17 min reading time

This week, you and I will write the global announcement together.

I’m inviting each of you to leave one comment that shares an insight you have about running a successful medical device business. Whether your expertise lies in design, development, manufacturing, operations, legal, regulatory, quality, marketing, sales, packaging, sterilization – you get the idea – let’s create a resource that no one of us could create alone.

That’s the power of our community.

If we collect enough insights, we can explore publishing our work in some fashion. I’ll start with mine, about medical device marketing.

Your #1 challenge is “producing engaging content.” I see it with my own clients. You may think your prospects are “too busy” to watch your video or read your post. No, they are too busy for things that don’t matter enough to trade their time for the information you are presenting. There are ways to fix this but it requires understanding and answering your customer’s questions at each stage of their decision process. (I’ll be talking more about this at https://MedicalMarcom.com and you’re welcome to subscribe for tips.)

Now you share. Perhaps something you’ve already written or something new. Let us learn from your experience – that’s why we belong to this discussion group!

I look forward to your responses!

+++

Free Webinar: Computational Modeling for Medical Device Development and FDA Certification

Very interesting: The ways engineering simulation helps with FDA certification, predicts device performance in clinical models, and reduces animal testing. Case studies in apnea, thrombosis, bioartificial kidneys.

Tuesday, Sept 19 at 2:00 pm New York time
Presented by SimuTech Group • Register at https://medgroup.biz/comp-modeling

+++

Make it a great week.

Joe Hage
Medical Devices Group Leader

P.S. 10x speaker applications through Sept 29 at https://medgroup.biz/callforspeakers

---

Joe Hage
🔥 Find me at MedicalDevicesGroup.net 🔥
This is great, folks. Exactly what I was hoping for. Keep ’em coming!

Julie Omohundro
Principal Consultant at Class Three, LLC
I do wonder about this industry’s ability to run companies.

The responses here focus on design and development of new products, and most people would say that new products are the lifeblood of a successful company. That seems to conflict with the widely reported profile of this industry, which is that the big companies aren’t good at and/or aren’t willing to develop new products, so they acquire them instead of developing them.

If you need new products to be successful, but you can’t develop them, is that really being successful? Or is that just dancing until the music stops?

Julie Omohundro
Principal Consultant at Class Three, LLC
Many of these suggestions are very good suggestions, but not for what I would call suggestions for “running a successful medical device company.”

Establishing a startup company and keeping it going just long enough to take it to acquisition is not what I would consider running a successful device company. More like the alternative. It’s common wisdom that those who succeed at startups are often not cut out to run a company. To the extent this is true, then what it takes to succeed at a startup is quite different from what it takes to succeed at running a company.

In addition, you don’t run a company at the micro level. If it is valuable to do usability testing, verify barcodes, incorporate biocompatibility, etc, you don’t do that at the level of running the company. Instead, you run the company to maximize the likelihood that someone at some level in the company will do that, without your direction or oversight.

Robert Mogel
International Sales and Marketing Expert
Selling your medical device overseas may require a modification to the product you are successfully selling here. Don’t view this as an obstacle, but rather as an opportunity to create a better product or a more diversified product line.

Rabea Affan
ProfessGene
From my decent experience i can tell that one of , if not the most, important regulatory attributes is persistence, persistence, and more persistence until you succeed.

Doug Limbach, JD
Patent Attorney at Shay Glenn, LLP
File your first patent application before talking with investors who won’t sign a non-disclosure agreement. To fully preserve all patent rights, including the right to file patent applications outside the U.S., a U.S. application should be filed prior to any public disclosure of the details of the invention, public use, sale or offer for sale of the invention. Patent law places a fairly low threshold on what is considered a public disclosure. Almost any disclosure without limitation or obligation of secrecy may constitute a public disclosure. However, in jurisdictions such as the U.S., in order to act as a bar to patentability the disclosure must be “enabling”–that is, it must give enough information to a “person having ordinary skill in the art” to actually duplicate the invention.

