Whitepapers

The Criticality of Process Validation
Process validation is a critical part of medical device manufacturing, but it often doesn’t get the attention it requires. This article explains why validation is imperative in medical device manufacturing, illuminates some regulatory changes currently underway, outlines the steps of creating validation processes, and identifies the personnel who should create and maintain them. Further, it discusses what medical device companies should be looking for in a contracted manufacturer regarding validation processes.

Clearing the Hurdles of Medical Device Prototyping
Medical device engineers are tasked with finding straightforward solutions for complex problems that can bring medical devices to market and enrich patients’ lives. However, material costs, functionality, and turnaround times can present mid-design and prototyping impediments to final components and products. This article will illustrate common obstacles in medical device prototyping, tools and techniques used to overcome them, and how the right partner can ensure medical devices are brought to market quickly.

Keys to Successful Design for Manufacturability
A product’s manufacturability is influenced by the materials used, requested tolerances, part geometry, process control limitations, and more. A successful DFM process considers each of these factors from the start.

Automation: The Future of Medical Device Manufacturing
In a perfect world, medical devices would be manufactured in a process with zero errors. Today, customers’ expectations for zero defects are higher than they have ever been and medical device manufacturers are looking for error-reducing solutions. Automation offers great promise. While automation is frequently thought of as a cost-savings solution, and it does reduce defects and scrap, what is less understood are its risk-reducing benefits that result from the consistency of parts and consistency of process.

How To Avoid Compliance & Timeline Risks When Selecting A Medical Device Supplier
Considering the severe consequences of noncompliance, it’s hard to imagine anything more important. First and foremost, the health and well-being of patients is at risk. A product intended to improve health must be safe, reliable, and accurate. From a business standpoint, noncompliance can result in costly approval and product launch delays, customer returns, and potential field corrective actions or recalls.

How To Conquer The Challenges Of Micro-Manufacturing
Manufacturing medical device parts and features in the micro range is not as simple as miniaturizing macro processes. New tools, equipment, processes, and technologies are rapidly emerging to meet the unique needs at the micro size. As the industry overcomes the challenges of producing ever smaller devices, the micro-manufacturing process of the future is beginning to evolve.

Micro-MIM Succeeds At Making Precise Micro Metal Parts
Micro-metal injection molding (micro-MIM) is becoming a go-to process for micro metal parts. Due to technological advances, micro- MIM has become a highly efficient method for manufacturing micro parts with tight tolerances at high volumes.

Case Study: Full Product Line, Tight Timeline
Developing a new medical device, especially a long-term implant, is never easy. But bringing an entire metal implant line of over a hundred parts to market raises the difficulty factor to a whole new level. That was the challenge a growing medical device company brought to Donatelle, along with the requirement that we complete everything—design, manufacturing, packaging and sterilization processes—within nine months.

Precision Manufacturing in the Medical Device Industry
The English (North America) dictionary definition of the word “precision” is accuracy (noun) or relating to accuracy (adjective). You will find the word “precision” takes on all the synonyms of the word “accuracy” in the manufacturing world. This rings especially true in the medical device industry.

Case Study – Development to Deployment
From development to deployment in six months flat

Case Study – High Stakes
Tall order, high stakes

Case Study – Critical Launch
Accelerated time-to-market keeps critical launch on track

Case Study – Full Product Line
Full product line, tight timeline

Case Study – Vertical Integration
Vertical integration adds value — and viability