GMTCC

By combining the GMTCC with the annual European MedTech Forum, the medtech industry is signalling that compliance is moving centre-stage, writes Nancy Travis, Vice President, International Compliance & Governance, AdvaMed For more than a decade, MedTech Europe and AdvaMed have jointly organised the key event on compliance professionals’ calendars. The Global MedTech Compliance Conference (GMTCC) is an annual gathering of the international healthcare compliance community. Over the years, it has grown into a forum where to share ideas, discuss challenges and promote best practices. Some people say compliance is a lonely profession, as the compliance department often-times is a department of one in smaller companies or for local offices in new markets. But compliance officers attending this conference will find a peer group ready to engage, an experience that can be enormously valuable and rewarding – and create a network that will live on after the event concludes. I’m particularly excited about this year’s GMTCC because it’s a little different from previous years. The 2019 conference will be held in parallel with the European MedTech Forum (May 14-16) – an event that has traditionally focused on business operations – for the first time. This shows that ethics is no longer a side-line to the business; it’s not a nice-to-have. Ethics and compliance are mainstream features of good business practice. More than that, compliance is a business enabler. As a relative newcomer to the field, I have been struck by the rapid transition of compliance from the periphery to an industry priority. As Bronwen Taylor said when closing last year’s GMTCC, compliance departments have moved from being perceived the ‘Department of No’ to become the ‘Department of ‘How’. In tandem with this shift, I’ve seen a strong appreciation from the business side for following ethical business practices. In many leading medtech...
Health data can transform our lives – but must be used wisely
This blog is part of the GMTCC 2018 blog series. You can follow the conversation under #GMTCC and find more details and at gmtcc.com . Check out related blogs: Swifter, Higher, Stronger: Promoting MedTech Ethics on the Global Stage, How to create and maintain an ethical culture, Global Responsibility, Global Ethics and Compliance, Global Principles for MedTech Innovation, Progress and new challenges after 10 years of collaboration, Distributors play key role in compliance and New industry code must safeguard independent medical education There is considerable hype around the potential of big data to change healthcare. Much of this is justified: large datasets and increased computing power are combining to make healthcare more personalised, more precise and more predictable. This revolution draws on the skills and knowhow of engineers, biologists, data scientists, lawyers and others, and is changing the life sciences industry in the process. However, all actors working in this space – from industry titans to newcomers with roots in the tech sector – must prioritise compliance. In particular, it is essential that we take data privacy seriously. From the R&D stage through to direct consumer interactions, we must think carefully about how we collect, store and use data. That is why security and privacy by design are essential to companies like Verily. The company’s history as the life sciences division of Google means data security is woven into its DNA. Indeed, Verily is a member of AdvaMed, and its compliance program follows highest standards of the medtech industry. Getting data privacy right We are at a crucial moment in the history of health data - we have a unique opportunity to transform the diagnosis and treatment of ill-health. Getting this right is critical to the future we envision to empower patients with the information they need to stay well,...
New industry code must safeguard independent medical education
This blog is part of the GMTCC 2018 blog series. You can follow the conversation under #GMTCC and find more details and at gmtcc.com . Check out related blogs: Swifter, Higher, Stronger: Promoting MedTech Ethics on the Global Stage, How to create and maintain an ethical culture, Global Responsibility, Global Ethics and Compliance, Global Principles for MedTech Innovation , Progress and new challenges after 10 years of collaboration, Distributors play key role in compliance and Health data can transform our lives – but must be used wisely The MedTech Code was designed by industry to ensure compliance with the highest ethical and legal standards. However, dialogue with professional medical societies is essential if we are to avoid unintended negative consequences for the quality and accessibility of education. It’s time to explore new models of collaboration Continuing medical education (CME) is a life-long commitment for clinicians. Through independently developed courses, they stay up to date with the latest scientific and technological advances in their field. Keeping doctors’ knowledge current directly benefits patients and helps developers of innovative technologies and techniques to disseminate information. CME has been successfully provided for decades through professional bodies at annual congresses and specialised seminars. As a past-President of the European Society of Cardiology and member of the Alliance for Biomedical Research in Europe ( BioMed Alliance ) – a network of 29 research-driven biomedical societies with more than 400,000 members – I have seen first-hand how professional societies support education. Congresses have attracted support from industry in a number of ways, including through unrestricted grants, and where companies cover the registration and travel costs of individual doctors. Income from these events have allowed congresses to grow; to cover a wide range of disease areas (including rare conditions); and to redeploy any surplus to other key activities...
