Challenges and Opportunities for the Medical Devices Industry
Guest Blog by IDC Bloggers: Nimita Limaye and Michael Townsend
Despite a challenging 2020, the medical device market is expected to rebound, albeit slowly in 2021. Increasing pressure on revenue and margins have spurred the industry to accelerate innovation and adopt agility at scale. The COVID-19 pandemic has further accelerated digital transformation, driven by the need for zero-touch, automated processes, and the use of real-time predictive analytics to enable decision making.
Challenges
Medical Device Regulatory Compliance
The medical device industry has long struggled with numerous country-specific and changing regulations such as QSR CFR 21, ISO 13485, and other evolving EU MDR and IVDR regulations. Accelerating product innovation further exacerbates the struggle of ensuring development processes are fully in accordance with compliance and an ever-evolving regulatory landscape.
Software-Intensive Medical Devices
The industry has acknowledged that product innovation and differentiation is dependent on increasingly complex software. The increasing demand for non-invasive, connected medical devices, complemented by the escalated demand for remote patient-monitoring due to the COVID-19 pandemic, is driving increased adoption of intelligent medical devices based on the Internet of Medical Things (IoMT).
Global Competition
Global competition requires companies to become more productive. Engineering teams need to focus more than ever on engineering and not process. Process is important, but short of hiring more engineers, businesses need to increase the productivity of the engineers they have.
Benefits of Engineering Life-cycle Management (ELM)
ELM serves as a digital foundational platform for leveraging artificial intelligence (AI), analytics, and virtual modeling across the engineering life cycle. It also helps to manage product complexity and ensure accurate reporting and regulatory compliance.
- Eliminates siloed development processes and strengthens controls around transparency and product traceability across engineering teams.
- Supports continuous verification and validation, helping to ensure product safety and reliability.
- Drives regulatory compliance, providing real-time contextual data and visibility to "smoke signals."
- Enhances productivity for medical device development teams by leveraging strategic reuse of product and software engineering work.
Recommendation
As medical device companies develop increasingly complex products, every organization needs to assess where it is in its journey. ELM can provide the foundation for medical device companies to be more competitive and ensure product safety and regulatory compliance through better management of parallel systems and software development.
Conclusion
The medical device industry is facing numerous challenges, including regulatory compliance, software-intensive medical devices, and global competition. To address these challenges, companies need to adopt Enterprise-level agility models and invest in Engineering Life-cycle Management (ELM) solutions. ELM can help manage product complexity, ensure regulatory compliance, and drive productivity.
FAQs
Q: What are the main challenges facing the medical device industry?
A: The main challenges facing the medical device industry include medical device regulatory compliance, software-intensive medical devices, and global competition.
Q: What is Engineering Life-cycle Management (ELM)?
A: ELM is an end-to-end, integrated systems and software development solution for complex development management.
Q: What are the benefits of ELM?
A: The benefits of ELM include eliminating siloed development processes, strengthening controls around transparency and product traceability, supporting continuous verification and validation, driving regulatory compliance, and enhancing productivity for medical device development teams.
