Much of my early days selling robotic systems to surgeons and hospitals centered on a risk/benefit conversation. I had to balance the perceived risk of a new technology, with the benefits to their patients, their hospital, or their practice by embracing a new standard of care. There inevitably came a point in the verbal chess match where, if I could get them to see that the benefits outweighed the risk, the result was a decision to move forward.
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The development of the robot itself is no different, but the nature of risk in this context certainly is. For surgeons and hospital executives in the early 2000s, their assessment of risk was around technology adoption and the opportunity cost for such an investment. For your robotic start-up, however, risk is evaluated in terms of what your device could do to the patient, the user, or those supporting its use.
In the previous article in this surgical robotics start-up series, I looked at the importance of system architecture in the blueprint for success. Managing risk is just as vital. Every successful executive who has walked this medical device path before knows this is something you can’t skip, skimp, or shun. It simply must be done. And how your team addresses and mitigates this patient and user risk is essential to the success of the regulatory submission of your product. So, this is not a conversation about if you should be doing risk assessment, but when. Correct timing of risk analyses will determine the level of success your company can attain.
The question of when often becomes the most contentious for start-ups. There are those that feel if the engineering is sound and it is driven by performance requirements, then risk management can come later, and is mainly about making sure there are no mistakes in the design. As such, a labor intensive (and therefore costly) risk assessment can be moved later in the development process until ‘we have a beta prototype’ or ‘when our system is manufacturing ready’. Still others will see a cursory risk assessment as sufficient and by ‘passing’ themselves they are free to move on even though the severity of some of the risks have not been nailed down.
A proper risk assessment, early
But even with the most seasoned of teams and the luckiest of engineering decisions, pushing your analysis later in the design process is opening yourself up to the likely possibility of missed milestones and thus a greater cash burn. You are, in effect, taking a huge risk by pushing out your evaluation of… well… risk! Now is not the time to trudge forward blindly hoping to ask the FDA for forgiveness later. After all the effort spent in raising the money needed for developing your groundbreaking system you owe it to yourself, your employees, and your investors to ensure you are spending the right money once, not the wrong money twice. Executing a proper risk assessment early in your process and revisiting it constantly will ensure you are not having to rework your device later thereby saving time, money, and morale.
Let’s look at an example. Four years ago, I was working with a stealth start-up on their device to assess different manufacturing methods to help with their COGS as they scaled up for an impending clinical trial. At the time of our assessment, the company had yet to execute a full risk analysis as their milestone of getting ready for in-human use took precedence in their eyes. As the analysis began to unfold, it was determined that in a fault condition the device posed a hazard to the user. Fingers started to get pointed and tempers began to flare. The ultimate question of why this wasn’t determined sooner came up.
Ultimately, it was because developers in a benchtop setting never caused the user error that led to this fault state. And because of that, the exposed hazard was never detected. Even today that device has not been submitted to the FDA. Yet, the time lost and cash burned in fixing this reengineering problem could have been avoided with the correct upfront due diligence.
The risk questions to ask yourself
Now before you blast this company’s executive team for negligence, ask yourself what your risk management assessment looks like. What are your hazards, your mitigation steps, and your acceptability criteria? Ask yourself if a large portion of your Seed, Series A, or Series B money has already been burned and yet your risk profile is ripe with holes. Are you going to drop what you are doing and execute it? What if it meant burning the remaining cash to get there? And better yet, would you wish you had started with that analysis and engineered based on mitigating those potential occurrences?
While it might not feel that way, mitigating risks in design can be less expensive in the long run, especially if those mitigations have architectural implications. And let’s not forget we are talking about surgical robots inside of a patient! These carry significant patient risk but don’t always have the easiest of mitigation actions compared to other devices. For the health of your company and the success of your product I would suggest you make that tough call to go back before you go any further forward.
When it all comes down to it, as founders of a novel robotic start-up you invest a tremendous amount of time and energy in the vision of your company. That vision becomes the lightning rod motivating your ever-growing team to change patient’s lives. The day it all becomes a reality is the day the FDA says we know you analyzed the risk, you documented everything, and yes, your device is safe for people to use. Hopefully at that moment there are some dollars left in the tank, but I can assure you the fastest path to that end point is by preventing or limiting the number of times you have to go back and repeat efforts.
We will continue to explore the topic of bringing transformational medical products to market and advising start-up companies towards profitability, and we’ll continue our exploration of our advised pathway to success. We look forward to having you join us for those discussions – and please email me to continue the conversation. Here’s to tackling risk head on for long-term reward!