June 8, 2015 Issue
The Most Powerful Name In Corporate News and Information
Innovative Injectable Drug Delivery Technology Platform
President & CEO
Interview conducted by:
Lynn Fosse, Senior Editor, CEOCFO Magazine, Published – June 8, 2015
CEOCFO: Mr. McWilliams, what is the idea behind Medipacs®?
Mr. McWilliams: In a nutshell, Medipacs has developed an innovative injectable drug delivery technology platform that is precisely controllable like an infusion pump, but you can wear it on the body. It is small and unobtrusive. This technology is going to revolutionize the future of personalized medicine, where drugs are adjusted to the patient’s physiological response. Chronic diseases like Chronic Heart Failure and Pulmonary Hypertension will be addressed by keeping patient’s from being re-admitted to a hospital for treatment, thus reducing cost.
CEOCFO: What is the science behind it? How does it work?
Mr. McWilliams: In drug delivery, with relation to injectable drugs, pumps have been used when precision doses are needed. The problem is that those pump mechanisms are very complex and expensive. An infusion pump can cost between five thousand and twenty thousand dollar.
What Medipacs has done is to create and develop a novel polymer that is revolutionary in its properties. Large size changes can be driven by electrical inputs, that create large expansions of the polymer volume, and thus can easily displace the drugs into patients. Therefore, we can replace the complex and expensive mechanisms found in all infusion pumps with a slab of material that expands to displace drugs from a separate small reservoir contained in the device. The result is a very broadly applicable technology for administering injectable drugs of all kinds. What is even more remarkable is that this new polymer technology is very precise. This enables us to deliver these drugs using native pharmaceutical forms directly under the skin in smaller concentrated amounts. Today, infusion pump technology requires those drugs to be diluted, perhaps to hundreds of times the drug volume while being delivered. When a small volume of drug is diluted into a large volume of diluent - that is required to work with current pumps, the drug has to be administered into the patient through an IV line. Therefore, the smaller Medipacs ‘polymer pump’ is uniquely able to administer, subcutaneously under the skin, many of the drugs now delivered via an IV line.
CEOCFO: The polymer expands in response to electrical inout. How does it get inside the patient and under the skin?
Mr. McWilliams: A small drug reservoir is contained in our matchbox sized pumps, which is attached to the patient with adhesive tape. There is a small soft rubber cannula that is inserted under the skin. It is initially introduced with a needle, then the needle is removed leaving the cannula behind - (Insulin patients have used this system for many years). There is a connection between the drug reservoir in the device and the cannula under the skin. As the polymer expands, it fills the volume inside the device, and pushes the drug into the patient.
CEOCFO: Have there been similar attempts at an end result like you have?
Mr. McWilliams: ‘Small,
wearable, low cost and convenient’, yes, this has been the Holy Grail for
injectable drug delivery
for many years. However, technologies that could function like this
have not been available. What Medipacs has done is
that might be used for
such a system.
CEOCFO: Where are you today? Is the product ready to go? Is it still in development?
Mr. McWilliams: 'What was key, from an engineering perspective, was to get that science into an engineered component. We call it an actuator. The polymer lives in our actuator. Two electrical leads come out of it and connects to a circuit board that controls its expansion, and in turn controls the drug being administered into the patient. Once we had the science reduced to practice in an actuator, using it to put that actuator in the pumps is a much more straightforward engineering process. First, we developed the technology and now we turned to developing the pump products.
We have completed a product for use in Veterinary Surgical hospitals and are commercializing that now. We’ve developed a product for hospital use that would be called a “blousing” product. It mimics syringe injections. Another product is a continuous rate infusion system. Once it has started it delivers the drug at a constant rate that is completely programmable within the range that we have for the device. That product is fully completed, validated and ready for sale in the veterinary surgical hospital market.
CEOCFO: What have you learned from past experiences that is going to help pave the way?
Mr. McWilliams: I would say three or four things: Starting with the end in mind (investor liquidity and customer outcomes) and crafting a plan to get there from here, bringing on the right talent at the right time and letting them run, focusing on critical objectives that drive value and executing on the plan to deliver them.
CEOCFO: Are people excited with what you have developed?
Mr. McWilliams: This is one of the fascinating aspects of doing a new disruptive technology. People have not seen many devices like this before. Therefore, it takes a little bit of time for them to clinically understand that it is applicable to their work environment and it can solve many of the problems that they are dealing with. It works differently from what they are doing today, so it raises some new questions. However, once they get their heads around it and you answer the questions to their satisfaction, the light bulb goes on!’ Then they get animated with excitement. This happening in the vet market and it is happening in the human market, when we take it out and show it to clinicians. Now with demonstrable product, corporate interest is increasing as is investor interest. Momentum is building and with press releases we expect to come this year will create the market buzz we need to drive even more attention.
