What are the benefits of a bioskills lab to the medical community?
While the role of theoretical knowledge is critical to the medical field, the economic concept of hands-on training at a bioskills lab training facility also plays an integral part in the learning process. The rationale behind learning-by-doing is an increase in productivity achieved through self-practice, perfection, and minor innovations. This translates into getting products to market and in the hands of end-users faster and more effectively, ultimately bringing positive cash flow to startups.
Optimize Your Team With Hands-on Training
Utilizing a bioskills lab to perform and perfect new or existing procedures benefits both surgical teams and their patients. Surgeons, nurses, and technicians who learn and apply their skills in a real-world setting such as the bioskills lab at HeLiX Coworking achieve the necessary finesse to effectively transition from the treatment of cadavers to live patients.
Medical innovation is not without its challenges and translating theories and innovations into real world applications exposes the potential issues that end users might experience. Combining this theory with a state-of-the-art bioskills lab like the one offered at HeLix CoWorking, medical innovators can teach colleagues, doctors, nurses, and end-users new skills, more effective surgical techniques, and the proper integration of new medical devices and technologies with a minimal output of time and capital. Practice makes perfect and perfection is never more important than it is in the surgical theatre.
Get Your Product to Market Faster
In addition to the enhanced learning experience provided by hands on training in a bioskills lab, there are practical issues at play as well. Involving everyone from techs to nurses to surgeons in the bioskills lab accelerates product development by offering the unique perspectives of each member of the teams who will be using them in the field. The narrow focus of innovators or surgeons alone may miss an issue that would be blatantly obvious to a technician or nurse. By inviting entire teams to work together in the bioskills lab, startups have the advantage of gaining valuable insight from multiple end users.
Challenges can be met head on in a setting that mimics those found in hospitals. From the perspective of getting a new device to market, time in a bioskills lab provides the FDA and other regulatory agencies with evidence that proper safety protocols and quality control are already in place and were used throughout the development process. Because MedtoMarket also provides medical consulting, startups can seek out more experienced innovators for advice on getting products to market in the most effective way possible. This mitigates risk and maximizes reward for startups.
Everything Is Provided – Just Bring Your Team
In the MedtoMarket bioskills lab, you can expect to find all of the same equipment you would in a real-world hospital setting. In fact, it is one of the top bioskills labs in the country. MedtoMarket has invested in creating a state-of-the-art bioskills lab. Everything you need is right at your fingertips.
Capable of accommodating up to sixty or seventy surgeons at once or paring down for a more intimate setting, MedtoMarket provides a flexible and affordable place for medical innovators to learn, teach, and perfect the lifesaving practices of tomorrow. In addition to in person training, MedtoMarket has the capability of outfitting the bioskills lab with video equipment to remotely reach an even wider audience. Scrubs in various sizes, PPE, basic surgical instruments, human specimens, and equipment are all provided. The cadavers are treated with the utmost respect and their remains are returned to the family for cremation in accordance with all state and federal laws.
Centrally Located in Austin, TX
The bioskills lab is available seven days a week. While thirty days notice is preferrable, MedtoMarket has arranged reservations in the bioskills lab on shorter notice. Centrally located in Austin, TX, MedtoMarket is convenient to hospital, hospital, university, and university. Out-of-town guests will appreciate how close the lab is to several hotels in the area. Because it can be reserved in hourly increments, the bioskills lab is particularly attractive to startups that may not have large cash reserves available. Along with the lab, adjacent working space is available by the hour as well.
With the medical community in Austin growing at a rapid pace, the bioskills lab offered at HeLiX brings resources to medical entrepreneurs that were once only available at top universities. Medical enrepreneurs in the central United States can now more easily compete with their counterparts on the East Coast.
Want expert insight into the medical on-hands training? Set up a consultation and see how we can help speed up your time to market. Contact MedtoMarket today by calling 512-900-9633.
Early feedback during medical device development saves money, avoids risk, and accelerates time to market.
Back in 2007, the car maker Volvo included a heartbeat sensor in their S80 model. So if someone was in your car, your key fob would indicate a heartbeat. The demand for this feature, not to mention it’s use, was quite low. Volvo shelved the idea. See the video here.
When developing medical devices, companies fall into similar traps. Just because something appears to be ingenious, doesn’t make it viable. Let’s find out how to avoid medical device development pitfalls in the earliest stages.
