Transcending Borders in Consulting to Achieve FDA Compliance
How Cultural Intelligence, Regulatory Authority, and Respect Accelerate Global Project Execution in FDA Regulation Medical Device Compliance
By Frankie Breedlove | frankie.breedlove@nehimakinassoc.com
In global consulting, technical expertise alone does not guarantee success. The ability to understand cultural differences, establish credibility, and align execution with organizational leadership can determine whether a consultant becomes a trusted partner—or simply another external resource.
During a consulting engagement in Japan, I learned firsthand that successful international consulting requires more than overcoming language barriers. It requires understanding how people communicate, how organizations make decisions, and what earns the trust of those you are engaged to support.
The experience reinforced a fundamental principle: Before you can influence an organization, you must first understand it.
Understanding the Culture Before Driving Change
My experience in Japan reinforced several important cultural considerations that influenced how I approached the engagement:
Cultural Context: Japanese business culture places significant importance on established social and organizational norms, professional conduct, and contextual communication.
Professionalism and Appearance: Respect is demonstrated through both professional behavior and personal presentation, including appropriate business attire.
Harmony and Consensus: Maintaining productive relationships and minimizing unnecessary discord are important considerations when engaging stakeholders.
Leadership Alignment: Understanding leadership expectations, organizational hierarchy, and management direction is essential to effective project execution.
Respect Is Earned: External consultants must demonstrate an understanding of the organization's people, business, and needs before expecting their recommendations to be embraced.
These observations shaped my engagement strategy and reinforced the importance of adapting my approach to the organization rather than expecting the organization to adapt to me.
1. Establish Credibility Through Authority, Not Opinion
Before recommending changes, I invested time in understanding the host organization's business, product, processes, quality management system, and organizational hierarchy.
My approach was deliberate: recommendations needed to be grounded in documented authority rather than personal preference.
I consistently connected project guidance to:
Applicable regulatory requirements and regulatory authority guidance.
Recognized industry standards and applicable technical requirements.
Documented organizational policies, procedures, and quality management system requirements.
Leadership expectations and the organization's established business direction.
This approach positioned discussions around objective requirements and documented evidence, rather than individual opinions.
When addressing unfamiliar regulatory or product requirements, I researched publicly available licensing information, product filings, technical and marketing literature, and other relevant information to better understand the organization's regulatory and operational environment.
The result was a shift from being perceived as an external consultant to becoming a trusted resource whose recommendations were grounded in the organization's actual business and regulatory obligations.
2. Adapt Communication to How People Learn
One of the most valuable lessons was recognizing that communication barriers extend beyond language.
During the engagement, I observed that team members responded particularly well to visual explanations, graphical representations, and illustrated presentations.
Rather than dismissing PowerPoint presentations because they were not controlled quality management system documents, I sought to understand why the team valued them.
I learned that visual presentations helped personnel understand the narrative and relationships between processes.
I adapted by incorporating:
Graphical process representations and visual workflows.
Annotated images and illustrations to explain complex concepts.
Simplified visual explanations connecting technical requirements to practical execution.
The objective was not to replace controlled documentation, but to improve understanding so that personnel could more effectively implement and maintain the requirements within their quality management system.
Effective communication is not measured by what the consultant delivers, but by what the recipient understands and can apply.
3. Bridge the Language Gap Through Preparation and Simplicity
Working through interpreters introduced another dimension of complexity, particularly when discussing technical subjects involving design and development, product functionality, and quality system requirements.
I found that interpreters with relevant technical knowledge could communicate complex concepts more accurately and efficiently than those unfamiliar with the product or processes.
To address this challenge, I began meeting with interpreters before team discussions to review the subject matter, clarify technical context, and establish the intended meaning of key concepts.
When direct technical translations were unavailable or unclear, I simplified explanations using familiar analogies and everyday examples.
This required additional preparation and time, but it improved the interpreter's ability to convey the intent of the message.
Written communication required similar attention. Translation tools sometimes produced results that, when translated back into English, no longer conveyed the original meaning.
I therefore adopted a reverse-translation practice to evaluate whether the translated message retained its intended meaning.
