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Blog: Are You Sure?

Seven years of engineering, and especially the last two in the medical device space, has taught me that this is the most important question an engineer can ask. It doesn’t matter if you are a design engineer, a manager, or even a quality or testing engineer.

Successful engineering requires you to interact with a complex mix of industry experts in a variety of roles, including quality managers, vendors, coworkers, bosses, partners, suppliers, contractors, and engineers at other companies. In all these cases, you are asking the other party to provide some sort of expertise. And in each of these cases, the success of a project depends on that expertise being real.

There’s nothing insulting about asking someone if they are sure of their opinion. You are asking them to be accountable, to prove that their opinion is actually based on fact. You are challenging them to produce data, past experience or references, which will corroborate the expert’s advice to you. Asking them “are you sure?” means they must back up their claim, and if they can’t, you realize that the opinion they gave you was based on presupposition and/or illusion. In an age where self-promotion is king, where self-assurance is currency, getting beyond bravado is crucial for long-term success.

We’ve had our fair share of this at EMCI. On one project I was leading, our “FDA Expert” turned out to be more of an “FDA Guesser.” His assurances that a clinical trial was not needed for the device and that a bench-top study would be sufficient turned out to be exactly wrong. It delayed market entry by more than a year, and cost us thousands of dollars and hundreds of man-hours in wasted resources. If only we had asked “Are you sure?” when the “FDA Expert” outlined the regulatory path…

More than once, an inventor has come to us with a medical device they think will have a $10 billion/year market and will need little or no further development from the prototype in their briefcase. “It works,” they assure us, “and it costs almost nothing to manufacture.” We have quickly learned that asking “Are you sure?” must be the first three words out of our mouths with these folks.

Machine shops have told me parts aren’t machineable. Coworkers have told me deadlines are impossible. Suppliers have told me lead times are immovable. In all these cases, asking “Are you sure?” quickly tests the passion and reality of their stance.

Asking “Are you sure?” helps an engineer break down dangerous assumptions as well. Thus, constantly asking themselves this question is critically important. For example, I took over a project mid-stream that had been designed by an inventor in collaboration with a machinist. When I took over the project, I was instructed by my manager to get the inventor to stop making design changes so we could wrap up the project quickly. So I did, we closed the design phase, and when we went to the testing phase, the device didn’t work. I’d never asked anyone “Are you sure the design is done?” I’d never asked myself “Are you sure what they came up with is sound engineering?” Because of that, we had to go back and redesign several components of the device. Time, and money, were lost.

Another time, we were told by a distributor that they would be ordering roughly the same amount of product the following year as they had the current one. “Sales are good, we expect only a minor dip,” they told us. And we hoped they knew how to forecast. And our hopes were dashed. Their sales dropped by almost two thirds in the next year.

Certainly, asking “Are you sure” won’t break down every illusion. Once in a while, someone will simply lie to your face. Whether they are malevolent or clueless doesn’t matter, what matters is you have asked them “Are you sure?” and they confidently say “Yes.” And then they turn out to be wrong. So you have to dig. You have to follow up “Are you sure” with a second question: “How are you sure?” Press people until they give up their illusions. Until they admit what was known fact and what was assumption. Then right down the assumptions. These are the things you must test.

For example, we had a device that needed additional certification and the regulatory authority told us the device had failed to meet required specifications. Rather than figure out how to redesign the device and make it compliant, I started by asking the regulatory authority “Are you sure we aren’t compliant?” Then I asked how they were sure. They told me they had referenced a specific document. Reading the document, I realized they had tested our device against the wrong standard. When I pointed this out to them (politely), they agreed, and tested our device against the correct standard. It passed. We estimated redesign and recertification would have taken 6 months and cost at minimum $12-15,000 – and it was saved with two simple questions.

So start asking everyone, especially yourself “Are you sure?” At first others might be annoyed at your constant skepticism (very different, I should point out, from cynicism). But soon enough, those who interact with you daily will learn to come prepared. And they won’t bring any assumptions with them.

