Life Sciences IT
As we begin the New Year we’ve gone through our resolutions. Now the focus for us is to gain a fast start and the aim of this first blog post around the idea of the Life Sciences Industry Cloud. I’ll provide the background and challenges you will face, and what you could consider that will put IT in a position to help meet your business goals.
Background: The Enterprise in 2015
Cloud computing has been often discussed as the innovation option for Life Sciences companies. Back on September 7th, 2014 I wrote about an initial way of getting into cloud via Testing in Planning your Move to the Cloud? as an option to get the organization used to using cloud applications.
I read an interesting article from Alison Wagonfeld (@awagonfeld) The Enterprise in 2015. Which takes an investor’s perspective on technology trends for the Enterprise, and the focus on “industry cloud” applications. The article points our examples from Salesforce and Veeva of applications that can be rapidly deployed and consumed by business users. This puts Enterprise software vendors in a place to play catch-up with two distinct reactions/approaches. One is to buy up point solutions, and leave the integrations to the systems integrators (SIs) or the end-user. Cloud applications are easy to deploy the key here is to make sure you plan out the business process. The second being a hybrid approach where part of the solution is deployed as ‘on-demand’ (in the cloud) and integrated with the rest of the back office application (on-premise). This forces the end-user to rely on their SI to have the right resources and plan for every interface and data point.
There is a nice summary on the software challenges we will face as we seek to improve the business with technology. Lora Cercere’s (@lcecere) article “Undeniable Truths of Software” provides some very good perspectives on the challenges that Enterprise Software vendors face. She describes a variety of challenges with software companies.
Because the cloud vendors come at the problem from the user side it is easier to create a solution with no back-end integration. The challenge for the Enterprise Software vendors is do they re-write the application or develop only a portion of the business process. There are some Life Sciences clients that are waiting to see how the enterprise software vendors respond to the challenge from cloud applications. There are other considerations from a business user perspective that is driving these discussions*.
[*I will look at the issues with Big Data and Mobility in another blog post.]
Best practices that allows you to leverage cloud applications
Prior to cloud applications the focus was on ‘best practices’ for each industry. I contend that we have to resurrect these processes as a guide to reaching the Life Sciences Industry Cloud.
The focus should be on the business process and the integration points needed to offer the complete process for the end-user. This allows for an easier time to ‘validate’ the process. In 2015 we are at a point where business users are clamoring for IT to improve the business. The benefits are as follows:
- Enterprise software vendors can pick which part of the business process to move into the cloud or stay on-premise. Timing for all this is inevitable as the users of the solutions prioritize business process that give the highest benefits and can rank them so.
- System Integrators (SIs) will have to live with the fact that deploying cloud applications are more about the experienced resources used in faster and quicker projects than long program deployments. Done well repeat business will help drive net new opportunities.
- Clients need to become more aware of the users and how they work to give the right business process. Change should be the motive in all this – failure to recognize this will lead IT to fall out of favor with the business.
For many customers the move into cloud applications can be daunting given the investment in on-premise software applications. Today’s users want to work more efficiently and have already personal experience with cloud applications. The goal for 2015 is how well you can adopt the Life Sciences Industry Cloud into your organizations.
Let me know what you think?
This month my focus is on Supply Chain in Life Sciences. As we head towards the end of the year budgets are being planned and IT projects are being prioritized for next year. Many companies are reviewing their current IT investments in light of mergers and acquisitions and projects that will add to the company’s business ability. My discussions have been around how best to improve your operations at a minimal cost. No one seems to want to buy new IT systems and they want to extract ‘value’ from their current IT systems.
Time to ‘Tune-up’ your Supply Chain
Ask yourself if you are getting the most from your current Supply Chain? Do you feel you’re gotten significant return from your SAP or Oracle investment? It seems everyone had one of these IT solutions. I believe the reason most companies should be looking at their Supply Chain is as follows:
- Most firms have invested in IT solutions to help react quickly and expect demand. We now are moving to ‘collaborative’ business processes as a means for extracting added value from your partners.
- Companies need to give supply chain ‘visibility’ so that the organization can make faster and better decisions.
- Business process improvements need re-training for your people.
I get this now how do I get there?
The answer is to create a ‘road-map’ for your supply chain that includes opportunities (projects) specific to your business systems. The key is how to develop this road-map. You need to have the following:
- Supply Chain experts that can analyze your data and processes.
- IT ability to look at how your SAP or Oracle solutions have been installed.
- Our company has developed a unique set of tools that can analyze your Demand, Supply and Inventory.
We’ve created a project approach to this kind of analysis. Over the next few months I plan to promote this approach for Life Sciences and yet this approach is not just for this industry. I know this can be applied for any industry that is looking to get more value out of their IT investment in supply chain. As we gain traction in the market I hope to offer some proof points to this approach.
