Medical Device Development Process: Trends and Risks Involved

“The use of medical device development is opening new frontiers across the healthcare industry.”

Have you ever wondered what innovative development a medical industry can implement?

Since the onset of COVID-19, societal changes have occurred in embracing healthcare remotely. However, with the evolving Internet of Things, and Online Connecting Tools have rapidly changed medical practice.

Although remote healthcare is growing, it demands increased medical device software development for quick and efficient care and convenience for doctors and their patients.

By now, many healthcare businesses have incorporated data automation into billing and EHR systems using medical device design services.

A medical device product design adds value to the end-user in terms of quick and remote access. Next, you need to go through the medical device approval process, for it to be aligned with medical regulations and specifications to meet the requirements that suit the best.

Hence, a medical device product development company takes a comprehensive approach to create a medical product design. The development process requires precision at every stage, from conceptualization to compliance, design, testing, and marketing of the medical product.

Let us now understand in-depth why medical device development is important, how to design, and what development trends 2022 has in store.

What is Medical Device Development?

Designing and developing are critical aspects of a medical device’s success. A poorly defined and loosely designed medical device does not comply with regulatory standards and has no market value.

Medical device development is designing, testing, and implementing medical devices. The development of a medical device begins with conceptualizing an innovative idea, creating and engineering a design, prototype development, testing for quality, acquiring regulatory approval, and final manufacturing of the approved product to address a particular medical need or problem.

Medical devices include instruments, apparatus, machines, implants, and any article intended to be used to diagnose, treat, and prevent disease or any critical medical condition. The medical device development from prototype to regulatory approval is a complete process before it goes into manufacturing final products.

Finally, the device is manufactured and distributed to healthcare providers and patients. An ongoing and post-market surveillance is conducted to ensure that the device continues to perform as intended and to identify the potential safety concerns.

Medical device development transforms a medical device design into commercially feasible equipment. Medical device development engineers must create products thoughtfully, and strict adherence to regulatory requirements is necessary. An adequately documented file needs to be maintained for all the work done.

These medical devices are used to diagnose and treat patients, allowing them to prevent, manage and overcome diseases and severe medical conditions. These devices help to prolong and improve the quality of life.

Why is Medical Device Product Development Important?

Medical device design and development is more than just ideation, prototype development, and mass manufacturing, it also includes compliance and regulations that each product needs to benefit the entire market.

The fundamental concept of a medical product development is to prevent, diagnose, treat illness and disease safely and effectively. The medical device product development process involves the manufacturing of medical devices, regulation, planning, and management. The development lifecycle of medical products are complex but are essential to guarantee the quality and compatibility of each device.

With the varied options available regarding increasing technology, it is necessary to guarantee high-quality, safe, and effective models to restrict unsafe clinical, regulatory processes.

Medical device design and development is hard to crack, and so a medical product takes years of extensive research and development before its launch. Strict regulation processes, testing, and experiments will recognize the need for today’s trends.

However, medical device development companies have set out the latest trends to anticipate the need for today’s medical products.

Trends of Medical Device Development

• Healthcare startups have adopted IoT for continuous real-time monitoring of their patients.
• Telemedicine enhances clinical services for patients to consult remotely.
• Big data and security processes are structured or unstructured data to generate insights.
• Wearables monitor vital signs with sensors developed on the devices.

Let’s study each of them in detail.

IoT- Internet of Things

IoT is gradually entering the world of the medical industry. It appears that small medical device design firms are finding it challenging to identify the potential of implementing smart devices.

Large-scale companies have already introduced IoT-enabled medical devices that have become the sole leaders in the market.

For example, wheelchairs, nebulizers, oxygen pumps, and monitoring equipment are designed with IoT sensors that help track the patients’ real-time location proactively.

Our research says that Goldman Sachs estimates IoT digital market revenue in the healthcare industry to increase more than $135 billion in the next three years.

