The Heartbeat of the Business
The Heartbeat of the Business
February 17, 2006: The pioneering Australian medical device innovator Ventracor uses Microsoft Navision to help take its revolutionary heart pump to the world and improve the lives of thousands of people. Stuart Finlayson finds out how
Ventracor is an international medical device company focussed on the rapid commercialisation of the VentrAssist implantable heart assist system.
VentrAssist is being trialled as a permanent alternative to a heart transplant for people with heart failure. It is also being trialled to help heart transplant candidates survive long enough until a donor heart becomes available for transplant.
VentrAssist is essentially a blood pump connected to the left ventricle of the heart to support its function so the heart can recuperate. Its unique design has only one moving part, a hydrodynamically suspended impeller, which is designed to never wear out and minimise any damage to the blood.
It weighs just 298 grams, is made from titanium and carbon and is suitable for a range of body sizes because of its small size but high power output.
The company is poised to enter an international market independently estimated to be worth up to US$12 billion annually. More than eight million people worldwide suffer congestive heart failure. Of these, approximately 800,000 have less than a year’s life expectancy, yet only 3,500 will receive a transplant due to the scarcity of donor hearts.
The company is currently in clinical trials with VentrAssist in Australia, New Zealand and Europe and is close to approval from the United States Food and Drug Administration (FDA) for a trial in the USA this year.
Tectura (Australia), a provider of integrated business solutions to the mid-market, has worked closely with Ventracor to implement Microsoft Business Solutions' Navision Enterprise Resource Planning (ERP) software to assist the company to complete its total transition from research and development (R&D) to the manufacture and distribution of the VentrAssist heart pump.
To facilitate this evolution, Ventracor needed to implement a system that would allow for advanced Quality Control and Assurance as well as administer inventory of more than 700 different stock items.
It also needed to be robust enough to manage Ventracor’s financials, enable Ventracor to adhere to Good Manufacturing Practice (GMP) regulations and to stand up to future scrutiny by regulatory authorities in Australia, Europe and the USA.
Ventracor's design and development manager, Steven Marshall, says the company foresaw the need to implement a uniform ERP system across all of its departments.
“In 2003, we were basically a research company but we were heading towards commercialisation of our product which meant we were moving into manufacturing so we needed a system that would support that. Previously, there was no company-wide system."
Initially, the new system’s task was to update and streamline Ventracor’s finance department which was using a Sage legacy system.
According to Ventracor’s systems accountant, Paul Curlisa, the company knew that if it was to replace the accounting software, it would eventually need an ERP system so it could add on manufacturing, warehousing or sales modules or whatever else it needed.
“We didn’t have an exact picture of what the finished product was going to look like but we approached it with the view that it had to fit our entire organisation," recalls Curlisa.
Finding the SolutionVentracor drew up a specification and invited tenders from six ERP system resellers including suppliers of Navision, Great Plains, Sage and SAP.
"After that, we narrowed it down to Navision and Sage. We then asked them for a more detailed proof of concept," recounts Curlisa. "We wrote up our specifications for what functions we wanted to see the systems perform and we evaluated the demonstrations."
Specifically, Ventracor wanted to compare each solution’s capacity to interface with Excel, as well as their electronic purchase order functionality and the ability to drill down to trace individual transactions to their source.
“Security was a priority and the solution needed to be able to lock out different levels of users from specific sections of the system,” says Curlisa.
Ventracor was initially attracted to the possibility of migrating to an upgraded version of their existing Sage system.
“We could see an advantage in that but then we looked at the future of both products and we thought Sage may have reached the end of its life cycle. Navision, on the other hand, especially with Microsoft coming on board, seemed to have a lot more potential in every way.
“Selecting a partner was the next step and we chose Tectura because they gave us the answers we were looking for," offers Curlisa.
Tectura Navision solutions architect, Tim Shaw says Tectura introduced Ventracor to its Life Sciences module, which was developed by Tectura (Germany) and was not offered by any other Navision reseller in Australia.
“One of our major competitive advantages was that the Life Sciences module integrates Quality Control functionality to reduce duplication of tasks,” explains Shaw. “Normally this functionality would have to be added on by non-integrated products but the Life Sciences module integrates it.
“It also conforms to GMP (Good Manufacturing Practice) regulations which are a legislative requirement for companies that manufacture pharmaceutical products or devices which can be implanted into humans."
