Yuan-Ming Hsu, Director of the R&D Department at HCmed Innovations, shares his thoughts and experience working in the medical device industry. He has accumulated 16 years of experience in developing and designing medical equipment, which include orthopedic materials, suture-based surgical products and mesh vibrating nebulizers.
1. Please share your experience in developing and designing medical devices or other products.
Throughout my 16 years of experience in the medical field, I have gained experience developing medical devices, regenerative medicines, and drug-device combination products. I first started out as a researcher at a medical center, focusing on the research of biomaterials for orthopedic applications. The biomaterials, which are implantable scaffolds, were designed to deliver medications to facilitate the regeneration of bone or cartilage, which served as my first experience conducting research on a product that is a combination of drugs and devices. My interest in the medical device industry led me to later become a developer for a suture-based surgical product that is utilized after cardiac catheterization procedures. Other than medical devices, I have also taken part in the development of regenerative medications derived from mesenchymal stem cells. All these past experiences have helped me enhance my skills and expand my knowledge in research and development, helping me pave my way to my current position as the head of an R&D team specialized in developing drug-device combination products involving nebulizers and inhalation drugs. As we are developing a device that should be paired with a particular medication, it is necessary for us to have a thorough understanding of how the drugs work with a nebulizer in order to create a device that can work exclusively with the targeted formulation.
2. You are currently developing a drug-device combination product for inhalation purposes. What are the similarities and differences between this and the past devices you have developed? What do you think are the most important factors to creating an effective combination product?
In terms of orthopedic bio-scaffolds and nebulizers, they both serve to deliver medications to the area where treatment is needed. However, the method in which the medications are delivered or administered by the users is different. The drug-contained bio-scaffold transmits the medication directly to where it is being applied; on the other hand, medications are loaded and administered through nebulizers. Although the nebulizer and medication may seem like two products that are developed separately, we actually customize a nebulizer to be used specifically with a certain kind of drug, creating a drug-device combined product. Moreover, as the usability of a medical device is user-dependent, we would also need to take into consideration the usage behavior and the background knowledge of each user population in the process of product development. For a surgical product, the targeted users are trained surgeons from similar educational background, thus we majorly just needed to take the operating environment and surgeons’ usage feedback into account when designing the device. However, as targeted users of nebulizers include patients of diverse demographic characteristics, and with different respiratory conditions, breathing patterns and usage experience, there are several impact factors that we would need to evaluate. The main principle is that the operation steps should be simple and straight forward to make the nebulizer intuitive and ergonomic for people to use.
3. As a developer of combination products for inhalation therapy, what do you think is the biggest challenge faced by this industry?
Nebulizers designed by different manufactures operate and perform differently; however, every device developer faces the same challenge: as every medication has its own nature and physicochemical properties, we could say that it is almost impossible for them to design a product that suits all kinds of drugs. Moreover, as more and more pharmaceutical partners are targeting nebulization of biologics, the development may be even more challenging for the device manufacturers as biologics are inherently sensitive to the environment and difficult to deliver. Given this situation, if device manufacturers are to collaborate on the development of an innovative combination product, they would need to be equipped with state-of-the-art technology and experience in identifying what optimizations can be made to achieve the best efficacy and effectiveness of the product.
4. In order to design an effective combination product for inhalation therapy, how do you harmonize the patients’ needs and the technology to make a highly efficient product?
When designing a product to be used by people, it is important that we understand what their needs are. Even though we can create a nebulizer that produces fine mist, it will still not be a good product if it is inconvenient or difficult to use. We should always keenly observe what the users are looking for, which makes market survey and requirement identification very important. By identifying the right needs, we can place the right resources and steer the development team in the right direction. Knowing what the unmet needs are help us acknowledge the contributions we can make for the patients. For instance, it is preferable to reduce the medication waste when nebulizing, therefore, we developed a device that only nebulizes the medication when users inhale. Besides devices, I believe that if adjustments can also be made in the development of new medications, then this could probably facilitate the process in designing an effective combination product for inhalation purpose.
5. Following the previous question, what kind of skills or professionality do you think are required in the R&D team to reach this goal? How do you lead a team this diversified?
First of all, as our medical devices are to be used by a wide range of population, human factor is one of the main focuses in our development process. Our responsibility is not just to create a product that can nebulize drugs, but we are also aiming to provide users with a high-quality and comfortable treatment experience. To achieve this goal, we would need to look from both the mechanical and electronic engineering aspects, and as our device is designed to be small and portable, it would require more expertise to have everything integrated into a small-sized medical device. Other than skills required in the R&D team, collaboration with other departments is equally important. We learn from different channels about what the needs of our clients are and make sure that our design fits their requirements. Through verification and validation in each development stage and through constant discussions with PM, BD, and RA teams, we make sure the performance and functions of our products match the market’s needs and fulfill the regulatory requirements.
