Aline Lautenberg

Aline is MedTech Europe’s General Counsel and Legal & Compliance Director General. As such, she is advising on MedTech Europe’s contractual, regulatory and statutory obligations. She is also assisting the Chief Executive and the Board of Directors. Moreover, Aline leads the association’s working groups on legal matters, including data protection and compliance.

The Legal & Compliance team’s goal is to provide a clear framework assessing the appropriateness and legality of any and all matters affecting both the association as well as the medical technology industry more broadly.

Aline has more than 15 year experience in the MedTech industry. She’s a graduate of the university of Louvain-la-Neuve (Belgium) and speaks fluently French, English and German.

Outside of work, she is desperately trying to learn Greek.

At first sight, EU policy on mergers and acquisitions might not need to concern patients and frontline healthcare workers too much. However, a subtle shift in the rules on whether two companies can agree to become one could have a profound impact on access to medical innovation. To understand why this might be, it’s important to think about where new technologies come from – and how they travel the complex path to the end user (either a patient or a clinician). First, it is no secret that small and medium-sized companies (SMEs) are a key source of tomorrow’s technologies. Start-ups are typically established to develop an idea that its founders hope could solve a problem, such as treating a disease or diagnosing illness. Anyone who has met medtech entrepreneurs will recognise the enthusiasm that drives individuals and small teams to address unmet health needs. Of course, not all will succeed. For those that do, developing a viable technology in a field such as diagnostics, monitoring or implantable devices is challenging. It is not enough for the product to work. Some of the biggest hurdles come when a company seeks to scale their business up and bring their technology to market. Achieving this in a timely fashion requires considerable investment, as well as expertise in regulatory and reimbursement. Joining forces to reach the market One well-worn path to market is to join forces with another company with the experience required. This is where mergers come in. Companies with complementary expertise often pair up. In some cases, a larger firm absorbs a smaller one because it has a game-changing technology. In return, the smaller partner has access to the infrastructure and expertise needed to go to the next level. It comes with defined rules and processes. Long-standing EU rules are in place...
Bringing innovative medical technology to patients around the world is a priority for the medtech industry. This task often relies on a wide network of third-party intermediaries and distributors. While third parties provide valuable local knowledge, logistics and skills, it is important to appreciate that everyone working on behalf of medtech companies is bound by strict rules and standards. Compliance with applicable anti-bribery and corruption and/or international laws is essential, not only to avoid severe penalties but also to ensure that patients continue to trust in life-saving technologies. Confidence in medtech is priceless: patients want to know that decisions about their diagnosis and care are based exclusively on clinical considerations. New training video So, what can we do to ensure that the highest ethical standards apply everywhere that medical technologies are used? At MedTech Europe, we have been working with our member companies and sister organisations around the global to develop distributor compliance guidance and toolkits, including training material, to ensure legal and ethical distributor interactions. ( Find out more ) Specific aspects of training play a key role. This brings some challenges of its own. For medtech companies, large and small, providing training to partners in dozens of countries is no small task. For third-party distributors and sales agents working for several companies, the burden of keeping up with multiple sets of standards and codes can be significant and sometimes even confusing. At MedTech Europe, the latest tool, produced in collaboration with AdvaMed and APACMed, is a video addressing the main aspects of compliance training for distributors and intermediaries.The video aims to address an unmet need for a high-level introduction to compliance training. It sets out the key principles that companies and their partners must follow if they are to maintain the highest standards of ethics when doing business...