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!

Behavioural Economics Tactic: Mirroring - The engagement hack that gets you on track with clients

We all want to be heard and we’re most comfortable with people who are like us. That’s the premise of this technique that you can use to connect with prospective clients or get back on track when there’s a disconnect with a current client. 

The best part? There’s no learning curve as humans do this naturally when they are in sync so you’re just helping nature take its course. Here’s how:

1. Mirror words - be attentive to what your client is saying; not just the message itself but the words they use to convey it. When you respond, either in the moment or in later communications, use some of the words you noted. This is especially powerful when they are words that express their goals and feelings or thoughts about their current situation.
2. Mirror Body Language - whether in person or video call, one of the fastest ways to get in sync with a client is to emulate body language. Be subtle - things like hand gestures, head tilting, and orientation in your chair work best. 

Obviously the key is to be subtle, appearing to mock them or coming off as unhinged will not end well for you.

How to Network Better On Linkedin - Most agree that even at the best of times, Linkedin can be pretty cringe. Yet here we are, connecting through this newsletter because we both know that despite the inherent awkwardness of the platform, it’s the best place (for now) to find and connect with smart medtech people doing interesting things. Having only recently started to explore how best to use LinkedIn, I’m no expert, but there’s no shortage of resources to become one. Here’s one article that I thought appropriate for our crowd as it suggests thoughtful,  non-transactional tips to reach out and connect on Linkedin. 

There’s An App for That: Keep Your Finger on the Pulse With Google Alerts - a super simple, free tool offered by Google, Google Alerts enables you to set up an alert when anything pops up on the interwebs pertaining to a particular keyword or term. You can choose the sources you want to monitor (news, videos, blogs) and the frequency with which to be notified by email. Use this to monitor updates in your area of expertise as well as news from clients and key prospects. Doing so enables you to seize opportunities, be more attentive to clients, and demonstrate your industry authority.

In Beta

Medtech Expert Directory

MedTech-Specific R&D, Manufacturing, Commercialization, Operations, Finance & Turnaround Experts Promoted To Prospective Clients, Investors, Media & Conference Organizers

Your Key to Being Found & Connected With Your Ideal Clients

Our exclusive online directory showcases our outstanding consultant and subject matter expert members with search engine optimized profiles.

Your feature rich profile is expertly tweaked to highlight your best and highest value and is promoted through Synaptx marketing channels to your ideal clients. Why languish in anonymity on a generic platform with a fickle algorithm when there are medical device developers who need, and are actively searching for, your specific expertise?

What's In Store For You?

Feature Rich Profile Page with AI Assist

Here's your chance to present yourself in a way that speaks directly to your ideal clients using the metrics and pain solutions that they value most

Showcase Media Hits, Videos, Audio Files, & Awards

Media mentions or features, podcasts, tutorials, and awards can all be showcased on your profile page neatly in their own tabs

Sell Digital Products & Packaged Services

Created templates, ebooks, courses, or a packaged service? Offer it to your market through the directory and Synaptx

Appointment Booking - Accept Online Payments

Your time has never been more valuable. Enable prospects and clients to book it (and if you like, pay for it) online, right from your directory profile page

Click-to-Call & Direct Message Functions

Email has its benefits; immediacy is not one of them. Direct messaging & click to call features connect your prospects with you quickly & efficiently

Interested in joining as a beta member? Get in touch and I'll send you the details!

Have a great weekend and we'll see you again in two weeks!