I would be interested in your comments and suggestions on this topic.
Last month I spoke about the ‘model’ for integrating clinical operations. In this blog post we’ll review the solution that was presented at the Oracle “OpenWorld” conference held earlier this month. There is also two links to collateral that you can use to help understand how the solution works at the end of this blog post. I welcome your reaction and comments.
I’ve written about ways to improve R&D from the idea of “ERP for R&D” through “Integration” of key business processes. In summary the background issues that I think drive this solution are:
- Access to relevant data
- Getting out of the IT business within R&D
- A solution that is scalable to meet tomorrow’s business needs
How does this solution solve these issues?
Starting with ‘Access to relevant data’ – there have been many attempts to create an IT landscape for R&D. This best-of-breed approach favors decisions that support the best solutions to meet a specific need. Yet if you take a step back and ask how I can get access to facts to make ‘key’ decisions this approach falters. The solution approach being offered starts with the premise that the user needs access to key data. Based on an individual’s role you get access to key data and permission to upload new data. This removes the user from having to make the required ‘conversions’ between solutions to create the information needed. The benefits include:
- Adaptive trials can now be easily facilitated
- Financial decisions tied to key outcomes of clinical trials can be reviewed and decided upon
- Users get to focus on the science of creating new medications and treatments and not the nuances of the technology
Getting out of the IT business – the biggest advantage to this solution is that Pharmaceutical companies can focus on their core business goals of producing new products to complex diseases.
You now have a scalable approach to R&D. This solution not only accommodates your scientists and statisticians you can also invite clinical research organization (CROs). Data security is also key to this solution since you may be adding other teams to help in the development of new clinical products. The solution also takes globalization into consideration as a result of today’s clinical trials.
The purpose of this blog post is to summarize a model for ‘integrating’ clinical operations. I’ll summarize the goals for this model and describe the background and next steps around such an offering. Over the past few months I’ve been engaged with several clients in discussing how our IT Services Company could create such a platform. This new platform should meet the following:
- Lower Operating Costs
- Increase Productivity
- While maintaining Quality and Compliance
There are several very good software solutions yet we know that there is a lack of an ‘integrated’ process that can ‘unify’ the R&D clinical data landscape of IT solutions. The key here is a focus on ‘transformation’ rather than ‘yet another technology implementation.’
In a earlier blog post titled “Improving the Business of RandD” (31Mar2011) the focus was on cloud computing and how this technology could lead to an ‘integrated’ business process. Since companies would be relying on IT Service providers to host these applications. In another blog post “Is It Time for “ERP for RandD?”” (30Apr2011) I spoke to the need for integrated business processes. Now I’ll look to pull these to thoughts together for a more complete view across clinical operations.
Let’s start with the Users
This integrated approach would address users that include Pharmaceutical companies, Clinical Research Organizations (CROs), and any Healthcare entity. We would leverage cloud computing solutions to offer the users with a portal that supports:
- Single point of information capture
- With access to data by role, study and function
- Single sign-on
Here there is a dedicated source of content by pharmaceutical company. Various databases would be organized with content ranging from electronic data capture (EDC) to clinical and scientific data warehouse (CSDW).
Key to the content layer:
- Dedicated source by pharmaceutical company
- Providing flexibility to support variety of data sources
Business Shared Services
Supporting the users and the content is layer of business services ranging from:
- Component user support
- Change management
- Staging and data migrations services
- Data reconciliation
Our team will be presenting this approach at the upcoming Oracle OpenWorld conference in October. In addition to this we will also be presenting on the topic I wrote about last month – Serialization. I am very appreciative of my colleagues – specialists in a variety of topics. What I find satisfying is in ‘stitching’ all this together. We now have several interested clients and the possible next steps are to deploy this solution and that will take some time. I would be interested in hearing from you – and your comments on “Integration for RandD.”
I recently attended an Oracle product training session for ‘serialization.’ The Life Sciences industries, and especially pharmaceutical and medical device companies, are gearing up for the need to offer product traceability. This blog post will be the basis for a possible industry presentation later this year.
There are several solutions that address pedigree and serialization. A recent article by Carla Reed provides a great background to this topic. (Reed, Carla. “Beyond the mandates: Finding business value in mass serialization and supply chain visibility.” Pharmaceutical Manufacturing June 2011: 34-36.) I can recall as early as 2006 when radio frequency identification (RFID) tags were introduced as the solution for the industry. We know that for various reasons this never panned out due to price for the tags and adoption within the industry. Today a good example of this technology is the use of RFID with the devices that help automate toll collection on the various US highways.