CEOCFO: Does the cost savings get a foot in the door?
Mr. McWilliams: That is a great question! What nurses that manage infusion products want are products which deliver superior outcomes that are simpler and safer to use, improve workflow and are lower overall cost. If the product does not deliver cost reduction in the current environment, it will be a difficult uphill sales battle. I do not care how good the product is. Unless you are solving a problem that cannot be solved another way, then pricing is an important aspect. Therefore, to position a disruptive technology in current markets, I think it is important to be able to be on a path that shows your customers lowers costs.
For emerging markets where the new technology is enabling, then price is not so much a factor in the sale.
CEOCFO: What will be happening in the next year or so for Medipacs?
Mr. McWilliams: Visibility. I would say that the biggest thing that is happening for Medipacs today is visibility in the marketplace from our fully functional veterinary product. It is really a technology proof case. It demonstrates the utility of the technology, the precision of the technology and the convenience and simplicity of its use. Once it is set up, it is essentially fool proof. People like that! When they can use a tool that makes their life simpler and safer and you get better outcomes and lower costs; yes, that is when it really clicks. Visibility for us is what is next. That visibility will bring with it corporate interests and channel partner interests. As we get out there and explain to these folks what we can do with the technology, that is where the next step is for us. It is to get this technology positioned in the hands of people and companies that own channels that we can access.
CEOCFO: Do those types of companies look at the veterinary market for new ideas or is it more that you can reach them and point it out?
Mr. McWilliams: That is also another great question! There are mixed opinions about going into the veterinary market. If you are looking to flip the company, why bother. Go to the human market where the biggest value is going to be achieved. We are trying to build a business that gets the platform into the hands of many users because it is going to save thousands of lives by eliminating medication errors and IV infections. As such, it is important for us to generate a base of business that will enable the company, over time, to drive broad adoption of the technology. To that, it can affect as many lives as possible. We do not feel that we can rely on others in the marketplace to do that evangelism. Therefore, crafting a business plan that insures that the company is going to get this technology out into the hands of the people that need it is an important consideration for us, and is why we are seeking to generate revenues quickly.
CEOCFO: How do you deal with some of the frustration in the length of time it takes to get a product noticed?
Mr. McWilliams: Stay focused on the goal to save lives! Medipacs technology can save thousands of lives in this country every year because of medication errors and IV infections. This product platform will be able to eliminate many of the mistakes that occur due to the required drug preparation steps between a “Pyxis” * pharmacy supplies dispenser and the patient. The Pyxis system enabled pharmacy control of the drug to move out of the basement and into the recovery wards where medicine is used. Think of Medipacs product as “Pyxix on the patient”. What that means is full electronic control of the drug right at the patient. That is huge! This is akin to moving word processing from characters on a screen to pixels. When you do that the whole world changes. That is what we are trying to do with this technology in the hospital and in other medical spaces.
Our technology platform will not only enable control of the drug on the patient, but medication overdoses can be eliminated, as well. Delivering drugs under the skin will also enable elimination of many IV infections. Both are unreimbursed “events” that cause provider systems billions of dollars annually.
* Pyxis a registered trademark of CareFusion Corporation.
CEOCFO: Why pay attention to Medipacs today?
Mr. McWilliams: Medipacs is going to be an enabler of the future of personalized medicine. There are many investments going into the drug development side of personalized medicine; from genotyping - to genetic typing, and the right drug to the right patient at the right time.
The open question is “Where is the safe, effective, simple, wearable drug delivery system that can fulfill this objective? It has to be wearable, yet unobtrusive and thin. It needs to be able to titrate each patient’s dose and report adherence and compliance. It needs to deliver potent drugs precisely, and it needs to be low cost and disposable. Our technology is uniquely able to meet all of these confounding requirements.
Already, people are wearing all kinds of electronic sensors. The data is going to be collected in the ‘cloud’. The doctors are going to be able to review that. If they need to make a change to the patient’s drug delivery they will need a system that is completely programmable. That is where Medipacs comes in! It is this part of the personalized medicine that enables the desired therapeutic intervention to be delivered to the patient remotely, outside the hospital.
“Medipacs has developed injectable drug delivery technology that is uniquely able to reduce thousands of deaths annually in US hospitals due to medication overdoses and IV infections and it is enabling to personalized medicine in alternate sites of care.” - Mark McWilliams
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