I also learned to reconsider familiar English terminology, including technical terms associated with design verification and design validation, and identify alternative phrasing that more accurately communicated the intended concept.
The lesson was clear: Successful global communication requires validating understanding—not simply translating words.
4. Build Organizational Capability Instead of Creating Dependency
My consulting philosophy has always been rooted in the principle that teaching someone how to solve a problem creates more sustainable value than simply providing the answer.
During the engagement, I encouraged personnel to understand the rationale behind regulatory requirements, quality system controls, and appropriate problem-solving methods.
When team members approached me with challenges, I directed discussions toward the applicable regulatory mandate, standards, and their own quality management system.
Rather than relying on my personal opinion, I encouraged the team to evaluate the underlying requirements and develop an informed response.
This approach was not universally embraced. Some personnel welcomed the opportunity to deepen their understanding, while others were more comfortable with established practices and were reluctant to change.
Nevertheless, the objective remained consistent: develop the organization's ability to independently understand, execute, and sustain compliant processes. This approach will ensure that the client maintains compliant systems, which ultimately ensures regulatory compliance (i.e FDA compliance)
For consultants supporting regulated industries, this distinction is particularly important. Sustainable project execution depends not only on resolving immediate issues, but also on strengthening the organization's internal capabilities.
5. Align With Leadership and Respect Organizational Boundaries
An external consultant must recognize that their authority is defined by the assignment and the organization that engaged them.
Throughout the engagement, I maintained alignment with the leadership under which I was reporting and ensured that my communication, recommendations, and direction supported the organization's established objectives.
This required balancing technical guidance with organizational awareness, respecting existing leadership structures, and avoiding the assumption that external expertise supersedes internal authority.
By consistently aligning recommendations with leadership's intent, I established productive relationships across organizational levels, including senior leadership outside my immediate reporting structure.
This experience reinforced an important principle of executive consulting:
Credibility is not simply the ability to influence decisions; it is the discipline to exercise that influence within the boundaries of the client's objectives and authority.
The Business Impact: Trust Accelerates Execution
Within less than a month of joining the engagement, I had established productive working relationships and made a meaningful contribution to project execution.
Other consultants had been engaged for longer periods but were still working to establish their footing with organizational personnel.
My experience reinforced that the speed of effective consulting is not necessarily determined by how quickly recommendations are delivered. It is determined by how quickly a consultant understands the client, earns credibility, and creates the conditions for productive collaboration.
The greatest impact came from listening, observing, researching, and adapting before attempting to direct or influence.
Key Takeaways for Global Consulting Leaders
My experience in Japan reinforced several principles that apply to international consulting and cross-functional leadership:
Understand before you influence. Research the organization's culture, business, products, processes, and leadership expectations before introducing change.
Earn respect through preparation. Demonstrate an informed understanding of the client's actual business and regulatory obligations rather than relying on generalized expertise.
Adapt communication to the audience. Account for cultural context, learning preferences, language limitations, and the recipient's ability to apply the information.
Lead with documented authority. Ground recommendations in applicable regulations, recognized standards, and the client's established management system.
Develop capability, not dependency. Equip personnel to understand the rationale behind decisions and independently sustain improvements.
Remain aligned with leadership. Respect organizational authority, understand the boundaries of the consulting assignment, and maintain alignment with the client's strategic direction.
Put the client's needs first. Recognize that the most important requirements are not always explicitly stated. Listening and observation often reveal the underlying needs that determine engagement success.
Final Perspective
Global consulting is ultimately a human endeavor supported by technical expertise.
Regulatory knowledge, quality systems experience, and project management capabilities provide the foundation. Cultural intelligence, professional humility, and the ability to communicate across organizational boundaries determine how effectively that expertise is applied.
At Nehimakin Associates, we believe that meaningful consulting outcomes begin with understanding the people, the business, and the requirements that govern their success.
The objective is not simply to deliver recommendations. It is to build the trust, alignment, and organizational capability necessary to make those recommendations sustainable.
Learn more about our consulting approach and services at nehimakinassoc.com.
Comments