Dear Network, I am so lucky to stand in front of a new marketing initiative within my HealthCare Marketing & Branding Agency Amazing Hall, which will be a fantastic adventure and help so many companies. As with all new beginnings you need a little help from your friends and I know a lot of you are in here too in this group. Therefore I ask you, my network within LifeScience and especially MedTech, which sources do you use, when you wish to know about your market; e.g your products, competitor-activity, market-trends and procedures? Which magazines, websites, do you follow? How do you approach this? Having been a marketeer within MedTech for more than 15 years I know this is a big challenge for every marketeer. Please let me know. Thank you so much for you help. Anne-Marie
It's seven years since the Supreme Court decided Mayo v. Prometheus, 566 U.S. 66 (2012).
My takeaway from a three year-old conversation with Gavin Bogle (below) was "diagnostic devices aren't patentable."
Of course, it's more nuanced than that, says guest contributor, medical device IP practitioner Peter Sleman.
Thank you, Joe, for the opportunity to address the Group this way.
There is a growing sense among inventors the patent system has become too complex, inconsistent, and unpredictable. A client recently shared a story of how he invented an orthopedic device, filed an application, and was granted a patent. The device was a success.
Almost a decade later, he filed suit against an infringer in a district court. Weeks before his decision, the Supreme Court decided an unrelated case known as Nautilus that “clarified” the law on indefiniteness. The District Court, taking Nautilus into consideration, deemed his claims indefinite and invalid. He lost.
It is a bitter pill to swallow. His patent claims were valid when he filed them, valid during examination, and valid when he brought suit.
But it all changed when the Supreme Court waded into patent claim construction.
Patent attorneys have become accustomed to following court decisions closely to spot trends and adjust their prosecution strategies. This is why the recent CardioNet decision in the District of Massachusetts has gotten some attention from practitioners focused on medical devices.
What happened in CardioNet?
The CardioNet suit revolved around a system and technique for monitoring cardiac activity in U.S. Patent No. 7,941,207. The patent claims relate to a heart monitor with a beat detector, a ventricular beat detector, and certain logic components that determine variabilities.
In this case, the District Court deemed the claims not patent-eligible under 35 U.S.C. § 101. This statute bars a person from attempting to patent laws of nature, natural phenomena, or abstract ideas, and over the past few years the § 101 inquiry has been informed by what is known as the Alice-test.
What exactly is Alice?
Like Nautilus, Alice was a Supreme Court decision. The Supreme Court does not look at patents often, but seismic shifts occur when it does pick up a patent case such as 2014’s Alice. To determine whether claims are patent-eligible under 35 U.S.C. § 101, the Supreme Court articulated a two-step test.
- Ask whether the claims directed to laws of nature, natural phenomena, or abstract ideas.
- Ask, if the claims at issue are found to be directed to laws of nature, natural phenomena, or abstract ideas, whether the elements of each claim both “individually and as an ordered combination transform the nature of the claim into a patent-eligible application.”
In CardioNet, the Court applied the Alice two-step and decided the claims to the heart monitor at issue were not patent-eligible. This is more common in software cases, but rare when the underlying technology is a medical device.
CardioNet decision will probably be appealed, and its reach is limited. Additionally, the specific wording in the claims of the CardioNet patent left much to be desired. Medical device innovators and manufacturers should not panic and can learn a few lessons from this case as to how to articulate a claim with enough specificity to avoid invalidation by Alice.
Will this affect me?
It depends on your field. CardioNet has almost no bearing on traditional mechanical medical devices (think orthopedics), but the same reasoning may be used to invalidate other, more complex medical devices with electronics components. As more medical devices employ sensors and processors, you can be sure that Alice will become more relevant. Look no further than the new Apple Watch heart rate monitor to see this in action.
In fact, Apple was recently granted U.S. Patent No. 1,007,6257 on a similar “seamlessly embedded heart rate monitor.” Would the claims in Apple’s patent survive Alice? That’s an interesting conversation for another time, but when you view the claims side-by-side with CardioNet claims you will see a difference in approach.
What are the implications for my business?
Patent claims are fences around your invention. It's tempting to push those boundaries and pursue a claim as broad as possible to expand your territory; yet, the broadest claims are usually the easiest to invalidate and most susceptible to an Alice challenge.
Instead, when software is involved, present claims with varying scope including general claims, intermediate claims and more narrowly-tailored claims. Presenting claims that are specific and have multiple “meaningful limitations,” will ensure that at least some of the claims will survive an Alice challenge.
Applicants can file a number of linked applications. We refer to those as “patent families.” Typically, when a patent nears allowance, the Applicant may choose to file a “continuation” application to pursue additional claims, but this must be filed before the original patent issues.
By keeping a continuation application pending, Applicants retain the opportunity to pursue adjusted claim language and scope as needed. Continuations also present a hurdle to your competitors because they may know what is protected by granted claims, but they are left with a degree of uncertainty as to what else you may be able to cover in the future.
