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OVERVIEW
I began my design career in the medical industry at a consulting agency, which was later acquired by our client, Wellell Inc. While my duties remain the same, I adapted to the shift from agency to in-house. The medical industry and my time at Wellell Inc. have played a significant role in shaping my design perspective and approach.
OBJECTIVE
I aim to demonstrate my growth and insights gained from this experience, emphasizing my resilience and adaptability in a complex field, and proving that these qualities can be applied in other fields.
BACKGROUND
About Wellell Inc.
Wellell is a medical solution provider specializing in pressure injury prevention and obstructive sleep apnea, providing healthcare services globally for the last three decades.
Wellell Headquarters, Taipei
TAKEAWAYS
Initiated Design System
I was at the forefront of a major transformation, as a design department was introduced to the company. We decided to implement a design system in fostering collaboration and efficiency within the company.
I spearheaded the implementation of the design system, educating the team, and bridging communication between designers and developers. I updated the team twice a week on my progress and insights.
Testing for Quality Control Regulation
At Wellell Inc., I gained hands-on experience in working with the quality control team and complying with ISO 13485 standards. My experience gave me a deep understanding of the designer's role in the medical device Quality Management System (QMS), essential for producing top-quality products.
I sharpened my skills in documenting designs, effectively translating them into clear and concise language for cross-functional teams.
Experience the Manufacturing Process
I gained a unique perspective on product creation at Wellell as a large OEM company, through touring the production line and learning about the manufacturing process. This gave me a comprehensive understanding of the teams involved and the journey of bringing our products to life.
Challenging Field
Entering the medical industry presents challenges, but also offers personal and professional growth. In Taiwan, a key player in the global medical device market, I see a unique opportunity for growth through overcoming challenges.
DESIGN CHALLENGES
Regulation
I learned the challenges of navigating the complex regulatory landscape in the medical industry. Compliance is key in medical device design, and understanding regulations such as HIPAA and GDPR for data security in electronic health records (EHR) is critical.
Source: secureframe
I gained knowledge of legal compliance by attending seminars and lectures, ensuring that our designs follow regulations and data security standards. I also made sure to include these requirements in our specs so developers are aware.
Restricted Accessibility
In the medical field, access to information and data can be restricted due to its sensitive nature and close-knit professional network. This can present difficulties for research.
Source: Wellell
Despite limited access to information for research, I faced a challenge in observing the impact of my designs since they were mostly used in private and ICU environments.
Complex Business Model
Designing services in the medical industry presents challenges due to its complex business model with multiple levels of stakeholders. Understanding these relationships and business operations is crucial for successful service design.
To design medical services, I must comprehend the intricate system and business model, including attending seminars on US health insurance to benefit all stakeholders and secure user retention.
Limited Creative Freedom
To design medical products, designers must meet strict safety standards to protect patients and healthcare professionals. This often means adhering to specific guidelines and constraints, limiting creative freedom, and requiring a focus on compliance over aesthetics.
These regulations can be as small as a symbol or the use of colors. For instance, the symbols shown above must remain unchanged due to critical safety regulations.
Length of Production
The medical device launch process is prolonged due to extensive regulatory checks, like FDA approval, which require time-consuming legal procedures.
Source: qbdgroup
This presents a frustration for me as I am unable to see my designs come to life in a timely manner during my time in the field.
CONCLUSION
I embrace the challenges of the medical field, relishing the opportunity to overcome them. However, not being able to see the impact of my design in use due to restricted accessibility and the lengthy production process is frustrating. Nevertheless, my adaptability will accompany me to future fields I pursue.
