Medtech Consultants Now at Risk of Rolling in the Deep

When was the last time you said 'no' to a client?

Perhaps they were pushing for a 510k strategy when clearly a PMA was required. It could have been their proposal to use less costly, but unproven, materials or manufacturing techniques to reduce COGS. Maybe it was pressure to embellish device capabilities or prevaricate over the potential indications and patient risks in marketing materials to secure investment and clinical endorsements.

Or maybe it was you, the consultant, who suggested some of these measures. After all, we're hired to get the job done to the benefit of the client, often using our expertise to stretch within the bounds of regulatory compliance.

We might have ethical misgivings if it feels the stretch is too far, but then it's our choice to carry on, attempt to dissuade the client, or terminate the contract. As long as we were colouring within the legal and regulatory lines, our duty of care was to our client.

The McKinsey civil court settlement in February 2021 and criminal probe in April 2024 arising from their work with Purdue Pharma changed that for all consultants, especially those of us in the lifesciences.

A precedent has been set and we are all on notice that we are vulnerable to civil and criminal consequences through our work with our clients.

As I am not a lawyer and in no way qualified to give you legal advice, this would be an excellent time to have a heart to heart with your attorney to discuss best practices and changes to your service contract to mitigate the risks.

In the meantime, here are some bare minimum practices we should all be following for good professional governance:

Keep it Separated:

Maintain a distinct, separate relationship with your client

According to this article in litigate.com written by Paul-Erik Veel, a key aspect of McKinsey's culpability was their 'deep integration' with Purdue. According to the article, the allegations were unspecified so without a codified set of particular actions that indicate deep integration, McKinsey's relationship with Purdue was vulnerable to broad interpretation. Given that, it's in our best interests to preserve an arm's length status with clients in our communications and processes.

Keep Your Own Counsel: 

Use your expertise to the benefit of your client, with wide ethical margins

How many times have you been in a blue sky brainstorming session with a client and come up with strategies that landed more in the grey zone? It's natural, as your expertise for which you were hired enables creative solutions. It also allows you to recognize the boundaries far better than your client can, so it's your obligation to your client (and now your client's stakeholders) to abstain from suggesting, even in jest, off-side strategies.

Keep Good Records: 

Emails, contracts, and client notes - confidential, yet discoverable

Long email threads, quickly jotted notes, and video/phone call transcripts are common place for professional service providers and we employ measures to keep that information confidential by using secure servers and devices. We file away that information for future reference and often take pains to put critical information in written format to avoid confusion or obfuscation. What we may not remember is that all those records are discoverable should a civil litigation or criminal investigation take place in the future so ensuring that our communications accurately represent our actions, intentions, and client relationship status is crucial.

Keep Good Company: 

When in doubt, opt out.

It's never easy to end a client relationship but if the situation is going in a direction that doesn't jive with your ethics or own code of conduct, you do yourself and the client no favours by continuing the professional relationship. It's not necessary for the client to be engaged in anything nefarious for you to feel justified in terminating the contract. A fundamental difference in approach is reason enough for you to step aside so they can find a consultant more aligned with their viewpoint.

Keep Your Eye On the Prize: 

Chances are good you went into medtech to help people. That's the prize.

We're all pretty idealistic when we first start out in medical device development. After awhile the economic realities and IP litigations can tarnish the shine, causing us to place focus on helping clients appease investors and protect their stake while trying to make a decent living for ourselves as consultants in a volatile industry. That reality is going to present a few conundrums for every one of us.

At the end of your career, you want to be proud to see the devices you developed or helped to market being used by patients or clinicians, safely and for the profound betterment of their lives.

That's the end goal. Make good choices!

This article is from my Linkedin newsletter, Medtech Consulting Success, where I share tips, tutorials, and templates to help you attract & best serve your ideal clients. You can subscribe here.