- Software capabilities
- Implementation
- User adoption
- Support
- Vendor characteristics / attributes
- Unique business needs
Table of Contents
- Executive Overview
- Identify Your Challenges
- Transition from Document Centric to Product Centric
- Consider the Complete Lifecycle
- Manage the Product
- Manage Requirements (Customer Needs to Regulatory)
- Support Product Development for Hardware
- Support Software Development
- Enable Smart and Connected Products
- Ensure Regulatory Compliance
- Support Quality Management
- Plan for Manufacturing
- Control Suppliers
- Plan for Service
- Assess Implementation Requirements
- Consider Vendor Attributes
- Identify Specific Needs for your Company
- Conclusion
- Recommendations
- About the Author
Executive Overview
Medical device companies are in the business of making people’s lives better. As Joel Hembrock, Senior Designer and CAD Administrator at Medtronic says, “Our patients are the people who benefit from our products. Restoring life is our main focus. [We want] to be giving people their lives back, restoring their health, allowing them to actually live again and not have their disease or any other ailment keep them from being able to live.” With lives at stake, patient safety is of the upmost importance. As such, the industry faces heavy regulations. Compliance is so critical that if medical device companies do not adhere to FDA, EU and other worldwide standards and regulations, they will not be profitable. However, so much time, effort, and cost goes into compliance documentation, it takes efforts away from innovating and ensuring high quality products. Consequently, it is harder to take advantage of opportunities that will boost profitability. On the other hand, medical device companies who adopt practices focused on high quality devices can expect greater patient satisfaction, improved competitiveness, and higher profits. In fact, McKinsey estimates that companies who adopt quality focused best practices can increase profits by 3% to 4% of revenues. They estimate the revenue increase alone could be a $3.5 billion opportunity for the industry and this doesn’t even factor in profitability improvements by avoiding costly quality issues. To achieve this, companies need to be empowered to shift from a document centric process to one that focuses on high quality, innovative products that meet patient needs. The good news is that with investments in the right technology, this is possible. Technology can reduce manual, time intensive reporting processes to a push of a button. Rather than structuring processes around documentation, technology can allow you to focus on developing the right products and services that will meet patient needs. For these reasons, some medical device manufacturers are integrating quality processes into core product lifecycle management activities. By integrating quality processes throughout the product design and delivery lifecycle, companies can improve efficiency. With this approach, time spent searching for compliance supporting documentation and reporting, can instead be invested in quality and innovation. The result will be greater profitability. Other changes in the medical device industry are coming from recent trends such as the transition to outcome-based healthcare in the US. In some cases, to be compensated, medical professionals must show positive patient outcomes. One way to accomplish this is to take advantage of innovation enabled by the Internet of Things (IoT). This along with requirements for Unique Device Identifiers (UDI’s) can provide new levels of traceability and communication that can demonstrate device effectiveness. However, to take advantage of this and manage it, the right technology must be in place. While many of these issues may require new investments in technology, existing systems that are working well, should be leveraged. Working solutions such as Manufacturing Execution Systems (MES), Enterprise Resource Planning (ERP) and Product Lifecycle Management (PLM) should be considered when selecting a complete solution to manage medical devices. The new solution should use a platform that will leverage and extend the investments made in existing solutions. With so much to consider, how do you know what will be the right technology? This buyer’s guide will serve as guidance to help you select what is right for your company. This guide consists of four major sections covering software tool functionality required for medical device companies, implementation requirements, vendor attributes, and special company considerations (Figure 1).




Table of Contents
Executive Overview
- The Business Value of Integrating PLM
- When do Companies Begin Integrating?