Security challenges must be addressed to make the most of IoT medical devices. The data collected by the devices qualify under HIPAA regulations, and IoT software secures any unmonitored devices to protect against attacks. Get connected to an IoT software development company for developing a HIPPA Compliant app for your medical device development project.

Telemedicine Solutions

Telemedicine app development companies watch out for the industry’s trends to keep up with consumer demands. Medical device manufacturers should combine the ideas with current digital transformation and shift to remote care.

Remote patient care includes telehealth, telemedicine, and mHealth. This has become a successful way of treating patients after Covid swept the globe.

With technology miniaturization, cloud services, data management, security, remote healthcare, and Telemedecine app development benefits patients with faster access to healthcare services.

Medical device design consultancy is jumping on the rising telehealth trend. There are multiple benefits of telehealth solutions to both patients and healthcare providers.

Big Data & Security

Big data involves gathering the data and analyzing it to conclusions. Analytics provides tools to collect unstructured medical data information.

The volume of medical data will increase exponentially in the coming years. Big-data solutions will monitor the quality of the patient’s medical data and detect the disease earlier to enable better treatment.

For example, if the data shows particular blood hematology that develops colon cancer, it can be identified earlier. The development of medical devices will detect and find ways to see various types of cancer or other cardiological problems.

While this embedded data also offers security with software to share, it also poses possible risks vulnerable to cyber threats. A secure medical device development design will guarantee a secure medical design device lifecycle.

Risk management should be the top priority for any medical device development. Imagine you are using a smartphone for testing sugar, BP, etc. and you find it has been interrupted by unidentified threats. This would result in different diagnostics with wrong values.

Both these devices should work seamlessly to avoid any interruption to the wireless connection between the device and the phone to give you same diagnostics values.

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Smart Wearables

You may find individuals interested in buying smart wearables to track their health and record personal health data for further consultation. The most prominent role pandemic has played is the acceleration of technologies in this sector.

Companies have developed wearable sensors to fit in during medical device development. And the smart wearable app development company creates wearable device apps that enable additional clinical monitoring, for example, blood sugar level, blood pressure, etc.

The new wearables are manufactured for daily use and designed as accessories or hidden objects in the cloth. The information gathered from the device can alert if any emergency arises, and the doctors can benefit from staying updated and continuously monitoring the health of their patients.

Now that you are aware of the trends to develop medical device, let us brief you about the medical device development process.

Design, Develop and Deliver Your Medical Device – Phases

The exact process to build a medical device will differ for every product according to the standards and regulatory requirements of FDA and HIPAA. The medical device product development lifecycle is not easy to implement and has layers of regulations. 

Over the years the medical industry has seen the good, the bad, and the ugly. There are several ways to plan the phases of medical device development. 

The below image portrays 5 phases of medical device development with factors involved along your journey to the market. Let’s discuss them in detail.

Initiation Opportunity & Risk Analysis

• Plan the development of the product and don’t forget to document it. 
• Discuss and decide the funding strategies and the market you want to target. Know the how, where and why of the product development. 
• Put a QMS to provide a solid base to build a new product. 
• The quality management system will include the procedures, templates, forms.

Formulation Concept & Feasibility

• Concept and feasibility go along and it becomes critical to proving the idea of developing the product working in real. 
• Once you are convinced with the device position, is viable financially, only then look for funding the prototyping. 
• Start formulating the risk at the early stage.
• Take the feedback of the customers, competitor analysis and market research, etc. 
• Again, don’t forget to document this. 

Verification & Validation

• Now that you have completed a few trials, get the validation and verification done to prove that the device will withstand any pressure. 
• Check the failures that came across while testing and managing the risk involved.
• Ensure you know the regulatory requirements of the product that you need to develop for your healthcare company.

Product Launch Preparation

• It’s time to think about marketing and branding.
• All the validation and verification should be thoroughly completed.
• Gather the evidence of testing, electrical safety, etc.
• If the company is upscaling then you are almost there. Will you implement these in other productions? 
• Don’t throw the baby out of the water until you complete the testing and trials by fulfilling the regulatory requirements.

