Understanding the Five Stages of Regulatory Grief
Iāve been involved in software medical device regulation for a decade now, and advised all sizes of companies, from startup to huge corporations, on their regulatory strategies. Over the years Iāve noticed a behavioural pattern that has emerged amongst clients that I would like to share with a wider audience, since I feel that recognising the emotions that come with tackling regulatory compliance, and learning how to overcome them, can be a force for good. Hopefully this will help others on their journeys.
As a practicing clinician by background, I remember my medical school training fondly. In particular I remember when studying psychiatry as an undergraduate that we were taught about the five stages of grief. This is a well recognised and documented framework which helps describe some distinct phases of the bereavement process. These phases can be felt by anyone experiencing a loss, and all are common to the innate emotional reactions that we as humans are programmed by evolution to feel in certain situations.
Reality bites
Why am I talking about grief and loss in a regulatory article? Good question.
For many people wanting to make a positive difference in the world, building something in healthcare is a desirable goal, one that comes with obvious benefits of doing societal good. Founders and engineers are naturally attracted to solving some of the worldās toughest problems in a sector that is fundamental to the health and wellbeing of us all. Itās often with great excitement that they set out on their journeys to make someone elseās life better, however they can. This is to be commended, encouraged and celebrated - in a world where all too often bad actors are out to make a quick buck, itās always a beautiful thing to see people trying to make a genuine positive change to other peopleās lives. I love working with founders in this space - they have amazing dreams, and they are actively trying to make them come true. Their energy is both palpable and exciting.
However, the journey to building a regulated product in healthcare is not easy. In a very real way, regulation can threaten that noble dream, causing a cascade of emotion that is very similar to grief. Coming up against unexpected regulatory barriers that can seem at the same time unsurmountable, intangible and confusing can be an earth-shattering wake-up call to those who started out with such keen intent. This is when the stages of regulatory grief kick in - when a builder feels that their dream is threatened, or potentially lost. Itās a gut wrenching emotional experience, which Iāve seen drawn across the faces of founders all too often. Hereās what it looks like, and how to get through it.
Denial
The most common stage of regulatory grief is by far denial, by orders of magnitude. Denial that regulations apply to your company or your product, denial that they need to be dealt with, and in some cases denial that the regulations even exist.
Denial can be either passive, when you are blissfully unaware of any regulation, or denial can be active - you know that regulations exist, but you deliberately choose not to engage with them.
I get it - I really do. Iāve been through this exact stage myself. Itās what galvanised me into dedicating my career to helping others get through it. My first job in industry was at Babylon Health, where one day, out of the blue, the regulators turned up and told us that we had built a medical device, and please, could we kindly become compliant. This was a watershed moment both for me, and the company. I reacted how I thought one should react - with due respect and deference to the regulators, and a willingness to co-operate. Others, well, lets just say they reacted less positively. Denial quickly turned from passive ignorance to active avoidance. The rest of the story, as many of you will no doubt be aware, is not so pretty.
Denial makes people react in a very particular way at first - they carry on as normal as if nothing has happened. At some unconscious level, they believe that the regulations really do not apply to them, and concoct all manner of internal excuses to prove themselves right. This is the brainās way of making things simple to deal with - by ignoring them. It is quite incredible to see just how far humans can twist their own internal logic to make themselves believe something that isnāt true, in order to protect their dream which has been so overtly threatened.
The worst form of denial extends beyond the individual. When people actively start to share misinformation in order to gain approval and agreement from others about their denial, then the denial can become almost malignant - a sneering denial that poo-poos regulations entirely. Imagine for a second that someone was going through a bereavement of a loved one, but was in such denial that they were telling people that everything was fine and normal because their loved one was actually still alive. It would be bizarre, and likely require an intervention. Unfortunately, Iāve seen this happen in healthtech, where founders or engineers in denial have written posts on social media, or letters to me, denying that the regulations apply to them, no-one told them about this before, and regulation will kill their business, which all gets rather aggressive, and leads us directly to the second stage of regulatory griefā¦
Anger
Dreamers who have their dreams shattered by reality will naturally feel a sense of unfairness, of loss, of helplessness, maybe even that they are being treated cruelly. This often leads to anger. This anger is often directed at the bearer of the bad news (regulatory consultants) even though they are just the messengers. Iām used to this, as I know it is only a phase that will pass. Anger is also directed towards the regulators, the law makers and the whole ecosystem of people that make up the faceless bureaucracy of medical device regulations.
In this stage of regulatory grief, logic is gone. It is pure unbridled rage triggered by a broken dream that crashed head first into reality. In this stage, itās very hard to think logically about the reasons why the regulations exist, how many countless patientsā lives have been saved because of them, and the decades of work that has gone into producing them and enforcing them. No, in this stage, it feels personal, it feels threatening and it all feels too much. Fight or flight responses kick in, and in order to fight, it helps to be angry.
