FlexMedical Solutions https://www.flexmedical-solutions.com Serving the Life Sciences Tue, 19 Jan 2021 13:48:39 +0000 en-GB hourly 1 https://wordpress.org/?v=5.5.3 https://www.flexmedical-solutions.com/wp-content/uploads/cropped-site-icon-32x32.png FlexMedical Solutions https://www.flexmedical-solutions.com 32 32 Come Join FlexMedical Solutions! https://www.flexmedical-solutions.com/news/career-opportunities-at-flexmedical-solutions-2?utm_source=rss&utm_medium=rss&utm_campaign=career-opportunities-at-flexmedical-solutions-2 Tue, 19 Jan 2021 13:48:32 +0000 https://www.flexmedical-solutions.com/?p=212017 We are looking for people who are passionate about what they do, who thrive in fast paced environments and who work because it excites them.

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Come Join FlexMedical Solutions!

FlexMedical Solutions is a successful and flourishing scale-up business. We are looking for people who are passionate about what they do. We are looking for people who thrive in fast paced environments and who work because it excites them. If this sounds like you and you are attracted by the prospect of helping our customers create a healthier tomorrow, then please read on.
FlexMedical’s newly appointed CSO – Donogh FitzGerald
We provide diagnostic solutions for a host of disease states – including COVID-19. Our client base has grown considerably over the last 12-24 months and we are in the process of expanding our footprint whilst growing our team. As a contract developer and manufacturer, we pride ourselves on being the best at what we do.

We have several roles available including:

If you have the ambition to join us then we’d invite you to contact our recruitment partner Kleboe Jardine https://www.kleboejardine.com/about to discuss any relevant opportunities with Ewan, Natalie or Campbell.

Successful applicants will be rewarded with a competitive salary and a wider package that includes pension, bonus and volunteer days.

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Quality Assured – FlexMedical secures ISO 13485: 2016 https://www.flexmedical-solutions.com/news/iso13485?utm_source=rss&utm_medium=rss&utm_campaign=iso13485 Wed, 06 Jan 2021 10:37:47 +0000 https://www.flexmedical-solutions.com/?p=211972 FlexMedical has been awarded ISO 13485: 2016 certification – representing the best internationally accepted model a medical device organisation can implement to help demonstrate compliance to laws and regulations of the medical device industry.

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Quality Assured – FlexMedical secures ISO 13485: 2016

FlexMedical Solutions Limited has been awarded ISO 13485: 2016 certification – representing the best internationally accepted model a medical device organisation can implement to help demonstrate compliance to laws and regulations of the medical device industry.
ISO13485
When it comes to medical device manufacturing, patient safety greatly depends on the quality and consistency of medical products, and ensuring effectiveness, control and maintenance of your QMS is critical to customers, stakeholders, patients and users, and regulatory agencies.

The ISO certification provides assurance that FlexMedical’s products are being designed, developed and manufactured to the highest standards. It also signifies that a robust risk management system is in place and there is a company-wide commitment to improvement.

A world leader in biosensor development and manufacture, FlexMedical Solutions partners with innovative companies and helps them bring their point of care diagnostic ideas to life, from concept to commercialisation.

ISO13485

Kevin Fallon, Chief Executive Officer, said:
“Our vision is to be the global partner of choice for diagnostic design, development and manufacture – helping our customers create a healthier tomorrow.
We are growing exponentially and serve a truly international client base from our modern facility near Edinburgh, Scotland.
Whilst we have operated a quality management system for a number of years, and have in the past been successfully audited by the US FDA, it is a great testament to the team that we now formally hold 13485 accreditation.”

Kevin added:
“It’s been a huge team effort to achieve certification of our quality management system. Special thanks go to our quality team who have worked incredibly hard to make this happen.”

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Electrochemistry – One Size Doesn’t Fit All… https://www.flexmedical-solutions.com/news/electrochemistry-one-size-doesnt-fit-all?utm_source=rss&utm_medium=rss&utm_campaign=electrochemistry-one-size-doesnt-fit-all Mon, 19 Oct 2020 08:32:03 +0000 https://www.flexmedical-solutions.com/?p=211939 By utilizing FlexMedical Solutions’ electrodes, we can move from sensor generation, to cyclic voltammetry, and on to square wave voltammetry in a day!