- Introducing the PLM Integration Lifecycle
- Implementation Challenges
- Operation Challenges
- Maintenance Challenges
- Business Impacts
- Quantifying the Impact
- Identifying the Top Performers
- Top Performers Experience Fewer Negative Impacts
- Top Performers Integrate More
- Top Performers Integrate with More Advanced Tools
- Top Performers Integrate with More Advanced Enterprise Applications
- Top Performers Integrate More PLM Data
- Top Performers Use More Advanced Integration Techniques
- Focusing on the Future: The Impact of IoT on PLM Integration
- Conclusion
- Recommendations
- About the Author
- About the Research
- Copyright Notice
Executive Overview
Product Lifecycle Management (PLM) helps manufacturers in many ways ranging from operational efficiencies to top-line financial improvement. It improves business performance in multiple dimensions including increased revenue, reduced product cost, and decreased product development cost. But PLM is just one of many systems in the engineering and enterprise software ecosystems, and provides greater value when it shares data and connects workflows with other software. As reported in Product Lifecycle Management Beyond Managing CAD, “Top Performers are much more likely to integrate PLM with a host of other systems.” We surveyed over 150 companies to understand their PLM integration strategy, processes, and technical enablers in order to understand how proper integration can extend PLM value. The findings indicate that the vast majority of manufacturers view PLM as “Strategic” or “Important.” It also finds that many believe that PLM integration will become even more strategic (and challenging) as IoT initiatives progress. In order to understand how companies get the most business value from PLM integration, we identified manufacturers that were gaining the largest operational benefit from their PLM implementation, the Top Performers. These leaders achieve significantly better than average PLM business benefits. We analyzed what these companies do differently related to PLM integration in order to offer advice to poorer performing companies. The analysis determines that Top Performers in gaining the benefits from PLM:Are more likely to view PLM integration as strategic
- Integrate PLM to more design tools and more enterprise applications
- Integrate PLM to more advanced tools and applications
- Are more able to implement, operate, and maintain PLM integration in an agile, cost-effective way
- Experience fewer operational issues including:
- Needing to look for data in multiple systems
- Duplicate data entry
- Data inconsistency across systems
Conclusion
PLM helps companies improve product innovation, product development, and engineering efficiency and helps enhance communication across the enterprise and the supply chain. Improving PLM integration helps companies achieve the benefits PLM has to offer, making it a highly strategic investment. The level of importance, along with the level of complexity, will only increase as companies move to smarter, more connected products and the IoT. Top Performers, those that get the most benefits out of their PLM systems, are more likely to view PLM integration as strategic. They integrate more design tools and enterprise applications with PLM, and integrate PLM to more advanced tools and applications. They also integrate more data, including more information that spans the enterprise and the supply chain. The leads us to the conclusion that better PLM integration is simply good business. Top Performers take different approaches to integrating PLM, employing a variety of tools but more likely including adaptable techniques like a hub and spoke approach that provides benefits across the PLM Integration Lifecycle. The result is that these Top Performing companies are more able to implement, operate, and maintain PLM integration in an agile, cost-effective way and experience less need to look for data in multiple systems, perform less duplicate data entry, and find less data inconsistency across systems.Recommendations
Based on our experience and the research for this report, Tech-Clarity offers the following recommendations:- Manufacturers should integrate PLM with a broader number of enterprise applications and design tools
- Companies should integrate with more advanced systems, including those that extend beyond Engineering into the enterprise and the supply chain
- Companies should use a variety of integration techniques depending on the specific solutions and connectivity methods available, leveraging more advanced approaches such as hub and spoke when practical to provide more agility across the PLM Integration Lifecycle
- Manufacturers should consider outside expertise to fill the PLM integration knowledge gap
- Companies should focus integration plans and efforts beyond the initial implementation to optimize across the entire PLM Integration Lifecycle






Table of Contents
- It's Time for a Cloud Strategy
- Understanding the Options *
- Comparing Your Options *
- Assessing Company Readiness *
- Sample Cloud Decision Tree *
- Reviewing Vendor Cloud Maturity *
- Special Cloud Opportunities for Product Innovation and Engineering *
- Weighing the Options, Looking at Timing *
- Next Steps
It’s Time for a Cloud Strategy
The shift toward cloud computing is undeniable. An increasing number of companies are transitioning to cloud solutions in order to take advantage of significant advantages, including:- Cost reduction
- Reduced IT resource needs
- Scalability
- Agility
- Rapid deployment
- Shifting capital investments to expenses

- Cloud delivery models
- Software capabilities and scope
- Timing and transition
Next Steps
The time is right to take advantage of the cloud, but it’s not a trivial decision or transition for product innovation, product development, and engineering software. The reality of the market maturity requires companies to develop a strategy that jointly considers vendor cloud maturity, company readiness, and the availability of needed capabilities.