Launch & Post Launch Assessments

• After amending the failures, do you need to re-test?
• Technical file review is done.
• The license and certificate is ready.

I think we are now ready to launch the product in the market. With this, we complete the 5 phases of medical device development. If you have made it through all the stages of medical device development and not received a regulatory clearance, your device will not be recognized in the market. There will be continuous feedback and review by the internal systems. 

Do you think to reach your goal, its path would be clear and easy? 

Certainly not!

The road to success is always tricky and that involves risks to overcome. Let us continue to discuss the same. 

Medical Device Development Associated Risks

Product development consists of a workflow and meeting the FDA requirements involves more risk. Managing each risk and the entire portfolio is an essential activity during any medical device development. Let us study the three important risks involved in developing medical devices with the solution to manage them. 

Product Level Risk

• The most important risk you may face is the product level risk. The product risk is associated with the safety of the device as it is associated with the patient. 
• It can connect to immediate injury while using the device or long-term risks. This is why FDA approval is necessary. 
• Complying with these regulations does not come under conflict of the manufacturer as it’s their duty to produce right products.

Project Management Risk

• This goes beyond the product tech and safety as it influences how well the project establishes. 
• It involves what tools the project manager uses and at what level. 
• Project that has a high degree of uncertainty can be handled by the project manager.
• Complex projects and products are at risk with its design or its business model.

Overall Project Risk

• After the launch, the product is exposed to new risk factors that need to be addressed. 
• Earlier the risk identified the team can manage well rather than ignoring it.
• NPD-Risk Assessor is the best tool to identify and quantify the risk of the entire project. 
• Use the tool that is based on the statistical model to identify that risks are pushing closer to success.

After identifying all the possible risk factors and managing it to prevent any pitfalls, here comes the most important question from the medical companies, how long will it take to develop the device?

How Long Does it Take to Develop a Medical Device?

Medical device development is not an easy process and it may take several months or years to complete the development depending on the complexity of the product. The medical device development timeline includes the entire phases of the development. 

The time taken for medical device development from prototype to regulatory FDA approval brings different classes of devices to the market. 

– Class 1

These are small devices or equipment that gain quick approval from the FDA. The majority are non-invasive devices self-registered with FDA like electric toothbrushes, oxygen masks, tongue depressors, etc. that are completed within a week’s time.

– Class 2

Class 2 devices are catheters and syringes that involve a little risk and the manufacturer needs to be more careful with safety through substantial comparison to other devices. FDA takes nearly 60 days to approve such devices. Anesthesia devices take the longest to gain approval while toxicology takes the shortest time.

– Class 3

These devices are highly invasive and expose a higher risk to the patients. These include items like cochlear implants, defibrillators, and implanted prostheses. FDA takes a longer time as these go through stringent testing to check the safety and efficacy of the devices. This takes eight months to a year to gain approval from FDA after its development. 

Does a Medical Device Need FDA Approval?

All the medical devices that are developed, relabelled, repacked, or imported for sale need some level of FDA approval. Every medical device classified according to the mentioned class, needs FDA approval, the only difference is the approval timeline. 

If you want to reduce the time for FDA to approve medical device development, follow the below points that help in the early approval of the device:

• Prepare early
• Partner with FDA
• Comprehensive submission
• Get help with the prototype

Are you Future Ready to Adopt These Medical Device Development Trends?

There’s plenty to look forward to in the medical device development market.

Yes, there will be challenges to navigate but an opportunity on the horizon. These medical device trends are the key to success. Partnering with IT companies housing medical device developers can help you develop smart trends in the early stage of design and development. Furthermore, it will add the capacity to move faster in the market.

If you are unsure what a partnership can look like, reach out to the medical device development engineer at Excellent Webworld. This healthcare app development company has years of experience and gives you the best way forward to get innovation to healthcare products.

FAQs For Medical Device Development