Medical Devices & Technologies

medical_devices_technologies

 

 

William Fry is recognised as a leading Irish law firm for medical device and technology work.

 

 

Our MedTech team prides itself on working with:

  • start-ups;
  • the world’s leading MedTech companies such as Edwards Lifesciences, Life Sciences Partners and ResMed;
  • finance providers / venture capital investors; and
  • academic institutions.

Ireland’s MedTech sector which has grown exponentially, resulting in Ireland being recognised as one of five global emerging hubs. It is at the forefront of innovation in medical technology that plays a key role in addressing the challenges global healthcare systems face. 

The intersection between the development of digital technology in healthcare, the protection and retention of personal data, cyber security, product safety and liability is an increasingly important area for the industry. 

The new medical devices regulation (MDR) and in vitro diagnostics medical devices regulation (IVDR) represent a long-awaited strengthening of the existing regulatory system for medical devices in Europe. However, over the coming years, compliance represents a real challenge for the MedTech industry. Our team of regulatory experts is up to speed with the Regulations and ready to assist companies in meeting this challenge.  

The knowledge and experience of our multi-disciplinary team sets us apart from other firms and comprises: 

  • Ireland’s leading Intellectual Property team with expertise in complex, multi-jurisdictional patent disputes;
  • Specialist lawyers with in-depth and exceptional regulatory knowledge in the MedTech sphere, not only on a standalone basis but also as a key factor enriching the quality of our M&A transactional and commercial work; and
  • Experienced lawyers recognised for theilr expertise in IP, data protection and technology and at the forefront in advisory/transactional work in commercialisation/licensing projects, process outsourcing, cloud computing, e-health and connected technology. 
 

Examples of matters on which we have acted include, advising:

  • Boston Scientific in defending Commercial Court patent infringement proceedings relating to coronary stents issued by OrbusNeich and in a counterclaim for invalidity of the relevant patents.
  • Edwards Lifesciences on corporate, tax structuring, construction, planning, employment and regulatory issues in relation to the establishment of new facilities in Ireland.   
  • Medical Protection Society, the world's largest medical defence indemnifier, on a wide variety of cases, including dePuy hip device product liability claims and claims arising from the implantation of TransVaginal Tension Free Tape (TVT) and Transobturator Tape (TOT) devices.   
  • Life Sciences Partners, the leading European life-sciences venture investor, on a series of equity investments in several promising Irish MedTech companies, including Atlantic Therapeutics (focused on the development of products for pelvic floor strengthening and nerve stimulation), Vivasure Medical (specialising in arterial and venous closure devices) and OneProjects Design Innovation (developing a connected platform technology to revolutionise the treatment of atrial fibrillation and cardiac arrhythmias).
  • ResMed relating to its range of cloud-connectable medical devices for the treatment of sleep apnoea, chronic obstructive pulmonary disease, and other respiratory conditions.
  • Silvercloud Health, the developer of a digital mental health and behaviour platform, on the contractual and data protection aspects of its relationship with a global pharmaceutical company.
  • Diaceutics, a leading diagnostic data analytics and implementation service provider in diagnostic commercialisation, on a comprehensive GDPR compliance programme and other data protection matters. 
  • Point of Care, a health services division within the Uniphar Group, on IP and liability issues relating to its innovative "HealthPoint" e-health platform.  
 

Launch of our Medical Device Publication

William Fry are delighted to launch our MDR/IVDR publication. To assist medical device companies navigate the new MDR & IVDR regulatory regime we have published under one roof the Regulations with easy access to the annexes and a table of equivalence comparing key articles from the MDD/AIMD & IVDD with the MDR & IVDR.


Low Rate of Notified Body Designations under MDR and IVDR Causes Bottleneck Concerns for the European MedTech Industry

Continuing our series of publications, in this briefing we explore which EU Notified Bodies have been designated under the new Medical Devices and In-Vitro Devices Regulations, and the slow pace of approval despite increased demand for their services.


Act Now to be Ready on Time – Guide to New Classification Rules for In Vitro Diagnostic Medical Devices

Continuing our series of publications, we outline the key changes to the classification of in vitro diagnostic medical devices in advance of the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) becoming fully applicable on 26 May 2022.


Medical Devices – New Classification Rules – Is your Business Ready?

A guide to the classification of devices under the new Medical Devices Regulation


Regulatory Flexibility - Key Measures to Support Availability of Medicines and Medical Devices During COVID-19

The COVID-19 pandemic has propelled the healthcare and life sciences industries into uncharted territory. We explore the flexibility of regulators at a national and European level enabling accelerated approval of pharmaceuticals and medical devices so that demand emanating from this global health crisis can be met.