Welcome to the IIoT
Supporting the Industrial Internet is now an important part of the Engineering domain. For some, it’s because their customers are operating their products in the Industrial Internet of Things (IIoT). For others, it’s because their company is using the IIoT to monitor and control equipment and devices in their own facilities. For many, both are happening at the same time. The IIoT movement changes the game for companies, their customers, and their Engineering department.
The potential value of the IIoT is immense, and companies are responding. Potential benefits range from productivity and cost savings to fundamentally resetting the value proposition and relationship between companies and their business partners, including suppliers, service partners, and customers. Whether a company is pursuing an IoT or IIoT initiative to support customers, improve their own business, or make sure to keep up with the competition, it will have an impact on Engineering.
Adapting Engineering to the IIoT
What do engineers need to do in order to survive and thrive in this brave new world? One thing that’s clear is that the IIoT drives new product design requirements. Beyond products, it also drives significant infrastructure requirements, as discussed in Ten Build-Buy Factors for IoT Platforms. Engineers play a key role in unlocking the IoT and the IIoT value in both areas. This introduction shares some of the ways engineers need to think differently to support company-wide IIoT initiatives. But Engineering can also gain their own value from these initiatives. This introduction highlights the potential benefits Engineering can receive directly from participating in the IIoT, and highlights specific areas in the ten build-buy factors that are the most important for engineers to consider. Let’s get started.Engineer’s Role Supporting the IIoT – Design
Engineers can play multiple roles supporting IIoT initiatives....... *This summary is an abbreviated version of the post. Please see the full Top Five Factors for a Successful Industrial IoT Implementation post on the Autodesk website (free of charge, no registration required). If you have difficulty obtaining a copy of the report, please contact the author at jim.brown@tech-clarity.com or by clicking our Contact button. [post_title] => Top Five Factors for a Successful IIoT Implementation (guest post) [post_excerpt] => [post_status] => publish [comment_status] => open [ping_status] => open [post_password] => [post_name] => iiot-intro [to_ping] => [pinged] => [post_modified] => 2022-11-14 22:25:32 [post_modified_gmt] => 2022-11-15 03:25:32 [post_content_filtered] => [post_parent] => 0 [guid] => http://tech-clarity.com/?p=5737 [menu_order] => 0 [post_type] => post [post_mime_type] => [comment_count] => 0 [filter] => raw ) [14] => WP_Post Object ( [ID] => 5717 [post_author] => 2572 [post_date] => 2016-09-27 13:37:22 [post_date_gmt] => 2016-09-27 17:37:22 [post_content] =>
What’s Happening with Systems Development?
Research from Tech-Clarity’s Developing Software-Intensive Products finds that 53% of companies report significant increases to the amount of software in their products. Further, 75% say that over the next 5 years, they will be adding even more software to their products. This growth makes sense as software offers lots of opportunity. However, it also introduces challenges. Ignoring these challenges will hurt company profitability, while companies who address them will be far more successful, win new customers, and beat their competition.Key Takeaways
With the increasing amount of embedded software and the need to stand out from the competition, Product Line Engineering across systems and software can be a helpful way to enable platform design. With the right software solution, companies can avoid some of the challenges of systems engineering. Qualities to consider in a PLE solution include facilitating collaboration across engineering discipline, managing complexity, and supporting design automation. *This summary is an abbreviated version of the report and does not contain the full content. Use this link to download the full report. If you have difficulty obtaining a copy of the report, please contact us using the "Contact" link below. [post_title] => How Product Line Engineering (PLE) Creates a Competitive Advantage [post_excerpt] => [post_status] => publish [comment_status] => open [ping_status] => open [post_password] => [post_name] => product_line_engineering_ple [to_ping] => [pinged] => [post_modified] => 2022-11-14 22:27:51 [post_modified_gmt] => 2022-11-15 03:27:51 [post_content_filtered] => [post_parent] => 0 [guid] => http://tech-clarity.com/?p=5717 [menu_order] => 0 [post_type] => post [post_mime_type] => [comment_count] => 0 [filter] => raw ) [15] => WP_Post Object ( [ID] => 5702 [post_author] => 2 [post_date] => 2016-09-26 10:19:39 [post_date_gmt] => 2016-09-26 14:19:39 [post_content] => This short Tech-Clarity TV animation explains how manufacturers