Your First Medical Device Prototype
A list – that’s it. And maybe a sketch. Medical devices aren’t pet rocks, so if the idea alone isn’t viable, you won’t get far. The first step is to outline your product definition and features. Items to include are:
- Intended use – What does your device do?
- Indications for use – What condition will your device diagnose, treat, or prevent? Who is your target demographic sector?
- Features and functions list with brief descriptions
And that’s it. That’s your first prototype. Before you spend a single second in the development lab, real end users and stakeholders should vet this summary. The early validation of the items listed is critical. Otherwise you might head down an expensive path that results in a key fob nobody wants or uses.
Intended Use And Indications For Use
Pay special attention to these categories. They carry a large impact on your development process. Furthermore, regulatory bodies will classify your device based on these definitions which also determine approval process times. Finally, indication for use will determine how to collect payment for your device when it hits the market. Considering these factors early save you time and help define your market position.
Documentation of Your Prototype
From this early stage, be sure you meticulously document everything. This serves two purposes. One, you build a library of info upon which to guide further development. Second, you construct a solid platform upon which you can please regulatory requirements.
When you provide this list for evaluation, questions and suggestions will arise. This forces you to come up with answers helping ensure eventual market and regulatory success.
Ongoing Iterations of Your Design
After this first evaluation round, you might be tempted to do some benchwork, but wait. Review all the data gathered and come up with a second, refined list. Then go back with your new prototype list and get feedback. From there you can move forward with actual lab testing and development.
Set Milestones for Developing Your Prototype
Along the development process, be sure to set logical milestones where you’ll ask for more third party input. Avoid the temptation of going overboard seeking feedback. But for each major advance, consider returning to gather end user and stakeholder opinions.
Alone, the developer might not recognize a new need or an unnecessary function. An objective view often provides valuable insight that escapes the development lab.
Avoid risk and shorten time to market. Get advice on medical device development from industry experts. Contact MedtoMarket today.
Medtronic spent $10 million lobbying against it.
Besides being very vocal, AdvaMed also put its money where its mouth is with a $4 million effort to repeal the law. Was it worth it? Considering the Medical Device Tax cost Medtronic $112 million in 2014, it’s a no brainer. The industry applauded the recent announcement that this tax has been suspended. What are the long term implications?
Affordable Care Act Roots
The Medical Device Excise Tax went into effect January 1, 2013. From that point medical device makers paid a 2.3% tax on revenue under the law. The impacts of the tax were widespread, including workforce layoffs. In many companies, research and development was slowed or halted due to the shortage of funds.
Small Companies Hit Hardest
Larger corporations absorbed the tax impact as best they could. But the smaller enterprises were often stretched beyond their limits. With smaller and tighter budgets, entire projects were put on hold indefinitely due to the excise taxation. The pinch was especially painful since the tax was on revenue, not profit.
Reasons For Repeal of the Medical Device Excise Tax
Besides heavy lobbying, lawmakers also looked at the facts surrounding the device industry upon deciding for the tax suspension. Prior to the tax law taking effect, Amy Klobuchar (D-Minn.) and Kay R. Hagan (D-N.C.) authored a letter to voice concern over the negative impact the tax could have on the medical device industry and the overall economy. The letter was signed by 16 other Democrats, including John Kerry (D-Mass.), Joe Lieberman (D-Conn.), Charles Schumer (D-N.Y.) and Al Franken (D-Minn.).
The letter stated:
“The medical technology industry directly employs over 400,000 people in the United States and is responsible for a total of two million high-skilled manufacturing jobs. Additionally, this industry is also one of the few that enjoys a net trade surplus, significantly boosting U.S. exports around the globe.”
Many other critics of the law said that it stifled innovation in a field where the US continues to hold a leadership role.
Concerns About Repeal
Those against the suspension of the law are concerned where the dollars will come from to replace the tax income. In the first half of 2013, the tax raised $913 million. For now, the suspension comes within a package of tax cuts which the next president will likely modify.
The Future of Medical Device Innovation
The Medical Device Excise Tax has only been suspended for two years. That means it could come back to haunt medical device manufacturers in 2018. Although it may not see a permanent repeal, indefinite or repeat suspension could be an option. Another possibility is that the tax takes on a different iteration, such as a tax on profits not sales.
