Medical Device Link.

Inflammation is a major factor in the development of the foreign body response to biomaterials and medical devices, including compatibility with blood, and the mechanisms are obviously complex. It has been realised recently that nitric oxide (NO) gas is continuously generated by some cells in the body and that the molecules of this gas are able to modulate inflammatory and thrombotic processes. The challenge has then become one of incorporating NO releasing materials into medical devices to control biocompatibility.

Silicone is the material of choice for many new applications. Those examined here include drug delivery and peristaltic pumps, pacemaker leads and tubing used in minimally invasive surgery and to deliver high pressure gases and liquids.

Part 1 of this article¹ demonstrated that knowledge of coating science is important in the formulation and early development of a functionally active coating for a medical device/combination product. Part II focuses on the testing challenges and verification of the finished coating on the product.

A major challenge in the industry is the creation of a degree of control over electromechanical prostheses in severely disabled spinal injury patients or loss-of-limb patients. Of the many techniques being researched to alleviate disabilities and damage of the nervous system, one approach is based on engineered electrodes interfacing with the brain. The case study described here illustrates the use of microelectrodischarge machining, which is a critical component in the creation of an engineering system that interlinks directly with the brain.

This article focuses on the development of a packaging format for drug eluting stents where the package not only has to meet the needs of the stent, but also the needs of the drug incorporated into its polymer coating. The package has to allow the transfer of ethylene oxide gas for sterilisation, but when in storage, must provide a barrier to keep out moisture and oxygen. A pouch and commercial scale manufacturing process were developed to incorporate this dual function into one item.

Medical device design and manufacturing organisations, and their suppliers, that are pursuing operational excellence are urged to employ Six Sigma. It is a validation activity that addresses risk and by harnessing this methodology companies can accelerate and improve their risk management. This article explains how.

The potential benefits of outsourcing are well known, but the decision to contract with subcontract partner can be daunting. This article examines how to determine if a product is suitable for outsourcing and the steps to take to identify and qualify the correct outsourcing company.

A new European guideline on drug-eluting stents (DES)¹ introduces for the first time detailed information that European drug authorities should review concerning the medicinal substance that is incorporated into this type of drug–device combination product. Part I of this article discussed European requirements that apply to DES.² This article discusses the new guideline, other stent guidelines, and the evolving process of drug–device regulatory review in Europe.

The industry’s continued success is the result of sound strategy and its application. The next tranche of planning extends up until 2013 and its important elements are outlined here.

How to achieve better products, greater product quality and increased profitability.

A review of some of the issues affecting today’s industry and some insights into the future.

Medical Device Technology’s (MDT) series of interviews offers personal perspectives on the diverse and dynamic medical device technology industry. Here, we talk to Charlie Mulvihill.