Alternative technologies to RFID tags include 2D barcodes. Printers can create these unique tags at a fraction of the cost of RFID tags. The Oracle solution allows you the ability to attach these tags and their associated numbering at any level within your product hierarchy. This data can then be organized into a ‘pedigree’ document for your product. This would be analogous to ‘shipping’ papers that you would normally prepare once you prepare to send your product off to a distribution center or local warehouse.
Implications for supply chain
Now doubt that technology alternatives exist to help solve the problem of product traceability and authentication. Companies today are being forced by local and global regulations for the need to provide traceability solutions. The questions for many companies is just how to go about solving this problem. Let’s first decide what you want to ‘track’ within your product and your business process. I often describe the application of technology with the use of a ‘babushka’ doll (or Russian nesting doll). Where do you want to apply a tracking solution within your product? How do you want your supply chain to track your product?
Why IT services?
An interesting comment came out of the training session when one of the attendees asked “when would I use an IT services company?” Some manufacturers have looked to their packaging and labeling suppliers to provide the ability to ‘serialize’ and track their products. This would be a great idea were it not for the fact that these suppliers lack the resources and ability to discuss the need for traceability within a ‘business process.’ This became very clear when the discussion turned to when do you apply serialized information? You see no two products are manufactured in the same way.
Some manufacturers use production order with routing to make their products and some use process orders and recipes for their products. That was a tough conversation and when I raised the fact that production and process orders can often be mixed – well let’s say that the value of IT services providers that can navigate a client’s business process answered this question.
Some next steps
In my opinion IT service providers need to offer:
- The ability to understand a client’s business process and offer cost-effective solutions to the application of serialization and product traceability.
- Provide the ability to organize a series of steps within a project to deliver a solution. You need good project management – deliverables that includes documentation (yes it is a validated environment) – with skilled resources. Ask your IT service providers if they have any ‘accelerators’ for this type of work?
- Have the technical ability to apply Oracle and SAP solutions. This is a mixed technology environment and there is no one solution to solve this problem.
I will let you know if this turns into an industry presentation later this year.
Most of us are excited about the changes occurring in healthcare around mobile applications, electronic health records and the advent of social media just to name a few examples. Yet there is a mounting concern with the rise of drug shortages now reported at “178 a 3x rise since 2005!” A look at the FDA web site for drug shortages shows a list of both generics and branded products with the reasons for the shortages (including manufacturing delays, increase in demand, etc.). We’ll look at the background of the industry, the traditional view of supply chain, current factors facing the industry, and what companies can do to ‘improve’ their operations. Recognizing the need to convert your improve your existing operations will be good business and the consequences will directly impact you and I.
Key facts about the industry
According to IMS Health pharmaceuticals sales in 2011 is expected to reach 880 to 890Billion USD, which is a growth of 5 to 7%, and is 1% higher than the 2010 expectations. The current view of the supply chain includes:
- In the US market the top 10 pharmaceutical companies give some 60% of the total US sales.
- As products come off patent Generics control the prices of these products.
- The wholesalers may also negotiate prices between the manufacturers and the Pharmacies.
The traditional view of the supply chain
The driver for any supply chain is to offer:
- Product at a ‘reduced’ cost
- Faster to market
- Delivered at a high quality
Apply this to the previous diagram and you can see the challenges that face healthcare. As the view of the patient and pricing for these products are disconnected. This diagram gives you the full view of the Healthcare supply chain:
Current factors influencing the industry and the Healthcare supply chain
The following factors have influenced the market:
- Mergers and Acquisitions – have reduced the number of manufacturers as companies have consolidated to make up for the loss in patent expiry and look to increase market share (Merck and Shering Plough, Pfizer and Wyeth, and Teva and Barr Labs are just a few examples)
- Regulatory issues – it is harder for manufacturing sites to recover from an FDA violation. This delay can lead to drug delivery delays.
- Government control over pricing – as the cost of healthcare rises many governments are dictating the price of drugs (Spain, Canada, Turkey and Greece). This puts the supplier at a disadvantage to be able to deliver products at these ‘reduced’ prices given the cost for raw materials.
- Globalization – in response to some of these factors many companies have already moved their operations to off-shore locations. India for API manufacturing.
- Risk Management – having the ability to ‘view’ any of these problems can lead to drug shortages. Supply chain operations must therefore give this visibility so the right changes can be made.
Taking these factors into account and with a view of the ‘future’ of the healthcare supply chain from Gartner:
How can I ‘improve’ my operations?
I now work with a variety of companies that look for solutions to ‘improve’ their processes. We began his discussion trying to understand why there are so many drug shortages, and I would suggest the following as a means of enhancing your supply chain operations:
- Refocus business growth and performance across the entire healthcare supply chain. This includes both the patient as providers of healthcare with a C level sponsor that understands that the aspects of healthcare lie outside of your companies boundaries.
- Collaboration. Look to improve demand from both your suppliers as well as your customers. Provide visibility and metrics that you can mutually share.
