Picking the right medical device product life cycle management (PLM) tool is a huge deal. Selecting the wrong PLM could lead to headaches and legal trouble. If you fail to manage compliance and quality throughout the entire device life cycle, you could face safety issues, recalls, and lawsuits.

Adopting the best device PLM tool from the earliest stages of device design can help you avoid unforeseen quality issues and regulatory headaches.

For instance, one critical way medical device PLMs drive improvements is “to ensure changes flow through our system and are applied globally,” says David Hughes, CEO of Surfatek. Qualio enabled us to seamlessly work through the ISO 13485:2016 requirements and design errors out of our quality management system.”

As a PLM for medical device companies with 5-500 employees, Qualio knows that you have to get the right tool for your business stage and needs. We're not the best fit for everyone, so we're going to show you some other good options.

Let’s take a look at the best medical device PLMs to determine which tools you need to avoid big problems and scale your medical device startup. The right software for your company’s needs can help you engineer quality into every stage of the product life cycle and move to the top of your market.

The 5 Best Tools for Medical Device Product Lifecycle Management

Medical Device Product Lifecycle Management (PLM) tools are a centralized solution for quality and compliance throughout the entire lifespan of a device, from the earliest design stages to commercialization and distribution efforts. A device PLM software can facilitate quality-driven collaboration improvement efforts to achieve continuous improvement in testing, re-testing, and safety monitoring once a design is finalized.

A medical device PLM tool can simplify compliance with regulatory requirements from the FDA and ISO. This software can act as a quality management system to create a structured, iterative approach to all stages of the device lifecycle, including design, prototyping, testing, regulatory approval, and commercialization.

Many of the best PLM tools for medical device manufacturers are marketed under the quality management software (QMS) category of technology. However, enterprise resources planning (ERP) software can also be used to manage the business aspects of the device lifecycle. The best PLM software for your medical device company could be listed among any of these category titles, depending on your company's size, stage, budget, and goals.

1. Qualio

A quality-driven approach can accelerate product development and market access for medical device startups and scale-ups. Qualio is the first cloud quality management software (eQMS) and PLM for the entire life sciences ecosystem, making it easy for companies to unite their teams, processes, and data and deliver products to market quickly and scale successfully. It cuts through unnecessary complexity to help medical device companies optimize and automate quality and compliance throughout the entire product lifecycle.

Qualio offers some of the fastest time-to-value in the industry. It’s built specifically in accordance with FDA cGMP, ISO 13485, and other guidance for device quality.

A quality manager writes, “without Qualio we would not have been able to achieve our critical milestone of ISO 13485 certification before the end of the year. We are now prepared to take the next steps towards...the CE Mark.”

Qualio’s Strengths

Qualio is ideal for both inexperienced, small teams who need to quickly create a baseline of compliance-ready quality processes as well as emerging medical device and pharmaceutical companies who want to use a quality-driven approach to accelerate growth. Qualio’s dedicated customer support and concierge onboarding processes allow teams to transition away from paper-based systems and achieve implementation in as few as 60 days.

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2. MasterControl

MasterControl is a widely-known option for enterprise quality management software (eQMS), which provides extensive PLM capabilities for medical device manufacturers and other life sciences organizations. Enterprise-wide quality processes, compliance, collaboration, and quality controls are offered as part of the MasterControl QMS product. In addition, the MasterControl BillofMaterial product can offer greater manufacturing visibility and control to device firms with large-scale production requirements.

A healthcare administrator using MasterControl says the product is “fairly simple to use. I attended their Configuration Essentials Workshop at their headquarters in Salt Lake City and....I rarely need to contact MasterControl Support for assistance.” Nevertheless, other users have challenges learning the product. A mid-market device manufacturer user notes it’s “difficult to use. The system takes a long time to learn. There are a lot of steps for each phase which becomes confusing.”

MasterControl’s Strengths

This product is definitely extensible and robust — it's used by several of the world’s biggest regulatory agencies. It’s a strong PLM contender for well-established device manufacturers and enterprise life sciences organizations that have significant time and resources to dedicate to implementation and product maintenance. MasterControl can be shaped to meet complex use cases, but its price tag and configuration requirements are a pretty big commitment.