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Electrochemistry – One Size Doesn’t Fit All…

Developing a commercial electrochemical assay starts off from a similar place….characterizing the core test method. This can be done very easily by identifying the electrochemical mediator to be detected by the sensor.
Performing a basic cyclic voltammogram is a good way to identify a suitable potential that should be applied with other more rapid electrochemical methods. The below mediator shows 2 peaks of interest at -0.1V and 0.371V
electro chemistry diagram 1
Applying a 0.37V potential in a chronoamperometric test method, across a range of mediator concentrations yields transients that when analysed using a standardized algorithm produces a dose response curve.
electro chemistry diagram 2
As the test method will ultimately be used with a clinical samples (such as whole blood, plasma, urine or other sample type), a potential of 0.37 is not ideal (due to the range of endogenous interfering substances that will also be “stimulated” at this potential, leading to the possibility of bias in the diagnostic device: lets fix this!

Changing the electrochemical interrogation of the sample on the electrode will open options in terms of more suitable potentials (in a less interferant-prone range).

Using Square Wave Voltammetry as an alternative allows for a significantly lower potential to be applied. The resultant transients can easily be integrated to yield sensitive and robust dose response curves as can be seen in the image below.

electro chemistry diagram 3
By utilizing FlexMedical Solutions’ electrodes, and our industry tried and tested rapid prototyping methodology, we can move from sensor generation, to cyclic voltammetry, and on to square wave voltammetry in a day (albeit a rather long day!), producing rapid data showing proof of concept for our clients in record time!

If we can achieve this in a day, think what we could achieve during your feasibility timelines!

FlexMedical Solutions: Bringing your point of care diagnostic idea to life, from concept to commercialisation.

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Exciting Career Opportunities at FlexMedical Solutions https://www.flexmedical-solutions.com/news/exciting-career-opportunities-at-flexmedical-solutions?utm_source=rss&utm_medium=rss&utm_campaign=exciting-career-opportunities-at-flexmedical-solutions Thu, 24 Sep 2020 10:30:48 +0000 https://www.flexmedical-solutions.com/?p=211928 The post Exciting Career Opportunities at FlexMedical Solutions appeared first on FlexMedical Solutions.

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Exciting Career Opportunities at FlexMedical Solutions

FlexMedical Solutions are seeking dynamic individuals who are both technically talented and have a passion for success. We provide diagnostic solutions for a host of disease states – including COVID-19.
FlexMedical’s newly appointed CSO – Donogh FitzGerald
If you have the ambition to join us then we’d invite you to take a look at our vacancies and apply via our recruitment partner Kleboe Jardin.

Vacancies:

Supply Chain Controller: View job details on LinkedIn.

Reagent Manufacturing Technician(s): View job details on LinkedIn.

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Career Opportunities at FlexMedical Solutions https://www.flexmedical-solutions.com/news/career-opportunities-at-flexmedical-solutions?utm_source=rss&utm_medium=rss&utm_campaign=career-opportunities-at-flexmedical-solutions Wed, 24 Jun 2020 13:51:09 +0000 https://www.flexmedical-solutions.com/?p=211908 FlexMedical Solutions is vibrant organisation providing tailored solutions to clients. The company blends an entrepreneurial approach with a commitment to providing products and services of the highest standards.

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Career Opportunities at FlexMedical Solutions

FlexMedical Solutions is vibrant organisation providing tailored solutions to clients. The company blends an entrepreneurial approach with a commitment to providing products and services of the highest standards.
FlexMedical’s newly appointed CSO – Donogh FitzGerald
We are a growing business and are seeking dynamic individuals who are both technically talented and have a passion for success.

If you have the ambition to join us then we’d invite you to take a look at our vacancies and apply via our recruitment partner Kleboe Jardin.

Vacancies:

Product Development Engineer: View job details on LinkedIn.

Product Development Scientist: View job details on LinkedIn.

Product Development Technician (Science): View job details on LinkedIn.

Manufacturing Operator – details to follow.

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An introduction from FlexMedical’s newly appointed CSO – Donogh FitzGerald https://www.flexmedical-solutions.com/blog/flexmedical-appoints-cso?utm_source=rss&utm_medium=rss&utm_campaign=flexmedical-appoints-cso Fri, 29 May 2020 07:34:33 +0000 https://www.flexmedical-solutions.com/?p=211854 I am excited to announce that I have joined FlexMedical Solutions (FMS) as Chief Scientific Officer, and wanted to take this opportunity to share this news with my contacts and friends in the industry.

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An introduction from FlexMedical’s newly appointed CSO – Donogh FitzGerald

I am excited to announce that I have joined FlexMedical Solutions (FMS) as Chief Scientific Officer, and wanted to take this opportunity to share this news with my contacts and friends in the industry. I have had involvement with FMS since its inception in 2015, and we agreed this year to consolidate the relationship and take up this permanent role to help introduce scientific muscle to the organization.

