The medical device industry is a core part of the global healthcare ecosystem. Over the past decade, more than 250 new medical device startups have been established each year. They stand at the forefront of redefining healthcare by developing ever-more innovative devices. Some of these start ups have changed med-tech product categories forever.
Bringing medical devices to market is a time-consuming, complex, and expensive process. This reality is one of the main reason why the med-tech startup failure rate is up to 90% in the US alone. And one of the most complex processes during the development of a medical device is surface modification.
In this article we make the case for startups utilizing a full-service, medical coating services partner to help them successfully launch their devices. We look at some of the challenges med tech start-ups face when launching products. Then we provide reasons why a coatings partner like Hydromer®, Inc. can help overcome these challenges and help startups achieve their commercial goals. In addition, we explore some of the many coating services we provide specifically for medical device startups. Lastly, we will share some of the most important things to look for in a coating company. So if you are a startup founder, device engineer, or project manager you will want to make sure to read to the end!
Why Should Startups Partner With a Coatings Services Provider?
Surface modification is essential when designing medical devices. This is because most base materials (metals, glass, polymers, or ceramics) used for medical devices do not meet the strict safety, performance, and reliability requirements. Surface modification, usually hydrophilic coatings modify the surface of devices, making them safer and increasing their functionality.
In other words, these coatings are a critical component of the device’s safety, performance, and longevity.
Developing a suitable coating requires a deep understanding of polymer chemistry, regulatory requirements, analytical testing, and more. However, many startups lack in-house polymer chemistry expertise and the resources to develop a medical coating solution that makes their ground-breaking product a success.
This is why finding an experienced, reliable, and innovative medical coatings partner is so critical.
Below we cover some of the common challenges and pitfalls faced by medical device startups. In addition we cover how a full-service coatings partner like Hydromer, Inc. can help startups overcome them.
Challenges Related to Medical Device Coatings
There are a variety of technical difficulties associated with formulating and applying surface modification coatings for medical devices. Developing a hydrophilic medical coating without the internal resources or polymer chemistry expertise can be quite difficult and expensive. Applying the coating correctly, testing its performance, and ensuring it meets regulatory requirements are just as tedious. This is especially true for startups.
Below is a list of challenges faced by many startups when formulating and applying coatings to their medical devices:
1. Material Compatibility: R&D, Polymer Chemistry, Formulation Expertise
Medical devices are made up of materials, such as metals, ceramics, glass, and polymers. Due to the distinct physical and chemical properties of each material, the coating formulation varies drastically. Simply put, the coating chemistry needs to be adjusted to ensure the proper adhesion, stability, and performance within a dynamic biological environment. The coatings need to work for multiple substrates.
Most startups lack the necessary, in-house polymer chemistry and coatings expertise. Without this, they run the risk of failing to vet material combinations meticulously.
Benefit of a Coatings Services Provider: A coating service provider, such as Hydromer, Inc., has deep polymer chemistry and coatings expertise. This makes the formulation of your custom medical coating faster and more efficient. Our team will help develop a coating that is both compatible with your substrate(s) and meets your product requirements.
2. Achieving Uniform Coatings: Experienced Contract Coating Services
Coating layer parameters, such as the thickness and coverage, drastically affect the performance and safety of the underlying medical device. Many clinical tests show that non-uniform and inconsistent coatings can pose life-threatening risks to patients. A lack of uniformity in lubricious coatings can also cause more trauma and discomfort for patients.
As a result, achieving coating uniformity is important. However, it is challenging to achieve. And it becomes more complicated for medical devices with complex geometries. Startups often struggle due to a lack of application experience and a lack of the proper application equipment to properly coat their devices.
Benefit of a Coatings Services Provider: A coating service provider, such as Hydromer®, has extensive coating application capabilities. We can assist with properly coating and testing prototypes. We also do full-scale contract-coating for your manufacturing runs. Our facilities are equipped with advanced equipment to ensure proper coating application for your device. Our in-house coating equipment can handle dip, spin, spray, and a proprietary meniscus coating methods. We are capable of coating both inner (ID) and outer (OD) surfaces of medical devices, and we can achieve full coverage even on complex geometries.
