Problem with organization

I started working on finding another role.

You're wiser than I am ... for a long time I did the "the boy stood on the burning deck" routine whenever the ship was going down, but I've since gotten used to sleeping in the same place every night and eating regularly.

It's not a job thing. I can find other roles. What I've found in many startups is that the leadership focuses on the following resources in order: 1) business development/ marketing 2) clinical and research 3) sales, 4)operations. 5) quality.

The quality should be at the top I know but we also have to admit reality for startup and investor mentality.

The goals for investors are entirely focused and based on fastest return and forcing the company management to get milestones that lead to immediate monetary return. Nothing else matters to those groups of investors. They invest money and beyond any rational comprehension, their charter is to invest the very minimum then force the maximum return in the shortest time without the potential to run out of money and have another round of funding that dilutes their initial investment.

Because of this the board and investors have policies that limit the ability to hire and bring on FTE resources. So dates and project timelines are entirely based on promises made by business development and investors. Often these investors say things like "will you get the manufacturing completed in the next quarter with the resources you have or do we need to find another CEO and let you go?".

Then the R&D staff and operations staff is given deadlines of absolute "get this manufacturing started" which takes 95 percent of their 70-80 hour weeks and the remaining is left for the quality people to beg for input and help.

Quality is told "just get us through but don't bother the operations staff".


This has been my experience with at least four startups. One that I was with had founders who put their own money in and covered the gaps and that was successful.

I think that it's the war of attrition. I liken it to a high school swim team near my town. They are huge, have enormous success from the outside. It's a high school with a giant team and huge number of kids. The feeders for it are these club teams that train elementary through junior high aged kids to me champions in swimming before they get to the high school. Then the team puts together the best of the best and they train them in overwhelming hours of time and effort. Many kids burn out or blow up their shoulders or other injuries. .but because the pool is so big enough are successful that the team reaps huge rewards.


Same thing in the startup world. If a pool of money from investors is dumped among 50 startups and 47 fail, the reward for the three successes in lean staffing, high work and low attention to quality is so enormous that the investors look like geniuses regardless of the burnout.

Occasionally there is a theranos as a global screw up but mostly it's just a few million in high risk startup, pushing ceo and cfo leaders to do with less and for those who have luck with product and development and time the payoff is big.

I'm not being cynical, I've just seen it many times. I see few R&D startup people who want to take any time or can afford to take time under their leaders to focus on developing a quality system. An example is the question of "how will we show the user doesn't have problems with the packaging"

The R&D goober wants to design and build and is told "you had better get that design completed or you are fired". So their focus is not on writing the documentation to understand the potential user problems with quality.

One of my startups had a Nobel laureate as the founder of the IP. When I reached out to him for details on the safety his secretary said "there is no way you're getting on his schedule" and to be honest I understand that. He was an advisor. But the CEO had no money to hire an engineer to help.me discuss the potential adverse events.

It's a process and a set of ups and downs and I'm ok with it.

Good points, thank you. And it's not just limited to startups - I've come into organizations (that thought they were mature) and had the owner literally tell me "Fix all our problems, don't make any changes, and don't spend any money".

Yes, what I think would help is starting before the work begins to define the value of the QA and regulatory and show it less as a cost center and more of part of the overall engineering and output. But that's hard. Owners and executives see this as 1) a time sink 2) a necessary evil and requirement to meet to market products and 3) a cost that is added to their business plans. And they communicate that the R&D: "I don't care what the QA person says, you had better get that delivered on time otherwise we are finished"

I don't want to control the production peoplea and I want to help them but I also have leaders who have wanted QA to be a separate set of requirements that are met similar to the local building or fire inspector coming out to make sure we have extinguishers or traps on our sewer. It's not the same but the leadership sees it as such.

But I know eventually I land at a place where the integration of quality works with the teams.

It has been almost a month... any updates @Tintypographer ? Either on your search for new employment or on the Sh(t show that you were dealing with?

Hello:

I'm at a new role. I think they filed for some extensions. What I learned is that there is a scale for involvement of production teams in quality systems and when management doesn't account for that it just doesn't work. I also know those teams have incredible time constraints so I need to do my homework with very specific questions and writing before they come in for input but if I have no input on technical details then we can't really justify things to either the FDA or the notified body.

