Sometimes it is helpful to look at where you have been to get a better picture of where you are going. In other instances, this review of the past is simply entertaining. The history of medical devices is fascinating and fun, the tremendous benefit the industry has delivered to patients over the decades is humbling, and the value of current and future innovations is breathtaking.
One of the challenges for the medical device industry and professionals in the field is the “uncontained” nature of the industry. Medical device technological advancements span a staggering number of materials, mechanical functionalities, information technologies, and manufacturing technologies. It is not easy to predict the skills and expertise that will be needed for the future of the industry. For instance, will more advanced materials scientists be needed, or will biomedical engineers be in shorter supply? Perhaps the demand for application developers or other computer science experts will be greatest.
This article will explore the current and future health of the industry, look at medical device industry trends, and consider some of the professional skills and attributes the market needs most.
Before diving into the present and future of the industry, let’s first have a little fun by looking back at the origins of the medical device industry.
A Brief History of Medical Devices
Dr. Elisha Perkins developed and sold the first recorded fraudulent medical device in the late 1700’s. His product consisted of brass and iron rods that were about three inches long and allegedly eliminated disease from the body. These rods were sold throughout the country and gained a good amount of popularity. Even George Washington was reported to have purchased a set for his family. Not surprisingly, the product was exposed for what it was: fraudulent and providing no medicinal benefit.
By 1917, fraudulent medical devices such as nose straighteners and height-stretching machines sold briskly in the market. It was obvious to the fairly newly formed Food and Drug Administration (FDA) that the law should be expanded to include agency authority over medical devices, and by the late 1930’s, medical devices were added to the Federal Food, Drug, and Cosmetic Act (FD&C). However, it was not until 1978 that a final rule was issued and became law for medical device GMPs.
Recent medical device innovations are incredible and in stark contrast with Dr. Perkins’ metal rods; robots allowing virtual examination by a doctor are one such innovation. The RP-VITA Remote Presence Robot produced by iRobot Corp and InTouch Health became the first autonomous navigation remote-presence robot to receive FDA clearance for hospital use.2 The robot has a navigational functionality allowing it to find a given patient’s room and uses sensing technology to avoid colliding with things or people.
Once inside the patient’s room, the doctor can see, hear and speak to the patient, and have access to clinical data and medical images. The physician can’t touch the patient, but there is always a nurse or medical assistant on-site to assist. While virtual examinations are not quite as good as the doctor being present in-person, it is the next best thing and in many cases allows specialists to be utilized more efficiently and to treat more patients in need.
The medical device industry has come an incredibly long way within the last 100 years, but where is the industry going, and what will the future hold for medical device professionals?
Snapshot of the U.S. Medical Device Industry
The U.S. medical device industry is expected to reach approximately $155 billion in revenue by 2017, and it currently represents more than 43% of the medical device global market. The industry is projected to grow at a compound annual growth rate (CAGR) of 6.1% between 2014 and 2017, and strong performance is expected to continue after 2017.
There are more than 6,500 medical device companies in the United States, and many of these companies are small to mid-sized organizations. In fact, more than 80% of medical device companies have fewer than 50 employees.
Key Factors Impacting the Future of the Medical Device Industry
The medical device industry is complex; the elements that will impact the future of the market are numerous and sometimes contradictory. Dramatic innovations have entered the market offering tremendous value to patients, and there is seemingly no end in sight to the progress in this industry. However, the industry continues to be plagued with mundane, long-term challenges such as research and development (R&D) productivity and regulatory issues. Finally, pressures to contain healthcare costs are and will continue to be a significant factor for the market. The following are some of the leading factors that are shaping the future course of the medical device industry:
From Diagnosis to Prevention
The global population is aging, and this certainly includes the U.S. population. An aging population coupled with an increased prevalence of chronic disease has moved the medical device industry’s focus from diagnosis to prevention. Remote healthcare, wireless enablement of device control, and devices that reduce or eliminate hospital stays are in very high demand. Therefore, there is currently an increased focus on preventative care, remote monitoring, self-monitoring, and telehealth.
Cybersecurity
Cyber and data security is becoming a very large issue for the market. As devices become increasingly connected with healthcare providers, other devices, monitoring systems and applications, patient data has to be secured. The industry and regulators alike will be struggling to meet these challenges in the upcoming years.
Industry Financing
Securing financing for a startup medical technology company is more challenging than it used to be. As the industry continues to consolidate, the investment community likely to invest in startups sees more risk because there are fewer companies to buy these emerging players. However, the investment community’s enthusiasm for investment in medical device companies is cyclical and unlikely to be a long-term impediment.
Recalls & Product Safety
The industry must improve management of regulatory and compliance issues to avoid the recent waves of recalls that cost the industry money, erode customer confidence, and often divert attention from innovation to the handling of these issues. Some sources cite a 97% increase in medical device recalls over the course of the last few years. The reasons for the recalls vary, but they are primarily rooted in human error, packaging/sterility concerns, and materials failures.