Rick Stockton
Product Designer (Medical, Scientific, Consumer)
Invoicing is about delivering. Delivering is about solving. Solving is about clients. Clients are about sales. Sales is about asking the right questions.

Chelsea Humbach
VP of Sales at Recoup
Very well said, Roger Cepeda.

John (Jack) Czajkowski
Manufacturing/Operations Consulting
Too often goals for departments involved in new product introductions are in silos. For example, Operations should have a piece of sales goals, Marketing and Product Development should have a piece of cost goals and everyone should agree and share in the timetable goal. Silos and hand offs simply don’t work in today’s competitive environment.

Clifford Thornton
Training Instructor at Naval Sea Systems Command (NAVSEA)
In developing and designing a clinical diagnostic tool, such as a diagnostic ultrasound system, it is very important to keep the technical user/technician in mind; in-fact they should be your focus, because they will be the primary user of it and driver of it. What I am about to say, does not apply to just ultrasound technicians, but any type of tech, be it respiratory tech, dialysis tech, audiology tech, etc.. Oftentimes, during a hospital’s capital equipment purchasing decision process, they will ask related technicians to test different vendors’ equipment and then give feedback. This was the case when I worked as an echocardiography tech. My fellow echo techs and I performed echo studies on each other (not patients) to test the various systems (i.e. GE, Siemens, Philips, etc.). In the end we went with Philips’ IE33 cardiovascular ultrasound system. Siemens Acuson was a nightmare for the continuity equation and GE records retroactively, which I don’t like. Need to focus on the user.

Tom Bromberger
Director at Pelican Manufacturing, Arizon Healthcare
1) Don’t forget the ‘old products’… for someone they will still be a ‘new product’.
2)Make sure all your staff, where possible, have tried any new product. Having personal experience of using a new product means a lot more than just being aware of it.

Daniel Gussin, MSC
Creating Value and Quality for Point-of-Care IVD and Life Science Devices
Don’t underestimate the cost – $$, time, effort, coordination – of development. It is easy to believe that all will line up, but there is always more risks than originally thought, more unexpected problems, and more interactions between the various product components and interfaces. Always allow for contingency budget and schedule.

Wade Goolishian, M.D., D.ABA
Anesthesiologist and Co-founder of OR-6, LLC
I’m certainly no expert but Joe and I have recently been working together on my marketing plan and Joe taught me something valuable in evaluating ideas for commercialization. As a healthcare provider, we are always coming up with “great” ideas that someone “ought to develop and make a fortune”. I believe there is tremendous benefit in talking to a variety of potential users early and often about the problem/pain point as you develop a minimal viable solution/product. if your potential users don’t think at least every day about the problem you’re solving, you might want to consider either redefining the problem or moving on to another

Roger Cepeda, JD, MBA, RAC
Medical Device and Biotech Attorney
Developing and commercializing medical devices requires at least a half-dozen disparate functional areas to work in concert, maybe for years, and it seems that the most successful products come from tight-knit teams who share a collective sense of ownership and understanding of one another’s KPIs– not just from the customer/user, but from other stakeholders within the same organization.

Mark Proulx, CQA, CSSBB, MS-GSD
Quality and Remediation Rock Star
PLAN for success by understanding the rules up front. Too many companies are all about “making money” or “driving value” but they don’t understand that when you are making a product to sell for money, that there is another product even MORE important – the documentation that allows you to sell your product for money. Knowing the rules of medical device business is a way to ensure a strong, fundamental foundation of quality that will sustain productivity, make it easier for your employees to be productive, and prevent large costs of poor quality. A solid quality system is imperative to having a sustainable and valuable business to keep or sell!

Tom KraMer
President & CEO, Speaker
It is hard to have a profitable finish if you don’t have a good start. Usability research that leads to good, human centered design is a must for a good start.

Clifford Thornton
Training Instructor at Naval Sea Systems Command (NAVSEA)
Need to drive home a marketing message which incorporates patient benefits in terms of safety, effectiveness, and long-term outcomes, while highlighting and communicating the improved features, functionality, and advantages over prior techniques with your device to the physician or surgeon; make the message crystal clear, concise, and one which differentiates your device.