This was on the very low end of the scale where the R&D and production engineers simply had no time as mandated by executive leadership for input to quality and regulatory. Executive leaders didn't want to jeopardize timelines or "bother the production teams". I've noticed this occurs at companies where the founders and product leaders are not experienced in regulatory. They tend to see that they did their clinical studies, they ran toxicology, they paid for GMP manufacturing and they have sales going on and their investors demand profit, not a bunch of justifications and meetings. I have learned to ask questions about a startup company's understanding of the regulatory requirements, path and effort and to say what I will be able to do and what will need input, thought and writing. I'll promise not to act as a blanket auditor simply dropping open questions and guide the production andnR&D teams through it but I can't solve the problems in a vacuum


There are also the problems my own profession and predecessors have made that take cleanup.

At a company I was with that had an approved producf with CE registration, the company didn't produce for three years because of funding and production supply chain issues and there were no sales in that time. Instead of filing to place a hold on the product, the regulatory person elected to simply open CAPAs about why no work was being done in production to reduce risks or why no post market surveillance was conducted. There was no thinking about the options done by that regulatory person in talking with the FDA or notified body. hE/she simply agreed with the auditor(s) and wrote ancapa saying they would fix the production review process. But clearly no manufacturing was going on or had any likelihood of continuing in the near future so in that case the regulatory person (my predecessor) did a poor job of advising and helping the management.

It's all a balance. Quality and regulatory should not be the sole purpose of a medical device company. We have to produce products that help patients. Those products should be designed and managed with a quality system under a regulatory framework. I can't say to a R&D scientist, "we should have a SOP for opening a drawer" in the face of real deadlines but I should be able to say, "we have to definine risks to a process change and implement a control."

My new company appears to be about a 6 on the scale from 1-10. They have some messes but management is committed to solving them.

Tintypographer said:

Hello:

I'm at a new role. I think they filed for some extensions. What I learned is that there is a scale for involvement of production teams in quality systems and when management doesn't account for that it just doesn't work. I also know those teams have incredible time constraints so I need to do my homework with very specific questions and writing before they come in for input but if I have no input on technical details then we can't really justify things to either the FDA or the notified body.

This was on the very low end of the scale where the R&D and production engineers simply had no time as mandated by executive leadership for input to quality and regulatory. Executive leaders didn't want to jeopardize timelines or "bother the production teams". I've noticed this occurs at companies where the founders and product leaders are not experienced in regulatory. They tend to see that they did their clinical studies, they ran toxicology, they paid for GMP manufacturing and they have sales going on and their investors demand profit, not a bunch of justifications and meetings. I have learned to ask questions about a startup company's understanding of the regulatory requirements, path and effort and to say what I will be able to do and what will need input, thought and writing. I'll promise not to act as a blanket auditor simply dropping open questions and guide the production andnR&D teams through it but I can't solve the problems in a vacuum


There are also the problems my own profession and predecessors have made that take cleanup.

At a company I was with that had an approved producf with CE registration, the company didn't produce for three years because of funding and production supply chain issues and there were no sales in that time. Instead of filing to place a hold on the product, the regulatory person elected to simply open CAPAs about why no work was being done in production to reduce risks or why no post market surveillance was conducted. There was no thinking about the options done by that regulatory person in talking with the FDA or notified body. hE/she simply agreed with the auditor(s) and wrote ancapa saying they would fix the production review process. But clearly no manufacturing was going on or had any likelihood of continuing in the near future so in that case the regulatory person (my predecessor) did a poor job of advising and helping the management.

It's all a balance. Quality and regulatory should not be the sole purpose of a medical device company. We have to produce products that help patients. Those products should be designed and managed with a quality system under a regulatory framework. I can't say to a R&D scientist, "we should have a SOP for opening a drawer" in the face of real deadlines but I should be able to say, "we have to definine risks to a process change and implement a control."

My new company appears to be about a 6 on the scale from 1-10. They have some messes but management is committed to solving them.

Click to expand...

Hi,

Congratulations with your new role!

As I find myself in a similar situation as you did, maybe people here can give me some insight:

Question:
A person is responsible and accountable for our one product (worldwide, class I) in QA&RA. The company is market leader.
If there is nothing 'exciting' going on and/or happening with the product and the QMS is not yet euhm let's say optimal (in every sense of the word), how many work hours would one person need to make sure all work is done?

Thanks for your input that will make my life hopefully easier.
Regards