can get started with Product Data Management. The video offers findings from The Business Value of Product Data Management that finds that manufacturers can get off to a fast start with preconfigured solutions but still leave themselves room to grow on a foundation that provides more advanced capabilities. https://youtu.be/RN5996fXgXo This episode is sponsored by Siemens PLM. Learn more about Siemens PLM and their Teamcenter Rapid Start Program. [post_title] => Getting Started with PDM (animation) [post_excerpt] => [post_status] => publish [comment_status] => open [ping_status] => open [post_password] => [post_name] => plm-start [to_ping] => [pinged] => [post_modified] => 2022-12-02 15:06:52 [post_modified_gmt] => 2022-12-02 20:06:52 [post_content_filtered] => [post_parent] => 0 [guid] => http://tech-clarity.com/?p=5702 [menu_order] => 0 [post_type] => post [post_mime_type] => [comment_count] => 1 [filter] => raw ) [16] => WP_Post Object ( [ID] => 5684 [post_author] => 2572 [post_date] => 2016-09-20 09:16:36 [post_date_gmt] => 2016-09-20 13:16:36 [post_content] =>
- The top improvement areas you should focus on to get even more value from simulation
- Best practices followed by Top Performing companies to overcome simulation bottlenecks
- Selection criteria to help you identify the right simulation solution for your company







All Results for "All"
Four Ways Medical Device Companies Can Become More Profitable – Guest Post on PTC Blog
In this PTC guest post, Michelle Boucher shares Four Ways Medical Device Companies Can Become More Profitable. As companies plan for 2017, medical device companies should consider these four suggestions to help them improve margins. The post touches on topics such as the cost of compliance, the Case for Quality, and considerations for the impact of IoT….
Tips for Designing IoT Products: Use Model-Driven IoT Code – Guest Post on PTC Blog
Michelle Boucher shares tips for designing IoT products and systems by using model-driven IoT code in this PTC guest post. As a result of reading this post, you will have a better understanding of how this can be a helpful step for those looking to incorporate the Internet of Things (IoT) technology in their products. Many products…
Medical Devices Manufacturers Software Selection Guide
Tech-Clarity’s Medical Devices Manufacturers Software Selection Guide helps manufacturers identify the right buying criteria for software solutions to support developing, producing, and servicing medical devices. This buyer’s guide also takes into account unique needs for medical device companies including regulatory compliance and support for the FDA’s Case for Quality. Tech-Clarity’s Buyer’s Guides go beyond software functionality to…
Medical Devices: Making The Right Choice – Your Case For Quality (webcast)
Michelle Boucher participated in a webinar for medical device companies on. In addition, IEEE Spectrum’s Dexter Johnson moderated the event. During the webinar, Michelle shares medical device industry trends. She will also offers advice to efficiently manage regulatory compliance and discuss the implications for the Case for Quality. She was joined by Mr. Sri Tupil, VP Software Quality Eng….
How Top Performers Implement, Operate, and Maintain PLM Integration (survey findings)
How Top Performers Implement, Operate, and Maintain PLM Integration – Best Practices for Integrating Product Lifecycle Management shares survey results detailing how Top Performers implement their PLM systems. The research uncovers integration challenges and best practices across the PLM Integration Lifecycle, recognizing that implementing integration is only the first step in the process. Please enjoy…
Five Ways to Beat Product Development Deadlines (webcast)
Jim Brown will present findings from his recent study on New Product Development and Introduction (NPDI) to help companies learn from Top Performing product developers. The webcast will share the strategies, approaches, and enablers they use to drive high profits from their new product initiatives. Learn how the leaders will meet (or beat) their new…
Better PLM Integration Drives Better Business Performance (Webcast)
Tech-Clarity analyst Jim Brown joins Razorleaf’s Director of Integrations and Development Derek Neiding to share the results of a recent study on PLM integration. The webcast will highlight the strategies, processes, and technologies Top Performers use to integrate PLM with design tools and other enterprise systems. Register now for the December 13 webcast, sponsored by Razorleaf Corporation (free…
Engineering Live PLM Discussion
Join an interactive discussion between Tech-Clarity’s Jim Brown and Autodesk’s Ron Locklin moderated by Advantage Business Media Editor in Chief Janine Mooney as they discuss the history, challenges, benefits, and future of Product Lifecycle Management (PLM). The event will be available on Product Design & Development, Manufacturing.net, and Manufacturing Business Technology. Watch the event live, October 31 at…