Aaron Joseph
Streamlined Compliance for Medical Device Development
Don’t rely on documents to manage your product documentation. Your company’s DHF documentation is too important and too complex for word processors–there are much better software tools available now for efficient and rigorous management of DHF documentation.

Warren Cutright DVM
CEO at Six Thirteen Biomedical LLC
From the product development trenches. For new implantable device designs, try to avoid the trap of doing model and product development simultaneously. It is time and resource intensive and can kill a good product concept.

Ginger Cantor
Founder/Principal Consultant at Centaur Consulting LLC
Success is really reliant on having a good eye on the regulatory landscape and being able to be flexible in different markets. Have a plan B. Be accountable to your timeline.

Michelle O’Connor
President and CEO | Director | Learning Strategy | Life Sciences Sales Training | Corporate Educational Partnerships
Ensure that you have a value proposition that speaks to the total cost of care –
cost, quality and outcomes – and that your sales teams can articulate the value of your product in terms that speak to the needs of changing decision makers, including the C-suite.

Antonios Katrantzis
Manager Quality and Regulatory Affairs – Division European Medical Systems (EX) bei FUJIFILM Europe GmbH (European HQ Düsseldorf)
I have noticed in the past 10 years an increase of specialisation. Too much of self-centeredness! Sales people mostly know only that part of the MD business, while developers have become specialists in hardware or software design or usability gurus and so on. And on top of that, executives do not lead anymore. Either they interfere all the time or they are not seen at all. There is missing the building-team-spirit part. Motivation to become an expert outside your expertise. Why is it so wrong to know how the warehouse guys do their job if you are a SW-Dev? Why is it so wrong to ask questions about other departments related topics? Does it need to be something negative to be curious? Or to ask for “let’s downsize this project” or “let’s put an end to this development for good”? Running a successful medical device business should be successful because of the people providing MDs for the people. Yes! Regulations shall be followed. Numbers presented. Risk Management implemented. Design results thoroughly tested…. but in the end it is this one medical device which makes all the difference for this one patient. And this patient will have a name…

Paul M. Stein
Chief Scientist, Inventor, and Entrepreneur – Dedicated to the Treatment of Critical Unmet Medical Needs
When your company wishes to work on any pre-clinical research and development project with a contract research laboratory, make sure only one person at your company does all the non-billing communications with another single person at the contract laboratory. Always, not usually or sometimes, but always, at your company and at the contract laboratory, there are massive differences in knowledge levels between employees regarding the status of all the aspects of the project. When multiple people with limited knowledge feel they must insert their questions-opinions-demands between the two companies, the only things that ensue are panic, frustration, and hurt relations. The contract research laboratory already funnels everything through one person, the Study Director. Make sure you select a Pre-Clinical Project Manager on your own end, and make it is absolutely known that everything heading to and from the contract laboratory gets funneled through that one person.

Kiran SM
Design Quality Assurance Engineer at Philips Innovation Campus
My advice to people running medical device companies: “Pay heed to traceability during product design.” The big idea behind the medical device needs to be translated to technical requirements. Good design of a device would ensure that these specifications are fulfilled. Verification and validation processes would confirm that the requirements are indeed met. The important point here is to ensure that traceability is consciously thought of, right from the very beginning.

Steve BEYER
Making Science work for Business as Automation
Excerpt from recent blog post: “Medical device testing is serious business. Big business. The medical device market in the USA alone produces over $148 Billion in revenue annually (pre-2017), according to SelectUSA. The market for these devices comes from everything from contact lenses to insulin pumps to Ventricular Assist Devices, to syringes and many, many more products.
…
Working with a partner experienced in the intricacies of these regulatory landscapes saves companies money, process integrity, and risk—both schedule and approval. Getting premarket approvals, other favorable findings that device manufacturers may want to pursue can be made more likely if the relevant process are understood and followed. As we have seen, from the engineering and design activities through to the build and the testing to the documentation, the details matter and they are very specific.” More:

http://blog.optimation.us/medical-device-testing-confirms-safety-and-reliability

Gadi Schneider
BD Manager Israel at Zeus
Always prepare a Plan B.
A lot of startups put all their efforts on one concept / solution, and if it fails they usually don’t have enough breath to survive.
Those that prepare a Plan B, know exactly what to do when that happens.

