What to do if your consulting partnership doesn’t work out; what are the signs that it’s not working?

Avoiding B2B Pitfalls in Medical Device Development

The road to medical device success is too frequently littered with failed business-to-business (B2B) relationships. 

While it’s true that there are companies out there that seem to prey on unsuspecting startups and founders, it’s far more often a simple lack of communication between otherwise sincere groups that leaves everyone feeling high and dry with no way forward. 

The prevalence of this failure mode is so common that many consultants make a living off of what they refer to privately as “burn victims.” This doesn’t mean that these consultants are themselves predatory… but it does mean that there are an awful LOT of “burn victims” in the medical device B2B space.

So, assuming that you’re doing your best to stay away from clearly predatory partners, what can you do to avoid becoming a burn victim, and what can you do if you find yourself becoming one?

While we could probably write a book on the different things to watch out for, for the sake of this article, let’s focus on just one word:

“Dependencies”

A related word is “complexity.”

When working with potential B2B partners, it’s crucial to understand that the process is iterative, not linear. With every project, you are faced with a complex system of interdependencies.

A request we hear a lot in our world is “I need a prototype so I can do a clinical trial so I can submit to FDA.” While this goal is valid in broad strokes, there are many missing steps or “dependencies” hidden within. If we were to say, “OK, that’s what the client wants,” we’d soon be missing real deliverables because of those missed dependencies. 

These dependencies must be identified during planning and day-to-day project operations. Your potential partner (hopefully) has seen many folks in your situation. If they’re asking a lot of questions, challenging your assumptions, and digging deep into the dependencies so that they don’t leave you high and dry, you can feel relatively confident that they have your best interests at heart.

Communication and Flexibility

Clear communication and ongoing identification of dependencies are essential once the project starts. Your project will likely have an increasing number of dependencies along the way, and the later stages will be less predictable than the earlier stages. Is your partner both helping you do gross budgeting long term AND being clear about near term deliverables? If so, that’s a good sign. Don’t hesitate to ask uncomfortable questions and ensure your partners are comfortable reporting changes in assumptions due to new learnings.

What If Things Go South?

Those are just a few suggestions of how to identify quality partners on the basis of clear identification of dependencies. But what do you do if you find yourself in a relationship that’s clearly going south?

Again, this could be a book, but here’s one idea to focus on today:

Be clear on what you own and can walk away with.

We’ve seen startups hamstrung, having to repeat work, because their B2B partners couldn’t or wouldn’t provide:

• Design files
• Quality system procedures
• Sterilization validations
• Tooling
• IP

A company that’s conscientious should spell out what you own. As a particular note, manufacturers will often offer to do design work for free to get your manufacturing business. This isn’t inherently bad, but remember, it means they, not you, own those design files.

Final Thoughts

We’ve only scratched the surface of what to watch out for in B2B relationships. Hopefully, this helps you start thinking critically about your partnerships. If you have any questions, please feel free to reach out for more insights!