- Leverage IT as an enabler to meet the first two points. Make investments that promote organizational visibility. Specifically analytics solutions that provides management with a view the business as a result of this investment.
- Governance. This process does not happen overnight. Change management is an ongoing process and you will need leadership and support to sustain these processes as they evolve over time.
- Invest in skills and talent within your organization. I’m in the IT services business and you would think this takes away from my opportunities. There is a tendency to think that these processes can be solved through off-shore support capability. While this is true I am taking about the need to enhance your folk’s ability to understand the entire healthcare supply chain.
I am convinced healthcare can improve yet the threat of drug shortages can impact any course of treatment if the right products are not available. What I hope to do with this blog post is a summary of the problem and possible solution. I welcome your suggestions or comments to improving this blog post.
Aligning Life Sciences and Healthcare IT. Part 2 A Practical Mobility Solution for Doctors and Nurses.
In Part 1 of Aligning Life Sciences and Healthcare IT – I introduced the ‘value chain’ for these industries, and discussed lessons learned from Life Sciences IT to help Healthcare IT in the use of technology. In Part 2 I am providing a practical application on the use of handheld (mobile) devices being used by doctors and nurses. The healthcare providers leverage this technology for patient care, and this provides Life Sciences manufacturers with a market ‘differentiation’ against their competition. At the end of this article I will provide a link to this ‘case study’ which we have named Patient Monitoring System (PMS).
As a background to this blog post I have been researching this topic. In an article by Jacob Goldstein, Can Technology Cure Health Care? , WSJ.com, April 13, 2010 (the main search title is “Can Digital Medical Records Fulfill Their Promise?). The theme of this article was on how hospitals can leverage the promise of technology. In this case the focus was on digital medical records. What I got out of this article was that technology, when misapplied, can be time consuming and take away from patient care. This got me thinking about the strategy behind the use of technology that supports our caregivers in putting the ‘patient first.’ The use of ‘change management’ is the key for any new technology. Especially when it is intended to reduce the workload for those involved. The last thing you need to worry about is how frustrated the users can be with new technology. This article did a nice job of going through lessons learned when implementing new hospital systems.
I find the Information Week Global CIO articles by Bob Evans to be very useful. In The Golden Age Of IT Has Begun: 6 Reasons Why by Bob Evans, Information Week May 24, 2010, this article summarizes the new opportunities available to CIOs. While IT vendors are coming out with functionality to help CIOs with their current IT landscape. I was very interested in the use of mobile handheld devices that can be used as strategic tools with access to analytics in order to make key business decisions.
Which leads me to the following….
The story which led to this solution
Our client is a global medical supplies company. They provide products for Ostomy and Continence care; Urology, Wound and Skin care. These are products that are sold to hospitals, institutions, as well as wholesalers and retailers. They are products that healthcare workers use to make life easier for people with medical conditions that are very personal. I have heard them describe this as “intimate healthcare.” As you can imagine there are competing products in this market. What our company provides is expertise in application development, maintenance and testing services. We were asked to help provide a “value added” service for their customers (targeting doctors and nurses) in order to help differentiate their products over the competition. This solution had to work in a hospital and home care environment. Doctors and nurses wanted to balance scheduling supplies, and services in their delivery of intimate healthcare to their patients.
The solution provided operates on both a personal digital assistant (PDA) and any desktop. Doctors and nurses are free to go about their daily routine since the application takes care of synchronizing patient information across these devices. The technology was delivered as an ‘integrated’ application including:
- GPS navigation – so when a nurse plans to visit a patient they can enter the address and the devices provide directions from that location.
- Calendar functionality – so that nurses can schedule visits, doctors can arrange appointments with nurses to discuss patient results, nurses can also schedule supplies to be delivered on the date of a patient visit.
- Photographic audit and document capability – these days a picture can tell you a lot about the patient’s healthcare outcome. This also allows for easy documentation for regulatory and financial purposes.
I would say we spent considerable amount of time working with the nurses and administrative staff to ‘fine tune’ this solution. Our client feels that this use of technology adds value in differentiating their products in this market. They currently bundle this solution with their products. Currently, they are being used in hospitals and for home care providers throughout the UK region in over 67 locations.
In this case information technology is used to align the needs of Life Sciences companies who want a advantage over competitors. Healthcare providers want to use technology that does not interfere with their goal of patient care. In order to reach critical mass on any new technology there has to be some iteration of the solution. We have the experience and proof that it can be done. I will offer to you a link to this case study. A brief document that covers some of the same detail I provided as well as some pictures of the desktop and PDA application. Please follow the link and download the pdf called Patient Management System (PMS).
I would be happy to help you learn more about this solution. Please feel free to leave me a comment regarding this blog post.