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.
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.
In our last post, we covered medical device risk management and how it relates to users, reimbursement, the FDA, and sub-components. In this article, we continue the discussion based on assembly, funding, patent, and supply chain factors. We’ll also touch upon missed opportunity risk. For every manufacturer, risk mitigation is critical to get your device to market as quickly as possible and ensure product longevity.
Many companies misguidedly delay this aspect of medical device risk management. Notions about assembly should be evaluated early as time, cost, and quality are intimately linked to assembly processes.
Even if a device meets user needs and clears the FDA, high labor costs or slow production times can nullify viability. Furthermore, if a device’s assembly leads to a shoddy presentation, this could damage sales acceptance. For these reasons, it pays to consider assembly early and throughout the device development process.
Stakeholders expect results, not excuses. When unrealistic promises are made, the manufacturer only sets itself up for failure. Funders, however, cannot be expected to set milestones either. In a way similar to user acceptance, objectivity cannot be understated here. It’s hard to accept near term losses, but if anticipated in the development timeline, you can avoid complete failure. When you fall short, shareholders become wary, but when you beat the benchmark, you foster trust.
Patent & Intellectual Property Risk
You’ve labored for years on your product. And just when you are about to launch, another company fills your niche with a nearly identical device. This nightmare scenario can and should be avoided. Patent attorneys can not only help protect your intellectual property, but they can also scan the landscape for competing claims. Even nascent projects can implement provisional patents to secure your position along the development pathway.
Supply Chain Factors
The most incredibly designed train never moves if a good rail system isn’t in place. Every entity involved in manufacture, assembly, delivery, and sales will either help – or hinder – your chances for success. A comprehensive supply chain strategy should be in place well before product launch.
Missed Opportunity Risk
A thorough validation and risk assessment should not be considered as a drain on resources. Not only do you help ensure the smoothest and safest path to market, but you can also identify new opportunities. For example, in the human factors assessment, real user feedback might show you where your product will fail miserably, or it may reveal new market applications you never envisioned.
A third party medical consultant can be a great asset in medical device risk management. Besides objectivity, industry experts can provide insight missing from a start-up organization. This remains true for scientific as well as business risk assessment. Viability threats are deflected more readily with a group-think approach that includes representatives from multiple disciplines.
Consult with device industry experts about your medical device risk management. Contact MedtoMarket at (512) 900-9633 or request a free consultation today.
A robust medical device risk management strategy greatly increases the possibility of success. It’s not enough to say, “My product is safe.” What about the risks of product acceptance? How about assembly risk? In this part 1 of 2 articles, we explore user acceptance, reimbursement, the FDA, and component associated risk factors.
Medical Device Risk Management
Like a book author, a medical device developer believes in their creation. Unfortunately, not every novel becomes a bestseller. For the device manufacturer it’s imperative to get real life user input during the design and development phases. It might turn out that the device has little appeal to users. Or maybe a different need can be met by adapting the original design.
Some questions to consider are:
- Does a qualitative and quantitative need exist?
- Is it easy to understand?
- How does it improve on what’s offered now?
Many times answers can be uncovered with surveys and subject matter expert consultation. In any case, moving out of the company’s bubble with an objective assessment mitigates acceptance risk.
Clear Reimbursement Identification
How will you get paid for your device? Do you have a specific reimbursement code in mind? Are you certain your device will qualify? No physician will use your product if a clear coding plan doesn’t come with the deal. If a code doesn’t exist, you can certainly embark on a multi-year campaign to have a new code established. But this type of planning will only lead to frustration if not identified very early.
Additionally, manufacturers should adopt a broad understanding of rising reimbursement trends, such as bundled healthcare. Long term success depends on positioning a product to adapt to current and future reimbursement models.
The manner in which your product overcomes regulatory hurdles requires significant advanced planning. At the outset, you should decide which FDA process will be followed, and every effort should be made to stick to the plan. Shifting pathways midstream can cause costly delays and even damage team morale.
Carefully study the various types of FDA clearances and choose the one that best fits your project profile. During development, periodically evaluate how well your trajectory matches the FDA guidelines and make adjustments as needed.
Typically many technologies converge to create a new medical device. The vulnerability of any single component jeopardizes the entire enterprise. For this reason, sub-validations should be performed on every component. Evaluation may include basic science processes, lab testing, and field simulation.
In many cases, a company lacks the resources and know-how to fully analyze and establish a solid risk management strategy. Third party consultants can be brought in on an ad-hoc basis at a fraction of the cost of hiring new staff. A seasoned consultancy can provide the due diligence required for issues such as FDA clearance, reimbursement, and user acceptance evaluation.
In our next post, we will discuss risk related to assembly, supply chains, patents, and funding.
Consult with subject matter experts regarding your medical device risk management. Contact MedtoMarket at (512) 900-9633 or request a free consultation today.
For medical device or product manufacturers, knowing the expectations of actual end users can make or break a product’s future.
Unfortunately, many companies attempt to predict reactions rather than objectively testing them. This can lead to lost resources and even project failure. A proper evaluation, however, can not only increase value, but also accelerate time-to-market. Let’s take a look at the best practices in medical technology assessment.
Can You Read Minds?
Mind readers and soothsayers typically have something up their sleeve. For those that attempt to predict the future in the medical technology industry, unpleasant surprises await. No matter what, your viewpoint is biased. Resist the temptation to think that you just know it’s going to work. Prove it instead.
Get Critical, Third Party Feedback
The most robust project assessments gather feedback from highly experienced, critical, and actual end users. Maybe your product’s safety profile isn’t exactly what your dev team envisioned. Or perhaps your best target customer is not who you think it is.
Focus groups can be particularly useful here as they provide a quantitative aspect to qualitative input. Participants should have no vested interest in the success of your project as only cold objectivity will uncover weakness that could hamstring your business progression.
Not Just Doctors
Physicians certainly play a central role in any product evaluation. But what about scrub techs, nurses, management, and supply chain experts? Your product will pass through many hands before seeing a patient encounter. The best way to get there is to identify potential obstacles along the entire journey.
The marketing and business sides are just as important as the clinical evaluation. Beyond product analysis, have you thoroughly considered competitive analysis? Also, the right person asking the right question just might reveal an important niche you overlooked. You need to get the most comprehensive picture of your customer’s motivations, behaviors, and purchasing patterns and how these specifically relate to your product.
Costs & Risk
In many instances, a thorough, objective medical technology assessment is difficult to generate in-house. Assembling the team, developing evaluation protocol, and generating high quality reporting all come with costs and skills that many companies may not be able to absorb. Plus, purging in-house bias can be nearly impossible.
Voice Of Customer
Remember, it’s not a singular end user, it’s an end user community. Many stakeholders will have a say in the success or failure of your product. Getting authentic insight from as many contact points as possible accelerates your time to market, reveals product weakness, and unlocks hidden value.
MedtoMarket’s 360 Medical Community assembles a wide spectrum of health care industry experts that can evaluate any project from an actual customer point of view. This insight has proved invaluable to the advancement and ultimate success of many medical device and technology initiatives.
Evaluate your medical device or product with the rigor that drives success. Contact MedtoMarket at (512) 900-9633 or request a free consultation today.