COMPANY

INSIGHT

Biocompatible Coatings for the Evolving Medical Device

BioInteractions has dedicated over twenty-five years into researching and developing innovative, biocompatible materials for medical devices. Throughout this time, we have maintained our position at the forefront of research and development of sophisticated biocompatible coatings.

Our commitment to advance healthcare through innovation, has resulted in a range of proprietary coatings which targets the core issues faced by medical devices. Our years spent tackling a wide range of challenges gives us a unique advantage when providing an optimal solution for our partners. Our coatings are proven to improve the biocompatible response of a surface over long periods of time.

The following are a few of the key medical applications where ElectroCraft motors empower medical motion control.

Commitment to Care Services:

Our expertise and broad product range has given us in-depth experience in tackling a wider range of challenges compared with other coating providers. This helps us to realise the importance of the application of the coating in order to achieve optimal efficacy on the surface. We have found that a quality application process improves the effect of the coating and allows the coating to be utilised on a wide variety of surfaces. Our know-how in these areas allows us to provide a high-performance coating and a tailored coating process to fit our partners’ requirements.

Additionally, we have spent a significant amount of time and effort developing test methods which help to highlight the benefits of our coatings on the device surface. This added value helps to add supportive data to regulatory submissions. We have assisted our partners with their regulatory efforts and have expertise with this process. Our support in this area combined with our ability to provide a tailored solution is a comprehensive service to help our partners with their challenges.

Our Commitment to Care service (C2C), and our high-performance coatings is the complete solution for our partners who require a coating. We provide world-leading coating technology optimised for specific applications, in combination with our C2C service to help our partners navigate through their product development, resulting in market leading medical devices.

We have created a range of non-leaching, biocompatible coatings which utilise the benefits of a multi-faceted approach in tackling biocompatible challenges. Our high-performance coatings provide significant benefits to the material as well as to the patient. This is achieved by using a combination of active components with passive components to give unique advantages offered by our technology.

BioInteractions manufactures and supplies these coatings, as well as the services to coat devices. We have combined our technology with our C2C services to provide the optimal solution for our partners.

Astute^®

Triple-Endothelial Action

Anti-thrombogenic Coating

Why Astute®? (Benefits)

The Astute® Antithrombogenic Coating is a non-leaching coating that actively improves the haemocompatibility of a device surface by mimicking the natural endothelial layer. Our coating enables a device to perform its intended function as well as reduce the risk of further complications from occurring in the patient.

The coating provides a unique way to prevent thrombus formation as well as cellular deposition and adhesion onto the device surface. This hinders thrombus formation at the site and reduces the risk of them forming further along in the patient. There are no leaching components which further reduces the patient risk and helps the coating to perform well over long periods of time without reduction in performance.

What is Astute®? (Features)

Astute® Antithrombogenic coating uses an active antithrombogenic component combined with additional passive components to mimic the natural endothelial layer. The active component causes the coating to interrupt the blood cascade mechanism.

This prevents platelets from activating and hinders thrombus formation. Astute® uses additional passive components to reduce deposition and adhesion on the device surface. This combination actively prevents thrombus formation, is non-leaching and reduces deposition onto the surface. This multi-faceted approach provides superior haemocompatibility to the surface and delivers significant benefits which leads to an improvement in the patient’s well-being.

AvertPlus™

Dual Active Contact Kill Mechanism

Antimicrobial Coating

Why AvertPlus™?

AvertPlus™ Antimicrobial is a non-leaching coating that eliminates bacteria on a surface and helps to reduce biofilm formation. The coating targets a broad spectrum of bacteria, without harming the patient’s cells. This significantly reduces the risk of infections and the risk of coating components to the patient.

The non-leaching coating provides a consistent effect without any degradation and helps it to survive long-term applications. Additional, passive components enhance the effect of the coating by reducing deposition and adhesion of cells onto the surface. The coating provides these benefits without the use of toxic compounds, eluting components or antibiotics. This reduces toxicity risk or risk of antibiotic resistance to the patient. The two-factor approach prevents infections from arising as well as from spreading, which significantly reduced the risk to the patient.

What is AvertPlus™?

AvertPlus™ Antimicrobial Coating uses an active agent combined with a passive component to eliminate the infection and prevent bacterial colonisation on a surface. This dual functionality gives the coating advantages over alternatives for tackling device related infections. The contact kill mechanism causes the cells to physically lyse and hinders biofilm formation.

This significantly reduces the ability of bacteria to remain on the surface and colonise. The combined active and passive components of the coating provide an effective method to eliminate bacteria, prevent biofilm formation and inhibit a broad spectrum of bacteria from colonising on the surface.

Assist™

Enhanced Lubricious Activity

Hydrophilic Coating

Why Assist™?

The Assist™ Hydrophilic Coating delivers a high-performance, hydrophilic surface for long term applications. The coating significantly decreases frictional resistance between the tissue and device interface. This reduces tissue damage and improves comfort when delivering or removing a device in a patient. Assist™ uses a two-factor approach to innovatively improve stability, which helps it to perform for long periods of time.

This allows the device to remain in its environment for longer applications and has the stability to withstand challenging conditions. The stability of our coating helps to reduce the amount of times a device is required to be changed and improves the patient’s comfort.

What is Assist™?

Assist™ Hydrophilic Coating uses a two-factor approach to reduce the friction at the device-body interface and maintains its function for long periods of time. The coating includes a non-thrombogenic agent which prevents deposition and adhesion of cells onto the device surface. This helps the long-term performance by reducing ability of components interacting with the surface.