Many companies included the tax in their 2016 budget. Now they’ve been given significantly more wiggle room. Shelved projects are returning to the table. R&D and infrastructure in particular have received new life. Hopefully, new hires will be on the way soon as well.
Want expert insight into the medical device industry? Set up a consultation and see how we can help speed up your time to market. Contact MedtoMarket today.
Where will the next revolutionary innovation in medical devices or life sciences come from?
Maybe right now, in some young genius’s bedroom, a world changing device is being developed. Don’t laugh. Apple I, the first Apple computer, was made in Steve Wozniak’s bedroom. But there might be a better place for this kind of work.
Silicon Hills – Austin, TX
Austin, TX has firmly established itself as the new U.S. tech hotspot. In biotech alone the city attracted $100 million in investment in 2015. This new wave of progress is highlighted by the 2016 opening of Dell Medical School along with hundreds of biotech startups already calling Austin home.
Now, many other of medical, life science, and healthcare startups are eyeing Austin as a key strategic location, much like Silicon Valley was on the verge of its heyday. This is an exciting time for our area. We plan to provide the space and resources that will help define Austin healthcare and biotech for the next generation.
Introducing HeLiX CoWorking Lab for Life Science Companies
In response to this unique opportunity, MedtoMarket is launching HeLiX – a co-working space for research, development, and collaboration in the medical, healthcare and life science sectors. By sharing space and costs, biotech and medical device companies have access to resources that might otherwise be unreachable at an early stage.
HeLiX will be the place where innovation, collaboration, and research intertwine to bring forth some of the greatest medical advances of our century.
Ideal members are:
- Members of the Medical – Life Science – Healthcare Fields
- Medical Device Industry
- Medical & Biotech Startups
- Physician & Nurse Consultants
- Pharmaceutical Industry
- Dental Industry
Ecosystem Of Innovation
HeLiX is more than just shared office space in an upscale setting. The project promises to be a melting pot of ideas and exchange. Close contact with others on the cutting edge of science will provide the synergy so valuable to ventures of this kind.
Plus, all members have access to the expert Medical Consulting offered by MedtoMarket. This includes R&D, testing, marketing, sales, and business planning advice. Our state of the art bioskills lab, mock OR, human factors engineering room, dental room, and clinician patient studio all add to the valuable resources available to HeLiX members.
Like many industry transforming ideas, HeLiX is disruptive. This is because it offers the highest quality facilities and resources in a non-institutional setting. This means no barriers to entry and no old guard making claims to any research or projects at HeLiX. All intellectual property and project strategy control remains exclusively with the member only. Consultation is available, but by no means binding or obligatory.
The Best Of All Worlds for Your Office and Lab
A plush stylish office and community setting, state-of-the-art facilities, close contact to new and seasoned innovators – it almost sounds too good to be true. But this dream is becoming a reality with HeLiX.
Want to be a part of the newest collaborative ecosystem in the hottest U.S. biotech center? Call 512-400-0194 to learn more
What will be the big medical device stories in 2016?
We can’t make any guarantees, but we can make an educated guess. Some of the groundwork has already been laid. So let’s see what might be in store for the New Year.
Personalized medicine develops individualized care based upon genetics, biomarkers, clinical history, environment, and even personal preferences. While the specter of cost cutting might threaten this trend, the hope is that personalization outcomes improve and cost goes down. We’ve already seen this occur somewhat with diseases such as melanoma, breast cancer, and heart disease.
Three dimensional printing is a big part of this movement and some manufacturers already successfully implement this technology. With 3D printers, customized prosthetics, for instance, can improve surgical outcomes and speed up recovery time. This results in an overall resource savings.
Personalized medicine is poised to make an even greater impact in 2016 especially in pharmaceuticals, medical devices, and diagnostics. One of the keys will be how technologies, such as 3D printing, are defined and regulated.
Transparency In Medical Device Industry
In the medical technology and pharmaceutical world, there is increasing pressure for companies to release unpublished research data. Some estimate that half of all US clinical trials go unpublished. Critics of this practice maintain that this increases costs (duplicate studies) and increases risk (under-informed clinical decision making).
With movements such as AllTrials gaining momentum, the push for transparency is likely to be significant for 2016 and beyond. For medical device makers, contingency plans for publishing all trials, even null or inconclusive, may help prevent regulatory headaches in the future.
