Regulatory Strategy – How Soon Is Too Early?

When it comes to achieving regulatory clearance, there is a reason the instructions flow ready, aim, and then fire. It’s understandable that you want to begin working on all of the urgent elements, as soon as possible, but take the extra time to plan in order to save a huge amount of future time, costs, and heartaches. And get help from those with the expertise to guide you to success.

Ready, aim, fire? Absolutely! And yet…

At the request of investors, we met with the CEO of a company interested in moving into the hospital market with particular equipment they had developed. They had done almost no market research in this new-to-them sector. A board advisor told the company that because the equipment would be used in a hospital, it would be a Class II device, requiring a 510K filing with the FDA for regulatory clearance. They were also introduced to a hospital in another state to immediately begin testing of the equipment, which they did.

We asked if they had utilized any of the guidance documents that the FDA provides in order to better determine classification as well as ascertain design and manufacturing requirements; and were they aware of legal repercussions tied to noncompliance of those documents. They were not aware of any of this and did not really see it as necessary as their board advisor was a medical doctor.

We appreciate clinicians tremendously. We are fortunate to have the opportunity to work with them routinely on projects. The question though, is what is an individual’s direct experience with the FDA and constantly evolving regulatory requirements?

We also asked whether the company understood that, if the equipment really was a Class II device, they could not actually use it in a hospital without first getting FDA clearance to market it. Again, their physician advisor told them if it was just being used and had not actually been purchased that it was all right. We sought to diplomatically explain that this was not accurate.

We strongly suggested that before they went any further, and invested more time and money, that they develop a regulatory strategy. And more importantly, a prioritized overall market strategy. We also advanced that there were two to three large markets immediately available to them, closely associated with hospitals, but with far fewer barriers to entry.

As hard as it may be to hit the “Pause” button temporarily, getting some experienced guidance will save time and tremendous costs and can focus you in a much improved direction; possibly even to a lesser regulatory classification. And if that guidance comes from a team with a proven track record for successfully achieving device commercialization and regulatory clearances, all the better.

An investment advisor asked us to meet with their client who had designed a medical device. We met and learned how very much work and money the client had already invested in preparation for the hospital market, knowing for sure that his device would be Class II. He wanted to further his understanding of the road ahead into the hospital market.

When we asked how he knew the device was Class II, he explained that his daughter-in-law was an ICU nurse. She had told him that most everything entering into the hospital market was Class II. Had he used any FDA guidance documents to confirm this? No, but he assured us that she was quite qualified because she had worked in hospitals for over a decade.

We diplomatically explained how and why this was not a Class II device, and did not, in fact, require any clearance through the FDA at all. He had spent 18 months working to get ready to go and was crushed.

Even a brief conversation on regulatory strategy as early as possible is always recommended.

A high-tech, custom electronics contract manufacturer asked us to meet with one of their clients, based on our expertise applying power to medical devices. This client had been in business for decades and had several Class I devices on the market. Now they wanted to add powered vibration to a device for patient interaction.

We asked them if they had worked with any other Class II devices or with powered devices before. They explained that this would not be a Class II device, because they did not want it to be. They adamantly assured us that it shouldn’t be a problem. They had already spent a fair amount of time and money headed in this entirely wrong direction.

We asked to go through guidance documents with them together. It clearly presented itself as exactly what we had indicated – Class II.

We then asked to review some of their other devices under development. As we got under way reviewing other devices, we immediately identified another set of devices which were being miscategorized.

Fortunately, we were able to help get all back on track quickly and focused through a comprehensive portfolio regulatory strategy.

We were introduced by key stakeholders and were asked to meet with a company who had developed a medical device and were ready to proceed with the second version.

Upon meeting, we were told that all that they really needed from us was a recommendation for a design firm. We stated with a few questions to seek to provide them the best solution.

Within a few questions it really was obvious that this would be a Class II device. They understood that. When we asked if the first version was just for prototyping, we were told that it was the free-standing surgery center version. We asked if the use case was different in the surgery centers. The response was that it was the same use case. They were already selling into surgery centers for patient use.

They went on to explain that the reason it would be a Class II in the hospital had nothing to do with patient use. It had more to do with other electrical fields operating within a hospital. They further explained that in order to gain a competitive advantage, their competition had simply gone to the FDA and paid for the Class II designation. Had they not done that, then this company would not even have to be doing this. This was all so unfortunately inaccurate. When we asked where they were getting their guidance, the principal responded that his brother was a hospital surgical clinician. That was their sole resource.

We suggested that before anything else, much less recommending a design firm, that we really needed to develop a regulatory strategy based on actual FDA guidance. We also clarified that they were already in violation by continuing to sell without appropriate regulatory clearance for their initial device.

Everyone involved meant well. They just needed experienced guidance to make immediate adjustments and focus their efforts.

At a recent seminar we met a scientific researcher, an exceptionally bright and gifted PhD. We met for several hours over the course of two meetings. He has conceptualized what will quite probably be a breakthrough cancer diagnostic instrument. He wants to get immediately underway. We do not blame him – his concept is brilliant.

As we discussed the project more, he explained that it was his understanding that you design it, prototype it, manufacture it, test it, and then go to the FDA. He is somewhat correct. We suggested developing an overall regulatory strategy first, including international requirements. This included even already having enough information to proceed with a pre-submission to the FDA.

This early work will help us to confirm all materials requirements, all standard(s) requirements, all testing requirements, all international crossover requirements, many other aspects, and potentially save us from any costly backtracks. This way, we get the chance to know, with some certainty, everything that we will have to do and then work that direction.

This is the best, actual Ready, Aim, Fire scenario.

Although we all want to begin working on the exciting elements as soon as possible, taking a little extra time and effort will save a huge amount of future time, costs, and heart-aches. Develop your regulatory strategy very early and get help from those with the expertise to guide you to success.

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