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With the industry showing no signs of slowing, this year’s forecast examines developments in medical device technology forcing original equipment manufacturers (OEMs) and suppliers to embrace technological advancements.

The global medical device market is around $350 billion, with projections for 4.9% compounded annual growth through 2020. That continued industry growth will spur manufacturers to accelerate design and production ideas to get their products to market quickly, often using new materials and advanced manufacturing technologies.

During a Frost & Sullivan webinar on global healthcare market predictions, Senior Vice President of Healthcare and Life Sciences Reenita Das notes that, “The global healthcare industry will register a stable growth rate during 2018, and it will cross the $1.85 trillion mark in terms of manufacturers’ revenues… this growth curve will continue as technologies and platform solutions that promote innovation around care quality, outcomes, and chronic disease management will continue to rise.”

Cloud-connected health-monitoring devices will continue growing in popularity while artificial intelligence (AI) will look to deliver deeper learning for improved diagnostics and patient care. Rising demand for high-end, complex medical devices also means contract manufacturers must respond quickly to technological changes as the medical device outsourcing market is projected to reach $101.7 billion by 2024.

Continue reading to find out what opportunities and challenges the industry will face in the future.

Medtech Mindset

By Dave Sheppard & Florence Joffroy-Black

The new year is here:

Are you ready for success?

Do your teams know their goals?

Are they specific, measurable, attainable, relevant, timely (SMART)?

Do they include stretch targets and realistic objectives?

What is your medtech mindset for this year?

More importantly, what is your team’s medtech mindset?

Is your organization ready to take advantage of the coming medtech growth worldwide?

The forecast (below) indicates continued rapid growth in medtech globally during the next few years. Winning, however, means being prepared to take advantage of opportunity, and being prepared begins with mindset. To start the year, you need to think globally and, relative to mindset, you must challenge your team.

United States

Are you ready for the ramifications of the medical device tax if it isn’t suspended or repealed? Are you prepared for the changing reimbursement dynamics of proving economic outcomes to be successful with new products?

It’s no longer good enough to win with a better bandage or surgical suture – reimbursement drives success. Reimbursement requires you prove equivalent efficacy (for FDA approval) and demonstrate economic savings to gain payor approvals. Are you confident of your ability to provide evidence of your economic value to your customer?

European Union

Are you ready for the changes in the regulatory process for medical products approval that will lengthen your time to market? Do you know that your EU marketing approach is not “EU”? Do you know which countries to target first?

The EU is comprised of 28 countries (27 after Brexit) that demand specific marketing approaches on a country-by-country basis. Many companies formerly started the process of launching medical products in the EU as the regulatory burden was less than the U.S. FDA. Unfortunately, that has shifted, and many companies will now start in the U.S. Have you defined your regulatory strategy for success?

Japan

Have you considered the changing demographics and impacts of the shrinking population and hospital budgets (and increasing home health expenses)?

The Japanese market is slowing due to a declining population, but that doesn’t mean it isn’t a good market. Japan still remains one of the Top 5 markets globally, however changing dynamics mean that Japan needs to reduce healthcare costs.

The current initiative is to achieve this through more care in home health and nursing homes – making these growing market segments. Have you put together your growth plan for this segment?

China

As China continues to explode with growth, have you identified your path to market? The Chinese FDA is more demanding than ever when it comes to obtaining regulatory approval for foreign companies. Have you considered your distribution or joint venture partner for China?

To succeed in China, a great local partner can help you work through domestic issues and challenges, helping you navigate regulatory and distribution opportunities. Reimbursement paths and distribution challenges vary by geographic region. Have you thought through which regions to address first?

India

The size of the Tier One cities alone are equivalent to approximately 50% of the U.S. market. Do you understand some of the medical device regulations regarding pricing? Are your products a good fit for the market?

India remains one of the world’s largest market opportunities. While its regulatory burdens are minimal compared to other parts of the world, complexities due to infrastructure, distribution, demand for low-cost products, and continuously changing political dynamics can make it frustrating. However, if you educate yourself on the local issues, it’s possible to succeed and thrive in India as these customers are looking for great products at the right value.

Latin America

While pockets of instability remain, have you noticed the growing stability of the majority of Latin American medtech markets? Have you put together a regulatory and distribution strategy for these countries?

Latin America is often overlooked. However, when targeting the right countries, it can represent one of the easier paths to international expansion, especially for U.S. companies. Is your team prepared for success in key countries in this region?

