As an engineer or any professional device person, you need to keep track of the trends in your field. Personally, for me, I tend to have a 30,000 ft view of the entire medical field, so I can give you some basics of what everyone is thinking as a whole, but not too much in-depth for one particular area, like orthopedics for example.
In this class we may have some people that can do that. Pick a field. If you do not work in industry, it can be any device field (ortho, cardio, neuro, etc.) If you do work in industry, you can use your current field. Tell me what you think the trends are in those fields as far as device design, usage, treatments that are coming out, US vs. EU, etc.
Here's some overall stuff I see personally:
More companies are going to the EU first because the regulatory hurdles are easier there. However this will flip flop dramatically as soon as the new EU Medical Device Directives come out and actually make it harder to get a device approved in the EU compared to the US. A giant reversal will happen.
Antibiotic releasing devices are popular in theory, but difficult to get approval and most companies shy away from them.
Pretty much every surgical device out there is moving toward less invasive forms.
Growth-factor or biologic based devices are still in development but have experienced some setbacks and have a ways to go.
3-D printing is all the rage and it's only a matter of time before approved devices really start to use it.
What else?
Spiral Medical Development
www.spiralmeddev.com
I currently work in Industry, and with the new age of technology the point of care diagnostic device that I work on added a new capability of connecting wirelessly with being able to transmit collected data up to a cloud. This includes storing patient information along with their test results, operator information, cartridge lists, etc. Additionally, as a phone receives pushed down wireless updates, our device implemented this same feature of updating the software on the device itself. However, with the advancement in technology, this comes with more security concerns in the means of cyber security, especially with this day in age of hacking that is occurring worldwide. Stronger firewalls and security is needed to protect this cloud, which shall contain all this private information.
Hi All,
I currently work in the pharmaceutical industry assisting pharmaceutical companies to outsource their pre-clinical research. I have also looked into medical device research outsourcing as well. One of the main trends I can see is the outsourcing pre-clinical research to more diverse suppliers. From what I have seen most pharma and medical device companies would outsource their research to a very small set of CROS, typically large CROs who can provide many services, such as Charles River. However as there are many new CROs with new technologies pharma have been expanding their supplier lists to save money and gain access to newer technologies Additionally, they are also looking to outsource to diversity suppliers, such as small businesses.
-Andrew Nashed
Hey,
I also work in the pharmaceutical industry but I try to keep my self up to date with 3D printing for regenerative medicine along with BioMEMS. These two trends are huge and I personally think really are the future. BioMEMs is being used for therapies right now and being looked into for mini organs for diagnostic, testing and hopefully replacement. With advancement such as lab-on-a-chip then organs-on-a-chip, this will be done in no time. I am a huge advocate of 3D printing of artificial organs, the progress that researchers have been making are astronomical. Once the problem of integrating blood vessels gets solved there is no telling what 3D printing, won't do.
Hi Andrew,
Yes this is a very common trend, that depends on company size but. My company is fortunate enough to have comparative medicine onsite so they do a lot of our pre-clinical animal studies but we do use CR as well. However I think there is a little bit of a push back going, I know for us upper management has decided to just expand our facility to accommodate more studies instead of transfer out. It is easier for the scientist to troubleshoot and honestly I think it results in less mistakes.
I want to talk a little more about the 3-D printing , we have learn that 3D printing is becoming more popular now days, the cost of getting one is really cheap, and many people can just go and purchase one and try to design something and printed, not many skills are needed to learn how to used it. Now, we as a scientist and engineers are taking this idea and try to make it work in the biological aspect, which raise the rage of many people that believe in their religion, this allow to set back and make it harder to be approved, of course this is not only that it set back but also the application behind. I have seen that with this machine we can improve a lot in the medical field. It would help a lot of patients health problem but unfortunately a lot of the ideas haven’t been approve that is why we as a engineers needs to keep improving this. hopefully soon we can used it and help to save many people life and also help others people to see that isn’t a bad idea, even if their religion believe is not.
I have to 100% agree with you I love your post, we have seen what 3D printing can do and how it can advance the technology in the medical field which allow us to help more patients health, which this is our major find ways to make it easier and better to prolong the life of someone. I do believe that 3D printing in the medical field is going to be huge in the future, because there is potential in there. About BioMEm I haven’t touch that and I can’t wait to learn about it so hopefully I will learn more about it, if you have any information that you believe is good to share please do so I would love to read about it and thank you great post here.
Hi All,
I have to agree with most of you regarding 3D printed medical devices becoming a popular trend. I currently work in a pharmaceutical company handling design controls and Risk management activities for their combination products. I see that many companies now are working hard to reveal the many possibilities that 3D printing brings to the table. The main issue with 3D printed medical devices is that it does not have established precedents yet. There are no clear testing standards and long term use effects are not yet clear. The regulatory agencies have very limited experiences dealing with 3D printed medical devices. This will result in a harder approval pathway for manufacturers.
On the other hand, I agree with Dr. Simon that most medical device manufacturers are going for EU approval first since it is the easier pathway to European Union markets and some middle east countries. The recent draft of the Medical Device Regulations (MDR) issued by the Council of European Union in June 2016 raises the bar of the EU regulatory requirements very close to the FDA requirements.
Finally, The recent "21st Century Cures Act" signed into law have redefined the classification of applications and software into medical devices. Some software have been granted exclusions from the medical device classification.
