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Q&A with Adam Nagorski

QA author

Emergo Group is a premier consultancy firm specialised in serving manufacturers of medical devices and in vitro diagnostics. Emergo assists companies with global regulatory strategy, device registration, quality management system compliance, in-country regulatory representation, clinical trial consulting, distributor qualification, and other needs. Its clients are located around the world and range from start-ups to the largest companies in the sector. 

Adam Nagorski is general counsel for Emergo Group and advises across a wide range of legal issues affecting the company. Prior to joining Emergo, he worked at a number of law firms in New York and Texas, including Chicago-based Kirkland & Ellis and London-based Clyde & Co. In addition to his role at Emergo, he is active in several professional and community organisations, including serving on the board of his chapter of the Association of Corporate Counsel. 

Tell us about your role at Emergo Group.

I am general counsel at Emergo Group and as such have primary responsibility for the legal affairs of the company and its nearly 30 subsidiaries and affiliates worldwide. Emergo has offices on every continent (other than Antarctica!) and that global footprint, together with the expertise and experience of our personnel, is what allows Emergo to provide its clients with services related to approximately 95 per cent of the global medical device market. I work at the corporate headquarters in Austin, Texas, but my role takes me on a virtual tour across all of our operations; for example, on a typical day I might start by addressing overnight communications received from Emergo Japan, spend my morning working with Emergo Europe before their close of business, my early afternoon with Emergo Brazil, and then the remainder of the day on US operations or intra-company matters. 

My responsibilities include the handling and negotiation of Emergo’s agreements with its clients, and one of my major undertakings since joining Emergo has been to update Emergo’s contracting procedures for its many services. I also manage the legal relationships between Emergo companies, and between Emergo and third party entities or individuals that may assist in the provision of our services. Happily, we do not encounter many disputes or litigations, but I am also responsible for the resolution of such matters when they do occur. As part of Emergo’s management team, I am able to weigh in on both risk management and general strategic matters.

What led you to a career in-house?

Moving in-house was a very fulfilling transition for me. The aspect of the in-house role that most appealed to me, and which I have most enjoyed, is learning about a company on a deeper and broader level than was ever possible as outside counsel and then applying that understanding to identify and implement ways to better protect the company and help it grow. Making such proactive improvements is very satisfying, even though the reward of avoiding problems is less tangible than successfully handling ones that do occur. In many respects, I feel more pressures in my in-house role than I ever did while working at law firms, but they are different in nature and ultimately, many of the responsibilities that underlie them are the same ones that contribute to my job satisfaction. I was particularly drawn to a career at Emergo because of its global presence, as I spent much of my life outside the US and have both American and EU citizenship.

How much work is completed in-house? When do you enlist the advice of an external lawyer?

Emergo is a company that grew quickly in size, client base, and the number of services it offers.  Like most companies, Emergo did not develop its own legal department until later in its growth, and initially relied heavily on outside counsel. Now, most legal work is completed in-house, but of course there remain areas for which we use the services of outside counsel. These include matters such as the establishment of subsidiaries, questions of local law, as well as situations where retaining outside counsel makes strategic and practical sense (this is especially true for dispute resolution, but can also apply to other matters that present singular challenges or that we do not have the in-house capacity to handle). 

What qualities do you look for in an external lawyer?

Intelligence, practicality, and cost-consciousness. I also greatly appreciate a willingness to think creatively, which may include questioning the task I have asked them to perform. For example, if I request assistance with pursuing a particular solution to a problem, I very much value when counsel’s response includes recommendations of alternate ways to approach that problem, which I may not have considered. I also appreciate when external lawyers are efficient; by way of example, I much prefer having a half-hour call to debrief about the main points of a meeting that occurred, rather than receive an unprompted detailed memo about it that required much more of the outside counsel’s time to prepare and is not as useful to me as a conversation. Of course, responsiveness and quick turnaround are always appreciated, though thoughtfulness is always most valued.

Tell us about any recent projects your team has been working on. Which law firm(s) did you hire?

Emergo has longstanding and strong relationships with some law firms, but we are always receptive to looking more broadly for the best firm to address particular needs as they arise. There is certainly value in large firms that offer one-stop global services; for example, Baker & McKenzie has been very helpful to Emergo in establishing and maintaining many of our subsidiaries around the world. However, we also receive quality guidance on corporate governance and other matters from a small Austin firm, Fleckman & McGlynn, with whom Emergo also has a longstanding relationship. We seek the advice of local counsel on subjects such as labour law (for example, Fasken Martineau DuMoulin has assisted with such matters in Canada) and trademark registration (on which we have worked with Kilpatrick Townsend & Stockton).

I also value and exchange recommendations with other in-house counsel, through personal relationships and networks like the Association of Corporate Counsel. For example, we recently required the preparation of some corporate documentation in Japan, and we engaged K&L Gates in Tokyo based on the strong recommendation of an in-house attorney at another company.

The company prides itself on its work helping smaller businesses to grow. What are the main challenges facing small businesses just starting out at the moment and how is the company dealing with them? 

Emergo is pleased to be able to help new and small companies gain regulatory approvals and access to markets. Unlike large companies, small ones often do not have the resources or institutional experience to handle most regulatory matters in-house, and Emergo is able to act effectively as an outside regulatory affairs department and offer services such as researching a regulatory pathway for products, preparing submissions to regulatory authorities, and implementing a quality system that meets those authorities’ requirements. Also, unlike some large companies, small ones typically do not have subsidiaries or affiliates in other countries, and therefore can quickly become very dependent on distributors and give up much control of their product registrations and market access to them. 

Through local subsidiaries, Emergo offers in-country representation services whereby the Emergo entity (rather than a distributor) performs tasks such as holding product registrations and serving as the primary point of contact with local regulators about those products. Since Emergo does not have a commercial interest in the products, this arrangement allows clients to retain much greater control over their products in other countries, while still developing strong relationships with their distributors. Of course, while the degree to which our large clients experience particular needs may differ from those of our smaller clients, there is significant overlap in the nature of challenges they face, and all of our clients benefit from services like those previously mentioned.

How do you see the life sciences market developing over the next five years?

Given the nature of our work, Emergo’s personnel see and respond to developments in the market as they happen. Particularly as many populations get older, we expect that the market for healthcare, including medical devices, will continue to grow. However, we have also seen that as that market grows, the corresponding increase in attention can lead to higher regulatory hurdles. Recently, we have seen multiple countries significantly revise their regulations and increase the requirements necessary to obtain and maintain product registrations in their market. Additionally, some countries that previously had little or no regulatory framework have put regulations into place, and we expect that trend to continue. Even some markets with very established regulatory systems may soon implement significant new regulations; for example, the EU is updating regulations for medical devices and IVDs that will present challenges in both understanding the new requirements and strategising about how to comply with them. Emergo is uniquely well positioned to help companies successfully navigate such issues. 

Emergo also conducts and publishes an annual survey of our clients regarding the outlook for the medical device industry, which is available at http://www.emergogroup.com/resources/outlook-medical-device-industry. 

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