“I used to design telephones but I find this far more rewarding”
Mike Smith works on the development of medical devices and combination products, such as auto-injectors and pre-filled syringes, which dispense drugs into the body. It is precise and painstaking work as the wrong dosage could have significant consequences for patients.
My job is to look at the easiest and most effective ways to administer the medicines that Teva makes. I lead teams that design and create combination products that release the correct dosage of medicine into the body. We have developed all sorts of delivery devices, from reusable auto-injectors and syringes pre-filled with a dosage of medicine that you take out of a pack, to pen devices with drug filled cartridges ready to inject and freeze-dried powders that can be dissolved in vial kits.
We try to make our devices error-proof. I’m very aware that patients could get the wrong dose of medicine if the device malfunctions or doesn’t work the way it’s intended. Even small things matter, like the labelling, so users know exactly what to do with the product. When operating an auto-injector, for example, the user needs to know whether it’s one click or two in order to administer the required dose and know when that dose has been delivered.
We try to prove ourselves wrong every day. We’ll test a device in lots of different ways and put it under different stresses and strains to see if it can be used effectively by the user. For example, we speed up the ageing of the device by using higher temperatures and humidity than what would be expected in normal use. This helps test its function over time. If the device doesn’t work correctly then potentially the patient won’t be able to take their medication. This obviously causes safety and efficacy issues but there can also be a knock-on commercial and reputational impact for Teva too.
Friends are often surprised to find out that I work in pharmaceuticals. There’s an assumption that this industry is just about the creation of medicines – whilst that is obviously a big focus, there’s also much more to it than that.
I used to design telephones but I find this far more rewarding. I started my career as a mechanical design engineer, but there is no end user that you can relate to when you are designing telephones. You manufacture a product that sits on a shelf until someone buys it. So I made a change and joined the healthcare industry, getting involved in HIV and cancer diagnostics. It really hit me how progressive this work is and I found it really rewarding knowing that I was ultimately making a difference to people’s lives. I finally decided to do a Master’s degree in clinical engineering and then moved to Teva…the rest is history!
There could be as many as 40 people developing a new treatment and combination product over several years. I bring the medical and engineering disciplines together to perform all of the efficacy testing for the device. We do a lot of work assessing the size of the market as well as understanding exactly what the product should do. We’ll then do extensive testing of the devices in our labs to help build up the remaining pieces of the jigsaw.
The way patients take their medicine has changed. Many patients now prefer to administer medicine themselves rather than having to go to a clinic – but that presents challenges. Auto-injectors and pen combination products have become very popular. Typically, patients press these against their body and then the device dispenses the correct dose. There is a lot of work that goes into making sure this device works well every time.
The unexpected often happens. During development we often find that devices don’t behave as we hoped. It might only be when we are making 2,000 devices on a manufacturing shift that we will observe variations that weren’t noticeable when we were developing them on a smaller scale, so we have to go back to the drawing board. This can be really frustrating but the team do a great job with investigating the issue and providing solutions that allow us to move forward.
We test everything. This is critical, so we run trials and human factor studies where we study how the product behaves in the hands of the end user, whether it be the patients, carers or healthcare professionals. We can observe how the products are used and explore whether people understand how it operates. We learn so much about the user experience during this process. If an instruction is not specific enough and the device is not being used properly, then we’ll update the instructions to make sure the device is effective to use. Ultimately, everything comes back to patient safety.
Paula runs Teva’s dedicated clinical trials facility in Florida, where healthy volunteers help to test the safety and efficacy of drugs before they receive regulatory approval.