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Team

  • Sources laud the team's "strategic thinking" in complex cross-border disputes, going on to say: "The firm is very efficient and has a lot of depth of talent." Another client adds that "the lawyers find practical solutions to complex and sensitive legal problems." Chambers Europe 2020
  • One client describes the lawyers as "incredibly responsive" and "very easy to deal with" adding that they provide "succinct and well-delivered advice". Chambers Europe 2019
  • One client admires the "width and depth of expertise within the firm" and lauds the department as a "strong practice that understands the minutiae of the life sciences sector." Sources appreciate the "first-rate access and availability" of the team and describe its advice as "considered, pragmatic and clear." Chambers Europe, 2017

Laura Scott

  • Laura has been described as an "expert in all areas of IP." One client reports they have worked with Laura "on a number of cases in the last 12 months ranging from SPC validity proceedings to copyright. We are awaiting judgment in one case where I expected we would lose at the proofs stage but now believe that we will likely win because of the work put in by the team. On the IP side I would rate Fry as the leading firm in Ireland." Another client adds that Laura "stands out for her technical know-how and is an excellent drafter." Legal 500 2020
  • Laura has been ranked in IP Stars 2019 as one of the Top 250 Women in IPglobally.  
  • Laura Scott  is a highly respected IP practitioner with significant expertise in patent litigation. Sources praise her client-oriented approach, highlighting her "commitment and attention to detail" and adding that "she's a pleasure to deal with." Chambers Europe 2019
  • "Outstanding and a real pleasure to work with...Laura is a highly experienced litigator with intimate knowledge of all areas of intellectual property."  WTR1000 2019
  • “She is calm under pressure and has a depth of knowledge and experience which inspires confidence in her clients,” observes one source. Chambers Europe 2018
  • Laura is "on top of the technical detail...strategic and practical" and is praised for her "attention to detail and drafting skills". Legal 500 EMEA 2018 
  • Laura Scott receives plaudits for her trade mark and patent litigation practice, with particular knowledge of the pharmaceutical and life sciences sectors. Clients say: "She is very hard-working, responsive and dedicated to leaving no stone unturned in considering and communicating all available options. She is also extremely pleasant to work with." Chambers Europe 2017
  • Laura Scott has the ‘Midas touch with clients’. Legal 500 EMEA 2017

Fiona Barry

  • According to Chambers Europe 2020, clients appreciate that Fiona Barry is "very careful and thorough," while market commentators highlight her ability to "efficiently find her way to the core of the case." Another clients add that Fiona is "very timely and clear in her advice."
  • Sources say Fiona Barry is "knowledgeable, practical, clear, concise and not afraid to express an opinion." She is widely esteemed for her contentious experience, including acting on defamation suits. One source says: "She is excellent: confident, careful and easy to get on with."  Chambers Europe 2019
  • Fiona is particularly noted for her work on matters related to medical negligence and for acting for insurance companies on personal injury claims and is well regarded by market commentators for her media expertise. Chambers Europe 2018 
  • Fiona Barry is "straightforward and clear". Legal 500 EMEA 2018
  • According to Chambers Global 2017, Fiona holds a commanding position in the medical negligence and healthcare litigation sphere, including regulatory and insurance matters where clients praise her as being "responsive, knowledgeable and pleasant." 
  • Fiona Barry is ‘responsive, calm and considered’. Legal 500 EMEA 2016

Mark Quealy

  • Mark regularly acts for companies on cross-border disposals to private equity funds. Clients value Mark's knowledge and experience, with one source reporting: "He is very knowledgeable in terms of the market and gives good guidance." Chambers Global 2020
  • Mark progresses in the rankings, with one client describing him as "very proactive and pragmatic," and another saying that "he is very focused on commercial outcomes." He has particular experience of transactions involving private equity and venture capital elements. Chambers Europe 2019
  • Mark Quealy is "well-prepared." Legal 500 2018
  • Clients appreciate that he is "very quick to determine what to do from a practical point of view to get the deal over the line quickly." He has played a key role on numerous recent acquisitions. Chambers Global 2018

Charleen O'Keeffe

  • Charleen is ranked as a 'Rising Star' with Managing Intellectual Property IP Stars 2020.
  • Charleen is described as ‘an original thinker’. Legal 500 EMEA 2018

 

Key Contacts

Laura Scott Partner

Mark Quealy Partner