Joanne Harack
H.R. Architect for Biotech Growth Companies
Optimism is good; wishful thinking is not. “It worked in the lab” is no guarantee that it will work in a clinical setting. If you are experiencing technical challenges, solve them if you can – don’t deny they exist.

John Nachtrieb
Barcode Quality Trainer – Consultant – Barcode Testing Service Provider – Fix Present and Avoid Future Barcode Problems
Verify your barcodes to the applicable industry spec–HIBC or GS1–to make sure your medical device gets to its destination without delay. Do the verification yourself or use a testing service.

Shailesh Kher
Director at Lebentec Medical Systems Pvt Ltd
What ever it is it has to be user centric.
Be it the concept or design or end product and solution. Rest will automatically follow.

Rainer Moosdorf, MD, PhD, FAHA
Cardiovascular Surgeon, Medical Consultant, Member of Healthcare Shapers
The first question should be, what the market – our patients- need. Then we should ask, how far we can meet these needs with a product and if we can offer it for a fair and realistic price. Many products fail, because we first have to create a market – a need – for them or, because the price is so far away from real world, that they remain niche products and finally disappear in a too small niche.

Son Nguyen
Managing Director at Fresenius Medical Care Vietnam LLC
After over 20 years in medical device business, I realize that we are generally limited by the people we have. So, keep, buy and/or borrow (don’t build, as talents can hardly be built) the best people from different types of companies (small, big, family, public…) and they will challenge, push you to actions and success. When we have issues/problems with teamwork, engagement etc… don’t forget that Task Management = Ctrl + Alt + Del.

Victor Pikov
Founder and CEO at Medipace Inc
Our startup is in the development/V&V phase, so rather than commenting on overall success, I will focus on a successful transition from the design to the development phase. There are sizable organizational, financial, and psychological shifts that need to happen in the team within a short time interval. Specifically, V&V engineers and preclinical validation team need to take full control of the process, while embracing strict document and design controls. This will ease the pain of ramping up the QMS and regulatory efforts, which are absolutely essential in preparation for a clinical trial. Also, spending extra $100K on designing a well-controlled animal GLP study with reasonable group sizes and outcome measures can save $1M+ in subsequent design and execution of a clinical trial.

BE (Barbara) Alink
Founder of The Alinker – Paradigm-shifter with “Reverse-Design” life’s Practice – Edge-walker – SheEO Activator – B Corp
design needs to be for how people want to live their lives, not for a body with a problem. Also don’t design for people, rather enage and connect with people to understand how they want to live, then translate your learnings.

Also listen to an interview with me on a podcast just published: http://carolsanfordinstitute.com/regenerative-business-barbara-alink-alinker/

Gary Morton
Author of Commanding Excellence, Co-founder and retired General Manager of Stryker’s EMS Equipment Business
How can you grow in a market that is not growing or even shrinking? That was the challenge my marketing, sales, and R&D teams faced with our Emergency Medical Service Equipment business. We had, had entered the EMS market with the launch of the RUGGED ambulance cot in 1994. Sales grew nicely, but after five solid years, momentum began to slow. I was the the senior co-founder and General Manager of the business that was part of a larger company, our challenge was to grow at least 20 percent annually in a global market that was at best increasing only 2–3 percent and, in most years, shrinking. It seemed a daunting task, similar to one faced by many businesses today. We identified critical challenges facing our customer base and then developed a series of breakthrough new products that created entirely new product categories by solving those issues with technology. It was an example of a quintessential win-win.

Chris Elliott
Chief Regulatory Officer at Leman Micro Devices SA
It’s very hard to squeeze cost out of an existing product, for two reasons. Technically: the early design decisions lock in costs, squeezing them out requires a radical rethink. Psychologically: no-one likes to rethink an existing successful product. So if you don’t design for low cost from the start, your competitor will.

