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Post on 25-Jul-2018
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Warning: Everything You Know About Medical Design Is Wrong
Achieve PLM product design utopia in Medical Device
2015 Arena Solutions, Inc. Arena and Arena Solutions are trademarks of Arena Solutions, Inc., Reg. U.S. Pat. & Tm. Off.All rights reserved. Other product and company names are the property of their respective holders. 1
An Industry Defined By High Hurdles and High Margins Developing a medical device has always been a complex process.
Manufacturers must continue to drive innovation while facing ever-intensifying business challenges, including the onslaught of fierce competition, the difficulty of managing globally dispersed teams, and an increasing need to address quality and risk. On top of this already challenging state of affairs, OEMs must also comply with strict and ever-changing regulatory requirements imposed by governing agencies around the globe.
So how does a medical device manufacturer navigate this balance beam at high speed?
Its a tall order because so much is involved in developing a medical device. Medical device manufacturers face complications with component changes when developing a product. They have to meet compliance regulations and face risks more dangerous than other industries. After all, human lives are at stake. And every time a medical device company makes a single change to a product design, the government needs to know and it doesnt matter whether its just a labeling issue or single component change.
And heres where things get really crazy: the medical device industry has such extended regulatory approval cycles that by the time a part is approved it can be deemed obsolete. Replacing the part means the submission process starts all over again.
The medical device industry is defined by a number of high hurdles that stand in the way of an OEMs success. But for those who can overcome these challenges there is the promise of high marginsand vast riches.
The only way to manage the entire medical device product lifecycle from regulatory compliance, to global monitoring, quality assurance, risk management and part nonconformance is through a holistic approach that brings all of these moving parts together into a single, integrated view. When quality, design control processes, and risk management are embedded as an integral part of the day-to-day product design and development cycle, OEMs can dramatically reduce supply chain oversights, employee missteps and product design errors.
Misleading reports that extol the virtues of best of breed solutions, so-called linked systems, and even the traditional model of isolated systems claim to be able to deliver the holistic solution described above; however, recent evidence points to the contrary. Medical device executives, whose use of siloed systems has led to product delays, scrap, rework and risk exposure, can attest to the painful truth that everything they had been told about medical design control waswrong.
According to an Aberdeen Group report, embedding quality and design control processes within a product lifecycle management (PLM) solution can reduce internal and external failure costs by more than 50 percent and the total cost of quality by 8 percent.1
2015 Arena Solutions, Inc. Arena and Arena Solutions are trademarks of Arena Solutions, Inc., Reg. U.S. Pat. & Tm. Off.All rights reserved. Other product and company names are the property of their respective holders. 2
For medical device companies, the ideal design environment to avoid risk and ensure quality is a three layer stack: the foundation is a modern cloud-based PLM solution with an extensible architecture to support a range of current and future integrations; next is an embedded quality module with corrective and preventive action (CAPA) capabilities; the final layer are next generation design solution integrations, add-ons and even component databases all woven into the PLM-driven design environment.
In this medical device-focused whitepaper, we look at strategies and modern solutions that when integrated together can improve quality, streamline design control processes, reduce risk, control design and accelerate innovation. As we search for a utopian medical device design environment, we cover the following topics:
Advantages of Integrating Quality with PLM
Strategies for Managing REACH and RoHS Risks
How to Reduce Obsolescence and Counterfeit Parts
Extending Your PLM Solution
Why PLM?Before we begin to delve into buzzwords, such as holistic solutions, complete quality pictures and enterprise-wide visibility, lets investigate why PLM is the first step in a medical device companys plan to reduce risk and ensure quality in their design processes.
To start with, PLM was created to allow all product companies not just medical device OEMs to better manage documents to streamline their extended supply chain efficiencies, improve cross-functional collaboration and increase enterprise-wide visibility into the design process. By this very function alone coupled with configurable routing and electronic signatures companies can reduce costly risks and significantly improve compliance processes.
PLM specifically helps medical device OEMs by empowering them with greater management control over their quality documents. This expansive list of quality-related documents includes bill of material (BOM), change orders, design history files (DHF), device master records (DMR), validation and verification certifications, risk management reports and product records. And lets not forget the need for a well-documented paper trail for 21 CFR Part 11, 21 CFR Part 820 and CAPA.
PLM offers greater document control for med device companies by consolidating all design information in one centralized system, enabling OEMs to easily share BOMs with globally dispersed suppliers. Because quality-related documents can be complicated (a DMR is an enormous compilation of records containing the procedures and specifications for a finished medical device), a solution like PLM is necessary to avoid misplacing documents and keeping a tight rein on version control.
Collaborative Quality Management Life Cycle
Requirements denitionand management
Build and releasemanagement
Analysis and design
2015 Arena Solutions, Inc. Arena and Arena Solutions are trademarks of Arena Solutions, Inc., Reg. U.S. Pat. & Tm. Off.All rights reserved. Other product and company names are the property of their respective holders. 3
When quality processes (CAPAs, supplier corrective action requests (SCARs), corrective action requests (CARs), NCMRs, 8D, etc.) are integrated into the PLM system, supply chain teams have access to the quality product records, enabling them to be proactive rather than re-active in managing quality. And because this information is tracked and visible throughout the organization, auditors can quickly and easily verify compliance.
Advantages of Integrating Quality with PLMIn todays hyper-competitive medical device market, medical device companies must balance the need to meet increasingly stringent regulations while continuing to innovate quickly and be first to market. To succeed, medical device companies should ensure these quality best practices:
Processes complement one another: Manufacturing, engineering, quality control and compliance management must all work together to control costs and shorten development cycles and retain a First Mover advantage.
Compliance becomes part of the culture: Medical device developers must embed compliance into the day-to-day work life of all global teams; otherwise employees will never be able to keep up with, much less meet, the ever changing array of local regulatory requirements.
Ongoing, global monitoring of risks: Again, organizations need to take a holistic monitoring approach to account for the diversity of risks a medical device OEM faces, including lifecycle, compliance, multi-sourcing and inventory risks.
Ensure everyone participates: If the quality process is relegated to an isolated team using an isolated system, it is almost a guarantee that the product will face quality issues. Quality processes must be integrated into the day-to-day product record so that everyone, including members of the extended supply chain, can contribute to producing the highest quality product.
LNS Research recently released the results of a quality management survey that showed medical device executives ranked the ability to better manage operational risk and ensuring compliance as the top two quality management objectives. The roadblocks that executives felt kept them from achieving those goals were effectively measuring quality metrics and disparate quality systems and data sources.
Quality metrics are not eectively measured
Quality is considered a department not a responsibility
Disparate quality systems and data sources
Lack of visibility into supplier quality
No formal process for continuous improvement
Engineering lacks feedback on quality
Top Quality Management Challenges
Percentage of Respondents Source: LNS Research
0 10% 20% 30% 40% 50%
2015 Arena Solutions, Inc. Arena and Arena Solutions are trademarks of Arena Solutions, Inc., Reg. U.S. Pat. & Tm. Off.All rights reserved. Other product and com