A gradual processVentracor started Phase 1 of its Navision implementation with Tectura in September 2003 and went live in Financials on December 1 that year.
Curlisa says the implementation had been achieved by his team working closely with Tectura.
“We have a small finance department so Phase 1 was a one-on-one project which is how we wanted it - we didn’t want big teams and a huge process.”
Phase 2 was implemented over several sub-phases from August 2004.
According to Ventracor’s design and development manager, Steven Marshall, the sub-phases were based around the function that Ventracor wanted to automate such as purchasing, goods receivable, stock and production work orders.
“Since February 2005, we have been “live” in all phases in production."
Ventracor is now using Navision across its Finance, Logistics, Production, Quality Control, Quality Assurance and Design and Development departments.
Ventracor Documentation Controller, Chris West, says the results of Phase 2 are encouraging.
“We’ve established electronic purchase orders for every part of the business which has been an enormous help to us.
“Goods Receivable is now all receipted through Navision. Quality Control, specifically, the goods inwards inspection quality control, is all recorded through Navision. Stores, or Inventory Management, is set up in bin locations so all transactions in and out of Stores are being conducted through Navision.”
West says the assembly of VentrAssist is also being managed through Navision.
“We’re using production orders to build product. It has an Item Master Card for every part and we are compiling more and more information for that Master Card. Every part entered into Navision has to have its own master file that details its part number, description and supplier before we can do any transactions on it.
“As a part is booked in, it’s given a batch number and wherever it is used, that batch number goes with it so that whatever transaction we carry out, we can see where that batch has gone. Then, with a production order, we can see which batch numbers have been used.”
This means Ventracor can source the origin and history of every part used in every system implanted in every patient taking part in its clinical trials
Marshall says the company’s Navision purchase order system was much more advanced and reliable than Ventracor’s previous paper-based system.
“We had a purchase order system but it was manual and there was less control over the purchasing function. A high level of control is necessary for GMP purposes."
Ventracor has two types of purchasing, one for production components and the other for purposes such as administration and R&D. Both are raised and authorised through Navision.
“Purchasing is initiated by the purchasing officer and they will purchase components based on a pre-existing specification and a pre-existing supplier which is already programmed into Navision.
“Once they raise the purchase order, there’s an approval process for the purchase which goes to his supervisor, or, if it’s a very high value purchase, the purchase order is automatically routed to the head of manufacturing for approval.
“This cascading level of authorities, based on the value of the purchase order, is built into Navision and is what gives us such excellent control,” Steven said.
Cracking the US marketMarshall says Navision has brought Ventracor’s processes in line with the standards required for approval by the FDA as well as operating in accordance with Good Manufacturing Practice, also a requirement of FDA approval, which will allow Ventracor to market VentrAssist in the United States.
“They require us to manufacture the product in accordance with a set of fairly descriptive processes to ensure that the manufacturing processes are reliable and safe."
Marshall adds that the automated record keeping and reporting through Navision has improved the accuracy of Ventracor’s financial records.
“Importantly, Navision facilitates accurate record keeping of what components have been issued to which devices. That allows us to also provide traceability information in the event that we need to trace what components have been issued to which devices in the field.”
Navision has given Ventracor greater control over purchase orders with automatic requests for purchase authority and privileged access to areas within the system. It has also automated Ventracor’s Receiving and Inventory processes.
Additionally, Navision’s Life Sciences module by Tectura has ensured that Ventracor’s Quality Control functionality is intensive and integrated. It integrates Quality Control measures such as scrutinising inventory and the inspection of raw materials received from suppliers. Without Life Sciences, such functionality would stand alone causing duplication of tasks and greater opportunity for errors.
Peter Maggs, managing director of Tectura (Australia), says Ventracor has gained a strong foundation for its goal of bringing VentrAssist to rapid commercial realisation through its Navision implementation.
“Navision, and specifically Tectura, offered Ventracor ERP functionality that no other business solution and systems integrator could, in the form of the Life Sciences module.
“It attests to Ventracor’s strong vision for its future that they grabbed it with both hands.”
Chris West says Navision had enabled Ventracor’s transition from R&D company to manufacturer.
“Basically, we couldn’t run the business without Navision. Now that we’re in a production environment, we rely on the visibility over our whole operation that Navision gives us.”
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