Middle East/Africa

Have you considered where to start in this region? While Africa needs detailed analysis for success, do you know that major medical original equipment manufacturers (OEMs) often use Middle East markets as a point for rapid international expansion?

Africa (outside of South Africa) can be difficult for foreign companies to navigate. However, with a little research and focused targeting, you will find that some of the key Middle East countries are hungry for good technology. Therefore, this region is also great for rapid international expansion, especially for EU-based companies.

As a winning medtech organization selling medical devices to the market, all of these global issues and opportunities directly impact your organization. If you are a medtech OEM supplier, these issues impact your customers and these topics are relevant as the best suppliers help their customers win.

So, what is your medtech mindset? This is a worldwide marketplace where you have to be prepared for the opportunities in the various regions and you must prepare your team to have the right global mindset tied to SMART goals in 2018.

We will continue to address the medtech mindset for success in future columns. In the meantime, we wish you a great start to the new year and welcome your feedback or questions.

MedWorld Advisors
www.medworldadvisors.com

The MedTech MindSet, a monthly column in Today’s Medical Developments magazine, discusses opportunities in the medical industry.

About the authors: Florence Joffroy-Black is a long-time medtech M&A and marketing expert with significant experience in the medtech industry and is now the chief executive officer of MedWorld Advisors. She can be reached at florencejblack@medworldadvisors.com. Dave Sheppard is a former medical OEM manufacturer Fortune 500 executive and is now a principal at MedWorld Advisors. He can be reached at davesheppard@medworldadvisors.com.

Materials innovations, medical device trends

By Ashir Thakore

Medical device manufacturers are tasked with improving patient outcomes and reducing costs. Fortunately, advanced thermoplastic resins and composites are addressing these challenges.

Technology convergence

The convergence of consumer electronics, the Internet of Things (IoT), and Big Data enables designers to create smart wearables and other devices that shift care delivery away from the doctor’s office or hospital, saving money and empowering patients. But convergence is expanding beyond data collection and reporting. Tomorrow’s devices will electronically diagnose conditions, track parameters such as a patient’s glucose level, automatically administer insulin or another drug, and collect volumes of data for public health trending – improving patient compliance and lowering costs.

Specialized, high-performance thermoplastic and composite materials will optimize comfort, usability, reliability, and performance. Material properties can include shielding from unwanted electromagnetic interference, laser direct structuring (LDS) capabilities to integrate complex electrical and mechanical features directly into device components, and thin-wall capability that can help reduce device weight and facilitate miniaturization.

Human factors

Currently, evaluation of devices for ergonomics is done during FDA approval, based on testing under expected use conditions. With greater availability of convergence technologies, regulators can monitor device usability under real-world conditions by collecting and analyzing patient data.

Human factors extend to aesthetics and comfort. Wearable, hand-held, and portable devices promote patient compliance if they are not cumbersome, uncomfortable, or appear intimidating. Use of color and texture can make devices seem less clinical and more attractive, especially to children.

Thermoplastic materials can contribute to device designs. Overmolding an elastomer onto a rigid plastic substrate, for example, can enhance comfort with a soft, smooth feel; provide texture for a firm grip; or add color to highlight functionality.

In vitro to implanted

In vitro drug delivery, dialysis, and diagnostic testing are shifting to implanted devices. Upcoming implants will require advanced biomaterials and miniaturized batteries and sensors. Biocompatible and biostable polymers can be used to package implanted devices such as pacemakers and continuous glucose monitoring systems, and protect electronics from bodily fluids.

Micro-molding, minimally invasive

Minimally invasive diagnosis and surgery require ever-smaller tools, guides, and delivery devices. Designing and producing these tiny components call for advanced materials, and specialized molds and processes. Micro-molding and additive manufacturing (AM) technologies using biomaterials and specialized thermoplastics, such as polyetherimide (PEI), can produce extremely small components with intricate geometries and precision.

One noteworthy minimally invasive procedure is the application of microneedle arrays (MNAs) to the skin surface – long enough to penetrate the skin yet short and narrow enough to avoid stimulating nerves or puncturing blood vessels. Painless arrays create microscopic pores for diagnostics and drug delivery. Plastics could replace metals and other materials, enabling low-cost, high-volume production of solid MNAs, which may eventually replace hypodermic needles for injectable drugs.

Aligning materials, trends

Future medical device designs require fresh solutions to address better patient outcomes and lower costs. Materials innovation will be crucial, whether devices feature converged technologies, optimized aesthetics and usability, or extremely small components.

SABIC
www.sabic.com

About the author: Ashir Thakore is global segment leader – healthcare at SABIC.