Are we letting regulatory efforts blindingly drive the innovation process? What are the gaps? What are the roadblocks and how to unlock them? In the following podcast, Sava, Milos and Hristina will dive deeper into the challenges MedTech companies face when dealing with regulatory and compliance and discuss these critical questions.
The “necessary evil” all MedTech innovations have to abide by is compliance and regulation. Regulatory and compliance are two sides of the same coin because one dictates the safety requirements, measures, and controls that a new product needs, and the other represents actually building the innovation and new value propositions. But, are we letting regulatory efforts blindingly drive the innovation process? What are the gaps? What are the roadblocks and how to unlock them?
To answer that question, our podcast guests represent two sides of that coin: Milos Cigoj, Head of Quality and Compliance from our MedTech Excellence team who guides the rigorous process to make sure medical devices are safe, and Hristina Panovska, on the engineering side, who actually has to build the medical products that need to comply. In the following podcast, Sava, Milos and Hristina will dive deeper into the challenges MedTech companies face when dealing with regulatory and compliance and discuss these critical questions:
- What technical teams need to be aware of before building the product?
- How does quality and compliance contribute to innovation here?
- What is the difference between US and European market when launching a product and what are the requirements of each of the market?
- Are there ways to speed up regulation strategy and accelerate innovation?
- What is the most appropriate time to start thinking about Regulation Strategy and why?
- What processes are required to deliver the solution?
About the speakers
Sava Marinkovich — Head of HealthTech Practice, HTEC Group Inc., leads the Healthtech and MedTech practices at HTEC Group, a global consulting, product development and digital platform engineering company headquartered in San Francisco with offices in Minneapolis, Chicago, UK, Scandinavia, and the Netherlands. Sava is a veteran HealthTech executive with extensive product, strategy, and investment experience. Early career foundation at GE Healthcare, Sava has built and launched multiple consumer and medical devices from concept to manufacturing and market.
Milos Cigoj — An engineer at heart with a engineering passion from mechanics to PCB design, Milos specializes in software engineering and has amassed nearly two decades of hands-on experience transforming financial, energy-tech, retail, and healthcare IT systems. As an ITSec and IG specialist, as well as an ISO 9001, 27001, and 13485 auditor, he has honed his expertise in quality and compliance within healthcare IT over the past decade. His commitment to enhancing SDLC and QMS techniques in day-to-day operations drives him to create safe and effective medical devices and health IT solutions. Currently, he serves as the Quality and Compliance Lead at HTEC Group’s Healthcare and Life Sciences Excellence Team, where he continues to innovate and excel in the realm of quality management and compliance.
Hristina Panovska — Hristina is a software engineer with extensive background in leading cross-functional teams, managing projects and keeping close stakeholder collaboration to ensure the delivery of high-quality software solutions.
Having worked in both regulated and non-regulated industries she has developed an understanding of the unique challenges and opportunities in both worlds. By working on projects in regulated sectors, such as healthcare and automotive, she holds deep understanding of the compliance requirements, quality management, importance of diligent documentation practices that focus on critical system features like safety, security, privacy, and feasibility. Her involvement with fast paced, dynamic non-regulated projects, where agility is key, enables her to keep a flexible and adaptable mindset, stay in line with the latest technologies and deliver innovative solutions for changing client needs.
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