Beyond the "Magic Pill". Structural solutions for complex medical devices
MedTech Systems Engineering
Systems Engineering is not a magic pill. Neither is Agile, nor Scrum Mastery, nor any other buzzword. There is no magic pill for the complexity of modern healthcare.
But there are proven ways to cope with it. I help "Healthineers" and R&D leaders build the Enabling Systems that allow your experts to focus on innovation, not bureaucracy. I bring the rigor of Safety-Critical Engineering to your medical reality.
But there are proven ways to cope with it. I help "Healthineers" and R&D leaders build the Enabling Systems that allow your experts to focus on innovation, not bureaucracy. I bring the rigor of Safety-Critical Engineering to your medical reality.
The Systemic Solutions
The Transformation Dilemma
Challenge: Leaders know complexity is exploding and launch massive "Agile" or "Digital" transformations. Often, these are Top-Down rollouts driven by external consultants or detached "Process Groups" (Ivory Tower). They fail because they impose abstract methods (SAFe, Less) that ignore the physical reality of the medical device, alienating the actual engineering experts.
Solution: The "Lighthouse" Strategy. We do not start with a rollout; we start with a product. I help you select a high-priority Pilot Project and empower your best Product Engineers (not just process people) to define the new way of working. We build a "Lighthouse" that proves the value first. Then, we scale this proven reality to the rest of the enterprise—combining Top-Down sponsorship with Bottom-up expertise.
Solution: The "Lighthouse" Strategy. We do not start with a rollout; we start with a product. I help you select a high-priority Pilot Project and empower your best Product Engineers (not just process people) to define the new way of working. We build a "Lighthouse" that proves the value first. Then, we scale this proven reality to the rest of the enterprise—combining Top-Down sponsorship with Bottom-up expertise.
The Traceability Burden (MDR/FDA)
Challenge: EU MDR and FDA require absolute proof of safety. Engineers burn out manually mapping risks to tests in Excel. Teams often perform "Forensic Archaeology"—creating documentation for devices built months ago just to satisfy an auditor.
Solution: Compliance by Design. I do not write your reports. I architect a "Data-Centric" workflow where your existing tools (Jira, Jama, Polarion) automatically generate the Audit-Ready Evidence as a natural by-product of daily engineering work.
Solution: Compliance by Design. I do not write your reports. I architect a "Data-Centric" workflow where your existing tools (Jira, Jama, Polarion) automatically generate the Audit-Ready Evidence as a natural by-product of daily engineering work.
Connected Device Security
Challenge: Regulators (FDA, UNECE) now demand "Secure by Design." Bolt-on security is no longer accepted for connected devices (insulin pumps, pacemakers).
Solution: Organizational Capability. I mentor your System Architects to integrate Threat Analysis (TARA) directly into the early design phase. We build the capability within your team to satisfy security requirements natively.
Solution: Organizational Capability. I mentor your System Architects to integrate Threat Analysis (TARA) directly into the early design phase. We build the capability within your team to satisfy security requirements natively.
Cross-Industrial Cases
Experience from High-Tech and Safety-Critical Industries
You know the Patient.
I know the Approach
I know the Approach
The era of isolated medical devices is over. You are building complex socio-technical systems now. Let’s apply the rigor of Aerospace and the speed of High-Tech to your next product. Without reinventing the wheel.
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Alexander Efremov
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