MedTech Expert Explains Study Management Process at Test Labs | Pressure Tested

Hi, I’m Chris. I’m a healthcare science expert, starting in the NHS and then moving into contract research, and today I’m going to be pressure tested.

So what do you do at Test Labs?

So I’m the laboratory team leader. My role is to oversee the daily operations, schedule the work through the labs, and ensure everything runs smoothly, which includes making sure all the maintenance is done through the labs, resources are all there for everyone, and that we all know what we’re doing every day.

What is study management process at Test Labs?

So you’ll have already spoken to our sales team. Once you’re handed over to the accounts team, then I will become aware of the work. I’ll start discussing it with them.

There’ll be an SD, so a study director identified for it. I’ll start looking at what capacity we can put aside for you, what the timelines are for those. They’ll have the proposal out to you.

So even at this very early stage, I’ve already begun to determine what you need, and our SDs have started to think about those protocols that need to be written. As soon as that proposal’s signed, it’s their job to get that protocol written. I’ll be reviewing it with them, checking again that it meets the needs and making sure that I’ve got staff now assigned specifically for that work. Once we’ve got that test item, we can get the protocol signed, and then the work can begin in the labs. We move swiftly.

We make sure the resources are there beforehand, so that work goes straight through, hopefully without any problems. And then the SDs are always on hand. I’m constantly checking with the team and referring any information back to the SDs as needed, and then we can put in anything that’s necessary to make sure it’s completed on time. Then the SDs will write their reports and get it straight out to you as soon as possible.

Who is responsible for my project in the lab?

So overall, the SD always has final responsibility for the decisions, and your account manager is going to be the person who’s going to contact you to make meetings and discuss with the SD those things. But on a day-to-day basis, I’m overseeing the work going into lab. I make sure it’s there, and your analyst at the bench is going to be the person actually completing the work, making sure all the raw data is done correctly, ensuring that all of those quality checks are done. I’m coming in and confirming the quality checks. If there is an issue, if anything arises, then we liaise straight with the SD, and then they may reach out to myself or one of the other experts in the team to ask for advice, but they’ll make that final decision and come back to you if necessary to discuss any problems, to resolve them as quickly as possible.

What is the overall testing process and reporting?

So the overall testing process is obviously getting that work into lab, getting it complete, and getting the report out. So I mentioned earlier that we have protocols in place. That protocol will define exactly what should be done within that test. Some of our tests, like UKAS-accredited ones, will be driven by the actual standard itself, and so we’ll just simply follow that standard as expected by UKAS, and as we’re accredited. But the process will then be to take that work into the lab, complete the work. It will depend on the type of work.

Some work will be straight in on Monday morning, and we’ll start processing, getting it through. Other work that needs bacteria grown, the work will start on Monday when we start that bac culture, and then we’ll move on to completing the actual testing later on in the week when the bacteria is ready for use in the lab.

Once all the work has been completed, we’ll QC check, make sure that all of that data is correct. Our SDs will often send out some preliminary results to their clients to tell the clients how it’s done in the test. It might be that they suggest that some retesting that needs to be done if it’s not met the standards required, that will involve some changes to how it’s being done. And then once we’ve got a final result that we’re happy with, SD will move on to write their report in the reporting phase, and you’ll receive a draft report once completed for your review.

Do we get to see the draft report before the final report?

Yes. As previously said, you’ll get some preliminary results a lot of the time, and then a draft report will be issued by the SD once they’ve completed it for you to be able to review. You can confirm that it’s in the right format, that you’re happy with it, all the details are exactly as you’re expecting them to be. And then you can discuss that and make comments yourself on how you feel about that draft report. Once you’re happy with the report, then our SD will be able to finalise that report and give you a final ECTD report that’s suitable for submission.

I have a product and we decided to change materials. Can I stop the testing?

Well, this really depends on if it’s a UKAS test, then once we start testing, we have to complete that testing as part of UKAS and issue the report. So in those cases, no. However, for a lot of our other types of tests, like IFU validations, then we’re open to discussion on that. If you reach out and say, obviously, if work’s already commenced, then it will mean pausing that work. But we can certainly discuss making a change to the scope for the study, confirming what the new materials are, and rearranging the timelines to do that.

There’s no point in us completing testing if you’re intending to change the materials before the end, and we’re here to make sure that your product gets to market as quickly as possible, so we can start having that conversation as early as possible.

Why do validation projects miss their deadlines?

