Cultivating a Quality-First Culture at a Medtech Startup

As the QA/RA Manager at Enhatch, I take immense pride in our organization's commitment to product excellence and patient safety. Enhatch is focused on helping medical device companies, hospitals, and distributors easily plan, manage, and scale patient-specific solutions.

We leverage cutting-edge technologies, such as AI integration, to help increase the efficiency of the surgical planning process. So, as a fast-growing medtech, how do we ensure a quality-first approach in everything we do?

Here's a firsthand look at how we foster a culture where quality isn't just a priority—it's ingrained in all our operations.

Top-down commitment to quality

At Enhatch, our journey toward excellence begins with strong leadership support. From the executive level downwards, there's a collective understanding that quality isn't negotiable—it's foundational.

This commitment is firstly reflected in our quality policy:

"Enhatch is dedicated to providing health care professionals and patients with uncompromised quality products and cost-effective solutions. We understand listening to customer needs and meeting market needs are key to continued product improvement."

Some key points that have helped us in our startup journey:

• Regular management reviews of key performance indicators (KPIs) to understand what is working well and identify areas for enhancement.
• We review all key processes with executive leadership. This proactive approach ensures that our processes evolve continuously and meet the highest standards of reliability and efficacy.
• Our executive leadership team is always open to investing in technology to help make processes more compliant and efficient.

Safety by design approach to product development

At Enhatch, safety isn't an afterthought—it's woven into the fabric of our design philosophy, a key aspect of this is a culture of safety by design.

• When designing and developing products, we prioritize robust design controls. This ensures that every feature and functionality is meticulously planned and validated to meet stringent quality standards.
• Our software development life cycle (SDLC) is carefully structured to incorporate comprehensive risk management processes at each stage, from initial concept through deployment and beyond. Our robust SDLC process has helped enhance the reliability and safety of our products.
• Voice of customer (VOC), is a key aspect of our development process. We incorporate the requirements of all our target customer segments (medical device companies, surgeons, distributors, hospitals).

The recent US Food and Drug Administration (FDA) 510(k) clearance for Enhatch's patient-specific AI-driven instrumentation system for total knee arthroplasty is a perfect example of the benefits of our quality-first, customer-focused approach.

Our development approach aligns with regulatory requirements and underscores our commitment to delivering solutions that medical device companies, healthcare providers, and patients can trust.

Comprehensive risk management strategies

Patient safety drives every decision we make at Enhatch. We adhere to a rigorous risk-based mindset, where potential risks are meticulously identified, evaluated, and mitigated. Our risk analysis methodologies are thorough and systematic, enabling us to address potential risks early.

• For example, we proactively identify and mitigate potential risks by embedding risk management practices into our SDLC.
• Tools like preliminary hazards analysis (PHA), failure mode effects and analysis (FMEA) are used to identify potential risks.

Through proactive risk assessments and stringent mitigation strategies, we meet regulatory requirements and exceed industry expectations in safeguarding patient welfare.

Investment in systems for streamlined process management

Recognizing the pivotal role of technology and digitization in streamlining processes, Enhatch has invested significantly in cutting-edge systems.

One example is our investment in an electronic quality management system (eQMS). Enhatch has implemented Greenlight Guru, a state-of-the-art QMS solution, to ensure compliance and improve quality.

Our eQMS serves as a centralized hub for managing all aspects of quality, from documentation control to compliance. By digitizing and integrating our quality management processes, we minimize administrative burdens.

Robust CAPA process

Our robust corrective and preventive action (CAPA) process is central to our quality management framework.

• When deviations occur, we don't just resolve them; we delve deep into root causes to implement lasting solutions.
• Our source and root cause analysis methodology ensures that issues are tackled at their core and processes are improved to prevent recurrence.
• We track and report regularly on key KPIs, such as the time to closure for CAPAs and the number of nonconformances.

Comprehensive training

Training is another cornerstone of our quality strategy. We invest comprehensively in equipping our team with the knowledge and skills needed to uphold stringent quality standards.

By empowering our employees with robust training programs, we foster a culture where every individual takes ownership of maintaining and improving quality in their respective roles.