compliance
This blog is part of the GMTCC 2018 blog series. You can follow the conversation under #GMTCC and find more details and at gmtcc.com . Check out related blogs: Swifter, Higher, Stronger: Promoting MedTech Ethics on the Global Stage , How to create and maintain an ethical culture , Global Responsibility, Global Ethics and Compliance, Global Principles for MedTech Innovation, Progress and new challenges after 10 years of collaboration , New industry code must safeguard independent medical education and Health data can transform our lives-but must be used wisely In the global marketplace, multinational medtech companies must select partners carefully. A good reputation is hard-earned but easily lost. For international medical technology companies, ethical and compliant behavior is increasingly important. Global companies in Europe and the US have signed up to robust industry-wide compliance codes, setting out how their people should behave when representing the company. With these changes, staff are expected to be well trained and compliance with the industry code is closely monitored. However, compliance can become more challenging when operating in markets where manufacturers enter partnerships with local operators. Some regions have higher levels of perceived corruption. As the Corruption Perception Index illustrates, large swathes of the world map are considered to be risky when it comes to unethical behaviour. Opting out of all countries and regions where corruption levels may be high is impractical as it would close off some of the largest and fastest-growing markets in the world. There is good reason for collaborating with reputable companies familiar with the regulatory and cultural environment. Of course, partnerships are not without risk. The manufacturer’s reputation is only as good as the conduct of their local distributor. The key to maintaining high standards is close engagement between suppliers and distributors. Due diligence in advance of collaboration can...
This blog is part of the GMTCC 2018 blog series. You can follow the conversation under #GMTCC and find more details and at gmtcc.com . Check out related blogs: Swifter, Higher, Stronger: Promoting MedTech Ethics on the Global Stage , How to create and maintain an ethical culture , Progress and new challenges after 10 years of collaboration , Distributors play key role in compliance, New industry code must safeguard independent medical education and Health data can transform our lives-but must be used wisely Trust between patients and their physicians is critical in healthcare. It empowers patients and enables them to make informed decisions knowing that their caregivers have their best interests in mind. Though the practice of medicine does vary in different parts of the world this is a universal constant. As such it is important that everyone understands how healthcare professionals interact with the industries, which provide the tools of modern medicine. The medical technology sector is one of those key industries which develops and provides novel solutions to healthcare problems old and new. The Global Medical Technology Alliance (GMTA), of which MedTech Europe is a founding member, represents the medical technology industry around the globe. We are proud to announce that the Alliance has agreed on a set of global principles of ethical business practices through a Joint Global Ethical Declaration . One of the most important missions of the GMTA has been to advance compliance and ethical business practices globally, in way that promotes innovation and enhances patient access to innovative technologies. The recognition of these principles which are universally applicable is a key step in ensuring this. The GMTA principles lay down simple and pragmatic approaches for the development of codes of ethics for industry around the world, underpinned by two simple concepts: 1) Supporting...
This blog is part of the GMTCC 2018 blog series. You can follow the conversation under #GMTCC and find more details and at gmtcc.com . Check out related blogs: Swifter, Higher, Stronger: Promoting MedTech Ethics on the Global Stage , Global Responsibility, Global Ethics and Compliance, Global Principles for MedTech Innovation , Progress and new challenges after 10 years of collaboration , Distributors play key role in compliance , New industry code must safeguard independent medical education and Health data can transform our lives-but must be used wisely The value of behaving with integrity is increasingly clear: companies who understand the importance of ethics attract the best people, protect their brands and maximise business performance. However, good behaviour is not something that happens by accident. Ethics is intentional . The question is how a company can develop an ethical culture that helps associates find more meaning in their work, appeals to more customers and end-users, and ultimately helps business to thrive. It is common for companies to state their mission, vision and values. But what really sets your company apart is by helping your associates truly understand these and live them daily. Training – and regular retraining – is essential. While leaders can and must set an example, they also must train and educate associates about exactly “what right looks like.” A single associate’s lack of knowledge can have consequences for your company. For example, what if a new associate comes from an industry where doing business on the golf course is the norm? That person may have high integrity but still need training on the unique requirements of the ethical code your company follows. Providing easy access to training material and delivering in-person training are vital. Where your business operates globally, training resources should be locally relevant and, wherever...