David Seitelman
US Managing Director at Safersonic
No is simply a yes deferred.

Gadi Schneider
BD Manager Israel at Zeus
Always prepare a Plan B.
A lot of startups put all their efforts on one concept / solution, and if it fails they usually don’t have enough breath to survive.
Those that prepare a Plan B, know exactly what to do when that happens.

Heather Peacock
Marketing Manager at Peacocks Medical Group
our company has been supplying bespoke medical devices to the NHS for over 100 years. During that time there hasn’t really been a huge amount of change, comparative to the time.

Our success lies with our people – their knowledge, expertise and craftsmanship has stood the test of time.

That’s not to say we shouldn’t innovate – we innovate all of the time, in terms of processes, technology, and efficiencies. We have also innovated in product design via 3D printing but this is still very niche.

D. Ronald Yagoda
Executive Chairman CyMedica Orthopedics
What makes you successful is not what you do right, but what you don’t do wrong. Eliminate the negative variables and the positives will take care of themselves. Our business is customer service because without a customer we don’t have a business.

Phil Burnette
Developing complex product specific solutions beyond traditional logistics services
A COMMON MISTAKE AVOIDED: Good system design, quality manufacturing, and meeting the market need for a product get much of the attention when discussing a great medical device, and rightfully so. But in most situations, customer satisfaction is not achieved until the product is operational in the customer’s facility. Minimizing or ignoring the importance of the “back half” of the supply chain process can be problematic. Shipping, white glove delivery, and installation service providers are seen by the customer as extensions of your company. Selecting the wrong (MLP) medical logistics partner can undue all the hard work put in to creating a great medical device. #mlp

Steven Arey
Manager, Biomedical Equipment Service Technicians of Rowan, LLC
For repeat business, I always try to do more than what is expected.

Art Pichierri
CEO at Coast to Coast Urological Associates and Infection Control
Michelle’s comments are spot on. This process erodes the insulation between you the client and the big brand names, their rebates, grants and perks a smaller company cannot afford nor, ethically, should be involved in.

Dereck Wheeldon
Medical Devices Professional
Hi – I am retired but spent many years in the VAD and TAH field. An overlooked area is in relation to providing a quality of life which meets each individual patient’ s aspirations. What trade- offs are they willing to make and what do they want to avoid. Longevity may be less important than quality time . Read Atul Gawande on this subject.

Andy Fry
Founder of Team Consulting Limited
For any medical device to be truly successful (which has to mean successful for the patient, the HCP and the manufacturer), the usability and manufacturability must be regarded as equal in importance to the clinical function. There is still a view that usability and manufacturability are a garnish which can be sprinkled on at the end of the development. Wrong, I’m afraid, it just doesn’t work like that.
If these Cinderella’ aspects of the development process are made foundational elements, problems don’t magically disappear, but we can spot them a long way off and design to avoid or eliminate them. Everyone wants devices which work right, are easy to use right and are at the right price. This is the way to hit all three objectives.

David Amrani
Member at Amrani Consulting LLC
Device companies particularly those that produce and market devices for use with human blood and tissues often have excellent engineering, design, quality, regulatory aspects of development and maintenance. Unfortunately, it has been my 30 years of experience that the lack of incorporation of biocompatibility/hemocompatibility at the beginning of conception and design and development is what most often leads to significant problems in trials and the field. Many companies fail to develop multidisciplinary teams working together to provide at the onset of development and beyond the proper quality development of these types of products. It is often why I see the same issues arise in different companies making diverse products. A company that recognizes this issue upfront and makes this a priority together with quality and regulatory control will be the more productive and successful one.

Annelies D’hondt
Chief Quality Officer bij Aptec Diagnostics nv
Try to not assume when doing a risk assessment.

As a non-scientific person working knee deep with Medical Devices, I learned I could contribute by standing still where other, more scientifically schooled people would scoot over, thinking it’s common knowledge. Since we work with other non-scientific personnel, it’s best not to assume anything when doing a risk assessment.

