Your First Prototype Is A Scrap Of Paper

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.

Explaining The Medical Device Tax Suspension

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.

2016 Medical Device Industry Outlook

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

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.

Is The Medical Device Repless Model Viable?

In the OR, everyone wears a mask. Can you spot the sales rep?

Today, there’s a real chance that a rep isn’t even scrubbed in. The repless medical device sales model has been generating a lot of noise lately. What are the risks, benefits, and fallout?

It Still Costs Too Much

Medical Device SalesDespite recent advances, the cost of medical care is still high. With the era of bundled care upon us, hospitals are cutting costs – and reps – out of the picture. For example, Loma Linda cites a 50% markdown in its joint implant prices thanks to a repless sales model. This program began in the spring of 2013 and shows no signs of slowing. These are the kinds of cost savings that can profoundly transform a system looking for new solutions.

The potential savings are 2-fold. First, is the immediate price drop that comes with a direct purchase; second, since no rep is in the OR, there’s no added sales pressure.

Manufacturers are also taking notice since this model can lead to coveted exclusive contracts with medical centers and their affiliates.

Is It Safe?

The primary concern among all stakeholders should be patient safety. If a qualified rep isn’t in the OR, could a device be used improperly? What if a critical situation or question arises?

Those that point to price savings say technicians trained in-house can field questions and lend a hand just like an industry rep. Those against the change, including some doctors, state that patient safety could be compromised.

Reasons For The Trend

Besides the immediate price advantage, several other factors give the repless movement momentum. These are:

  • Mature hospital supply chain/procurement practices
  • Hospital based clinical support models edging out device industry influence
  • Generic device market growth
  • New technologies and software
  • More hospital employed physicians
  • Increase in outpatient procedures

Tech Vs. Rep

Nobody is arguing that technical expertise isn’t necessary in the OR. In fact, some hospitals are hiring ex-sales reps to be OR techs. We can even imagine device companies renting out technicians who have no sales agenda – at least not explicitly.

Training Is Essential

In the midst of this discussion lies the importance of adequate training for the technician, whoever that might be. This must be done diligently and with periodic updates when necessary, for example in human cadaver & bioskills labs.

Both the manufacturer and the hospital have a vested interest in training, and there are ways the cost could be shared. For example, a lead tech at a hospital could be trained by the manufacturer for a one-time fee or as part of a purchase package. This training could then be handed down to OR staff with hospital absorbing the costs.

Still A Niche

Currently, the repless model fills a relatively small niche in the medical device world. However, as price pressures continue to mount, the device without a rep is likely to become more common.

Develop training sessions in a bioskills lab with state-of-the-art human cadaver resources. Contact MedtoMarket at (512) 900-9633 or request a free consultation today.

Internet of Things & Cyber Risk

The Internet of Things (IoT) creates many opportunities for medical device makers.

But if it’s connected, it can be hacked. Forward thinkers in the industry are examining the growing threat of cyber security and how it impacts product safety and viability. Let’s see why.

Improved Efficiency & Care

Online interconnectivity provides enhanced efficiency and communication. For instance, wireless capabilities allow for data to be downloaded from pacemaker and defibrillators (ICDs) to the doctor’s office. This makes life easier for patients and practitioners, and it improves quality of care.

Home monitoring can alert physicians, in real-time, about any significant events even in the absence of symptoms. Furthermore, automatic adjustments can be made without direct intervention. We can even envision doctors tweaking device parameters at a distance.

What’s The Risk?

Today, hackers can control automobiles from a laptop. Steering, braking, even acceleration can be taken over. Imagine the implications if someone hacked your patient’s pacemaker or ICD?

Early in February 2014, Medtronic, the world’s largest medical device maker, Boston Scientific and St. Jude Medical experienced a high level cyber security breach. The attacks were “very thorough” and may have come from China. The exact motives of the attacks continue to remain hidden.

Motives

We can invent all kinds of conspiracy theories behind why these things take place. But motives such as financial gain or a competitor’s dirty tricks don’t require much imagination. Cybercrime is big business generating costs of $455 billion per year worldwide.

Picture a criminal, holding your company hostage. If you don’t pay, they’ll start shutting down your devices. Is your cyber security plan prepared for such a scenario? Do you even have a strategy in place? If anything, the tech world expects an increase in ransomware cases, and the medical industry is notoriously vulnerable and unprepared.

The Reality

Since medical devices can be hacked, the onus of prevention lies upon the manufacturer. This must be an integral part of design and development. Criminals look for easy prey, and the less prepared enterprises could be setting themselves up for disaster.

For years, experts like Dr. Kevin Fu, Associate Professor in Computer Sciences, Electrical and Computer Engineering at the University of Massachusetts Amherst, have been warning about the risks of malware and viruses (cyber, that is) to patient health. The FDA offers some guidance on the topic, but it is far from comprehensive.

