Get to Know MedTech Basics
Learning Objectives
After completing this unit, you’ll be able to:
- Define the role of medical devices and technology in life sciences and healthcare.
- Identify the main business goals of medical technology companies.
The healthcare industry information in this module applies mainly to the United States. Keep in mind that healthcare experiences around the world can differ vastly.
From Treating Simple Cuts to Cutting-Edge Technology
You benefit from medical devices and technology so often that you may not even realize it.
If you scrape your knee and want to protect it from infection, do you apply an adhesive bandage? That bandage is considered a device by the medical technology companies that operate in the healthcare and life sciences industry.
Medical devices and technology (MedTech) fits into the life sciences sector of the healthcare industry. Life sciences focus on the research and manufacturing of drugs and devices used in healthcare.
MedTech produces the familiar and the futuristic. MedTech companies include those that manufacture devices, like bandages or robotics, and those that provide services, like software to translate x-rays into images.
MedTech is one of five market sectors in the healthcare industry.
- Providers
- Payers
- Pharmaceuticals
- MedTech
- Public Sector health
For an overview of the primary aims, trends, and sectors in healthcare, check out The Healthcare and Life Sciences Industry: Quick Look.
Let’s see where MedTech can help our friend, Alvin, a dog walker who walks several dogs at a time. One day, he gets tangled in the leashes as they chase a squirrel across the street. He breaks his leg. The moment he sits in the wheelchair to get an x-ray, he enters the world of medical technology.
According to the World Health Organization (WHO), a medical device can be any instrument, machine, software, or material used for a medical purpose. Medical devices, or med devices, have a diagnostic purpose or a therapeutic effect. So, what’s the difference?
- Diagnostic purpose means the device is used to analyze or detect diseases or other medical conditions.
- Therapeutic effect means the treatment with the med device provides desirable and beneficial health results.
Take the adhesive bandage, for example. It protects a wound from bacteria and dirt, and it helps the healing process. That’s its therapeutic effect. How about a knee-joint replacement? Its therapeutic effect is alleviating pain, which helps provide greater range of motion and more flexibility.
Simple enough, right? But most countries regulate the MedTech industry, so it’s good to be aware of the complexity that adds for MedTech companies.
For example, in the US, med devices, drugs, and blood products are all regulated by different centers within the Food and Drug Administration (FDA). According to med device regulations, adhesive bandages are regulated differently than pacemakers.
The FDA’s Center for Devices and Radiological Health (CDRH) regulates firms that are responsible for premarket approval of all medical devices. This premarket approval is required to sell medical devices in the United States. The CDRH also oversees the manufacturing, performance, and safety of these devices. These regulations are classified by risk into Class I (Low Risk), II (Medium Risk), and III (High Risk).
| Risk Class | Examples |
|---|---|
|
Class I: Low Risk |
|
|
Class II: Medium Risk |
|
|
Class III: High Risk |
|
Medical devices have existed since the beginning of history. But now, in the US alone, over 6,500 MedTech companies are part of a US$430 billion global market. We won’t go into more detail here, or that would be another class of its own. But don’t worry; there are plenty of references for you to rely on.
What MedTech Companies Care About
MedTech companies build their business by delivering safe, functional, and cost-effective therapies and diagnostics. They set themselves apart by putting out more innovative and less expensive products faster than their competitors.
Innovation
Why is innovation important to the MedTech sector? Just imagine having open-heart surgery while you’re still awake. Thanks to innovation, we have anesthesia and stents. What’s a stent? It’s a tube placed in the heart to help blood flow. This innovation changes the way we treat heart disease, leading to faster recovery times, reduced costs, and positive long-term outcomes.
Another great example of innovation is the pacemaker, a med device that uses electrical stimulation to regulate the heart’s rhythm. In fact, the first implantable pacemaker patient went on to receive 26 pacemakers throughout his lifetime!
Here are some other interesting MedTech innovations.
- Robotic-assisted surgery
- Brain-powered prosthetics
- Needle-free diabetes care
- 3D printing of things like finger splints, or organ models for surgeons to use for surgical preparation
Medical technology companies develop products like these to produce better patient outcomes—the driving force behind the healthcare industry.
Working with Payers and Providers
Before a MedTech device or service becomes commercially available, companies need to ensure that payers will pay for them. It’s all about the clinical evidence. How well does the device work? What treatment or diagnosis does it replace? What risk does it pose? Does it improve patient outcomes? And is it better or more cost-effective than current treatments? Getting payers interested can be as tricky as getting FDA approval.
MedTech companies also need to get the providers involved. Doctors need to know how to use the products correctly and believe in their ability to improve a patient’s outcome.
MedTech reps train the doctors in a variety of ways by:
- Matching them up with other doctors already using the device successfully
- Working with residency programs at medical schools to train residents
- Using training simulators that mimic real patients, so doctors can practice using devices under a rep’s supervision
- Coaching surgeons in the operating room during the placement of a device
Go ahead and re-read that last one. You thought eating with a cast on your arm was a hassle—med device reps coach doctors during surgery.
Patient Programs
MedTech companies develop programs to support patients directly in the use of their products. While there are products that patients don’t need to know about, like surgical instruments or ultrasound equipment, there are many categories of devices and diagnostics where patients require support and enablement, like glucose monitors, drug-delivery devices, or prenatal genetic tests. MedTech companies use online and in-person programs to improve access, adherence, and patient experience with their products.
That’s a full agenda for MedTech. But with speedy innovation to serve the needs of patients, payers, and providers, MedTech companies can operate at their best.
Next, let’s learn more about the product categories, key customers, and major trends in the MedTech industry.
