Amanda Winstead, Freelance Writer01.12.24
Within the quickly evolving healthcare industry, Internet of Things (IoT) devices are technological solutions to various needs in this sector. These tools streamline healthcare operations and improve patient experience.
There are steps your business can take to successfully launch a new IoT medical device while avoiding becoming just another product in an increasingly competitive market. By developing an adept and comprehensive strategy involving careful market analysis, regulatory compliance, and organized marketing, your company’s product can be profitable and make a difference in patients’ lives.
Identify the Target Market and the Competition
Recognizing current market trends helps investors understand the latest breakthroughs and newest products in the medical industry. You will need to research potential buyers, users and their pain points, then analyze existing solutions and their shortcomings. Then you can evaluate the market size and potential for the product.
For example, let’s say that your team is looking to create a better smart bed. Your team could analyze the latest medical studies, focusing on the device's key components: adjustability, sensors, and digital engagement. A Hunan University study notes that smart beds do not always align with major body pressure indicators that affect the user’s comfort. If you were to develop a product with your team that solves this issue, then your company could turn a profit while helping patients.
The United States Food and Drug Administration (FDA) uses Ingress Protection (IP) classification and ratings to distinguish different medical devices and ensure the safety of patients. FDA approval is expensive due to its myriad regulatory processes for developing medical devices, although clearance is optional for consumer care devices. For instance, the FDA Code of Federal Regulations Title 21 provides an in-depth explanation of FDA regulatory requirements for medical devices.
Some IoT manufacturers may opt to use smart manufacturing technology to ensure that their product meets standards throughout the production process. Smart manufacturing tech uses analytics software to collect data from robots and machines at each step of the process as part of strict quality control measures. Advanced analytics, cloud computing, and 5G connectivity are other aspects of smart manufacturing that can help boost security during the manufacturing process and ensure regulatory compliance.
Another vital aspect of IoT device production is abiding by embedded privacy laws and IoT regulations. In December 2020, the U.S. passed the Internet of Things Cybersecurity Improvement Act which establishes the minimum security standards for devices controlled by federal government agencies or connected to information systems owned by the government. While the bill does not set out specific provisions for compliance, there are several ways that IoT medical device creators can protect their devices from cybersecurity and privacy risks. Some technologies that could be useful in this regard include:
IoT devices should have safeguards such as device authentication, cyber threat monitoring, and data encryption. Due to the sensitive nature of the data collected by these instruments, higher standards for accountability and transparency are necessary, from the safe collection of data to the physical condition and chain of custody data trail.
Determine Your Company and Product’s Brand
Establishing a solid brand for your product means knowing your company’s purpose and mission. Make your goal — to improve patient outcomes and support medical professionals — a focal point. Then, discuss how your product was developed, why it exists, what solution it provides, and a concrete plan to implement the solution.
Establish a consistent message and tone throughout the customer’s sales process. You can also look to your competitors to build your marketing strategy, by determining which niches or angles they are not using.
Create Multiple Buyer Personas
Medical professionals such as doctors or surgeons may be your primary customer base, but you can branch beyond the traditional to open up new avenues of potential revenue. Differentiate your company from the rest by creating multiple buyer personas and adapting sale pitches to address the needs of these other individual roles, such as:
Following this strategy allows your business to expand the profiles of your potential customers.
Get Reviews for Your Device
Look for medical journals and papers that support your product, even indirectly. Find studies that profile a challenge your product can address, or contact these sources to determine if your device qualifies as a technological advancement with multiple benefits and uses.
If you can get your product featured in a medical journal, use that opportunity to show that the instrument and your company are relevant regarding advancements in the medical device field.
Amanda Winstead is a writer from the Portland area with a background in communications and a passion for telling stories. Along with writing she enjoys traveling, reading, working out, and going to concerts. If you want to follow her writing journey, or even just say hi you can find her on Twitter.
There are steps your business can take to successfully launch a new IoT medical device while avoiding becoming just another product in an increasingly competitive market. By developing an adept and comprehensive strategy involving careful market analysis, regulatory compliance, and organized marketing, your company’s product can be profitable and make a difference in patients’ lives.
Market Analysis
A practical market analysis is required before launching an IoT medical device. You will need to determine your team’s primary goal and then identify the target market for your product.Identify the Target Market and the Competition
Recognizing current market trends helps investors understand the latest breakthroughs and newest products in the medical industry. You will need to research potential buyers, users and their pain points, then analyze existing solutions and their shortcomings. Then you can evaluate the market size and potential for the product.