Blog: The FDA

The regulatory environment has clamped down in the USA in recent years. The FDA is ramping up its efforts in the medical device space, and the requirements are rapidly changing, and in most cases, increasing.

Take for example the 510k process. For many years, it was common practice to use multiple predicates to show substantial equivalency. That is no longer a method the FDA is in favor of seeing. Instead, they want a single predicate, and data to mitigate risks that fall outside of equivalence with that single predicate device.

Clinical data requirements for medical devices are generally not well defined by the FDA, at least not publicly. Instead, it falls upon the filing party to present sufficient data (in its own estimation) with enough statistical significance to satisfy the requirements. Occasionally a filed 510k may get a reviewer that is willing to help guide clinical data collection, but as a corporate strategy, it isn’t safe to rely on it.

Getting past the hurdles of properly filing the required documents and having your application accepted are only the minimum steps required to gain approval. If your goal is to be approved without further clarifying submissions at their request, your plan needs to be comprehensive in scope and scale. Even then, the FDA may find reason to question your claims beyond what you anticipate.

Take for example a recent 510k filing by EMCI. Our application was complete and accurate, and in line with what predicate filings for the device class had used. However, the FDA had just gotten a smattering of adverse events from a product with the same device class… thus, they required us to go back and perform additional clinical trials to mitigate this newly-discovered risk. Had we filed the identical 510k three months earlier, very likely it would have been approved without any additional data.

We have regulatory experts and ex-FDA reviewers at our disposal to use as a resource, and still, we are often surprised by the particular claim that sticks out to the FDA. The key to keep in mind is that once they request information the clock is ticking. If you can’t collect the necessary data before the application expires, you’ll have to refile from scratch, with no guarantee that you will get the same reviewer. A new reviewer may have completely different information requests, and the process can become a vicious circle without careful planning.

The FDA’s role in keeping a lid on unsafe drugs and devices is incredibly important. Indeed, as a device company our goals are not at odds with those of the FDA. We want to provide human health advancing technologies without introducing any unexpected consequences for the patient or physician. It’s a goal we share with those that regulate us.

The information provided through this blog is not a substitute for legal, regulatory or other professional advice where the facts and circumstances warrant. If anyone in your organization requires legal, regulatory advice or other professional assistance, they should always consult his or her own legal, regulatory, or other professional advisers and discuss the facts and circumstances that apply to their specific project.

Welcome to EMCI’s Blog

The medical device industry is fraught with peril. There are a million ways to misstep, lose your shirt, or even hurt or kill an end user.

There are numerous regulatory bodies with an interest in protecting the public (and their own credibility), and by their very nature, they are extremely risk averse.

There are patents to file, fight, and defend. There are prototypes, bench trials, clinical trials, sterilization validations, packaging discussions. And even when your product is proven, ready to manufacture, and has regulatory thumbs up, there are still countless pitfalls in things as simple as the wording on the instructions for use.

One small comment in a marketing piece that makes a claim beyond the scope of the FDA approval (even if it’s widely used by doctors for that purpose off label) will get you a visit from, at best, an FDA inspector, and at worst, federal marshals.

This is not an industry for the risk averse. But it’s also nothing to fear if you have the right partner. EMCI has dealt with all of these pitfalls, worked with federal regulators and certifying bodies, seen patents through from start to finish, and manufactured a wide array of medical products.

You don’t have to start a new company when you come up with an innovative medical device. You need a partner you can trust to walk you through the process and help you avoid all of the pitfalls. That partner is EMCI.

This Commercialization Blog will be an ongoing source of information written by the experienced members of EMCI’s commercialization team. We hope that you find the information you read here helpful, informative, and practical.

The information provided through this blog is not a substitute for legal, regulatory or other professional advice where the facts and circumstances warrant. If anyone in your organization requires legal, regulatory advice or other professional assistance, they should always consult his or her own legal, regulatory, or other professional advisers and discuss the facts and circumstances that apply to their specific project.