FlexMedical’s newly appointed CSO – Donogh FitzGerald

Donogh FitzGerald in the FMS Lab

As you may (or may not) know, FMS is a  company based in the central belt in Scotland  who specialize in contract development and manufacturing of point of care diagnostic sensors, with a client base consisting of SMEs covering industries such as IVD, Chemical/Biochemical and Agri-Food. We have a sizeable cleanroom facility housing an enviable amount of equipment capable of high precision device manufacturing, as well as volume production. We have an established quality management system in place and expect to gain ISO13485 accreditation this year, which will allow us to support our client base on a broader program, and we will now expand our chemistry and reagent capability to complement this.

I’ve been working in R&D in IVD since 1996, holding senior leadership jobs across a range of large diagnostics companies and have had the privilege to lead large groups responsible for the delivery of some fine diagnostic platforms (both in the realms of point of care and high throughput lab instrumentation). During this time, I’ve developed and launched assays for different disease states, and developed assays and surface chemistries for a broad range of assay architectures such as chemiluminescence, electrochemistry, fluorescence and colorimetric, leveraging micro particle science, magnetic separation and electrode chemistries to achieve this. In addition, I’ve gained great knowledge of 6-sigma (and other similar philosophies) and how it can be leveraged within chemistry development (using tools such as design of experiments, creative problem solving, and Kaizen) to shorten development timelines, and improve the robustness of technical decision making.

I couldn’t be joining FlexMedical Solutions at a better time, as we broaden our horizons with the implementation of ISO13485 and expand our scientific lab capability and capacity. I will help FMS expand its offering in the areas of assay and reagent development and manufacturing, electrode characterization and optimization, electrochemical method development on our new functionalized electrodes, development of heterogeneous and homogeneous assay technologies on FMS electrodes, system integration (combining chemistry, electrode, algorithms and settings) and quality control (onboard controls systems, external controls for POC, and product release).

So as the work progresses, I’ll keep you posted on the ups and downs as we develop and implement these added capabilities, and the new processes and functionalities we develop with our electrodes in order to expand their applications, and support our client base further.

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Customer Bulletin 23rd March 2020 https://www.flexmedical-solutions.com/news/customer-bulletin-23rd-march-2020?utm_source=rss&utm_medium=rss&utm_campaign=customer-bulletin-23rd-march-2020 Mon, 23 Mar 2020 09:22:53 +0000 https://www.flexmedical-solutions.com/?p=211759 As a responsible employer and supplier, FlexMedical Solutions (FMS) continues to monitor the Covid-19 outbreak closely. Starting Tuesday 24th March 2020, we are implementing a 2 shift pattern for the remainder of the crisis.

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Customer Bulletin 23rd March 2020

Communication in Response to Covid-19 / Coronavirus Pandemic

FlexMedical Solutions

As a responsible employer and supplier, FlexMedical Solutions (FMS) continues to monitor the Covid-19 outbreak closely. As the virus spreads and the government continues to tighten measures to limit infection levels, the likelihood of business interruption increases.

As such, starting Tuesday 24th March 2020, FMS is implementing a 2 shift pattern. These teams will not come into direct contact with one and other for the remainder of the crisis.

This decision has been taken in order to: –

  • Protect our employees and their families
  • Ensure FMS continues to operate efficiently
  • Maximise our ability to meet customer demand

We remain entirely committed to meeting your requirements – particularly as some of you are actively working on COVID-19 diagnostic solutions.

IMPORTANT: Until further notice, no FMS staff are permitted to travel or enter the premises of our customers or suppliers. Similarly, no visitors will be permitted onsite. No exceptions given.

We appreciate your understanding and support.
Thank You
Kevin Fallon, CEO
FlexMedical Solutions Limited

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Insane in the membrane! https://www.flexmedical-solutions.com/blog/insane-in-the-membrane?utm_source=rss&utm_medium=rss&utm_campaign=insane-in-the-membrane Thu, 23 Jan 2020 16:03:33 +0000 https://www.flexmedical-solutions.com/?p=211711 The post Insane in the membrane! appeared first on FlexMedical Solutions.

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Insane in the membrane!

The development of analytical methods employing biosensors has observed a significant growth in recent years. Immunosensors, a class of biosensor that consists of a bioreceptor and transducer, are widely used and are particularly important for the rapid diagnosis of diseases.

Immunosensors take advantage of the specific interactions between antibodies and antigens, preserving the antibody onto a surface in order to achieve high sensitivity and accuracy.

Functionalised Sensor

Immunosensors take advantage of the specific interactions between antibodies and antigens. Antibodies are proteins that are generated by our immune system to identify viruses, parasites, and bacteria. The specific interaction between the antibody and antigen will produce a signal, which can then be further analysed by different techniques.