For example, let’s say that your team is looking to create a better smart bed. Your team could analyze the latest medical studies, focusing on the device's key components: adjustability, sensors, and digital engagement. A Hunan University study notes that smart beds do not always align with major body pressure indicators that affect the user’s comfort. If you were to develop a product with your team that solves this issue, then your company could turn a profit while helping patients.
Regulatory Compliance
Because IoT medical devices must comply with a determined statistical accuracy and because of the sensitive nature of patient information and confidentiality, there are strict compliance rules and quality control measures that medical device manufacturers must follow.The United States Food and Drug Administration (FDA) uses Ingress Protection (IP) classification and ratings to distinguish different medical devices and ensure the safety of patients. FDA approval is expensive due to its myriad regulatory processes for developing medical devices, although clearance is optional for consumer care devices. For instance, the FDA Code of Federal Regulations Title 21 provides an in-depth explanation of FDA regulatory requirements for medical devices.
Some IoT manufacturers may opt to use smart manufacturing technology to ensure that their product meets standards throughout the production process. Smart manufacturing tech uses analytics software to collect data from robots and machines at each step of the process as part of strict quality control measures. Advanced analytics, cloud computing, and 5G connectivity are other aspects of smart manufacturing that can help boost security during the manufacturing process and ensure regulatory compliance.
Another vital aspect of IoT device production is abiding by embedded privacy laws and IoT regulations. In December 2020, the U.S. passed the Internet of Things Cybersecurity Improvement Act which establishes the minimum security standards for devices controlled by federal government agencies or connected to information systems owned by the government. While the bill does not set out specific provisions for compliance, there are several ways that IoT medical device creators can protect their devices from cybersecurity and privacy risks. Some technologies that could be useful in this regard include:
- AI and machine learning as real-time threat assessment tools that use predictive modeling and behavioral analysis to detect anomalies and identify patterns;
- Ransomware mitigation to determine best practices for preventing, identifying, and responding to ransomware attacks;
- Cloud and IoT security to establish strong security measures to protect sensitive information and data in cloud environments and IoT-based programs.
IoT devices should have safeguards such as device authentication, cyber threat monitoring, and data encryption. Due to the sensitive nature of the data collected by these instruments, higher standards for accountability and transparency are necessary, from the safe collection of data to the physical condition and chain of custody data trail.
Marketing and Launch Strategy
After the product design is created and the IoT medical device is developed, perfected, and tested, it must be launched. Here are some essential steps to create a marketing and launch strategy that will allow your business to realize value propositions.Determine Your Company and Product’s Brand
Establishing a solid brand for your product means knowing your company’s purpose and mission. Make your goal — to improve patient outcomes and support medical professionals — a focal point. Then, discuss how your product was developed, why it exists, what solution it provides, and a concrete plan to implement the solution.
Establish a consistent message and tone throughout the customer’s sales process. You can also look to your competitors to build your marketing strategy, by determining which niches or angles they are not using.
Create Multiple Buyer Personas
Medical professionals such as doctors or surgeons may be your primary customer base, but you can branch beyond the traditional to open up new avenues of potential revenue. Differentiate your company from the rest by creating multiple buyer personas and adapting sale pitches to address the needs of these other individual roles, such as:
- Hospital stakeholders and board members;
- Nurses and nurse practitioners;
- Physician assistants;
- Non-medical administrative staff.
Following this strategy allows your business to expand the profiles of your potential customers.
Get Reviews for Your Device
Look for medical journals and papers that support your product, even indirectly. Find studies that profile a challenge your product can address, or contact these sources to determine if your device qualifies as a technological advancement with multiple benefits and uses.
If you can get your product featured in a medical journal, use that opportunity to show that the instrument and your company are relevant regarding advancements in the medical device field.
Harnessing Success in the IoT Medical Device Market
For the best chance at success in launching your new IoT medical device into a crowded sales industry, you need a powerful marketing strategy. As technology continues to shape a significant portion of the future of healthcare, you want your business to stay ahead of the curve of innovation and focus on the development of the device the user needs to establish a brand and quality products.Amanda Winstead is a writer from the Portland area with a background in communications and a passion for telling stories. Along with writing she enjoys traveling, reading, working out, and going to concerts. If you want to follow her writing journey, or even just say hi you can find her on Twitter.