What will help MedTech companies stay competitive in an era marked by rapid innovation, rising regulatory complexity, and global disruption?
As the industry moves toward smarter, more personalized, and increasingly connected healthcare, MedTech manufacturers face mounting pressure to reduce time to market, improve patient outcomes, control costs, and ensure compliance without sacrificing quality or patient safety. Achieving success in this environment requires digital transformation. With it, MedTech companies can realize greater efficiencies while developing, building, and servicing products and devices across their lifecycle. What should companies consider to successfully select the right solution?
This buyer’s guide outlines key buying criteria across four critical areas: software functionality, implementation support, vendor capabilities, and company-specific needs. Based on expert interviews and market research, it’s designed to help MedTech leaders evaluate and invest in the tools that will drive innovation, efficiency, and compliance in the years ahead.
Please enjoy the summary* below. For the full research, please visit our sponsor, PTC (registration required).
Table of Contents
- Executive Summary
- Business Needs Driving Development Investment
- MedTech Development Challenges
- The Value of a Digital Thread
- 1. Requirements Management
- 2. Hardware Development
- 3. Software Development
- 4. Smart Connected Products
- 5. Regulatory Compliance
- 6. Quality Management
- 7. Plan for Manufacturing
- 8. Service & Post-Market
- Adoption and Implementation
- Vendor Considerations
- Specific Company Needs
- Conclusions and Next Steps
- Acknowledgments
Executive Summary
MedTech Opportunities
By 2030, one in six people worldwide will be over 60, which will lead to an increase in age-related disorders. Additionally, there has been a rise in chronic diseases, such as diabetes, among younger populations. Trends like this are leading to the development of novel treatment and therapy options. This significant surge in innovation is evident in the 19,100 submissions the FDA received in 2023, along with the record 167 breakthrough designations it granted. Artificial intelligence (AI) is driving even more innovation as the FDA has now authorized over 1,000 AI-enabled devices. Given these trends, the global MedTech market is projected to grow 6.5% annually through 2032.5 The companies that thrive will likely be those that prioritize novel innovations, as incremental improvements won’t be enough. R&D excellence will be essential for growth.
Challenges to Overcome
Despite the strong market potential, MedTech companies face increasing regulatory complexity, rising costs, and growing product complexity, all of which reduce R&D productivity. To succeed, manufacturers must look beyond minor process improvements. Life sciences leaders see digital transformation as critical to success.
To support digital transformation, MedTech companies need an integrated product development solution that connects hardware, software, quality, manufacturing, and service. This solution should enable traceability, compliance, and collaboration, thereby reducing risk, accelerating innovation, and improving outcomes.
How to Use This Guide
This guide comprises four major sections covering software tool functionality, service requirements, vendor attributes, and special company considerations. Each section includes a checklist of key requirements to support your selection process. While it is not an all-encompassing requirements list, it provides a high-level overview of criteria considerations.
The Value of a Digital Thread
Operational Resilience
As regulations tighten and risks rise, full traceability has become critical. MedTech companies must demonstrate how decisions are made, how changes affect safety and performance, and maintain compliance from design to post-market support. Legacy systems cannot maintain this end-to-end visibility. A digital thread, enabled by an integrated solution, supports traceability, audit readiness, and proactive quality management.
Overcome Silos
A digital thread links requirements, design, engineering, manufacturing, quality, and service, making every decision traceable, every change visible, and every team aligned. Traceability accelerates root cause analysis, simplifies compliance, and improves first-time-right development. When requirements are linked to test results, quality and regulatory assurance become built-in.
By integrating Application Lifecycle Management (ALM), Product Lifecycle Management (PLM), Quality Management Systems (QMS), ERP, Manufacturing Execution Systems (MES), and Service Lifecycle Management (SLM), companies improve collaboration, manage requirements, plan for manufacturing, and leverage real-world service data in a shared digital environment. This integration yields numerous business benefits (see graphic).10
Prepare for the Future
This approach enables MedTech companies to transition from document-based processes to data-driven development, integrated quality systems, and connected service operations. It provides the agility needed to thrive in today’s disruptive environment. The right solution will also support next-generation capabilities like AI, digital twins, and open interoperability.
Adoption and Implementation
Accelerate Adoption
To realize the expected value of the solution, it’s essential to drive adoption across teams, ensure systems integrate, and support long-term scalability. In a high-stakes, regulated environment, MedTech companies must transition with minimal disruption while transforming digitally.
Why it Matters
A modular, scalable architecture lets you start small and expand, minimizing disruption. A cloud-based deployment improves performance and global accessibility. Seamless integration with ERP, MES, and QMS reduces friction for cross-functional adoption.
Flexible workflows and customizable UIs accommodate different process maturities and user roles, boosting usability. Low-code/no-code tools let admins adapt workflows, forms, and templates without heavy IT involvement. Combined with built-in analytics further supports adoption and performance. MedTech-specific templates, best-practice workflows, and structured onboarding all accelerate time to value. Validation-ready solutions simplify maintaining compliance under Computer Software Assurance (CSA).
Conclusions and Next Steps
Prepare for the Future
The MedTech sector is facing a perfect storm of challenges, including tightening regulations, geopolitical instability, rising costs, and constant pressure to innovate. To stay competitive, manufacturers must not only ensure product quality and patient safety, they must also build agility, resilience, and efficiency into their core processes for designing, developing, manufacturing, and servicing products. This requires a fundamental shift from fragmented systems and manual processes to a unified solution.
These challenges jeopardize not only efficiency but also compliance, customer satisfaction, and even patient safety. The right solution can eliminate these bottlenecks by connecting every phase of the product lifecycle, integrating quality and compliance by design, and providing the digital agility that MedTech organizations need to thrive in a rapidly changing environment.
Next Steps
Use this buyer’s guide to define your organization’s priorities and must-have capabilities. Begin evaluating solution providers that offer integrated PLM, ALM, QMS, and service lifecycle tools tailored to the MedTech industry. Look for platforms that support regulatory compliance, multi-disciplinary collaboration, and scalable deployment. Engage cross-functional stakeholders early to align on goals and ensure a successful transformation.
*This summary is an abbreviated version of the ebook and does not contain the full content. For the full report, please visit our sponsor PTC.
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