Hello,
Previously, I worked in the OTC pharmaceutical field but since becoming a full time graduate student, I have a stemmed interest in medical devices for women’s health and have recently become involved in a project focusing on intrauterine devices (IUD’s). IUD’s were not popularized until the early 2000’s and have continued to rise in popularity since then. However, it seems reasonable to rationalize that they will steadily plateau in use for several reasons. The main reason being that everyone who is interested in the use of an IUD, should already have one. To balance this, the IUD should be replaced every 3 or 5 years, depending on the type of IUD administered and this will keep a steady flow of users for quite some time. Furthermore, as women age and either do not require an IUD for family planning purposes or for age related reasons, they will not continue its use. The aging population of young women who may become new users to the product once again balances this.
Currently, there are only 5 IUD’s approved for use and/or coverage in the United States and of those, 3 are manufactured by Bayer Pharmaceuticals. Due to the difficulty to obtain FDA approval and the long, costly process, many companies have not entered the market to make it more competitive yet. The future for this device may allow for more generics to be approved and make more IUD’s readily available, thus decreasing their price and possibly increasing the popularity of the product.
-Michelle F
Hi all, gh56 I saw that you have not been able to touch upon BioMems yet. I took this class during my last undergraduate semester and I would like to give you a little information about it from what I understood from the class. First, BioMems stands for Biological or Biomedical micro-electro-mechanical-systems. In terms of meters, we are talking about 10e-6, therefore these are very small devices that integrates mechanical and electrical components (such as sensors, transducers, actuators) that can sense, measure, communicate and act. They have a biological or biomedical function and application. For example, a microcantilever transducer can be produced and can be coated with antibodies that captures a certain virus while ignoring the other components in the sample, this is a chemical sensor array. Another example of BioMems, is the lab-on-a-chip device (a small, portable, low cost and easy to use device) which uses microfluidics to measure and diagnose and it only needs microliters of a sample to do this.
In terms of microfabrication, the basic building block of these devices is silicon and every process starts with lithography followed by thin film deposition. etching which could be done Isotropically and anisotropically. Etching has many techniques in order to create a preferable undercut feature. There is more to microfabrication techniques but this are some useful basics of BioMems that could give you an idea of the subject.
Hi All,
I am currently working at Ethicon within Operations. As some of you may know or if you don't know Ethicon is known for developing surgical devices or materials. One such device that they are widely known are there sutures and microneedles. Fortunately for me, I deal with the validation aspect for the manufacturing of sutures and microneedles ranging from 0.061 inches to 0.00240 inches. From what I know, there is a need to develop sutures that decrease healing time and are more durable then the current ones in the market. In addition, as Dr. Simon mentioned there is a need of developing antibiotic releasing devices, particularly within suture design. The manufacturing of these sutures and needles is very time consuming, and I have heard that the sutures of tommorow may be 3D printed, but I am not sure how effective they would be compared to current standards.
Yes, I agree that 3D-bioprinting has become a very popular trend. I also became very interested on the subject during my senior project design. Particularly, I think the projects that wake forest are performing with 3D printing are amazing since they are using this technology towards military applications. Currently, they have two 3D printing projects. One is about bioprinting skin cells on burn wounds for soldiers. During phase I of the project, they designed, built and tested a printer designed to print skin cells onto burn wounds. The "ink" is actually different kinds of skin cells. A scanner is used to determine wound size and depth. Different kinds of skin cells are found at different depths, therefore the scanned data guides the printer as it applies layers of the correct type of cells to cover the wound. Now, they are undergoing phase two, in which these team will explore whether a type of stem cell found in amniotic fluid and placenta (afterbirth) is effective at healing wounds. The goal of the project is to bring the technology to soldiers who need it within the next 5 years.
Wake Forest's second project is about exploring 3D printing for head and face injuries. As we know, Blast injuries and injuries from high velocity projectiles are difficult to repair with current methods and there is a need for novel approaches to generate replacement tissues such as bone, nerve, blood vessels, fat, and muscle. As a result, this team is exploring printing these complex tissue components for facial and skull reconstruction using a 3-D printer. The link to this is: http://www.wakehealth.edu/Research/WFIRM/Research/Military-Applications.htm
Hey gh56,
There is a graduate course on BioMEMs with Perez and it is very interesting where we read plenty of articles about the current practices. Yes I have been fascinated by 3D printing for a long time and I hope one day I can be a player in the field. Also Anthony Atala in Wakeforest has one of the leading institute in 3D bioprinting in the US followed by Melissa Little in Australia. There are plenty of hurdles in bioprinting organs though, besides the vasculature problem cellular organization has yet to be figured out. The scaffold, growth factors, environment cues, bioink I think are pretty easy at this point but putting them all together remains to be a challenge.
Hi Jnm22,
Thank you for providing this information, it was interesting in actually looking up the wake forest I did not know nothing about it. It was interesting in reading it about it. Yes I do I agree on this matter that there a many problem to be able to putting all this techniques together is going to be hard to achieve but how technology keep advancing I believe soon it will be done.
I used to work for an IT firm where I was assigned to a client that used to focus on VR for physical rehabilitation. Earlier, that company was hiring their own technology experts/consultants to provide the technology. Over the course, they chose to contract the work out. Therefore, they gave the contract to my company for the software development, maintenance and support of their products. While working in IT, I have come across that many companies are contracting lot of their work out of the company to maintain budgets and efficiency.