One of the major challenges of an immunosensor is the ability to preserve the antibody onto a surface in order to achieve high sensitivity and accuracy. Antibodies are very sensitive to their environment and are susceptible to loss of activity when near the solid surface of the sensor. In order to overcome this, effective surface functionalisation or modification of the surface of the sensor offer the most important steps in the manufacture of immunosensors.

Poly (vinylidene) Fluoride, or PVDF, is a chemically resistant and durable fluoropolymer that is used as a sensor surface modifier. When applied to a surface, PVDF forms a 3D matrix which helps to immobilise and distribute antibodies over the entire surface area. The polymer has a high protein binding capacity which offers optimum performance for all immunosensors, especially those assays involving lowly expressed antibodies.

Other membrane polymers, such as nitrocellulose, (charge modified) nylon, and polyethersulfone are also used for the purpose of surface functionlisation of biosensors. Each one offers different primary binding mechanisms that can help create an improved site for binding for a variety of biosensor applications.

Healthcare has now become more consumer focused and as a result, the need for convenient monitoring and testing has expanded globally. Technology is catching up with this demand with innovative medical device organisations already developing point of care devices that can provide real time results.

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A Sticky Situation – The Use of Adhesive Tapes in Diagnostic Tests https://www.flexmedical-solutions.com/blog/a-sticky-situation-the-use-of-adhesive-tapes-in-diagnostic-tests?utm_source=rss&utm_medium=rss&utm_campaign=a-sticky-situation-the-use-of-adhesive-tapes-in-diagnostic-tests Fri, 22 Nov 2019 11:50:08 +0000 https://www.flexmedical-solutions.com/?p=211699 The post A Sticky Situation – The Use of Adhesive Tapes in Diagnostic Tests appeared first on FlexMedical Solutions.

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A Sticky Situation – The Use of Adhesive Tapes in Diagnostic Tests

Point-of-care (POC) diagnostics are a rapidly growing technology allowing for the effective and efficient delivery of healthcare. The demand for faster analyses and results have led to the development of more sophisticated diagnostic tools; however, the fundamentals of the design and development of such medical devices remains unchanged.

The FlexMedical team won the Rising Star: High Growth Company Award at Scotland’s Life Sciences Dinner and Annual Awards.

One critical point to consider when developing a POC device is material selection including the adhesive used to laminate the layers that may be incorporated within the design. Adhesive tapes are commonly used in the manufacture of medical devices. They are lightweight, offer an invisible bond and have high performance characteristics that make them an ideal component in a device. Nevertheless, these characteristics and the way the adhesive interacts with other components directly imparts on the performance of the device.

There are many categories of adhesive available (e.g. silicone, acrylate, hydrocolloid, and synthetic based rubber) and within each type there are varying configurations (transfer adhesive, single coated, and double coated). With such a variety on offer, testing of the selected adhesive against the intended substrate becomes imperative to ensure it is fit for purpose.

Typical measurements that are commonly used in the testing of adhesive tapes include:

• Tack – the measure of the adhesive’s ability to adhere quickly to the substrate
• Peel – the measure of the adhesive’s ability to resist removal from the substrate by peeling
• Shear – the measure of the adhesive’s ability to remain in place on the substrate when a shearing force is applied

Adhesive bonds can typically undergo two types of failure; adhesive and cohesive failure. An adhesive failure occurs between the substrate and the adhesive whereas a cohesive failure is an internal failure of the adhesive to adhesive bonding. Any adhesive failures within a device can have detrimental effects on the system’s performance and accuracy/reliability hence the reason material testing is of paramount importance when developing point of care medical devices.

Rigorous design practice, coupled with sound material choices, will pave the way towards successful point of care design with organisations involved in the development of such diagnostic devices are at the forefront of the advancement of better diagnosis, monitoring, and management of diseases.

 

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MEDICA 2019 https://www.flexmedical-solutions.com/news/auto-draft?utm_source=rss&utm_medium=rss&utm_campaign=auto-draft Mon, 04 Nov 2019 17:19:25 +0000 https://www.flexmedical-solutions.com/?p=211684 The post MEDICA 2019 appeared first on FlexMedical Solutions.

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MEDICA 2019

We are delighted to confirm that FlexMedical Solutions will be exhibiting at MEDICA from 18th to 21st November 2019. 

FlexMedical Solutions offers contract design, development and manufacturing services to the diagnostics industry. The company has a specific focus on point of care (POC) test consumables.  

You can visit us at Hall 16 Stand K03-1, contact info@flexmedical-solutions.com if you have any questions or would like to book a meeting.

For more information on the exhibition please visit the official MEDICA website: https://www.medica-tradefair.com

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