So quite frankly, communication. Often the client communication. We will obviously assign all of that capacity, the resources, everything needed. But if a device doesn’t come through when it’s expected, we obviously can’t test without the device there on-site. And during the actual validation itself, it’s not uncommon for the first run comes back and goes, “Oh, it’s not met the expectations that we were hoping for.” That’s fine. We can adjust it. But a lot of the time, I’m then chasing SDs. I’m like, “When can I get this work back in the lab? Can I do it next week?” And they’re going, “I’ve still not heard back from the client.” I’m still waiting for them to respond. I’m waiting for them to confirm they’re happy with us to make this change because ultimately, it’s your product, it’s your testing.

So although our SD can make a decision, it will be you guys to actually confirm that you’re happy to do that, and that often we’ve had weeks of delays before where we’re ready, we’re prepared to go, but we’re just waiting for somebody to say, “Yeah, we’re happy for you to make that change to our IFU so that this actually succeeds in the end.” And ultimately, that’s a delay on your deadlines. That’s a delay on when you can get the product to market if you’re still waiting for the validation to complete.

What’s the biggest planning mistake manufacturers make?

The biggest planning mistake is not really being realistic with their own timeframes. We get told all of the time that it’s going to be with us in two weeks’ time or a month’s time, and then that day comes around and there’s delays and things. Consider whether you genuinely are going to have a product ready by then. We don’t mind. We’re prepared to slot it in when it needs to be done, but we need a realistic timeline of when it’s going to be there.

Other things can include stuff like you’ve got an IFU, but it’s quite a generic one, and there’s something really specific about it. So we get in a device, and it’s got a really basic IFU to follow, and then we find that when you dismantle it, there’s lumens that have not been taken into consideration, or there’s mechanical parts, or you’ve got a specific requirement to lubricate a moving joint or something, but there’s nothing there in the IFU about that, which later on can cause problems.

Obviously, it has to be the complete device as well when you’re submitting. So we don’t want people to be coming back saying, “Oh, you tested half the device, and now we’ve just submitted to the regulators,” and they turned around and said, “We need another IFU validation for the whole device,” and things. Upfront, we’ll tell you it needs to be the final device that you intend to put to market that we do our IFU validation on. That way, when it goes to the regulators, you’ve got every part of that device covered.

How do you schedule work in the lab?

So we are agile. So I’m constantly reviewing our workflow. I’m constantly looking at it on a daily basis. Every morning, one of the first things I do is look at the work that we plan for going through today, but I’ll also look at what we’ve got planned for tomorrow and for next week and the week after. And it’s really a case of prioritising. I know the deadlines for all the projects that are supposed to be going through. I know whether we’ve got test items for them, and we’re constantly ready to shift our workflow to ensure that we’re still going to hit those deadlines, but also so that if we are, I’m expecting test items this week for work next week. We get to Friday, and we still haven’t got the test items, then I’ll be reorganising next week’s schedule.

That’s how we are able to move things through so quickly because we’re constantly prepared to shift our workflow for it.

What is a lead time?

So lead time is the expectation of how quickly we’re going to get work through. So from when you’ve got that test item to us to when you’re going to get a report. So if we tell you that our lead time is four to five weeks, that means once we’ve got the test item and a signed proposal in place, we’ll be able to shift that work through the lab in four to five weeks and have your draft report at the end of that time period ready for you to review and then hopefully finalise.

What is a sample submission form?

It sounds so simple. A sample submission form is actually really important to us. That is the form where you’re going to detail all of the important information, batch numbers, quantities, storage requirements, whether or not you want it disposing off at the end of the study or returning to you.

Often it’ll also include things like surface areas for devices, which are very important during testing. We can’t really start any work without it because it does hold all of that key information that we’re going to make sure is accurate and correct before we begin work in the labs. So the sample submission form is a document that you’re going to complete. Basically, as soon as we get a proposal, you’ll receive a sample submission form. You’ll fill that in. Hopefully, you’ll know at that point the batch numbers and all of these things. You’ll complete the form, you’ll send it in to us, preferably prior to even sending the device so that we’ve got a copy of that, we know what to expect. When we get that device, we’ll check it against the sample submission form. We’ll check the batch numbers are matched to it and that everything’s there appears accurate, and then that will stay with your test item throughout the entire time it’s here at Test Labs to make sure that it never gets lost. We know the quantities and everything else, so it’s really important.

What are the main things that delay testing?

So like I mentioned in the IFU validation delays, client communication, if we’ve sent a request for information, we’ve not received that information, we won’t go into testing. So that can cause delays in testing. Not receiving the test item on time. So the previous question I mentioned about the fact that if you’ve come into us with a proposal and you’re not realistic with when you think the device is going to be ready to send to us, then obviously that’s going to cause delays in testing if we’ve not got the device. Additionally to that, I think there’s lots of little things within the lab itself, we can sometimes have bacteria doesn’t grow as expected, so we’ll end up having to restart the sort of process from the beginning. That can add a couple of days delay.

