Article | March 9, 2020

Medical Device Design & Manufacturing Challenges: 2020 And Beyond

By Dr. Frank Gindele & Dr. Thomas Zetterer, SCHOTT

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Medical device manufacturers and designers must overcome various challenges to succeed in an expanding global marketplace. Lucintel’s report Growth Opportunities in the Global Medical Device Market asserts that the industry is projected to reach approximately $409.5 billion by 2021, with a forecasted CAGR of 4.5 percent between 2018 and 2023. While this growth paints a positive picture for industry-wide innovation, medical device manufacturers will be challenged along the way to design, research, validate, and bring their devices to a competitive market in a cost-effective manner.

To meet and exceed patient needs while maintaining a healthy bottom line, these companies must reduce time to market while coping with multiplying competitors, rising healthcare costs, evolving regulations, and shortened product life cycles. For manufacturers and designers facing these challenges, it will become even more important to aim high, taking every opportunity to innovate and enhance quality in anticipation of evolving regulations and faster-approaching, game-changing technologies. Therefore, these companies — many of them small-to-medium enterprises (SMEs) — must continue to lean on their vendors as resources to navigate an ever more competitive marketplace.

Beating the Competition with Innovation

Commensurate with industry growth projections, there is a feeling of optimism amongst medical device manufacturers and designers in the United States and Europe. Emergo’s Global Medical Device Industry Outlook for 2019 reported that more than 60 percent of medical device company executives felt positive about their company and their industry as a whole. This feeling of confidence comes with a heavy dose of success: less than five percent of respondents in that survey reported a sales decline in 2018. Ultimately, the positive outlook is welcome news that challenges the conventional wisdom that the market is oversaturated, leaving little room for growth and innovation. Silicon Valley Bank’s Trends in Healthcare Investments and Exits 2019 reports a record year for investment, with a doubling of M&A and IPO activity in the medical device segment.

Innovation and quality improvements are important measures needed to differentiate products and brands in this crowded marketplace. Medical instruments require precision, functionality and, most importantly, reliability. When developing new instruments, designers seek to implement state-of-the-art technology, granting their customers the most up-to-date and innovative solutions available. This can be an arduous and costly task, given the speed at which technology is advancing.

Anticipating Rising Costs & Regulatory Changes

The federal government’s budget proposal for fiscal year 2020 included an estimated 6 percent increase in fees for healthcare companies seeking U.S. regulatory review of medical devices and drugs through the Food and Drug Administration (FDA). This will bring the total amount of medical device user fees collected by the FDA to approximately $221 million, equating to an industry average of about $340,000 for a company to pay. The fee hike’s proposed aim is to fund part of a longstanding agreement between the industry and the agency to accelerate the FDA’s review and approval process. In 2020, total review time for devices that are substantially similar to others on the market are expected to average 116 days, and 310 days for devices that are new to the market.

Though medical device companies may reduce their new products’ time to market via a quicker review and approval process, they still will have to act fast to beat their competition out the door.

It also is critical for medical device manufacturers to lean on a wider network to fully understand and anticipate the effects of pending regulations. Knowledgeable suppliers perform more like partners in assessing where product changes must be made to minimize regulatory delays and accelerate time to market.

Streamlining R&D Amid Shorter Product Life Cycles

Kalorama Information Research reports that medical device manufacturers invest approximately seven percent of their revenue into research and development.  Innovation trends for new devices suggest R&D investments will continue to increase. With product life cycles shortening, it is critical for medical device companies to streamline these processes and reduce costs.

The trend of declining product life cycles can be attributed to the exponentially increasing rate of technological advancement. Every year, medical device designers and manufacturers adapt their product designs to integrate innovative technology and keep up with the latest features, functions, and available software. Medical device manufacturers can minimize costs by eliminating redundancies created by the use of low-budget solutions that do not deliver high-level performance. Manufacturers should consider the big picture of cost savings and “future-proofing” by using high-quality components to minimize testing timeframes, and have solutions on hand that can be integrated in both current and upcoming product lines.

Utilizing components with forward-thinking engineering provides a level of confidence that allows for more stable design cycles, enabled by the repeated use of reputable components through multiple design iterations. This ultimately helps reduce costs and eases manufacturing processes through minimized disruption — in other words, there is no need to “reinvent the wheel” when using reliable components.

A Need For Growing Support Networks

A notable attribute of the medical device sector is its make-up. Of the approximately 7,000 medical device companies in the U.S., most are SMEs, employing 400,000 people directly and two million indirectly. SMEs benefit tremendously from a more agile business structure with fewer layers of decision-making and red tape. It’s no surprise the sector has grown so quickly and innovates at a rapid clip compared to other industries.
 
To overcome the many challenges they face in the coming years of 2020 and beyond, medical device manufactures and designers must continue to expand their networks of experts and lean more heavily on suppliers who can help them streamline R&D processes, understand and anticipate regulatory changes, and uncover opportunities to compete on innovation – no matter how small. By improving collaboration, these companies stand to streamline time to market while enhancing — not sacrificing — performance and quality.

Dr. Frank Gindele and Dr. Thomas Zetterer are Senior Development Managers for the Medical Components division of SCHOTT’s Electronic Packaging unit.