Optimizing the Compliance Process for Business Agility with Jules Keghile, Ph.D., VP and Head of Systems Engineering and Architecture at Elekta [Speaker Spotlight]

In this Speaker Spotlight, Jules Keghie, Ph.D., VP and Head of System Engineering and Architecture, Elekta, will give a preview of his upcoming session at the European Medical Device Summit titled, "Optimizing the Compliance Process for Business Agility."

Introduce yourself and describe your role/responsibilities as the VP and Head of System Engineering and Architecture at Elekta and your journey into the medical device world.

I am Jules Keghie, and I am leading System Engineering and Architecture for Linac Devices and Solutions within LSS (Linac and SW Solutions) Research & Engineering at Elekta.

After my first years of professional experience in developing industrial automation controllers and an exposure to the aircraft and defense R&D, I started a meaningful 14-year plus journey in the medical devices world, including several roles, initially as a technical expert in different specialties and later in (senior) leadership roles.

This journey has been gratifying in terms of the contributions to the important mission of improving health outcomes for patients. Collaborating with other functions and partners to deliver the best meaningful value for our customers and our companies is a key driver in this.

What strategies has Elekta implemented to make compliance a business enabler rather than a bottleneck in product development?

At Elekta, we have the mission to improve patient lives by working together with our customers and partners. Being a trusted partner to customers and partners means developing and maintaining safe, effective, and secure products and solutions in the global markets.

Our experience shows that ensuring proactive compliance for our products supports higher customer satisfaction and less rework and, as such, contributes to better overall performance.

How do you manage employee resistance to change in traditional manufacturing settings with deeply ingrained processes?

Managing employee resistance to change, especially in traditional manufacturing settings with entrenched processes, requires a strategic approach centered around effective communication. Transparent and ongoing communication is key to alleviating concerns and fostering a positive outlook toward change. 

Initiating change involves clearly explaining the reasons behind it, the benefits it brings, and how it aligns with the company's long-term objectives. Employees need to understand not only the 'what' but also the 'why' behind the changes. This clarity helps in addressing uncertainties and building trust.

It's also essential to highlight how the changes will positively impact employees' roles and job security. By demonstrating the tangible benefits and addressing potential concerns proactively, we can mitigate resistance and foster a more receptive environment for change. Engaging employees in the change process and seeking their input can further enhance their buy-in and support.

"Managing employee resistance to change, especially in traditional manufacturing settings with entrenched processes, requires a strategic approach centered around effective communication. Transparent and ongoing communication is key to alleviating concerns and fostering a positive outlook toward change."

What lessons have you learned from optimizing compliance processes at Elekta that could be applied across the broader medical device industry?

There have been a few learnings along the journey, and more have been added even today.

One key learning is that optimization of processes requires good change management skills and cross-functional and interpersonal collaboration. 

There is much that can be leveraged from the classical tools of Lean Management, such as establishing and leveraging global standards to support a common direction.

Third but not least, the use of the appropriate (digital) tooling for the tasks to be addressed can make the difference.

What best practices do you recommend for navigating compliance in emerging markets with varying regulatory landscapes?

There are a few ideas, such as developing and maintaining a good understanding of the fundamentals of design control, as these are common across markets with some local specializations.

Understanding how the combination of product features and target markets correlate with the applicable regulations and (product) standards.

Identifying the commonalities in terms of standards and compliance requirements across markets and optimizing the product certification in line with this.

It is also beneficial to proactively optimize the regulatory compliance plan, taking the relevant national deviations into account as this contributes to time and cost-effectiveness.

Engaging early in the process with local competent authorities and certifiers in framing the formal requirements for market access can improve the efficiency of the overall process.

What strategies do you use to proactively adapt to evolving global regulatory requirements, such as EU MDR, FDA’s evolving cybersecurity expectations, and ISO 13485 updates?

We proactively monitor the development of the global regulatory landscape through active engagement with different product standardization committees.

Additionally, we make timely and good use of the information provided by relevant authorities and bodies such as the FDA, EMA, the EU Commission, the IEC Committees, the NMPA, and AERB, to name a few.

Keeping on track with the work done by such stakeholders and looking at these more as opportunities to continuously improve has proven to be beneficial, for instance in coping with the recently increased requirements on cybersecurity or AI.

Elekta operates in a highly regulated space, particularly in oncology and radiotherapy solutions. How has Elekta optimized its compliance processes to accelerate product approvals while ensuring patient safety and regulatory adherence?

Compliance requirements are embedded in our holistic requirements framework as a non-negotiable requirements category.

Using the framework of requirements-driven engineering and following our quality management system with the required traceability ensures we do the right things to deliver safe, effective, and secure products.

What has been a favorite memory from the 2024 European Medical Device Summit, and what are you most excited about this year?

There have been several highlights for me from the 2024 European Medical Device Summit. The reminder to differentiate between the regulations aimed at patient safety and those relating to compliance, two important categories but not the same, was important.

Learning from very experienced leaders in the medical devices industry is always an opportunity to accelerate the growth path on topics that could have necessitated otherwise much effort or time.

Attending and participating in the European Medical Device Summit is a great opportunity to connect, learn with and from others, and return the value captured to our respective organizations.

I am looking forward to the opportunity to connect, share, and learn at the European Medical Device Summit 2025.

We are grateful for the insightful contributions of Jules Keghile, Ph.D., in this blog post. His expertise will add significant value to our discussions at the European Medical Device Summit. We look forward to his upcoming session, "Optimizing the Compliance Process for Business Agility," taking place on June 3-4, 2025, in Düsseldorf, Germany.