I think we all are aware that you can get technical issues. Instruments sometimes go down. Generally, that doesn’t happen too often to us, but occasionally that’ll add a small delay in. But generally, we actively seek to get engineers out immediately, get it fixed within a day or two so that doesn’t have any impact on our lead time when possible.

How do you handle sample shipping?

So obviously, with all the care we possibly can. Depends on if we’re shipping samples back to a client at the end of a study, everything’s always going to be packed. Sometimes it’ll be in the original box if it’s come in a very specifically shaped and designed container. Other times we may use alternative packaging, but we’ll always take good due care to ensure that it is properly packaged so it can’t move and get damaged during shipping. And then we use a preferred provider to then ship the parcel back to yourselves or wherever you’ve asked us to ship that parcel to. We also occasionally arrange for shipping to actually bring the parcel to ourselves. Obviously, it’ll be up to you to do the packaging side, but we can make arrangements to ensure it’s brought to us as quickly as possible and safely by a provider that we consider trustworthy for doing this task. And then we also send samples off to some of our contracted or consultancy labs as well that assist us, though we’ll arrange, again, in the same manner. We always take as much care as we possibly can with that package.

What documentation gaps slow projects?

Sample submission forms, as discussed earlier, very important for us writing our protocols and being able to go into testing and the instructions for use. If we’ve not got those, we can’t write a protocol. They are going to define that is your intention for how that product is going to be reprocessed once it’s out on the market. They’re the instructions that you’re going to submit alongside this report to the regulators, and they’re going to make the decision based on that. So if you’ve not provided the IFU, we can’t write a protocol, we can’t do a study at all. So those are probably the two biggest gaps, is not having the sample submission form or having an incomplete one.

A lot of the time, we don’t have the sample surface areas, and these are required for the back calculations at the end of the report to make sure that we’re meeting the acceptable criteria and then not having the actual instructions for use to be able to follow.

What should clients prepare before testing?

Obviously, the two documents previously mentioned. You need to ensure that you’ve got your test item ready, you’ve got a suitable number of them. We have clients come to us saying they’ve only got a prototype, and they go, “We can send you one sample.” Well, we’re going to need a positive control device, a negative control device, and at least three test devices, so you’re always going to need to send at least six. So you need to have six of the final product ready to go and send to us.

You will need to have your instructions for use, so how you intend for it to be cleaned and sterilised, and you’ll also need to have the sample submission form completed, ready to send as well.

What timeline mistakes are common?

So I think common mistakes that are made with the timelines is assuming that certain work can be completed like on a Monday. If it’s so, for instance, for our 17272 disinfection studies, these require the growth of bacteria. So we can’t ever do a run on a Monday. It’s always going to be Tuesday, Wednesday, or Thursday. We can’t do a run on Friday either because we have to wait 24 hours for that bacteria to grow. So there can be those timeline mistakes.

They’re quite common for people to just misinterpret how we can fit those testing into the labs. Additionally, I’ve mentioned it a lot before, but manufacturing of a device, expectation that you’re going to be able to send it off to a manufacturer, have it produced, and then have it sent over to us. We’ve certainly had, with the Chinese New Year being quite recent, a number of devices where unexpectedly they take their holidays and we end up saying, “Well, where’s the device?” And they go, “We’re not hearing anything back from them. They’re all on holiday.” It’s going to be March before you actually see any devices and things. So those sorts of mistakes in the timelines. We’re experienced. We know what we’re doing. We are quite good at ironing out our timelines, but at the same time, even we are not infallible.

There are times where we have an expectation that certain stuff can go through in a specific order, and we end up having to rearrange things. Might be that we don’t have enough devices to be able to do the sterilization and the reprocessing at the same time, so we end up having to wait until the end of the study. That’ll add a few days onto it for the sterilization process as well. But generally speaking, we’ve become quite good at spotting these sort of timeline problems right at the very earliest stages, and we’ll contact you and say, “Well, if you want us to do both at the same time, we’re going to need more devices, or it’s going to have an impact of X amount of weeks or days onto your study for us to be able to do both things with the devices that you’ve sent through.

How do you handle urgent validations?

So we’ve actually got one currently going through the lab, and honestly, it’s a huge team effort. We have myself overlooking the schedule constantly, seeing how we can fix things in, prepare things. I’ve put two analysts down for it. We probably wouldn’t normally have two analysts, but this is an urgent one. They want it through quickly. So I’ve got two people on it working together in tandem to make sure that everything’s done as efficiently as possible. And then every morning I’m going straight to the SD, questioning about things. They’re going straight to the account managers, ensuring that meetings are booked in place just preemptively going, “Well, we’re going to have results on Friday, so let’s have a meeting prepared for Friday afternoon so that we can then sit down and discuss those results.” As soon as that meeting’s over, if I’m not in the meeting, I’ll go and sit with the SD and be like, “Right, what’s the plan for next week? What are we going to be doing? Is there any changes needed? Can I continue as we’re expecting?” So in this case, it’s a big study, but we have managed to do a validation In a very short time period for them, less than a few weeks, essentially. But that has taken a huge team effort to get that through quickly.

