Ontogen Medtech News & Articles

News, articles, and resources for medtech leaders—covering regulatory strategy, design controls, quality systems, and scalable manufacturing.

Ontogen Medtech Accelerates Growth with Opening of New Office in Western Chicago Suburbs

New office expansion enables Ontogen Medtech to accelerate growth in medical device design and development in the greater Chicago area and beyond.

UPDATE

November 14, 2022

What is a traceability matrix and how is it used in medical device development?

Traceability is an essential aspect of medical device development and manufacturing. It is the ability to trace the history, use, or location of a product or component. Traceability matrix is one of the tools that can be used to ensure traceability for medical devices. In this blog post, we will discuss what a traceability matrix is, how it can be used in medical device development and manufacturing, and best practices for creating and using a traceability matrix.

UPDATE

October 15, 2022

Ontogen Medtech Awarded $258k Phase I SBIR Grant From The NIH To Develop Innovative Pulmonary Embolism Catheter

The proposed novel catheter design, developed in collaboration with Flow Medical, improves upon current catheter-directed thrombolysis (CDT) treatment methods to improve patient outcomes and optimize the physician experience.

UPDATE

September 12, 2022

Differences and Similarities Between De Novo Submission and 510(k) Pathway for FDA Medical Device Approval

The De Novo pathway is designed for medical devices that are deemed low to moderate risk and do not have a legally marketed predicate device. In other words, when a new device lacks a suitable comparison to an existing device, manufacturers can seek FDA clearance through the De Novo process. This pathway allows the FDA to evaluate and classify the new device's risk level based on its intended use and technological characteristics.

UPDATE

September 1, 2022

Design for Manufacturability in MedTech: What Actually Drives Cost, Yield, and Regulatory Success

Design for manufacturability (DFM) in medical devices is often treated as a late-stage checklist item. In practice, it determines whether a product scales efficiently, meets regulatory expectations, and survives the transition from prototype to production.In medtech, DFM is not just about simplifying parts or reducing assembly time. It directly affects scrap rates, cost structure, sterilization compatibility, and long-term manufacturing stability under quality system controls such as ISO 13485.

UPDATE

April 1, 2022

Why Early-Stage MedTech Teams Underestimate Verification vs Validation Workload

In medical device development, few areas create more late-stage friction than verification and validation. Early-stage teams often assume these activities are just the final “testing phase” before regulatory submission. In reality, they are two distinct, resource-intensive workstreams that can determine whether a product moves forward on schedule or gets stuck in rework cycles.

UPDATE

February 28, 2022

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