Optimising Patient Centric Design for Inhaled Products
Inhalation therapeutics allow for the direct delivery of therapies to the lungs, which can be beneficial for efficacious delivery of a drug, decrease side effects, and be less impeding on a patient’s daily life in some cases. As the field of inhaled delivery evolves, physicians, pharmacists, and drug formulation scientists are actively trying to involve the patient needs early into the drug product development cycle. Here we discuss the patient centric design of inhaled products.
Ananth Pannala, Principal Lecturer and Course Leader OSPAP at the University of Brighton, chaired a panel on this topic at Oxford Global’s 7th Annual UK Inhalation & Respiratory Drug Delivery Congress. One example that Pannala explained was that often when a new product is developed, only patients with normal breathing capacity are considered. “If you’re formulating for a COPD or asthma patient, then their lung function and capacity is completely different” said Pannala, adding, “we cannot apply the same principles.”
Patient Centric Means Understanding the Patient’s Needs
Martyn Biddiscombe, a Medical Physicist at the National Heart & Lung Institute, Imperial College London, gave his input on achieving patient-centric design. “In terms of the patient not being able to inhale as well as a healthy person, the resistance of the devices available plays an important role,” he explained.
Biddiscombe added that some devices — especially dry powder inhalers — have a very high resistance while others have medium resistance. This means that if a patient has difficulty breathing, they could struggle to use those kinds of devices. “I believe that the whole product — the formulation, the drug, and the inhaler should be considered as one entity,” said Biddiscombe.
Fatima Bennai-Sanfourche, Senior Director of QA & RA Compliance for Medical Devices, Combination products, and eHealth at Bayer brought up a different aspect of patient centricity. The problem is adherence to the medication: “in the majority of cases, we have a drug–device combination — an inhaler with the medication,” said Bennai-Sanfourche. She added that often, “the patient is not correctly informed from their physician on how to use the device and why it is important that it is used in the correct way.”
Bennai-Sanfourche also explained that for diseases like asthma, the advice given by physicians can sometimes not reflect the daily lives of patients. For example, a patient may not want to reveal to everyone that they have a health condition, so they may not want to use their inhaler publicly. “So, we need to have this perspective when developing medication for asthma in the future, and take these aspects into consideration,” said Bennai-Sanfourche.
Communication Between Physician and Patient
Sometimes there is a lack of optimal asthma care: for instance, Bennai-Sanfourche stressed the importance of communication between the physician and their patient. Furthermore, the way the patient manages their disease in their day-to-day life is equally important. “Perhaps, in the future, a digital tool may be able to help with this: for the information that goes to the physician and for the patient-management of these diseases at home,” added Bennai-Sanfourche.
Nélio Drumond, Senior Principal Scientist of Manufacturing Sciences at Takeda Pharma, added his opinion to this point. “Going forward, digital healthcare will play a huge role when combined with medical devices for inhalation,” he said.
Also to consider is the training of physicians and pharmacists: “we need to put more emphasis on how patients use their medical device and teach them how to use it properly,” said Drumond. He stressed that this needs to take place not only in the beginning, but also throughout patient supervision: “follow-up sessions need to be put into place so that we can be sure that patients are administering their inhalation therapy correctly.”
Biddiscombe concurred this point: “Some of my colleagues who are pharmacists that dispense these devices, realise that the patient hasn’t been told the first thing about how to use it — so the pharmacist has to do that themselves.”
Involving the Patient in the Design Process
Biddiscombe believes that “using these devices should be empowering and not an obstacle.” But he said that in order to accomplish that, the patient should be involved in the early stages of the design of the devices.
Bennai-Sanfourche agreed with this idea: “taking the patient into consideration should start before — in the design phase, not just in the training.” She added that this consideration had already made its way into some parts of the design process by implementing ‘design control’ for devices in development. “That starts by defining first the user need,” said Bennai-Sanfourche, “we involve the patient during the design process using surveys and market research.”
She explained that the patient’s opinions should be gathered on aspects of any new device, such as its weight, ergonomics, dose, and delivery. Bennai-Sanfourche concluded that when it comes to patient-centric design, training is essential but before that, the design of the device itself should be advised upon first. She wondered whether the new European regulation on medical devices and the definition of clear requirements for drug–device combinations “will help us complement the development process for combination products.”
For this, Drumond suggested following the example of the consumer industry: “they do exactly what you’ve just mentioned.” He explained that consumer industries involve their customers in the early stages of the development lifecycle. The goal of this market research is to try to understand the consumer’s needs, preferences and how they perceive the product. “Those industries then use that knowledge to implement this understanding into their products to ensure that the population will use the product as according to their needs,” added Drumond.
Biddiscombe exemplified an effort that he had been involved to implement this approach into inhalation device development. “I’m involved in a project developing a questionnaire that will be used ultimately to assess patient perception of the inhalers that they are going to use,” he said. Biddiscombe continued: “it involves the patient early on so that we can facilitate patient perception about the use of potential new products.” The questionnaire will give insight into the use of dry powder inhalers from a patient’s perspective, focusing on their perceived experience of inhaling from the device.
After the discussion section of the session had ended, the panel took a variety of questions from the audience on patient-centric implementations of inhaled formulations. We were happy to host such an important discussion that highlights the fact that what makes good device design are communication and consideration.
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