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Guest Author: Tasha Bond, Founder of Ikigai Medical Development and COO of Sana Health, Inc.

Many medical device manufacturers relegate the work of their quality and regulatory departments by keeping it isolated from the rest of the organization.

Not seeing the value in sharing information regarding technical documentation, evaluation reports, or test plans is a missed opportunity to increase efficiencies and reduce costs across your organization.

Adopting an integrated knowledge sharing approach expands the value of your quality deliverables to ensure you’re not reinventing the wheel, wasting time, money, and resources.

Read on to get my perspective on the benefits of a holistic approach to quality and more, including:

  • Quality as a value-add service for your company
  • Use-cases beyond FDA approval
  • Innovations changing the industry and driving value
Quality as a Value-Add For Your Organization

I approach quality and regulatory requirements as a carrot, not a stick. Have you ever stopped to think about the benefit of a good set of requirements?

A good set of requirements can help your organization save time and money during testing, accelerating the test planning process and helping teams move from the what to why.

Your company culture and leadership must prioritize quality to realize the benefits of an integrated knowledge approach. Standardization of technical documentation and an efficient QMS can help speed time-to-value.

Quality shouldn’t be considered an overhead but rather a shared responsibility that benefits the entire organization.

Beyond FDA Approval

When you take a holistic view of quality across your organization, it’s easier to see beyond the checkboxes.

While many medical device startups focus on FDA approval, they are quick to overlook the importance of reimbursement. Organizations that take an integrated approach can use information from their technical literature, up-to-date instructions for use, and other details from their quality deliverables to inform their go-to-market strategy, including understanding reimbursement.

Evaluating all the ways your quality deliverables can be used across the product life cycle is a hidden way to accelerate your go-to-market timeline while also saving money in the long run.

The Future of Medical Device Technology

As device manufacturers start to take a more holistic approach to quality systems and regulatory affairs, I’m excited by what’s ahead in the industry.

Specifically, the FDA’s breakthrough devices designation will require even greater knowledge sharing and coordination within organizations, especially in areas of increased complexity such as device-led combination products.

The technological boom in advanced 3-D printing, additive manufacturing, and devices used at home will require device manufacturers to develop new approaches and processes to bring these innovations to life.

Prioritizing quality and integrating knowledge across your organization is one way to maintain a competitive advantage in this quickly evolving industry.

Why QA Consulting?

The medical device quality systems and regulatory affairs landscape are not black and white. Having a sensible group of FDA consulting experts to use as a sounding board can put your organization on the path to success.

That’s why I turn to Anne Holland and her team. Their experience seeing “behind the quality and regulatory curtain” on hundreds of medical devices helps me and my organization better understand the big picture.

About the author:

Natasha Bond is a proven leader in medical device program delivery, with 20+ years experience integrating technical and commercial teams for success. She is the Founder of Ikigai Medical Development and currently serves as the COO for Sana Health. Ms. Bond was recently recognized as one of The Top 25 Women Leaders in Consumer HealthTech of 2021.