Founders have to sell other people on their dream - they need to excite investors, entice employees to join them on their rocketship journey, to convince potential customers and to create a positive story. Funding is tight, runways are short, promises have been made - however butting into regulations too late puts all of this into extreme jeopardy. Will they be able to fulfil their promises and achieve their dreams? Suddenly itās all put into question, and this makes them angry.
It is inevitable when your world view is questioned that your reaction is denial and then anger, but this does not last long, and then without fail, the next stage of regulatory grief begins.
Bargaining
Every single time Iāve seen someone go through the stages of regulatory grief there is a period of bargaining. A whole array of questions stream out of them. Hereās what they always ask:
How fast can I do this?
How cheap can I do this?
What if we claim to be a Class I device?
Can I outsource or automate this?
Can we avoid this somehow?
Why are my competitors not doing this?
What if we donāt comply?
What if we switched to another market?
What if we reduced or changed our claims?
The answers, of course, are highly dependent on multiple factors, including the intended use, the claims being made and the geographical jurisdictions involved. The good news is, anyone can actually get regulatory clearance if they plan a strategy properly. But that requires acceptance, which many are not quite ready for yet, at least at this stage.
There is an unfortunate side effect to the bargaining stage - and that is the rise of a cottage industry of solutions designed solely to capitalise on answering these bargaining questions from desperate founders. There are now countless offerings of varying quality claiming to get fast, cheap, seamless regulatory compliance - because that is what they think founders need. The truth is that when people are in pain, they look for easy answers that will address that pain - regardless of whether they are correct or not - sometimes manifesting in abuse of unhelpful products like alcohol (or āget compliant in just 20 daysā SaaS offeringsā¦). Donāt get me wrong, there are useful tools out there, but tools themselves are just that - tools - they do not help you actually understand or learn. A more sensible, and ultimately ethical approach, is to help these founders by working closely with them to understand that quick fixes arenāt necessarily the best option, that they are on a journey that many others have succeeded in, and that quality done well will actually improve their business.
It can be hard to admit that you need to change your thinking or approach, and can certainly stir up some strong emotions, which leads us to the next stage of regulatory grief.
Depression
In my observations over the years, the depressive stage of regulatory grief is thankfully the most short-lived. Builders in healthtech are some of the most optimistic people on the earth, and tend to have incredible resilience and an amazing ability to bounce back from adversity, and I have rarely seen anyone fall into a truly deep depression caused by regulations. That said, the trend I have observed is that the longer regulatory matters are left, denied, ignored or delayed, the stronger the anger, and ultimately the depression.
This is due to the fact the longer the delay, the more promises have been made, the more money raised, the more product built, the larger and more real the dream has become, and therefore the more crushing the realisation is when it hits that there is this huge iceberg of regulation heading your way.
My advice to founders and developers in healthtech wishing to avoid regulatory depression is simply to engage as early as possible with the regulations. It is Day 1 priority stuff. By being prepared for the journey, it massively reduces chances of shock - this of course requires the final stage of the regulatory stages of grief - acceptance.
Acceptance
Embrace the boring, revel in the challenge.
This is the mantra of the acceptance stage of regulatory grief. Are regulations fun and exciting? Arguably, not at all. But they are vitally important to the thriving functioning of human civilisation.
Those that accept the need for regulation, who understand its purpose and place in our lives, and believe in the scientific method and observable proof - those are the ones who will usher in the next era of healthcare responsibly, safely and effectively.
To go from denial about regulation, to anger, bargaining, depression, and then full acceptance is a truly emotional journey. One of the most beautiful things in my work is when we receive a heartfelt thank you from clients after they have successfully received their CE mark or FDA authorisation. It makes all the long hours and hard work worth it.
Redacted email from a Hardian client
These are often people who came to us in their depressed stage, and we were able to to counsel them through it, show them they were not alone, work step by step, move forward hand-in-hand, teaching and training them, until one day, they were able to fly on their own. Yes, theyāll come out with a few scars, everybody does, but theyāll be joining the elite club of builders who did things the right way. Suddenly, their dream is a reality - just as theyād hoped. They manifested it, and it came true.
You see, for me, regulatory consulting is more about teaching people how to cope, rather than simply offering to take away their pain for a brief moment, or getting them addicted and tied in to a solution that doesnāt actually handle the grief at all. The goal is to get to the point where YOU donāt need US anymore, because you understand and feel confident navigating the regulations on your own.
Like a driving instructor, we sit patiently in the car with you over many hours, watching you learn to handle your car (or in this case your QMS), occasionally tapping on the breaks, giving helpful tips, because ultimately it is YOU that has to sit the driving test, alone, but with full confidence that you too can drive on the highways of healthcare safely and effectively. Trust me, itās a journey worth going on.
Hardian Health is a clinical digital consultancy focused on leveraging technology into healthcare markets through clinical strategy, scientific validation, regulation, health economics and intellectual property.