Emphasis On Usability
While 2015 saw advances in usability, 2016 promises to see even greater strides. Home health care continues to expand quickly, and device makers are answering the call. The successful products will be the ones that even a lay caregiver can understand. Intuitive design will be the key and may be the deciding factor among devices of similar purpose and cost.
Usability for the healthcare entity will also make a difference. For instance, if your product’s packaging makes storage a nuisance, then buyers might look elsewhere. Ultimately, the devices that provide the best overall user experience – from initial contact to purchasing/distribution to implementation and service – will find themselves doing well by the end of 2016.
Beyond Pinching Pennies
Without a doubt, the trend of cost cutting will continue and even magnify. There is much at stake in the year to come. The best prepared medical device manufactures, however, will find success in every circumstance.
Some differentiating factors will be:
- Data based market acceptance evaluation (surveys, etc.)
- Highest value for cost
- Clear usability advantages
- Assembly time and cost efficiency
- Packaging, logistics, supply chain, etc.
- Well-developed reimbursement strategy
- Clear cyber risk plan
- Regulatory and transparency understanding
- Well trained representative, technical, and service personnel
Learn more about medical consultation that will improve your 2016 device performance. Contact MedtoMarket at (512) 900-9633 or request a free consultation today.
As the old year ends and a new one begins, the medical device industry has plenty to consider. In this two part series, we’ll first look at what happened in 2015 – but keeping an eye on the future. Our next post will look at emerging trends that will shape 2016.
The Growth of Mobile Apps
Just like in the consumer world, mobile apps have exploded in healthcare. From heart rate monitors to oxygen monitors to weight loss help, the market has become highly populated. However, the usefulness of many apps remains in doubt, and the sheer number alone makes competition stiff.
The future lies in large part upon regulation. What happens when you put powerful diagnostics in the hands of the masses? Will doctors get overwhelmed with incoming information? Will patients begin self-treatment? How do you verify the accuracy of the data?
The FDA has announced that the intended use of the app decides if it’s just an app or a medical device. Currently their definition is quite broad. The next year will likely see refinement and a bit of a purge in the number of apps. Investors, consumers, and doctors are going to get pickier and seek out apps that only add true value to their lives.
Reimbursements and Getting Paid
This year showed continued mounting pressure in medical device reimbursement. As bundled healthcare gained momentum, the trend towards creating lower cost devices intensified. Meanwhile, device makers jockeyed for position to score key group purchasing organization contracts.
The year ahead will see more package offerings, like rehab service included with orthopedic prosthetics deals. Some brave manufacturers will still forge ahead to offer truly new devices. The hope is that the clinical data will support higher costs. Meanwhile, others will strip down current devices to make them more affordable.
Finally, device makers must dedicate themselves to educating payers that good value must accompany low cost decisions. And the companies with the best developed reimbursement strategies will come out on top in 2016.
Cutting Costs in Manufacturing
Due to intense economic pressure, manufactures are taking a much closer look at cost cutting measures. The analysis of factors like supply chains, logistics, assembly, and packaging has become nearly as sophisticated as device development itself. Those who plan in a comprehensive and strategic manner will have a clear advantage. The key: address all cost issues as early in the game as possible.
Big Data And The IoT
It’s well known that the likes of Google and Apple are edging their way into the healthcare arena. These players know how to leverage big data. This means gathering, processing, managing – and of course selling – the information.
Along similar lines, the Internet of Things (IoT) has reached deep into the medical device market, and this will continue. Smart technology will penetrate deeper into the clinical setting, such as with patient data access. This change will also expand beyond the hospital borders to the ambulatory setting.
Look out for more joint efforts between tech and medical device companies. But also be aware that many tech startups just might end up doing it faster and cheaper than the bigger actors.
Cyber Risk in the Medical Industry
Just like in every other industry, cyber risk worries the medical device industry. But not nearly enough is being done about it. Since many questions must be addressed, the situation creates abundant opportunities. For example, devices with a well-defined risk strategy can differentiate themselves from the competition. Also, cyber risk mitigation is an industry in itself that has yet to be fully exploited.
More To Come…
In our next post, we’ll go over some trends we believe will make 2016 truly memorable for the medical device industry.
If you would like to learn more about medical consultation that will improve your positioning in the 2016 device market, then contact MedtoMarket at (512) 900-9633 or request a free consultation today.