Note from the Editor

…NOT TODAY, GRANTED, and that does muddle the cadence of the sentence, but at my age it’s difficult to resist a Beatles reference. Be that as it may, Medical Device Technology (MDT) magazine was launched two decades ago in January 1990. It was followed shortly by International Medical Device & Diagnostic Industry, which would become European Medical Device Manufacturer (EMDM). MDT and EMDM merged at the beginning of 2010 into European Medical Device Technology. To celebrate 20 years of publishing for the medtech industry, we asked members of our editorial advisory board and long-time columnist Maria Donawa to reflect on the achievements of the last two decades.

As Donawa notes in her column, the regulatory framework within which the medical device industry operates has gone through significant changes. The New Approach to technical harmonisation that was applied to the medical device directives has had a profoundly beneficial impact. Before that, a patchwork of varying requirements regulated medical devices in European countries, creating significant barriers to trade, not to mention monumental inefficiencies. Improvements are still needed, as Donawa points out, and there is an unfortunate impulse among authorities to sometimes let perfect be the enemy of good, but seen from a 20-year perspective, the progress is undeniable.

Technological progress during the past two decades has been nothing short of stunning. In the view of Professor Dr Jörg Vienken, the development of biomaterials has been a fundamental part of that process. In his article, he posits that we are entering a new era in which our cumulative understanding of biomaterials will be applied to a systems approach that takes into account the effects of polymers and biomaterials and their active or inactive surface properties at the nano level. Vienken cites a paper with the provocative title of “How the Sum of Its Parts Gets Greater than the Whole” as being emblematic of this next phase in the development of medical technology.

Sometimes progress can be measured much more simply. I thoroughly enjoyed Paolo Galavotti’s reflections on the evolution of medical device manufacturing as seen from the perspective of a humble solvent dispenser. The instrument overcame initial resistance to change medtech assembly techniques. 

There is much more to recommend in this section (links to the various articles in this section are provided below), but I will let you discover the many other gems on your own. Enjoy!

Norbert Sparrow
norbert.sparrow@cancom.com

By Way of Introduction ... As EMDT marks 20 years of publishing for the medtech industry, David Hill, Design Manager at Rocket Medical and longstanding editorial advisory board member, comments on the evolution of the publication and the industry it serves.

Two Decades of Evolution and Revolutions Significant changes in materials usage, the rise of electron beam sterilisation and a reminder of some unrecognised heroes are featured in this 20-year perspective on industry developments.

How Medical Device Technology Has Adapted to Changing Scenarios From a greater understanding of how biomaterials and living tissue interact to the advent of individualised therapies, here are some reflections on medical technology’s permanent revolution.

When Manual Assembly Goes High-Tech and Beyond The changing practices in medical device manufacturing are illustrated in the development of a new piece of dispensing equipment. Initially, it met with resistance, but over time it has been adopted by the majority of the companies involved in the manual assembly of disposable plastic circuits. Most recently, of course, high-volume production that requires a high level of labour has moved to areas of the world where labour costs are lower.

The Paradigm Shift from Replacement to Regeneration Exciting developments over the past 20 years include stem cell biology, advances in bioreactor systems for engineering cell assays, injectable interactive materials, nanostructuring of biomaterials and progress in directing biodegradability. This commentary, provided by a life scientist, also highlights some of the goals yet to be achieved.

Reflections on the Last 20 Years of Medical Device Packaging From robust validation protocols designed into packaging equipment to pristine orthopaedic implants that go directly from a sterile barrier pack to the surgeons’ hands, progress has been constant.

Medical Product Design: Yesterday, Today and Tomorrow What is the need? What will add maximum value for the end user? It is in this area that the design industry has developed significantly over the past 20 years.