3. Complex Regulatory Requirements: Need For Regulatory Expertise
It is not a secret that medical devices must meet international regulatory requirements. For example, the US FDA and the EU’s CE mark. These regulations frequently change. This means all medical device manufacturers need to stay up to date and comply with the specific rules for every market they sell their devices.
These strict regulatory standards are mandatory and must be followed. That is because they form the foundation of the device’s safety, efficacy, and patient protection.
The problem is that most startups do not have an in-house regulatory and compliance expert. Hiring external consultants for guidance, to prepare submissions and get quick regulatory approvals can be extremely expensive. Even worse, these costs are ever-increasing due to the complex and ever-evolving regulatory landscape.
Benefit of a Coatings Services Provider: A reputable coating service partner should have in-house regulatory experts. These experts are helpful during the coating formulation process, ensuring the coating meets regulatory requirements. This service can also be used to help aid in and speed up the submission and product approvals process. As such, startups can gain access to highly qualified and experienced regulatory experts, usually at a lower cost, by partnering with a coating service provider.
4. Rigorous Testing and Validation: Analytical Testing
Failure in this phase can delay the time-to-market significantly. In addition, the failure to catch product problems before go-to-market can cause larger issues later on.
Effective testing and validation of coating chemistries requires decades of expertise in material science and biomedical engineering. Additionally, a range of expensive equipment is required to perform various chemical, mechanical, and biocompatibility tests on devices.
It may not be feasible for a startup to do all the required testing in-house. It requires significant financial resources to hire in-house experts and buy high-tech lab equipment to evaluate coatings.
Benefit of a Coatings Services Provider: Coating service partners are extremely helpful in this regard. Coating partners have both the experts and equipment in-house to perform these tests. In turn, startups can utilize these service providers and get the job done at a fraction of the cost.
5. Supply Chain Management: Reliable Supply of Device Coatings
Supply chain plays a crucial role in meeting aggressive timelines and product quality requirements. Many OEMs rely on a well-developed network of suppliers, especially when the devices require specialized coating materials.
But startups often do not have access to a reliable supply chain network. In turn, they may not have the ability to withstand unexpected supply disruptions. These issues can lead to production delays, increased costs, and other damaging setbacks.
Benefit of a Coatings Services Provider: Having a dedicated coating service partner is a good strategy for startups in this area as well. These established companies have strong supplier relationships, a global supplier network, robust quality control, and careful planning to prevent the impact of unexpected disruptions.
6. Cost Control During Coating Development & Production
There are numerous costs associated with developing and manufacturing devices that use medical coatings. Multiple factors affect the final cost of the device, such as:
- Material Cost
- R&D Investments
- Production Cost
- Testing Expenses
- Regulatory Costs
If operations are not streamlined then these costs can add up significantly. Efficiency is key in controlling costs both during development and production of your device.
Benefit of a Coatings Services Provider: A coating service provider can help improve cost efficiency. The right partner can handle every aspect related to coating your device, including in development, testing, compliance, and production. This “one-stop-shop” helps to streamline your process and reduce costs. You will also have access to technical and regulatory experts, high-tech equipment, risk-reduction plans, and more. These services can help you launch the product and produce it at the expected price.
How Medical Coatings Can Make or Break Your Device
Medical coatings are a critical component for medical devices that are either inserted or implanted into the body. At their core, hydrophilic coatings ensure that medical devices meet the most stringent regulatory standards.
But the same coatings can also greatly help enhance device performance.
Hydrophilic coating technology is rapidly advancing to help device manufacturers meet the growing demand for advanced healthcare solutions. As a result, many new functionalities have been developed over the past few decades. Startups can leverage these innovative technologies to create the next generation of high-tech medical devices.
Importance of Medical Device Coatings
Here are a few reasons why it is essential to apply coatings to medical devices that are exposed to dynamic biological environments:
- Device Performance: Medical coatings help you improve device performance. For example, they help by enhancing lubricity, antimicrobial properties, drug-eluting capabilities, and more. Innovative versions can even provide advanced functionality with advanced products like stimuli-responsive coatings.
- Biocompatibility: Medical devices must be non-toxic and non-carcinogenic. They should not adversely react with their surroundings. In other words, they need to be biocompatible. The metals, glass, ceramics, or polymers used for medical devices can react with the surrounding environment. That’s why surface modification or surface modifying coatings are crucial. Medical coatings act as a barrier and also ensure a safe interaction between the device and the biological tissue or environment.