What’s the biggest misconception about lab capacity?

It’s an interesting one, the misconceptions. So one thing people often forget to take into account for is the routine maintenance and non-project work, the stuff that is required for the lab to function. All of the verifications of the photo spectrometer, all the pipette verifications, the filling up water baths, the cleaning down benches, all of these things are required daily tasks, but often get forgotten to be included in the lab capacity, which ultimately means that people try and fill up all of the time of the whole day with just project work. And then at the end of the day, we start running out of resources because nobody’s made media, because it wasn’t specifically lab project work, or we start finding that equipment is no longer able to be used because it’s not been validated recently. So that’s one misconception.

Then the other misconception is you can assign a certain amount of work and you say, “Well, this is going to be a six-hour project,” but a lot more of six-hour tests to be completed. But a lot of the time those tests will have gaps and breaks in them. So when you carefully plan it and organise it, you can in fact manage to fit multiple things into that. You can fit those pipette verifications into a waiting step during the testing, but they can get those in so you can look like you’ve got a really high usage of your lab or a low capacity if you like. But in fact, there’s lots more there that can be squeezed out just by being more organised within the lab as to how analysts are working.

How do you prioritise projects in the lab?

So my priority is about making sure those projects go through on time. So I’m always looking at the deadlines. I have a sort of consequence-based process where I look at the effects of if I push that out by a day, is it going to affect the deadline of getting that working when it’s supposed to? What is the impact on if there’s plate reading or if there’s other things? And I use that to define what’s most important to pull in and ensure it’s done on time. Generally speaking, we’re pretty effective at getting everything through that’s planned, and the accounts team are always working with me, so I can let them know if we’ve got space for them to be able to put more studies in, or if we’re completely booked up and there’s no chance of getting any additional work in, then they’ll make sure that that’s put in prior. But my priority is always about ensuring that we hit those deadlines. So if we said your work will be tested this week, it’s going to get tested this week. And I’ll be looking at if I move it to tomorrow, am I going to be able to complete all of that work by Friday? Or is there a plate counting?

Is there a step that’s going to cause there to be a delay?

In which case, there’s no way I can move that work out. Other work and things I’ll be looking at going, “Well, actually, the study’s got multiple large-scale tests to be done. It’s going to be running over three weeks. If I don’t do this work this week, it has no impact on the overall of the study.” So then I’ll be going straight to the SDs and saying, “We’re not going to fit this work in this week.” I’ll give them a good reason why we’re not going to fit it in. Perhaps something else has come up. Perhaps there’s an issue within the lab.

Perhaps a member of staff has gone off on well. Things happen, you can’t avoid that. But what I do is I look at what impact it’s going to have on your deadlines. We’ve got our lead times, we have our expectations of when things are going to be turned out, and I’m going to make sure that we hit that one way or another.

What data delays are most common?

I’d say plate counts are… We don’t get delayed in doing the plate counts, but quite often it might be that an SD says, “Can we wait one extra day and do another plate count to confirm?” if they’re not entirely convinced that the bacteria has grown as well as they would expect. In which case, that would obviously be a delay on it. And again, with things like in the reprocessing, it’s not always possible to be very definite. So we might say, “Oh, we’ll have data by Friday ready for it,” but the reality is that we reach Friday and there’s still one or two cycles to go because things have happened throughout the week. It’s taken longer to do the inspections than expected.

So then an SD might have to say, “We’ll need to rearrange to send out the preliminary data a few days later on the Monday or Tuesday instead.” So generally, it’s just in the preliminary phases. These areas are a lot more flexible, as we mentioned about lab work going through and how we move lab work around. It’s possible there sometimes, but our final reports, we have those deadlines for when you should receive that draft and all the data should be done well in advance for that, so that you’re able to get the report as expected on time.

So that was me being pressure tested. It’s really interesting actually going through these questions. I don’t always think exactly about it, and you just do it on a daily basis without considering it. But one thing I think this has really highlighted is that at Test Lab, we do things differently. I’ve worked in other places where it’s very stagnant, but here it’s like constant shift, constant ready to go to work and be agile and to meet everything that our clients want. And it’s a really great thing. And thinking about that and how I’ve done these things in other companies, it’s a different world here, and we love it.