Michael Flanagan
Helping provide rapid DNA for a safer world.
Figure out what is the hardest part, and solve that FIRST. I think it is human nature to do what we’re most comfortable with first, but that postpones the hard part until there are even more constraints, and then it is even harder to resolve.

Aditi Khattar
Quality Engineer at Cook Medical
An important question to constantly ask yourself throughout the product development process right from initial concept to having the product on the market is-Is this good/safe for the patient ? Is what I am doing going to benefit the patient ? It is easy to forget this a lot of the times. Asking this question keeps you in check and on track. Keeping the patient above all is very important. It also helps a business/company make important quality decisions.
For example, if you are validating a process or equipment in manufacturing and you decide to go the easier route by not doing a thorough and detailed validation then ask yourself whether you would want a device manufactured by that process/equipment to be used on you or your family member.

Michael Halloran
Mechanical Engineer, Boffin, Tinker
If your Plan requires overcoming one Major Technological Hurdle, whatever that means to you, I salute your enthusiasm and wish you great success. If your Plan requires overcoming two MTHs, your plan is doomed. Find something else to do.

Stephanie Gower
Sales Management | Business Management | Education and Training | Customer Centric Leader | Key Account Management.
Align as much talent as you can that are engaged in the disease/condition/problem. Not necessarily the solution … which is only the solution this year. Patient advocacy is key. Get a passionate team concerned about the problem or epidemic at hand.

Richard Fu
Manufacturer/ orthopedic sports brace/medical brace/sports therapy/ foot brace/knee brace/shoulder brace/back brace /
Step by step, success will be coming.

BE (Barbara) Alink
Founder of The Alinker – Paradigm-shifter with “Reverse-Design” life’s Practice – Edge-walker – SheEO Activator – B Corp
design needs to be for how people want to live their lives, not for a hody with a problem. Also don’t deaign for people, enage and connect with people to understand how they want to live, then translate your learnings.
Also listen to an interview with me on a podcast just published: http://carolsanfordinstitute.com/regenerative-business-barbara-alink-alinker/

Avital Arbel
QA consultant at Avital Arbel QA services
far be it for me to determine what makes a successful MD company, but from my experience a significant cause of failure is an inability to understand true user needs coupled with attempts to impose design solutions on users that are of no real benefit to them while disregarding clinical or HF inputs.

Dr. Fatima Sanfourche
Quality and Regulatory Affairs Manager bei Penumbra, Inc.
I think what contribute to the success of any medical device company is to have a strong Design Control and project management processes to to run the development of their product with a focus of the customers needs. It’s also very important to establish a good regulatory strategy assessment from the beginning of the project . But the most important element in my view is to put in place a experienced management team with a a good communication skill as well as to give the possibility for the employees to be trained for their tasks and to be part of the decision related to any changes in processes in the company impacting their daily work.

Katherin Awad
Freelance Marketing Consultant for early stage Medical Device companies
#1 rule in marketing: know what your customer needs & wants (2 different things) and let those drive your business.

Debra Leeves
CEO – Vertual Ltd
Strong clinical data underpins the commercial strategy. Take time to develop convincing clinical outcome data for a new medical device, it will show where the product has the greatest effect for patients ( and healthcare professionals) and rules out indications where it may not be successful. Marketing and sales strategy is developed on the back of the clinical data, and product pricing as well as the market access and reimbursement strategy require good clinical outcome data. Finally, if distributors are sought or the product is sold to another company or the whole company is acquired by a larger company, then a solid clinical trial program as well as the P&L are two areas buyers where buyers will look first.

Stacey Finn
Lead auditor and technical file reviewer at SGS (Notified Body)
Plan for product compliance testing from the start of your development life-cycle. Use your own standards checklist to feed into your spec. If you are developing new products right now (for EU) then work with the new MDR. And you have 14971:2012 covered, right?

Erik Hatlanek
Consultant principal chez MCH Management Conseil Hatlanek Sàrl
I have been lead auditor for a notified body CE 1253, which is not any more in bussiness. A have knowledge over training sessions with CE0123.