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Setting the benchmarks for a new paradigm in dialysis

Tuesday, August 23, 2016 - 05:50
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Prof Neo and Ms Wong are at the forefront of the industry and are also actively involved in shaping the content of certain standards as there are currently no standards for sorbent regeneration.
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The AWAK PD System, created with Temasek Polytechnic, has already made its debut, and is being tested at the Singapore General Hospital.

"OUR vision is simple," says AWAK Technologies executive director Neo Kok Beng. "We want to create a new paradigm in dialysis - to enable freedom, so that patients can go where they want, so that patients don't have to be stuck in one place while they do their dialysis."

AWAK Technologies is a medical technology company that is dedicated to the research, development, and marketing of its sorbent technology which has revolutionised dialysis by reducing the amount of dialysate needed for treatment by continuously recycling and regenerating the dialysis fluid.

This technology has enabled the development of light-weight, compact, automated, wearable, and portable medical devices, which in turn translates to higher quality of life for patients.

Its AWAK PD System (Automated Wearable Artificial Kidney Peritoneal Dialysis), created with Temasek Polytechnic, has already made its debut, and is being tested at the Singapore General Hospital. The 1kg machine can be worn on a belt or carried in a bag so patients can have water dialysis around the clock.

Patients on water dialysis strap themselves to a machine for about 10 hours a night. They can also manually run the solution in and out of their abdomen via a tube every four to five hours. The wearable kidney on the other hand mimics a real kidney and offers 24-hour dialysis.

In 2014, AWAK joined forces with Debiotech of Switzerland and Neokidney Development, an initiative of the Dutch Kidney Foundation, to develop a portable haemodialysis machine.

The machine is expected to be the size of a home printer and weigh less than 10kg. Traditional machines at dialysis centres typically weigh between 80 and 100kg .

Says general manager Jasmin Wong: "Dialysis is traditionally done in the centre, so patients have to travel from home to the dialysis centre three times a week. Each session is about four hours. This method uses up to 120 litres of fluid whereas our device for haemo dialysis uses only six litres of fluid. We regenerate it by recycling the same amount of fluid over and over for four hours."

It is imperative that AWAK adopt standards to ensure compliance with relevant legislation including European and US Food and Drug Administration regulations.

The company is ISO13485 certified. ISO13485:2003 specifies requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

Adopting this standard has translated into AWAK having a controlled design process that includes risk management, verification, validation and controlled transfer of a design to manufacturing.

It also affords access to international markets as Awak is recognised as a quality-centric company.

But being at the forefront of the industry also requires AWAK to be actively involved in shaping the content of certain standards.

In 2012, AWAK initiated the formation of the Singapore National Mirror Working Committee IEC SC 62D/MT20. Singapore became a participating member in the international committee in 2016. As a participating member, it is able to impact the creation of standards for dialysis. Awak was invited to join this committee as it regularly participates in annual international kidney conferences and is one of a few companies with sorbent regenerative technology.

"There are currently no standards for sorbent regeneration so we are participating in the drafting of the standards," says Prof Neo.

"In that sense, we are creating standards rather than adopting standards. Generally when you are new to the field, you (adopt) standards so you can sell your product. So that is if you are a follower; you value-add. But if you are leading in the field, then there are no standards to follow. You have to create the standards."

The Singapore National Mirror Working Committee maintains the following standards:

  • IEC 60601-2-16 Medical electrical equipment - Part 2-16: Particular requirements for the safety of haemodialysis, hemodiafiltration and hemofiltration equipment;
  • IEC 60601-2-39 Medical electrical equipment - Part 2-39: Particular requirements for the safety of peritoneal dialysis equipment;
  • IEC/ISO62653: Guidelines for the safe use of medical products in dialysis treatment.

AWAK is also a member of the Association for Advancement of Medical Instrumentation (AAMI) Renal Disease & Detoxification Committee, and actively contributes to the creation of AAMI Technical Information Report for sorbent-based regenerative haemodialysis equipment.

Being part of such committees means AWAK is able to receive first-hand information of new standard development. This translates into a first-mover advantage which affords substantial cost savings and greater efficiency especially in the research and development stages.

It also provides significant competitive advantage to AWAK, particularly as it expands its geographical reach.

"We are going global and every country has different requirements and machines. For example, the Japanese have their own machines, and the Japanese way of operating a dialysis centre is different from the American way of operating a dialysis centre. So every country has its requirements and therefore our objective is not to build so many machines."

"Since we are going to work with everybody in the world, everything we do must conform to some standards."

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