checks, audit trails, or phase-gated change management workflows.
As a result, data lives in silos, which affects data quality, collaboration and limits traceability. Medical device manufacturers need a data management platform that can eliminate these silos, aggregate data from multiple sources and store it in a manner that’s easy to use, and track data throughout the development lifecycle — from ideation and product design to post-market surveillance. That’s where an MDM (Master Data Management) platform can help.
Key Data Management Considerations Across the NPI Process
A solid NPI process can reduce the time-to-market, lower costs, improve product quality, and simplify the manufacturing of medical devices. However, the success of an NPI process vastly depends on automatically integrating data from all the systems, data sources, divisions, and third parties to form a single source of truth that facilitates open data sharing with all the stakeholders involved in real-time.
Using MDM, medical device companies can consolidate and share relevant master data throughout the product development lifecycle, which reduces the risks of data silos, inconsistencies, and redundancy. Let’s explore each step of the NPI process to understand how MDM can help.
How to Boost New Product Introductions in Medical Device Industry With MDM
Product Ideation
In the product ideation phase, companies define the business and functional requirements of a medical device. This stage involves extensive market, competitor, customer, and industry standards research to determine the problem to be solved. Simultaneously, it involves conversing with various stakeholders, such as doctors, nurses, patients, and sales reps via emails, calls, and in-person interviews.
Traditionally, this treasure trove of information is documented in spreadsheets or CRMs (or both), resulting in disorganized, duplicate data. Often, some conversations aren’t recorded, and in other cases, the documentation isn’t shared with other departments, complicating the product analysis process. This is a data consolidation and workflow challenge, which MDMs can resolve by building a central data repository with any time, anywhere access to the right people.
Product Analysis
In the product analysis stage, the medical device manufacturer assesses all the information gathered during the ideation phase to determine the probability of a successful NPI. This involves reviewing medical conditions that will benefit from the product, evaluating existing treatment options and technologies, verifying, and validating the business case for its viability, and understanding the requirements for approval by federal and international regulatory bodies such as FDA and EMA. These steps are essential to make a sound decision on project timeline and investments.
For the success of this phase, it’s crucial to have access to all ideation-related data with the appropriate context in a shareable format.
How to Boost New Product Introductions in Medical Device Industry With MDM
Product Documentation
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.
BoM Related Change Management
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.
Medical Device Regulations
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.
Quality Control Medical Devices
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 Suppliers
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.
Product Design and Manufacturing
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.
Post Launch Surveillance
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.
MDM provides a single portal to gather, prepare, store, and share all data related to the NPI process securely throughout the product supply chain. Product MDM is essential for managing product bills-of-materials (BoM), device master records, relationships with supplier and contract manufacturers, clinical trial data, submissions to regulatory bodies, post-market surveillance, and change management.
 
 
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