Postscript: Alice was the progeny of Mayo and relied heavily on it to frame how one should judge whether software is patent-eligible. While Gavin's thoughts were more focused on diagnostics and attempting to claim the relationship between analyte and disease, the CardioNet decision relates to hardware/software and attempting to capture algorithms, such as those for beat detection. Alice may only be an issue for certain classes of medical devices, and steps can be taken to frame the invention as one relating to a machine, not just an algorithm or a scientific principle or relationship.
Editor's note: That was great, Peter, thank you – and I encourage other group members to contribute so meaningfully.
A "Medically Accurate Webinar" next Wednesday
If you aid in the design, development, engineering, or manufacturing of devices for home-based patient monitoring, you'll want to attend a free session I'm co-hosting with Group member Walt Maclay.
What: "What You Need to Know Before Manufacturing a Wearable Device."
When: Live on Wednesday, January 23 at noon Eastern Standard Time and Replay on Demand shortly thereafter.
Where: Online! And it's free.
Why: Education = good. Join us! 😊
Brother, can you spare an answer?
- Gregory needs a cleanroom to pack Pasteur pipettes.
- Sean needs help quantifying the impact of fee-for-service work.
- Tsafrir needs feedback on the Spectre and Meltdown cyberattacks.
- A group member needs a contract manufacturer.
- David needs sales education audio for his long commutes.
- Joe needs more contributions like Peter Sleman's today!
Can you assist them?
Thank you for being part of our Medical Devices Group community!
If you're looking for work, we added new jobs this week here!
Make it a great week.
P.S. Join us for Walt's webinar next week. Click now to register.
As a General Surgeon, I'm passionate about medical device development, particularly as it relates to health economics and healthcare delivery in general. I would like to gain a better understanding of the reimbursement structure in the US (I'm at Berkeley now; will practice in Canada) so I can offer expert advice to companies who approach me for advice within the field of surgery.
Hi, I'm an ex-medical osteopath who has 'invented' a modern-day chamber pot for use in the home by everyone (not just the invalided or elderly).
Night-time urination is the biggest cause of sleep disturbance in all adult age ranges.
My product encourages users to pee by the bedside. They can sit or stand (versus taking a trip to the loo; thereby risking injury and/or having to wake up fully.
I need help marketing it. The potential market is enormous, the story and statistics compelling, and the product does what it says it can. Testimonials are hugely encouraging.
How can I break into a vertical market, and educate the public so they see the benefits and adopt the concept.
Design and attributes:
• It looks pleasing so doesn't have to be hidden away
• It's always open so no fiddling
• It baffles sound and captures odour
• It won't spill its contents if dropped (over two full bladders)
• It holds up to five average voids and remains incredibly stable.
• Its even got a glow-in-the-dark band for ease of location and is dish washable!
The product is called the Handi-P. Please take a look at handi-p.com and let me know your thoughts. Many thanks, Robin.
Hello, MedDevice Group!
I am helping a client with all-things-marketing and finalizing their launch plans for a US launch. They have a hardware/disposable model and the hardware will be priced upwards of $60K to cardiac centers. The units will come with a 2-year warranty but will require an annual tune-up; how have you typically seen this done before?
Options as we see them:
1) Create two item codes, one for warranty period maintenance + one at a higher price for post-warranty maintenance; or,
2) Build the tune-up cost into the price of the hardware, which does increase the hardware pricing by around $12-15K.
Thoughts? Have you seen this done in other creative ways?
We'd like customer compliance in using our maintenance plan, as we don't want system downtime. Thank you in advance!
My group is making realistic, full-sized, medical models that provide a high-fidelity surgical experience.
Used for medical schools' education and training, these durable, soft, silicone models can mimic nearly any organ or system (including normal, diseased, or patient specific) with tumors, bleed when incised, be scoped, sutured, etc.
I can’t help but think there may be potential for use or interactivity with some medical device items – but the students don’t know to ask, and both this group and I have little experience with what is available and where there may be opportunity to augment student learning.
Any ideas? Thanks so much! Barbara Duffy, email@example.com. P.S. We need more awesome groups like this!
We are an Italian medical device company promoting its products in the USA. Our products are related to post-op drain, chest tubes, and chest catheters. We seek an up-to-date information about prices, competitors' market share, SKUs and so on.
Which research companies provide that information? Recommendations welcomed.
PS: We seek local distributors too.
I am doing a market study for a high performance coating and I seek your expert advice.
The technology allows the deposition of a very thin coating (between 200nm and 1,5 micron) on glass, stainless or ceramic. It brings anti-sticking, anti-corrosion, and hydrophobic properties to the surface. It can be deposited on and inside complex parts.
How often this type of problems are found in medical devices? Are they critical?
If they are, how are they generally solved?
I'm really interested by your feedback and advice on this topic. Many thanks in advance for your help.
