A contract manufacturer servicing original equipment manufacturers in the endoscopy/arthroscopy, orthopedic, dental/orthodontic and vascular markets has been making significant inroads into selling machined components for medical blade applications over the last several years. This is partly because of its customers’ increased use of Custom 465 stainless, produced by Carpenter Technology Corp., Wyomissing, Pa.
In 2009, after more than five years in development, the members of an integrated drug delivery device team from West, The Tech Group and Insight Product Development gathered in Raleigh, NC for a final round of usability testing. This stage included mock self injection by perspective in-home users of a proprietary device with the potential to challenge the auto-injection market with a new, easy-to-use design featuring visual, audible and tactile features to help end users comply with drug delivery instructions.
Challenge: Homegrown Access database to manage product data PLC Medical Systems Inc. a medical technology company specializing in innovative technologies for the cardiac and vascular markets, was managing product data with a homegrown Access database system. Requiring a great deal of manual intervention and paper processes, something as small as a change in a Quality document required the document to be printed out, old documents pulled from a folder and put in the new version, and then brought from person to person (engineering, quality control, operations) for sign-off. This setup did not have the proper tracking for who was actually trained on a certain procedure, or who signed off on an Engineering Change Order (ECO) and when. In addition, it did not allow PLC to capture employee product knowledge should someone leave.
Corporate Acquisitions Pose Unique IT Integration and Product Development Challenges for Global Supplier of Medical Testing EquipmentAugust 19, 2010 7:50 am | by Don Cunningham | Comments
The Project: Waters Corp. needed to create a single, common software development platform for its technology tools and systems to leverage its distributed teams’ expertise in order to meet the needs of its global medical and pharmaceutical customers.
In the race for convenient, single-use diagnostics, an emerging American company is bringing speed, ease of use, and affordability to the detection of bacteria. By applying a simple, yet revolutionary, idea to the old-fashioned Petri dish, BioNanoPore test kits show quantitative results in a matter of hours compared to the potential one to three days with traditional Petri dish methods.
Product testing is a critical component in the development of a medical device. But how many engineers truly understand the importance of what are arguably the three most crucial tests for a medical device? This article reviews these three tests–cytotoxicity, sensitization, and irritation–and offers some insight that will ideally make them go more smoothly for engineers.
How Are You Influencing Wireless Medical Technology?
Asking the right questions when selecting a high performance plastic for micromolding an MIS device could reap some great competitive advantages. This article will review the micromolding process and cover the important aspects of each question that should be addressed by the outsourcing partner, the OEM, or both.
Should the FDA review process be more relaxed in favor of faster review times at the expense of potentially greater impact to the well-being of patients when a device does fail?
Ensuring the medical device packaging is sufficient to meet the needs of all challenges during a device’s journey is as important as the integrity of the device itself. This article outlines four key considerations OEMs need to address in order to ensure they are establishing a solid foundation upon which to build their package testing program.
The quality of 2D imaging has improved significantly over the years. However, it still cannot compare to the wealth of information that can be ascertained from viewing a 3D image. New technology offers 3D imaging results from traditional 2D equipment.
The “futuristic” technology of lasers is not so far fetched anymore. In fact, most don’t give them a second thought. They are used in a variety of industries, including both the manufacture of medical devices and in the finished devices themselves. This article reviews the critical role of lasers in the development of orthopedic implants and the key role they serve.
Medical Device Manufacturers’ business needs have changed significantly over the past several years, evolving the roles that technology plays within their manufacturing process. Two key technologies, Enterprise Resource Planning (ERP) and Product Lifecycle Management (PLM), have developed into critical success factors for these manufacturers.
The ATW Companies (A. T. Wall Company, located in Warwick, RI, Judson A. Smith Company, located in Boyertown, PA, and Parmatech Corporation, based in Petaluma, CA.) have found a niche as a valuable resource and strategic partner with its customers, rather than simply a supplier. By focusing on the factors driving its customers’ business and communicating with them to solve their problems, the firm has earned a reputation for making its customers successful.
The recent federal announcement of its $547 million grant release to facilitate Health Information Exchanges (HIEs) at the state level seems like new life is being given to the data exchange landscape.