104 results

Surgical devices
Regulation Value

Posted on 25.02.2013

Asking a butcher to bake bread makes no sense – so why ask EMA to approve medical devices?

The upcoming MDD revision can learn a lot from a 2007 mistake in woundcare regulation.
Burn wounds result in some of the most horrific pictures one can come across as a surgeon. Burn victims not only have to suffer the immediate pain associated with burn wounds, but also have to deal with often permanent scar tissue, a lifelong reminder of that terrible moment.

By Mario Marazzi Responsible Sanitary Service for Tissue Engineering Therapy. Regional Reference Center for in vitro human epidermis culture and tissue cryopreservation bank.

2007-05-30 European flag

Posted on 05.09.2012

Good practice in reimbursement of cardiac implant Telemonitoring – lessons from 5 member states

This week a very interesting group of people met on the last day of the ESC Congress (European Society of Cardiology) in Munich. Representatives of the Eucomed CRM Telemonitoring Working Group, individual member companies and leading representatives of the ESC came together under the chairmanship of the European Heart Rhythm Association (EHRA) to officially launch the White Paper “Moving towards good practice in reimbursement of CIED Telemonitoring”.

By Ralf Baldeweg Senior Manager - PwC

medical device labelling

Posted on 02.07.2012

Toward the best possible solution in EU medical device labelling

In summer of 2011, the EU’s Central Management Committee’s (CMC) published “Decision No 3”, requiring the placement on medical devices of the full postal address of manufacturers and authorised representatives. Since then, Decision No 3 has had the European medtech industry scratching its head in confusion. As we see it, the adoption of the decision has already led to great legal uncertainty, and implementing it in its current form would serve only to increase bureaucracy and additional, unnecessary costs.

By Merlin Rietschel Manager Regulatory & Technical Affairs, Eucomed

Patient safety
Ethics Value

Posted on 13.02.2012

Why patient safety and HTA are important – for us all

Too often we, as stakeholders in health, forget about whom we are talking when we say “patients.” We talk as if the patient is somewhere far away from our discussions rather than the person with whom, about whom and for whom we are having those discussions. In reality, we are all patients – for some it’s just once a year and for others it’s every day of the year. But it’s important to remember that health policy should, theoretically, benefit all of us when it is our turn to receive healthcare – no matter what that care is.

By John Bowis Honorary President, Health First Europe


Posted on 04.10.2011

Procurement – Kill or Cure

Innovation delivers better quality at lower total cost in all walks of life. Many of the things that are freely available today and widely used were considered unaffordable luxuries for most in my youth. All this has happened because entrepreneurs and industrialists have constantly sought better ways of doing things and have changed the value equation.

By John Wilkinson Former Chief Executive of Eucomed

EU Medical technology

Posted on 06.09.2011

Medtech industry must change its way of doing business to remain successful in the EU

Europe is an important and continuously growing market for medical technology products. Driven by budgetary pressure on the payer and provider levels as well as by strong competitive dynamics, the commercial climate for established medical technology companies is, however, deteriorating. The recent industry survey MedTech Barometer 2011 conducted by us (and with ‘us’, I mean global strategy and marketing consultancy Simon-Kucher & Partners) confirms the presence of increasing commercial challenges but still provides an overall positive short-term business outlook. Yet the longer-term outlook is less positive and suggests that in order to remain successful in the European market place, established players will have to adapt their way of doing business in the future.

By Joerg Kruetten Executive Vice-President at Simon-Kucher & Partners and head of the Medtech competence center


Posted on 18.07.2011

Hear, hear! We can really help current and future medical technology SMEs to innovate!

Small and medium sized enterprises (SMEs) are the lifeblood of the medical technology industry. Research in the medical technology industry, which typically occurs at the bedside not at the bench, is usually a result of small or micro collaborations between health professionals, academia and SMEs. This research model brings rapid innovation, which quickly tackles current and emerging medical needs. This innovation can only be good news for under-pressure European healthcare systems as there is clear evidence that more effective treatments are capable of delivering clear benefits; reduced hospital stays (with an associated reduction in cost of treatment); better outcomes, and faster rehabilitation and return to society.

By Sharon Higgins Chair, Eucomed SME Task Force


Posted on 06.04.2011

On e-health and medical technology: grasp the nettle or pay a high price?

Chairing a two day conference on e-health and presenting at a groundbreaking Innovation in Healthcare conference put on by DG Research has further fuelled my enthusiasm for telling the story about the power of technology to enable massive changes to the way that populations are cared for, whilst simultaneously improving outcomes, the patient experience and cost. If all this seems too good to be true just look at what the alternatives might be.

By John Wilkinson Former Chief Executive of Eucomed


Posted on 01.04.2011

UDI, GS1, GTIN, GHTF, ETF, EHR, ISMP… What does it mean to me and to you?

Having been involved with the medical devices industry for many years, I’ve seen how the industry has evolved using innovative solutions and has constantly embraced technological developments. Recently however I had a friend on the receiving end of this technology and I hope you find his ‘patient case report’ below of interest – do note he also works in the medtech industry hence his knowledge on this subject…

By Mike Kreuzer Chairman of the Eucomed Taskforce on E-Business and Supply Chain Management (ETF)