Medical Devices for 2019: Expect a Regulatory Submission Shake-up

In the U.S., revenue growth will continue, sparking a jump in compensation and innovation

With new products in the pipeline, new technologies on the horizon, and the hint of coming regulatory shakeups, 2019 promises to be an interesting year for the medical devices industry.

And, while the year holds plenty of promise for those who are well-positioned to capitalize on change and opportunity, there are several potential pitfalls to watch out for, says industry expert Milind Nadgouda in his webinar for Audio Educator, “5 Things the Medical Device Industry Should Expect in 2019.”

Expect Double-Digit Growth Forecast for Emerging Markets in Asia

For the healthcare industry as a whole, “2019 will be a year of value-based care as we expect the ‘outcomes-based care’ focus to globalize,” Reenita Das wrote in Forbes. “This will trigger maturation of risk-sharing in solution contracting between providers and drug/device original equipment manufacturers (OEMs), driving business value for providers.”

For devices in particular, future offerings and research and development investment will be weighted heavily toward the unique needs of emerging markets in Asia. Emerging markets make up nearly one-third of the global pharmaceutical industry’s value and boast double-digit annual growth. Global drug and device OEMs are tailoring new products to Asians, their lifestyles, and their purchasing abilities.

“By 2019, up to 10% of healthcare R&D will be invested to localize innovation for emerging markets in Asia,” Das predicted.

Prepare for Quality Appraisals

Greenlight Guru founder Jon Speer wrote that 2019 would see wearable medical devices become more common and that more consumer good companies would enter the medical device market. He also predicted that:

  • The European Union’s new Medical Devices Regulation will continue to challenge manufacturers hoping to move their products to market.
  • The U.S. Food and Drug Administration (FDA) will continue shake up the regulatory submission process.
  • The FDA will move away from 21 CFR Part 820 and toward ISO 13485:2016, which covers medical device quality management systems.
  • The FDA’s Case for Quality, which includes the Medical Device Discovery Appraisal Program, will continue to gain momentum.

Speer notes that ISO 13485 was revised in 2016 and will be in full effect by March, while the European regulations were revised in 2017. Canada will begin requiring ISO 13485:2016 and adherence to the Medical Device Single Audit Program on January 1, 2019.

Take Advantage: Embrace Innovative Commercial Models

Overall, notes a research study published by The MedTech Conference, revenues improved in 2018 and will continue to look up for 2019.

“Revenue growth has returned to the U.S. med tech industry,” the group noted. “Year-over-year revenue growth topped 5 percent last year, rebounding from a low of 3 percent in 2014.”

Despite gains, the pressure on revenues remains high, with sellers increasing revenue growth and investment.

Opportunity: “Those companies that embrace innovative commercial models can produce sales growth that is 3X the industry average and commercial investment levels well above average,” the group added. “Central to this kind of success is an agile go-to-customer model.”

The Medtech Conference also predicted that:

  • Intelligent and specialized customer-facing models would drive growth.
  • Post-acute care will continue to gain importance, eating away at hospitals as the main source of revenue for medical device firms.
  • Fulfillment, advocacy, and innovation would guide job development and revenue motions.
  • Increased industry growth and renewed commercial investment will fuel a talent war, with rising total sales compensation a chief byproduct.

While there the potential for the good news of 2018 to continue into 2019, those in the industry will need to continue to focus on medical device compliance, says Milind Nadgouda in his webinar, “5 Things the Medical Device Industry Should Expect in 2019.” Make sure you are fully cognizant of the potential challenges on the horizon and their impact to medical device policies.

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