Tanguy Van Regemorter
I'm an investor in a medical device start up and our Team is seeking an experienced marketing consultant. The patented device has two major features:
1. Esophageal biopsy and, 2. Therapeutic drug delivery.
We are on track for FDA trial submission in June for the esophageal biopsy feature. The device is a balloon. The design is a single-application geographically oriented, four quadrant, circumferential esophageal biopsy. The balloon’s proprietary pleat system deflates after sampling to preserve cell density. In comparison, the current brush method accesses only a small area, requiring the use of multiple brushes and applications for wider sampling. The therapeutic drug delivery feature is still being tested and we believe it will significantly change the industry.
We have many marketing needs but initially we need assistance from an experienced medical device marketing consultant with development of messaging, product benefits over current methods, and marketing materials.
Referrals and recommendations are much appreciated!
With that, I would like to open up a discussion into this and see what group members, especially senior executives who have successfully navigated these waters, think. More specifically, what are the key components and actions needed to give your new medical device and start-up company the best chances of commercialization success.
So if anyone can suggest suitable trade shows it would be greatly appreciated or companies that we should be talking to.
If so, which one? (I have a list below, with links.)
What do you look for in membership? A vague hope someone can introduce you to a decision maker?
A peer network to help get a new job? Continuing education? Experts with whom you can share ideas and from whom you can learn?
Personally, I like the Device Alliance Association here in Southern California where I live. http://bit.ly/21DrnwH Members are kept up to date on trends and industry news and they meet monthly.
Check out the links below and share with the group: Which associations are worthwhile for you?
American Associations of Medical Colleges http://bit.ly/1ScWPQ7
American Health Information Management Association http://bit.ly/1o1Dq9V
American Hospital Association http://bit.ly/1pF9nGL
American Medical Association http://bit.ly/1XHhPjt
Health Information Management and Systems Society http://bit.ly/1o1Etqq
Advanced Medical Technology Association (AdvaMed) http://bit.ly/22yUoMp
American Orthotic and Prosthetic Association http://bit.ly/1RuXPCd
Contact Lens Manufacturers Association http://bit.ly/25fB2OI
Dental Trade Alliance http://bit.ly/1pFaO8d
Device Alliance http://bit.ly/21DrnwH
Health Industry Business Communications Council http://bit.ly/1o1FIWG
Hearing Industries Association http://bit.ly/1S0xDJL
Independent Medical Distributors Association http://bit.ly/25fC1ys
International Association of Medical Equipment Remarketers and Servicers http://bit.ly/25fChh1
LifeScience Alley http://bit.ly/25fCNeX
Medical Device Manufacturers Association (MDMA) http://bit.ly/1o1GNh9
National Association for Home Care & Hospice http://bit.ly/1pvyeMA
The Association of Electrical and Medical Imaging Equipment Manufacturers http://bit.ly/1pXkf2G
The Society for Biomaterials http://bit.ly/1RuZWWu
The Vision Council http://bit.ly/1pFdmTX
May 2 at 10x: Neuro Sales & Marketing Mastery Workshop Added!
Learn the latest communication strategies that are working today by utilizing the latest in Neuroscience, Linguistics, transformational grammar, and message engineering.
See http://medgroup.biz/10x for information.
At this exclusive 10x Workshop, you will get a private lesson from one of the world’s best marketers in healthcare. In three hours presenter Mike Sperduti will show you how to:
• Breakthrough the 10,000 sales and marketing messages bombarding your customers each day – and grab their attention to motivate them to act on your offer.
• Learn how to write, speak, and sell more effectively so customers see, hear, and feel your value proposition and want to do business with you.
• Create an instant connection with your targeted audience and engineer meaningful conversations that accelerate action so you can sell faster and more profitably.
• Learn how to build a predictable and repeatable sales process so you can feel confident you know exactly what to do to meet/exceed your sales plan.
Whether you’re an industry veteran or new to sales, join this workshop for new material that will give you an edge over the competition.
Wishing you a productive week,
Manager, Medical Devices: Marketing + Sales subgroup
P.S. You’re welcome to connect with me at https://www.linkedin.com/in/dangolka. Perhaps we can feature you in a group announcement!
Customer or Money: Which Comes First in Med Tech?
As a strategic-thinking med device marketing or sales professional, you know it's all about putting the customer first. But how do you get your compan
Who benefits from the device? The patient. But the patient does not chose the device, the doctor does. But the doctor does not buy the device, the hospital does. But the hospital does not pay for the device, the insurer does.
When I buy a car, I do all four of the things a customer does: I benefit, I choose, I buy, and I pay. But with medical devices, very different entities, with at least somewhat different motivations, takes on each of these four essential customer roles.
So when we sell a medical device, who is our customer?
How Should Content Marketing Impact Your Selling?
How Should Content Marketing Impact Your Selling? by Douglas Karr on Marketing Technology Blog
Hearing a new term from Admin & Purchasing talking about a "Rep-Less" future . What do you think ?
Do you think Medical Sales Reps will disappear from the hospital ?
Hearing a new term from Admin & Purchasing talking about a "rep-less" future . What do you think ?