Hernan Cuevas Brun, Business Development Manager and Aerosol Drug Delivery Scientist at HCmed Innovations, this week shares his experience working in the industry of developing nebulizers and combination products. With educational background in both biomedical engineering and management science, Hernan applies both scientific research skills and marketing knowledge when collaborating with HCmed’s pharmaceutical partners. 

1. Please share your working experience.

After earning my bachelor’s degree in Biomedical Engineering, I first started working as a scientific researcher at National Tsing Hua University. Back then, my job entailed me to conduct research on the synthesis of polymers for nanoparticle encapsulation, which was intended for the delivery chemotherapy drugs. Working as a researcher for five years helped me enhance my skills in conducting research, structuring projects, and scientific writing; however, I felt it was rather difficult to see our development results reaching commercial stage and entering the market someday. This encouraged me to step into the industry, bringing me to my current position as the Business Development Manager and Aerosol Drug Delivery Scientist of a medical device company that focuses on a CDMO model for the development of inhalation products.
Before joining the industry, I first decided to study an MBA (Master of Business Administration) in Management Science, time during which I gained a good foundation on the concepts of business development, marketing, and project management. Going back to school helped me expand my horizons and equipped me with valuable tools I can put in practice nowadays in my daily work, in conjunction with the skills I gained when working as a researcher. 
Working at HCmed gives a great sense of accomplishment, as I am given the opportunity to continue conducting research, which is without doubt something I am immensely passionate about, and at the same time I am able to pursue my aspirations to bring new options for the treatment of diseases.

2. As the Business Development Manager at HCmed, what devices or services do you provide to clients?

Our ultimate goal is to provide users with a device that can help them with the treatment of their diseases to live more comfortable lives. When developing a drug-device combination product, our CDMO approach consists on working closely with our pharmaceutical partners to tailor our mesh nebulizer platforms and optimize the delivery of a specific drug product, being able to cover the entire development process from the pre-clinical stage to commercialization. Throughout the development process, we often conduct aerosol characterization studies as the initial step to observe what parameters could be adjusted. HCmed counts with a well-equipped aerosol characterization laboratory that allow us to understand the performance of our devices with the formulations, providing input to our partners on the requirements of the combination product development. We strive to generate and analyze the data to guarantee that comprehensive feedback on the delivery of the inhaled formulations. Moreover, by rapidly identifying and addressing potential issues, we rely on the dynamic attitude of our teams to respond to our clients in a professional and effective way, while ensuring that we are on the right track to deliver the service and devices that are needed throughout the development process. 

3. What do you think is the biggest difference between developing an over-the-counter (OTC) device and a drug-device combination product?

Since the purpose of an OTC device and a drug-device combination product are different, the collaboration approaches differ from one another. An OTC nebulizer is often produced to be used with a wide variety of drugs, which are mostly easier to nebulize. However, a drug-nebulizer combination product is targeted to nebulize a specific drug, making the development process more complex as both the drug and device development teams need to combine their knowledge to create the final product.
In the case of OTC nebulizers, developers usually target a more affordable price tag, focusing on a wider range of users who may suffer from conditions like asthma, bronchitis, or symptoms of a common cold. However, developing a combination device requires a totally different kind of mapping strategy. As each drug has its own physiochemical property, such as osmolality, viscosity, surface tension, among others, it is essential that we understand how the drug and the device work together to adjust the right parameters and provide a suitable nebulizer to our clients. On the device side, we are able to customize both hardware and software components, which includes the mesh membrane and driven mechanism.
When it comes to market access, there is also a major difference. While OTC nebulizers rely on obtaining approval or clearance from local and regional regulatory authorities as medical devices, obtained mostly supported by in vitro testing, a drug-nebulizer combination product is a much more lengthy process involving preclinical and clinical studies in which both parts, the drug and the device, are evaluated in combination before product commercialization.

4. What do you think patients value the most in a combination respiratory device? How do you provide a product that meets the customers’ or patients’ needs?

In simple words, comfort and efficacy. The device must be intuitive and easy-to-use so that patients do not struggle with their treatment. Otherwise, a hard-to-operate device may lower the patient’s adherence to the treatment, compromising its efficacy. 
With nebulizers, users can compensate for some of the shortcomings of inhalers, DPIs (dry-powder inhaler) and MDIs (metered-dose inhaler). It is well-known that DPIs mostly require a high inspiratory flow rate, while MDIs may be hard to use for young children and the elderly since hand-breath coordination is needed for actuation. Technology keeps on evolving, and some of these issues are already being addressed or may be resolved in the future; nonetheless, a patient’s willingness to use a product is essential not to hinder the completion of a successful and effective therapy. 
Besides comfort, the actual efficacy of the combination product is also of equal importance. The main target of a nebulizer is to help patients receive their inhaled treatment, which requires to continuously improve our products and generate value from innovation. In our latest nebulizer, we have incorporated breath actuation, aiming to enhance drug delivery efficiency, while reducing the emission of fugitive aerosol into the surrounding environment. Moreover, we have also added connectivity to the device, here targeting to better monitor the patients’ treatment adherence, thus making it easier for them and their doctors to track treatment records. 
Summarizing, in order to solidify the high comfort and efficacy of drug-nebulizer combination products, it is indispensable to understand the fusion of requirements that comes along from scientific research, medical input, and patients needs. 
At HCmed, the development of our nebulizer combination solutions impulse us to walk a path by firstly conducting a study on the market trends to identify what the unmet needs are, putting together an overall analysis to receive feedback from our R&D and regulatory teams. Furthermore, key opinion leaders (KOLs) guide us to determine the veracity of our intended approach to finally reach a point in which we are ready to proceed with the design, development, and subsequent steps. Hence, our motivation lies on bringing a better solution to combination development of inhaled products.

5. Co-developing combination products with pharmaceutical companies requires a long period of time. What do you think is the key to maintaining a long-term relationship with them?

I believe that the key to maintaining a smooth and trustable long-term relationship with our pharmaceutical partners is continuous open communication. Development teams of medical devices are not experts on developing drugs and vice versa; however, as both teams contribute to the final product, it is critical that the engineers, pharmacologists, and all professionals are in constant communication and present their ideas in the development process to contribute to the best odds of the product. 
There may be some challenges along the way, but they can always be overcome if there is a strong sense of purpose and commitment. By sharing the common objective of bringing solutions for patients who require inhalation treatment, we are able to create solid and trustworthy collaborations. I believe that we can always find a point where we can reach reconciliation and, eventually, create a product that is the best version of combined knowledge from both ends.