The coating hinders occlusion of the device and allows the device to remain in position for extensive use which helps improve the patient’s comfort. Assist™ utilises a two-factor approach to reduce the complications at the device-body interface. The friction is reduced between the surfaces to improve the delivery and removal of a device and minimises tissue damage which helps improve the patient’s comfort and well-being.

CONTACT INFORMATION

BioInteractions Ltd

Thames Valley Science Park,

Gateway Building,

1 Collegiate Square,

Shinfield

RG2 9LH, UK

www.biointeractions.com

General@biointeractions.com

Fax: +49 (0) 6172 27978-10

05/22/2024 21:37:22

www.biointeractions.com

General@biointeractions.com

Biocompatible Coatings to

Enhance Your Medical Device

Advancements in medical devices have demanded innovative coatings to enhance the biological acceptance and reduce the challenges faced when artificial materials are in contact with the body.

BioInteractions’ Biocompatible Coatings

BioInteractions have developed three unique polymer coatings to help with these challenges:

Astute^®

Anti-thrombogenic Coating

Triple-Endothelial Action

Astute functionalises an active component within its polymer backbone and is combined with passive components to actively prevents a thrombus from forming.

Astute^® Triple Endothelial Action:

Actively negates platelet activation
Prevents protein and cellular deposition
Non-leaching coating to give long term efficacy

AvertPlus™

Dual Active Contact Kill Mechanism

Antimicrobial Coating

AvertPlus™ reduces device related infections and targets biofilm formation. The active contact kill mechanism is paired with a passive process to reduce the presence of bacteria on the surface

AvertPlus™ Dual Active Contact Kill Mechanism:

Active disruption of a broad-spectrum bacteria that results in lysis
Prevents deposition and adhesion of proteins
Non-leaching coating gives long term efficacy throughout lifetime of the coating

Assist™

Enhanced Lubricious Activity

Hydrophilic Coating

Assist™ minimises the obstacles faced at the device-body interface. The polymer coating provides a highly hydrophilic surface which reduces friction as well as preventing protein binding and platelet deposition to improve patient well-being.

Assist™ Enhanced Lubricity:

Hydrophilic properties as well as prevents deposition onto the surface
Non-leaching, non-cytotoxic and stable coating
Available as UV Cured or Heat Cured

Commitment to Care Services

Our Commitment to Care Service (C2C) builds on our expertise in facing a broad range of challenges. We have combined our innovative coatings with optimised application processes and support services as a complete solution for our partners. We have discovered the impact of applying the coating on the result of the quality and efficacy of the coating. We are able to develop and optimise a coating process as well as provide the coating capabilities in our cleanroom facilities for our customers.

We have extended our C2C services to include testing methods to highlight the benefits of using our coating technology. This can be used to help support regulatory submissions. We have expertise in helping our partners through the submission process helping to reduce significant challenges during this process

Our in-depth understanding of the range of challenges faced by materials, provides us with an exclusive advantage to help our partners. Our coating technologies provide innovative advantages to the device and helps to Assist™ in improving patient well-being.

05/22/2024 21:37:22

COMPANY

INSIGHT

Medical Software – The Case for New Regulation

Continued scientific and technical developments have pushed the medical devices industry to the point of big change. What now?

The following are a few of the key medical applications where ElectroCraft motors empower medical motion control.

We can no longer imagine modern healthcare services without medical devices. They perform a vital role in diagnosis and treatment.

Medical devices range from basic equipment, like thermometers and syringes, to more complex surgical instruments, pacemakers, prostheses, catheters, and therapeutic and diagnostic equipment.

These more complex, high-risk devices are often responsible for protecting and sustaining human life.

Medical devices have become more complex, and so has the software at the heart of them. Besides controlling and monitoring medical devices, advanced software opens the door to a vast array of new functions and features.

For example, using wireless communication technologies means that medical devices can connect to other devices, including computers and smartphones. With wearables sensors and machine learning it’s possible to collect data, send it to a doctor and automate the delivery of treatment. Artificial intelligence is already helping to improve diagnostic image clarity too. And these are just some examples of how medical software has improved healthcare and medical devices in recent times.

However, this fast-paced evolution has also given rise to new challenges for manufactures, lawmakers and regulators.

Just last year, medical device recalls reached record highs, with software the most common factor for recalls. In fact, software issues have been the main reason for device recalls since 2016.

There seem to be three main reasons for this increase. First, the number of medical devices using advanced software is now higher. Second, this kind of software needs constant updates which can raise post-market issues after the device has been released. Third, as manufacturers create more innovative software, the number of variables in a clinical environment that need to be taken into account grows.

As the spread of high-tech medical devices continues, the challenges with software aren’t expected to reduce, especially now with a new medical regulation on the way.

In 2017, the European Council and Parliament approved the new Medical Device Regulation (MDR). This will come into effect in May 2020, introducing significant changes that are mandatory for companies to comply with. Medical devices can no longer be delivered to the European market without conforming to the strict safety requirements of the European Union’s new regulations.

Previous regulation had failed to consider software’s own role as a medical device. But this new regulation will change this. All devices containing software, including medical apps that were not previously considered medical devices, will be classified as a medical device.

Manufacturers will face new challenges because of this. Minimising failures and recalls caused by software while still encouraging innovation will be a delicate balance to strike. It will require continuous effort from manufacturers who will need to adopt a proactive approach to understanding and implementing the new regulation.

If you would like to know more about the impact of the Medical Devices Regulation coming into effect in 2020, download our free white paper.