Moving Production Innovation and Engineering to the Cloud (guest blog post)
Jim Brown contributed insights from his recent research on cloud options for product innovation, product development, and engineering software in a guest post titled Moving Production Innovation and Engineering to the Cloud, What’s Your Strategy? on the Siemens PLM Community. The post references findings our recent Exploring Cloud Options for Product Innovation and Development eBook. For more information on…
Successful Products Start and End with Your Customer (infographic)
Tech-Clarity’s Infographic, Successful Products Start and End with Your Customer provides guidance to CPG companies. By embedding your customer in the middle of your product life cycle, your products will be more successful. The infographic, shows that by capturing insights obtained during the shopping experience, you can drive a move successful approach to product development. To be…
Cloud Options for Product Innovation and Development (eBook)
The Exploring Cloud Options for Product Innovation and Development eBook shares our thoughts about the cloud software choices available for product innovation, product development, and engineering software including PLM, PDM, CAD, CAE, and more. The eBook details the different software models available and provides considerations for each. It also helps put the various options into context with a…
New Possibilities with IoT – Contribution to PTC eBook
To help manufacturers prepare for the future of product design, PTC has released a new eBook, 10 Expert Insights : The Future of Product Design in the Age of Smart & Connected Devices. Michelle Boucher’s contribution, New Possibilities with IoT, shares her thoughts on the future of product design. In this section, she explains how the Internet of Things will empower product…
Top Five Factors for a Successful IIoT Implementation (guest post)
Jim Brown contributed a post to the Autodesk Fusion Connect site sharing the Top Five Factors for a Successful Industrial IoT Implementation. The post provides an introduction to our Ten Build-Buy Factors for IoT Platforms eBook tailored to Engineers so they can understand not only how to support their company’s IoT initiative, but also how to gain…
How Product Line Engineering (PLE) Creates a Competitive Advantage
How Product Line Engineering (PLE) Creates a Competitive Advantage: Removing Time, Cost, and Complexity from the Systems Lifecycle discusses the growing importance of embedded software in today’s products and the resulting complexity. The report highlights the negative impacts of not managing this complexity. Despite these impacts, there are benefits of using the right software. Those using the right…
Getting Started with PDM (animation)
This short Tech-Clarity TV animation explains how manufacturers can get started with Product Data Management. The video offers findings from The Business Value of Product Data Management that finds that manufacturers can get off to a fast start with preconfigured solutions but still leave themselves room to grow on a foundation that provides more advanced capabilities. This episode is sponsored by Siemens PLM. Learn…
Addressing Bottlenecks in Simulation (webcast)
Hear Michelle Boucher share her recent research on Simulation Bottlenecks during a this webinar. Digital Engineering’s Kenneth Wong will moderate this webinar sponsored by Siemens Femap. This webinar will reveal: The top improvement areas you should focus on to get even more value from simulation Best practices followed by Top Performing companies to overcome simulation bottlenecks Selection criteria to help…
Top Five Five Factors for a Successful IIoT Implementation (webcast replay)
Jim Brown presented his recent research on building versus buying IIoT infrastructure in the upcoming Top 5 Factors for a Successful Industrial IoT Implementation webcast on Engineering.com (sponsored by Autodesk). The webcast also featured Autodesk’s Head of IoT, Bryan Kester, sharing how IIoT can help improve product service, close the loop on engineering designs, and…
How A&D Companies Get More Value from Simulation – Guest Post on Siemens Blog
How Aerospace and Defense (A&D) Companies Get More Value from Simulation is a new Siemens guest post. In this post, Michelle Boucher explores how A&D companies use simulation. The post highlights challenges faced by A&D companies and then shares survey results revealing some of the top ways A&D solve them. Read the post on the…
Avoid Product Launch Failure by Aligning Quality and Engineering (webcast replay)
Tech-Clarity’s Jim Brown joined Arena Solutions’ Ann McGuire on a TechBriefs webcast about avoiding product launch failures. Jim and Ann discussed why products fail and what companies are doing to improve product development success across the product lifecycle. The webcast, Avoid Product Launch Failure: Best Practices for Aligning Your Engineering and Quality Teams, is sponsored by Arena…