RELATED READING: 6 Signs Your Quality Management Process Is Failing

3. Oracle

The Oracle Product Lifecycle Management Cloud is a PLM that is designed to create a “digital thread” across the product life cycle for better process visibility and improved costs. This robust software offers features for innovation management, product development, quality management, and data management. Oracle is best known for its enterprise resource planning (ERP) suite, a comprehensive range of technologies to create visibility and control at some of the world’s biggest enterprises.

One Oracle user in the financial services industry notes, “I like the fact that this tool is highly collaborative in that people across my team can work on varying parts of the data and information control process.” Another Technical Program Manager says, “I do not see support for quality management integrated into PLM.”

Oracle’s Strengths:

Adopting Oracle PLM can be a logical move for companies that are already using other Oracle cloud products, specifically the ERP. Oracle’s ERP is used by over 17,000 of the world’s biggest companies, which are generally organizations with 1,000-5,000 employees at a minimum.

ERP implementation is no small undertaking, with an average cost of $1.3 million. However, an enterprise cloud suite can offer the greatest possible control over parts management and bill of materials use cases at huge organizations.

RELATED READING: Quality Management Software for Medical Devices: The 8 Essential Requirements

4. Propel

Propel is a “product success delivery” platform built on Salesforce, which combines PLM capabilities with Product Information Management (PIM) and QMS features. The software serves three industry verticals—high tech, consumer packaged goods (CPG), and medical technology. The PLM features suite includes tools for compliance, change management, global go-to-market (GTM) strategy, and collaboration.

One Propel user in the IT field states, “ It has a great layer of personalization and a flexibility to adapt your work and your interests…the range of possibilities the program is quite broad, which allows you to use it in different areas.”

A Pharmaceuticals Quality Engineer notes, “There are a few cases...where there are not quite enough controls in place to support our needed quality regulations and specifications. We've always been able to find work-arounds, but sometimes it would be nice to have a clear solution.”

Propel’s Strengths:

Propel is a strong option for mid-market and enterprise medical device manufacturers who are already heavily invested in the Salesforce Cloud, especially firms that are willing to dedicate some serious time to customization. While Propel is user-friendly and fast-to-implement, you’ll need to dedicate some regulatory experts and product experts to compliance configurations.

5. Arena Solutions

Arena is a cloud-based PLM software designed for product life cycle management at original equipment manufacturers (OEMs). It offers a robust suite of features to help manufacturing organizations design products, manage production, and deliver quality products on-time. One unique feature is “Arena Demand,” which is designed to help manufacturers in a multi-product environment. The feature helps calculate purchasing costs from a supplier network by averaging component costs across multiple product lines.

One satisfied Arena user at an aerospace manufacturing firm describes this PLM as a “mature software with many quick views and links to related information. [It is] easy to train users [on the] intuitive interface.” Another reviewer in the education management industry notes, “we had hoped Arena QMS could be integrated with other support areas...for instance, finance and HR.”

Arena’s Strengths:

Arena offers industry-specific solutions for several industries, including the Medical Device sector. It is specialized to create more comprehensive visibility for manufacturers whose existing QMS aren’t robust enough for complex bills of materials (BOMs) — a use case that most often occurs when medical device manufacturers have a broad catalog of approved devices or a large network of manufacturing partners.

RELATED READING: How to Manage the Medical Device Software Development Process in Your eQMS

Quality Product Lifecycle Management for Medical Device Firms

It’s never too early to start thinking about product life cycle management (PLM) tools. Even if your medical device startup is in the earliest research & development phase, a PLM tool can create a solid groundwork for future success. You can achieve a quality-driven culture and global compliance from day one. A PLM can also help you prepare for future success as you approach product testing, regulatory approval, and commercialization.

There are a large number of PLM solutions available, including several options that are targeted specifically toward the unique quality and compliance requirements of the medical device industry. The best solution for your firm is the software that offers the right capabilities with an implementation timeline and price tag you can afford. Choosing a cloud-based medical device PLM with built-in compliance features can allow you to skip unnecessary customization and configuration, so you can immediately achieve greater quality and transparency.

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Published by Robert Fenton February 25, 2020
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