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Driving Elevate, our holistic remediation and quality transformation program

March 2025

Focus Area 2: Compliance, Product Quality and Safety

To ensure patient safety while supporting business growth, since the beginning of the fiscal year ended March 2024 Olympus has been implementing a holistic, multi-year remediation and quality transformation program named Elevate. Here, the people leading the 20 workstreams that drive Elevate give us their thoughts on the program, and the changes achieved so far.

Shigeru Imai

Design Controls Workstream Lead
Based in Tokyo

Hitoshi Ogura

Production & Process Controls Workstream Lead
Based in Tokyo

Aimee Gogarty

Patient Safety & Quality Culture Workstream Lead
Based in the U.S.

Melissa Lake

Management Responsibility, Document Controls Workstream Lead
Based in Canada

A global team executes 20 workstreams

Elevate comprises 20  workstreams, driven by a strong team selected globally from each function. The four pillars of “Design & Development,” “Manufacturing & Supplier Management,” “Supply Chain, Market & Post-Market,” and “End-to-End (E2E) Quality Processes” will drive our efforts to meet regulatory commitments and strengthen the foundation of our quality culture.

The power of Elevate, as told by the individuals leading it

Q. What are the differences between Olympus before Elevate, and now that it has begun?

Imai: Elevate is a program that started in 2023, and within that program, we are working together with our fellow global employees on quality management system (QMS) activities. I was previously involved in R&D with new product development, including production and process management. In the past, Olympus manufacturing in Japan was a closed loop in terms of product development. That meant the culture, design innovation, and any product launches were all based on a Japanese mindset. and at the time there was a gap between what was being done globally and what was being done in Japan. However, through Elevate and communication with our global members, I feel like we have made great strides in closing that gap.

Ogura: I joined Olympus as an engineer, and based on my years in the company, I can see four specific differences in the Elevate program. First, the governance has been enhanced significantly, and priorities as well as goals are now clear and well defined.
Second, because we are all aware of Elevate, cooperation is quite efficient. Three, global initiatives. Four, thinking about patient safety on a daily basis: this is a priority for Olympus, and Elevate has been able to help with this cultural transformation.

Gogarty: I have been involved in the Quality Assurance and Regulatory Affairs (QARA) Transformation initiative since I first joined the company, and I agree with Ogura's point about strengthened governance. Additionally, it is now easier to stay informed, and to escalate decisions or risks. Communication, now aligned with our new core values, has also improved as information permeates both up and down the ladder of management and also across, since collaboration between different workstreams has also improved.

Lake: I too was responsible for driving the QARA Transformation initiative. This project evolved into Elevate, with governance strengthened from a cross-departmental standpoint. A strong feature of Elevate is its ability to foster collaboration across the organization. Elevate does this by allowing communities to be built, and enabling communication across workstreams and communication channels. It is also very refreshing to see that prioritization of initiatives is clear. And, it is encouraging to see these successes being shared organization-wide.

Q. What are some challenges to us as a MedTech company? Are there any current initiatives to address these?

Ogura: I believe Olympus needs to enhance four different components. The first component is expertise and technology integration. As a MedTech company, in addition to our core technologies such as optical technology, we need deep knowledge of medicine and biology as well as more and more specialists collaborating on the development of medical devices. The second is regulatory affairs. Medical devices are strictly regulated, and in different ways in different countries, so we work with regulators from around the world. We need to be able to comply with these regulations in our processes. The third component is an understanding of the market and customer needs. The fourth is quality and risk management.

Imai: The development process is also a challenge, I would like to point out. For a very long time, Olympus had been using an old model of development process. We needed to improve in this area, but the challenge was that our historical processes were limited by a cultural approach that isolated function. Formerly, we would assume that as long as the standard operating procedures were followed in development, there would be no issues. In reality, the development process and our QMS need to be tightly interlinked. With Elevate, the development process and QMS are more interconnected, and with the introduction of more global perspectives, we are better able to identify opportunities for improvement and to deal with challenges from different angles.

Q. How has the mindset of yourself or those around you changed through Elevate?

Lake: One major change I have observed is the move to a more proactive communication style, with employees taking greater ownership of their projects. Employees are feeling more confident in the processes, and in their own approaches.
I aim to continually promote a culture of quality, and aspire to really drive the management review process to monitor the health of the QMS. This is a journey that will take time, I know, but enhancing and harmonizing the global quality systems remains a key aspiration of mine.

Gogarty: For me, it is important to have not just reactive tasks, but also proactive ones motivated by patient focus. I would like to see incremental improvement that is based on a quality mindset, rather than just upholding the status quo.
As we move into a different mindset, I would like to see improved collaboration across Olympus, and an improved relationship with regulatory authorities. I also hope to see us ensure a good reputation within our industry, and raise the bar so that other companies are looking to Olympus for best practices.

For a more in-depth interview, please see Integrated Report 2024.
Elevate Employees Roundtable Discussionlink to pdf file

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