The industry and the FDA alike are working together to solve these problems, and the focus on these issues must be constant.
Big Data & the Internet of Things (IoT)
Hospitals across the world are making significant information technology (IT) infrastructure upgrades. As IT infrastructures continue to improve, so will the number of medical devices that are linked to them. Ultimately, devices will continue to become “smarter” and better at optimizing treatment. Unquestionably, medical devices will take their place among the broader IoT and be connected to healthcare providers, payers, each other, and of course to patients. Ultimately the goals are to improve the effectiveness of care, increase treatment efficiency, and lower costs.
Diagnostics & Biotechnology: Blurring Lines
Medical devices and pharmaceuticals are becoming increasingly intertwined as the number of combination drugs (combination medical device and drug) continues to increase. Specifically, biopharmaceuticals and diagnostic devices are becoming increasingly more incorporated. In part in effort to increase efficiency and lower costs, many pharmaceutical companies are incorporating diagnostics early in the R&D process so that better forecasting can be done to project the progress of a disorder within a patient and to predict which patients are most likely to respond favorably to a given treatment before treatment even begins.
Price Control Pressures Resulting in Therapeutic Value Assessment and Performance-Based Therapy
Due to pressures to control medical costs, providers and medical device companies alike are being increasingly required to prove the patient benefit of treatments and medical devices. Although this aspect of the industry is in fairly early stages, payers are working diligently to apply performance-based considerations as devices are selected and levels of payer coverage are being determined.
In addition, medical device companies will face increasing pressures to justify device prices and pricing increases.
Needed Medical Device Industry Talent
Given the rapid changes in the medical device field, what impact is this having on the availability of talent, talent acquisition, and career management for medical device professionals?
In the knowledge-based medical device industry, talent remains one of the main drivers of business growth. Overall, medical device companies are facing talent shortages, in some cases acute talent shortages and the challenge is likely to intensify in upcoming years as the Bureau of Labor Statistic sites a 23% increase in jobs between 2014 and 2024.
Assembly, production, and manufacturing workers are in short supply in most markets. In addition, the medical device industry is yet another “graying market” that is being impacted significantly by retiring baby boomers, particularly within the field of engineering. Finally, given rapid technology innovations and the changing structure of the overall market, new skills are needed.
What Talent Does the Medical Device Industry Need?
Engineering & Scientific
There is a strong demand for engineering professionals, including process engineers, lean six sigma engineers, quality engineers, validation engineers, manufacturing engineers, new product development engineers, automation engineers, process design engineers, polymer engineers, biomedical engineers, electrical engineers, and software/application engineers.
In addition, there is ever increasing demand for biotechnology and pharmaceutical skills given the increased importance and prevalence of combination drugs. Expertise in the biological sciences, chemistry, and pharmacology are subsets of the needed biotechnology and pharmaceutical talent. Finally, nanotechnology, software, information technology, mathematics (especially statistics), informatics and bioprocessing, and material science are all diverse areas of expertise needed within today’s medical device industry.
Analytical Decision-Making
Like so many other companies today, medical device companies are flooded with data. The ability to turn data into insights that ultimately fuel analytical decision-making is critically important. The ability to determine what information/data is important and what is not in order to fuel more rapid decision making is in high demand.
Global Knowledge
The medical device industry is highly global, and much industry growth is coming from emerging markets around the world. Therefore, professionals with a global mindset and understanding are in high demand.
Holistic Approaches
Today’s medical devices are increasingly serving as components in a bigger, very connected system. Holistic thinking and an understanding of the entire ecosystem in which the device operates is critical. Medical device companies need professionals who understand the final clinical use of a product, the varied interfaces with the patient, and how the device will interact with other factors like a given assay or consumables. In other words, medical device companies need engineers and other professionals who are experts in their own disciplines, but who have an understanding of areas outside of their specialty.
Conclusion
As technology and innovations continue to advance, the opportunities within the medical device industry are staggering. We have come a long way from Dr. Elisha Perkins’ two rods and the other quackery from the early days of the medical device industry. Thankfully, today’s creativity and innovation are delivering tremendous benefit to patients.
However, an ongoing challenge for the market will be to secure talent with the required skills to fuel the necessary innovations. There is no question that engineers with medical device expertise will be in high demand. But, medical device industry professionals will need to continually develop their skill sets to ensure maximum competitiveness within the changing market. 180 Engineering thrives on helping both medical device companies and individual professionals navigate this constantly changing landscape.
Sources:
- FDA website
- InTouch Health Receives FDA Clearance for the RP-VITA Remote Presence, InTouch Health press release
- The Medical Device Industry in the United States, SelectUSA
- Emerging Trends in the Medical Devices Industry, WiPro
- 2015 Medical Device Trends, Clarkston Consulting
- “What Does It Take to Get Hired In The Medical Device Industry These Days?,” MD+DI