- Regulatory Compliance: Coatings are used to meet the strict quality standards outlined by various regulatory bodies. They allow even the most complex and sophisticated medical devices to successfully gain approvals from agencies like the FDA and EMA.
- Enhanced Cell Adhesion: A few materials, such as metals, are inherently bio-inert and do not bond properly with the biological tissues. In these cases hydrophilic coatings can be used to improve cell attachment, tissue growth, and osseointegration.
- Corrosion Resistance: Many metals and ceramics are prone to corrosion, wear, and chemical degradation over time. This significantly reduces the device’s life span. Hydrophilic medical coatings create a protective barrier that extends the life of the device.
- Long-Term Cost Savings: Reduced early product failure rates minimize recalls and warranty claims. Coatings are proven to extend the life of devices while lowering the replacement rates and reducing repeat procedures. Due to such benefits, the application of hydrophilic coatings ensures long-term cost savings and helps increase your brand reputation over time.
Hydromer® – A Leading Coatings Services Provider for Startups
Hydromer®, Inc. has 40+ years of experience manufacturing high-quality coatings for OEMs, Startups, and CMOs worldwide. We are a full-service partner, offering every service needed to develop and coat your medical device. This includes contract R&D, contract-coating, testing, regulatory support, coatings supply, custom equipment building, technology transfer, and more.
Our goal is to allow our customers to focus on their core strengths while helping them bring new, high-tech medical devices to market.
Medical-grade coatings have gained massive popularity in the medical industry over the past few decades. But not all coatings are created equally. Similarly, not all coating service partners are either.
Choosing the right coating service provider is critical to ensure innovation, product performance, and long-term product success.
Hydromer® is more than just a coating supplier. We are your collaborative partner in innovation. We provide the specialized expertise and solutions that empower you to build safer and more effective medical devices.
Below we cover some of the many products and services we offer med tech startups.
Hydromer® Custom Hydrophilic Medical Coatings
We develop custom, hydrophilic medical coating solutions for our customers. Our coatings are far from a one-size-fits-all solution. They range from simple lubricious coatings to advanced formulations that provide multiple functionalities in a single coating.
The possibilities are far-reaching, but some examples include:
- Lubricious Coatings: Lubricity is a critical factor for patient comfort and safety during procedures. It also allows doctors to do their job better by giving them the ability to navigate tortuous pathways in the body that would otherwise be impossible. Lubricious coatings drastically reduce the friction between the device surface and surrounding biological tissues.
- Thromboresistant Coatings: These coatings reduce the risk of blood clot formation on devices, dramatically improving patient safety.
- Antimicrobial Properties: Our coatings can be formulated to prevent microbial adhesion and biofilm formation, which are key causes of device-related infections. We offer non-leaching, antimicrobial coatings versions as well.
- Enhanced Biocompatibility: Formulations that are safe for use in the body, non-leaching and can even encourage cell growth and wound healing, which is vital for implants and regenerative medicine applications. All of our formulations serve as biocompatible coatings.
- Speciality Medical Coatings, such as:
- PFAS-Free Medical Coatings
- Stimuli-responsive hydrophilic coatings
- Custom coatings with varying functionalities
- One-step and multi-step coatings
- Thermal and UV-Curable Options: Our HydrUV™ system offers fast curing times, which can streamline production and increase efficiency.
Learn more about all of our medical device coatings.
Coating Services for Medical Device Startups
The success of your medical devices heavily depends upon the successful formulation and application of surface coatings.
If you are a startup looking for a full-service coatings partner, Hydromer® can help. Our coating services for startups range from R&D, application, testing, and compliance submission,. You can leverage our 40 years of experience in polymer chemistries and application methods to quickly and smoothly overcome technical issues.
Our strength lies in decades of partnership with medical device innovators to solve your most critical surface modification challenges.
1. Contract Research and Development (R&D) Services
At Hydromer, we have a team of highly qualified Ph.D. chemists and engineers. Our contract R&D services include Feasibility Analysis, Coating Development and Customization, and more.
