MedCity Influencers, Devices & Diagnostics

Weathering the good and the bad: Why good business practices work

For most companies and medtech, in particular, good business practices (GBP) happens on multiple levels. On the micro level, it’s more prescriptive (i.e., regulatory best practices or good manufacturing practices). On the macro level, it’s expressed as a set of ethics and principles that govern a company’s conduct.

Wolves are fascinating creatures. They are intelligent, strong, and fierce. Many innovators are lone wolves. Many founders are as well. Sometimes the “lone wolf” moniker gets a bad rap, just as founders do. But the best of the lone wolf mythology is found in their independence, individuality, and a passion for a singular vision. These are the most universal and admirable traits of innovators and entrepreneurs.

Yet the power of the wolf is found in the real world, not mythology. In the real world, the wolf relies on their pack to survive. In fact, their strategies for the hunt are based on group organization, and the wolf that finds himself alone finds himself hungry. In fact, wolves have been so successful as predators—and therefore feared—largely because they work together so well as a social unit. The notoriety of wolves as loyal, collaborative communicators led to the creation of the term “wolf pack mentality.” As Rudyard Kipling said, “For the strength of the Pack is the Wolf, and the strength of the Wolf is the Pack.”

One way a founder can find their pack is by embracing Good Business Practices (GBPs). For the innovator and founder, their pack of trusted advisors allows them to traverse the precarious business landscape unscathed—particularly in the highly regulated world of MedTech.

In today’s complex market, GBPs are wolf pack mentality at its best. Relying on them allows the pack to function well. It is not so much a rigid structure as it is a large stable of experts readily available to advise dynamically on strategy and quickly remove any short-term barriers—barriers that can hinder a much-needed product from making it to the patients who need it.

With medtech companies often developing solutions for niche-specific clinical needs (read: underserved and/or underrepresented populations), the pack is not a nice thing to have; it is a “must” thing to have. It protects start-ups from failure and ensures that they have the best chance to bring their solutions to market for their benefit and for the benefit of the patients who need them most.

What good business practices (GBPs) look like

Healthcare is in the business of helping people, often when they are at their most vulnerable. Patients put their lives in the hands of other people and companies that make the products that they use—often when they have no other choice. Within that lies a burden of responsibility. GBPs foster integrity, trust, and treating people the right way. In today’s climate, this is what investors, consumers, and employees are looking for.

For most companies and medtech, in particular, GBP happens on multiple levels. On the micro level, it’s more prescriptive (i.e., regulatory best practices or good manufacturing practices). On the macro level, it’s expressed as a set of ethics and principles that govern a company’s conduct. It’s more than a statement of values or marketing strategy; it’s expressed in every decision a company makes and should include the following values.

Honesty and transparency

Companies that trust their partners and endeavor to be transparent come out ahead, particularly in the highly regulated markets. Companies that don’t often run into avoidable trouble.

My team and I have also had to learn (sometimes the hard way) how to identify early on companies that follow GBPs. We’ve worked with our share of companies that lacked transparency in our partnership. This includes an experience we had with an inventor founder who had your typical lone wolf trust issues. Though his lone wolf-ism had created an exciting vision in terms of product and company, six months into our engagement with him, we found out his product didn’t work as presented and we had to pull the launch. If he had been honest with us from the start (instead of thinking he could fix it in time), we could have potentially worked with him to problem solve and to avoid what ended up being a failure.

A good question to consider is:

How does communication and information flow within the organization and outside of it? What information is provided and how forthcoming is it (i.e., are they sharing ten zipped folders or is it three documents)? Closely held or filtered information is a red flag and may be a sign of an immature leader or company.

Takeaway: When it comes to transparency, finding alignment with partners as soon as possible eliminates risk.

A culture of collaboration

On the opposite end of the lone-wolf spectrum, you will find many companies who understand that operating with GBP is a real value-add. I recently worked with a company with a passionate leadership team who were not the founders of the technology that their company was trying to bring to market. It took them eight years to get FDA approval and because they had been so focused on approval, they were behind on their market access strategy. They asked us for help. After showing us their data and a productive give-and-take, they decided to expand their portfolio into other areas of focus, resulting in earlier approval on the tech and a more robust company. If they had continued unilaterally, they might have missed the opportunities that led to greater expansion of their offering and their company.

Having a pack of internal advisors only gets a company so far. It is essential to be able to draw on the expertise of outside consultants and professional service providers.

A good question to consider is:

How does a company or founder respond to feedback? How willing is a founder to say: Tell me all the reasons this won’t work?

Takeaway: Administrative complexity and regulation are systems of inertia, so having battle-tested partners can give you the competitive advantage when it comes to bringing a new product to market.

Open-mindedness

A challenge for founders and other lone wolves is self-reliance to a fault. No matter how innovative or brilliant a product, founder, or company is, blind spots are called blind spots for a reason. We all have them. Being open to outside ideas may not be the precursor of innovation, but it is the sustaining force—especially in healthcare.

I’m not just talking the talk; I had to walk it, too, and I know how uncomfortable it can be. Eleven years ago, when I started my company, I sat down with an advisor and showed them my financials. It felt vulnerable, actually. What was coming? What didn’t I know? But by doing that and being open and trusting, I was able to get unstuck in areas I didn’t even know I was stuck in. It brought greater clarity and propelled me toward success.

Consider: How open is this founder or company to new ideas? Are they willing to say, “I never thought of it that way”?

Takeaway: When you’re open, doors open, and new opportunities are created.

The benefits of GBP (especially for newcomers)

There is a flood of new players in the healthcare space, particularly in the direct-to-consumer subscription models. That can be a good thing or a challenging predicament. Many of these players bring innovative thinking but often lack experience operating in the regulated environment of healthcare; this is where the risk is, and this is where GBP delivers its value in spades.

When companies build a culture of openness, trust, and collaboration, it shows up in everything they do. It allows for greater innovation while avoiding unnecessary risk.

Photo: bluebay2014, Getty Images


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April Zambelli-Weiner

Dr. April Zambelli-Weiner is the founder and CEO of TTi-Health Research & Economics, where she oversees medical device business development and leads with a passion for patient advocacy and developing technologies that help address even the most niche clinical needs. As a Hopkins trained epidemiologist and healthcare business innovator and entrepreneur, Dr. Zambelli-Weiner leverages her experience to influence healthcare policy and transform healthcare from the top down and the bottom up.

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