5 Challenges of Medical Device Design For Consumer Use

The advent of medical devices designed for consumer use has revolutionized healthcare by making treatment and monitoring of some health issues possible at home. Thanks to devices like home infusion pumps or hemodialysis systems, many visits to the hospital for recurring care can be avoided. Looking to the future, medical device manufacturers have a unique opportunity to develop state-of-the-art devices that can further improve the well-being and quality of care for patients. However, medical device design is no easy feat - manufacturers must design safe, effective, and secure devices while also juggling regulatory compliance and development costs. This article will briefly explain the process of medical device design and then explore five challenges that medical device manufacturers face.

What is medical device design?

The facets of medical device design are split into four categories: mechanical, electrical, software, and biomedical engineering. As with designing any product, medical device design follows a methodical process. Once a client presents a manufacturer with a problem, it’s up to the designer and the manufacturer to deliver a solution. The design process is summarized below:

1. Recognize the need for a novel device based on new research.
2. Establish design specifications.
3. Conduct engineering design of components.
4. Create and iterate designs based on prototypes.
5. Seek customer approval.
6. Get regulatory approval.
7. Begin mass production.

Throughout this process, customer requirements should remain at the forefront of designers’ and manufacturers’ minds. Functional, financial, and manufacturing requirements must be balanced against the competing needs for device security and regulatory compliance to create the best possible product. This can present designers and manufacturers with significant challenges. More details regarding the medical device design process can be found here.

Medical device design challenges

Listed below are some of the challenges that medical device manufacturers often encounter.

1. Product quality claims

One of the most significant challenges to medical device manufacturers is maintaining consistently excellent product quality. Poor quality parts can be an enormous liability for manufacturers and can even lead to serious injury or death of end-users. Warranty claims can also affect a brand’s reputation with consumers and can devastate the bottom line.

Manufacturers can reduce product quality claims and ensure consistent quality by implementing quality improvement practices like the Shainin System or becoming ISO 13485 certified. ISO 13485 is an internationally recognized standard that helps establish and recognize the adequacy of a medical device manufacturer’s quality management system (QMS). The certification process and the periodic need to be re-certified require manufacturers to audit every aspect of the design and manufacturing process of a medical device - from raw material tracking, manufacturing, and quality assurance processes, to record-keeping. ISO 13485 places emphasis on meeting customer needs and continually improving manufacturing processes. As a result, a robust, well-developed, and multi-faceted QMS can help ensure consistent product quality and increase manufacturing efficiency. It also serves as a marketing tool that shows customers worldwide that this particular manufacturer is committed to meeting their needs.

2. Cybersecurity concerns

In the digital age, preventing cybercrime and ensuring cybersecurity in devices is vital. The rapid spread of Internet-of-Things (IoT) devices across the world have led to an enormous amount of data on the internet - data that can, if unprotected, easily be intercepted and exploited by bad actors. In the medical device industry, data security is important to prevent violations of the Health Insurance Portability and Accountability Act (HIPAA). Such violations can result in huge fines.

IoT-enabled devices pose a significant technical challenge for designers. IoT medical devices for consumers - like weight scales, blood pressure monitors, and infusion pumps - that transmit data to medical professionals must have that data secured through encryption, passwords, and/or biometric protection. Designers need to begin implementing security measures into devices from the start of design as it becomes harder and more expensive to modify devices as more components are added.

3. Material Selection

Material selection is one of the first parts of the design process. Depending on the application, medical devices can sometimes require special properties such as hypoallergenic, antimicrobial, or radiofrequency (RF) transparent, among others. While some of these materials - such as plastic resins and various metals - are easily obtainable, health emergencies such as the COVID-19 pandemic can halt supply chains globally. This can cause delays in product deliveries, material shortages, and price increases across the board while demand for consumer medical devices remains steady. Because of this and the fact that business activity can be diminished worldwide, there is a growing disparity in the way devices are designed and manufactured. Increased prices for raw materials, like steel and plastic resins, and manufactured goods, like semiconductor chips, make the design and manufacture of some devices prohibitively expensive. By considering this, designers should pick materials that are pre-certified for medical use and work with their partners in the supply chain to locate raw materials for purchase.

4. Regulatory compliance

The United States Food and Drug Administration (FDA) sets numerous standards for consumer medical devices to protect consumers from injury while ensuring the device’s effectiveness. However, compliance with FDA standards, HIPAA regulations, and potentially, ISO 13485 standards, can be difficult for medical device designers and manufacturers alike.

For designers, it’s important to understand the intent of the applicable standards in addition to the literal interpretation. FDA standards are purposely made vague to encompass a wide range of medical devices. But by understanding the relevance and purpose of the regulations from the beginning of the design process, designers can save themselves a lot of frustration.

5. Product development costs

Designers can go through several different design iterations before seeking approval from a regulatory agency. After achieving a final design that is safe, effective, and compliant with regulations, development costs can be extraordinarily high depending on the number of design iterations made and the amount of time taken to release the device to market.

Designers can combat this by establishing clear and concise goals and specifications based on customer needs and by understanding regulations from the beginning of the project. With a strong foundation for a project, designers can follow a methodical process of prototyping that will help reduce development costs, improve return on investment, and speed up time-to-market.

Unmatched expertise

While medical device design can be difficult, the consumer medical device industry is poised to continue to grow in the future. Consequently, the manufacturers who overcome these challenges are the ones who stand to benefit greatly. ACHB is your partner in medical device manufacturing. From precision machining to plastic injection molding, fast prototyping, and contract manufacturing, our unmatched expertise ensures that your product is made to the highest quality standards and complies with all applicable regulations. Contact us today to discuss how we can help your company with medical device manufacturing.