We have the technology to custom-formulate coatings to meet your specific device requirements. For example, Hydromer® can create hydrophilic coatings with antimicrobial properties, thromboresistance, drug-eluting capabilities, or other functionalities as needed. Additionally, the coating thickness and uniformity can be adjusted to match your device’s intended function.
2. Contract Coating Services
Our contract coating services include a wide range of application methods, from dip and spin to our proprietary meniscus coating. We have the ability to coat the inner diameter and outer diameter. In addition, we can coat complex geometries.
We will first study the best application method for your specific application. This professional coating application approach ensures consistency and scalability over time as the demand for your medical devices rises gradually.
3. Prototype Coating
Our specialized prototype coating services test multiple coating chemistries, thicknesses, and application methods to find the best fit. All prototypes are rigorously evaluated under simulated conditions before committing to full-scale production.
4. Material Compatibility Testing
Different substrate materials have different chemical and mechanical surface properties. Material compatibility testing is used to assess how different coatings perform on various types of materials.
These tests are used to assess a coating formulation’s adhesion to certain substrates or materials, including metals, polymers, and ceramics. Some of the material compatibility tests at Hydromer® include:
- Bending
- Stretching
- Exposure to biological fluids
- And more
5. Regulatory Compliance Consulting & Support
There are strict regulatory standards set by the FDA, EMA, ISO, and other high authority bodies.
Hydromer® has an in-house team of regulatory experts to assist in this area. We can help you meet the complex compliance norms required for medical device approval. Our service includes research, documentation, standards alignment, audit, and inspection support. Our in-house experts also help through the entirety of the process, helping to ensure that the coatings will meet the requirements.
6. Process Optimization, Technology Transfer, Custom Machine Building, and Manufacturing Consulting
Our process optimization services help startups maintain consistency and efficiency during both device development and production.
Based on our 40+ years of experience, we help manufacturers identify the best application methods, coating thickness, curing method, tips to achieve proper adhesion, and more. Your devices can be coated at our facility. Or you can utilize our technology transfer services to ensure that these processes are set up in your facility.
7. Post-Coating Quality Control
Our rigorous post-coating quality control (QC) protocols detect defects, inconsistencies, and more. We aim to ensure that every coated medical device meets the highest standards of performance, safety, and consistency.
The goal is to prevent failures, recalls, and regulatory setbacks before the device reaches the market.
8. Analytical Testing
Hydromer® has a fully staffed, in-house team of highly qualified Ph.D. Analytical, Bio, and Polymer chemists to perform product analysis testing and development. Lab personnel perform tests to ascertain the biological behavior of materials for safety and performance. Our team also helps with custom product development and applications.
Below are examples of our capabilities:
- Analytical Testing
- Fourier transformed IR (FTIR)
- GC/Mass Spec
- Goniometer (Contact Angle)
- HPLC
- Rheology
- UV/Visible spectroscopy
- Wettability
- Chemistry
- Coefficient of Friction
- Collagen analysis
- Cytokine qualification
- Free radical polymerization
- Viscosity measurement
- Microbiology
- Antimicrobial testing
- Minimum inhibitory concentration (MIC)
- Zone of inhibition
- Process Testing
- Cell culture
- Cell proliferation
- Cytotoxicity assays
- Endotoxicity
- Light and fluorescent microscopy
- Whole blood coagulation and analysis
Conclusion
Bringing a medical device from concept to market is an extremely complex task. It includes multiple steps, each that require different expertise and equipment. One of the more complex steps is surface modification. Getting your surface coating right can either make or break your medical device’s success.
As a result, it is a good idea to rely on experts in this area. By choosing the right experts or coating service partner, you can significantly simplify and accelerate the process. However, it isn’t just about finding a coatings supplier.
Choosing a coatings partner should focus on gaining a strategic resource. An ideal partner should provide more than just a product. They should provide decades of technical expertise, robust R&D capabilities, and a deep understanding of the regulatory landscape. They should be able to create innovative coatings that meet your product requirements.
At Hydromer®, Inc., we aim to transform your devices to meet the demands of modern medicine. As your partner, we will function as an extension of your R&D, regulatory, and production team. That is because we can help with everything from regulatory consulting to contract coating and custom machine building. The ultimate result will be your ability to bring a safe, innovative, and high performance devices to your customers faster.
