IDEAL Biomedical
Convincing Your Team Design Controls Are Worth It
The earlier you start, the better
Eric is an ‘experienced’ industry member of a biomedical research team. Last month he scheduled a 30-minute meeting to ask me for advice. We ended up spending a solid hour together.
First, let me give kudos to this team of translational academics for having such a member on their team. I do a lot of coaching with medical doctors, university professors, and postdoctoral researchers with entrepreneurial aspirations. Rarely do they have a seasoned entrepreneur as part of their team. It’s an X-factor.
Eric asked me, “How early should we start design controls and how do I convince the team this is time worth investing?”
What a lovely question! Usually, I hear, “What are design controls?” and “Why are we controlling design?”
At the end of our call, I promised Eric that I’d take the time to write down our conversation in an article that could be shared with his team. Alas, it turned into three articles (for now), including a ‘What?’, ‘Why?’, (both linked above) and this ‘How Soon?’. I expect there to be more where I’ll discuss some ‘How to …’ topics.
Eric: How early should we start design controls and how do I convince the team this is time worth investing?
Andrew: Are you a team of cooks or chefs?
My wife and I have been making pizzas together for nearly a decade. She’s been perfecting the dough. I like to be outside and cook on the grill, the smoker, and over campfires. I’ve been perfecting the bake. We collaborate on ingredients. Most of the time they come out great. Now and then we have a flop. Sometimes, we have an especially good run of pizzas that all come out incredible.
What do you think we did?
Did the humidity have anything to do with it?
We did precook the peppers and mushrooms on the cast iron this time, maybe that did something?
Abby and I haven’t formalized a repeatable process for an activity we’ve been doing for a decade. It’s OK. We are making pizzas. But we could do some simple things.
- Keep a pizza notebook
- Note the date and weather conditions
- List the ingredients we used on that given day
- Write down a real-time recipe (How we made the dough, temp of the grill, precooked veggies, etc.)
- Record a retrospective — How’d it go?
- Step 0: Read the notes before starting the next batch of pizza
Abby is a nurse and a holistic wellness coach. I’m a biomedical innovator and business advisor. When making pizzas, we are being super casual, and that’s OK. There’s a time and place for formal processes in our everyday lives.
If pizzas were life-sustaining medical devices, where would you want to eat? Would you take your chances on one of our masterpieces (or flops)? Or would you prefer to go to a Michelin Star restaurant?
Starting design controls does take an investment of time. However, it doesn’t need to be an overly burdensome investment. The simple process of having a notebook, recording some parameters, and doing a retrospective is a great place to start. The process itself can evolve. Don’t let ‘creating the perfect process’ get in the way of having a simple repeatable process that you can start today.
How soon should you start? Today!
Three big barriers to starting design controls include: 1) Not knowing what they are, 2) Not being motivated to invest the time, and 3) Believing they will constrain creativity.
Design controls don’t constrain creativity.
If you are lucky enough to eat at a Michelin Star restaurant, you might agree that the food is among the most creative you’ve ever tried. Going to one of these restaurants is a significant investment by the customer. They make reservations months in advance, often secure travel to dine there, and expect the bill to be jaw-dropping. No matter the day and the chefs in the kitchen, there’s a great deal of responsibility to deliver a quality meal every time. Along with that jaw-dropping bill, the customer is expecting a jaw-dropping dining experience. As much as customers invest their time and money, so do Michelin Star nominated chefs invest in their craft.
This combination of creativity and quality is key to being a standout chef.
Dining out is a luxury. We are biomedical innovators. Our customers are also investing significant time and money into our craft. More importantly, though, they are putting their health in our hands. Poor outcomes are not food poisoning, they could be the difference between life and death.
If you are a university professor, post-doctoral student, medical doctor, business mentor, or involved in any capacity on the journey of biomedical innovation, please consider investing in design controls.
Implement a simple repeatable process, take notes, and have design reviews. It’s as simple as that to get started.
Thank you, Eric, for taking the time to schedule a meeting and ask me this question.
Thank you for reading.
health. happiness. kindness. respect. to every-being and all-things
- ajds