Future Challenges

Just like in every other industry, a tsunami of interconnected software is entering the medical device market. The implications, both good and bad, are enormous.

As products increase in number and complexity, cyber risk grows. For the manufacturer, this means another layer of planning, development, testing, and validation that must be considered. For the FDA, the situation calls for the formation of a task force, calling in leading technology experts, to tackle this issue head on.

We shouldn’t fear the leverage technology provides us, but we must never forget our primary responsibility is to “do no harm.”

Learn about in-depth medical consultation to improve your product’s position and safety. Contact MedtoMarket at (512) 900-9633 or request a free consultation today.

The Odds of Being Drafted: NFL Players vs Surgeons

Pro Life – Surgeons Vs. NFL Players

Written by Dr. Aaron Ali, Founding Partner and CEO of MedtoMarket Consulting, Inc

The probability of playing in the National Football League is about 0.09% for a high school football player.  If the player makes it to the college level, he has about a 2% chance of being drafted by the NFL. Obviously, the odds are stacked against him.

The probability of becoming a physician is about 0.8%. If you want to become a surgical sub-specialist (neurosurgeon, trauma surgeon, cardiac surgeon, etc.), the odds are around 0.08%.

The challenges and odds of becoming an NFL player or surgeon are quite similar. Unfortunately, their paths diverge at the start of their professional careers.

Surgeon Training

This Is The NFL

When a team picks up a new player in the NFL, he’s completely immersed into training. A whole team nurtures him: strength coach, position coach, speed coach, hydration coach, sports psychologist, etc. The player spends many hours practicing just to get ready for a 2 hour game.

Come Monday post-game, he goes back to intense preparation. HD game film review, plays run over and over again, and milliseconds shaved off plays are standard. Evaluation is constant and the competitive pressure intense. Play poorly and you’ll be benched, traded, or dropped. The NFL player must improve every day, and training stops only at retirement.

Unfortunately, for surgeons, it’s quite different.

This Is The Medical World

During residency or fellowship, the surgeon-in-training has a faculty supervisor who teaches skills during surgical cases. The resident/fellow is also subject to rigorous didactics and cadaver training courses. The goal of continuous improvement is achieved by robust testing and review by faculty members.

But unlike the NFL player, this all ends on day one of private practice.

Lack Of Ongoing Improvement

The new surgeon has no supervision as an attending. The word “coach” is not even in their vocabulary. Having a coach actually creates the stigma of “remediation” or “bad surgeon”. So realistic training simply disappears. Medical conferences and courses are low yield as most of it is passive learning. Many skip the lectures and enjoy the venue instead (Las Vegas, Hawaii, etc.).

Competition is weak because your group already has an established market share. You come in to fill a void and bring in more cases. Real quality reviews are non-existent; no one ever comes into the operating room to assess you. And patients trust you whether you are a good or bad surgeon.

To top it all off, retirement is held off as long as possible. Even when well past their physical or mental capabilities, surgeons overstay their welcome since making them quit is extremely difficult.

So who suffers? In the NFL, the stakes are low. In medicine, it’s life or death. Bad surgeons equal bad outcomes. In our current medical ecosystem, it’s difficult to stimulate physician improvement. But there is a better way.

Keep Your Eye On The Ball

All specialties expect physicians to complete continued medical education (CME). Lectures and/or self-assessment materials make up the bulk of these exercises. Universities host these courses to qualify them as “accredited” CME. But it’s all passive learning.

As more surgeons are employed by hospitals, the opportunity exists for a complete disruption in CME. What if hospitals ran CME courses with the aid of private companies focused on high tech training, evaluation, and assessments? Universities could still offer CME at attractive destinations in addition to the mandated hospital requirements.

True Evaluation, Coaching & Value

CME should be an active and ongoing learning process. Imagine random, intraoperative analysis using HD cameras to evaluate surgical skills. All surgeons could also undergo rigorous training situations including cadaver labs and high-fidelity simulators.

Plus, surgeons could have a coach, without the stigma of remediation. Coaches would be physician proctors receiving a stipend from the hospital. For the hospital, the ROI would be evident with improved outcomes data. Better training means better doctors and less malpractice litigation.

Surgeons could have an intelligent continued training regimen that provides real value. Groups would be able to self-asses doctors and continuously improve practice quality. Hospitals could enjoy lower risk and a higher level of care. And best of all, patients would get what they deserve – a highly trained, elite surgeon at the top of his game.

Consult with our seasoned physician staff. Implement a bioskills lab with state-of-the-art human cadaver resources.

Contact MedtoMarket at (512) 900-9633 or request a free consultation today.