Ron Tedesco MBA, MPM

Do you have Buc-ee’s level belief? 🤔 This billboard got me thinking about how much they must believe in their product to have a billboard for their product that is 600 miles away! And you need to make a U-Turn to get going the right way! 🤣 That is some serious belief in your product. It got me thinking… do you need to believe in your products that much to be successful? There is something about someone who believes so much and is so passionate about what they do, it becomes inspiring. Passion is the first trait that I look for in a salesperson. It would be hard to be passionate about something you don’t believe in. Now the big question… who would turn around and rive 600 miles to a Buc-ee’s??? It’s a big ask! It’s a pretty great product though! #medicaldevices #medicaldevice #medtech #sales #meddevice #linkedin #zimmerbiomet #stryker #smithandnpehew #depuysynthes Tyler Swilley Blaire Biggers Makayla Wallar Kevin Brown 🎸 Jerry Ennett Stu Brandon Buc-ee's, Ltd.

59

37 Comments

"𝐒𝐲𝐬𝐭𝐞𝐦-𝐖𝐢𝐝𝐞" 𝐘𝐨𝐮'𝐯𝐞 𝐡𝐞𝐚𝐫𝐝 𝐢𝐭. Me too. Here's why... 𝐀𝐜𝐜𝐨𝐫𝐝𝐢𝐧𝐠 𝐭𝐨 𝐏𝐚𝐦 𝐊𝐫𝐧𝐚𝐯𝐞𝐤, 𝐒𝐲𝐬𝐭𝐞𝐦 𝐌𝐚𝐧𝐚𝐠𝐞𝐫 𝐨𝐟 𝐕𝐚𝐥𝐮𝐞 𝐀𝐧𝐚𝐥𝐲𝐬𝐢𝐬 𝐚𝐭 𝐏𝐞𝐚𝐜𝐞 𝐇𝐞𝐚𝐥𝐭𝐡 on Sutures and Cents. Link to the full interview in the comments. #sales #medicaldevices

7

1 Comment

𝐅𝐮𝐧𝐝𝐚𝐦𝐞𝐧𝐭𝐚𝐥 #𝟏: 𝐖𝐡𝐚𝐭 𝐢𝐬 𝐕𝐚𝐥𝐮𝐞 𝐀𝐧𝐚𝐥𝐲𝐬𝐢𝐬? I'm going to try to break a lot of this value analysis stuff down to the elemental components. Yes, I nearly failed chemistry. Check that... I withdrew or definitely I would have failed. Hello English Major! Nevertheless, I think we can do this. Just don't ask me about covalent bonds or molecular weight or whatever. Barry Bonds? Sure? Covalent? Hard pass. 𝐎𝐤, 𝐰𝐡𝐚𝐭 𝐢𝐬 𝐕𝐚𝐥𝐮𝐞 𝐀𝐧𝐚𝐥𝐲𝐬𝐢𝐬 𝐰𝐡𝐞𝐧 𝐢𝐭 𝐜𝐨𝐦𝐞𝐬 𝐭𝐨 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞? In essence, it is a group of people who come from different disciplines within a health system or ASC. Whose responsibility is to spend the health system's resources in the most.effective manner. Like Chemistry was for me, analyzing the products and services is difficult, because the VAC team members need to balance: 🏀Patient Care 🏀Costs 🏀Getting paid while paying bills 🏀Employee Satisfaction 🏀Federal and State regulations 🏀Best Practices (Joint Commission, DNV, AAAHC) 🏀Signed contracts 🏀Litigation (being sued) 🏀Education of staff on anything new or different PLUS there may be a strategic plan by the C-Suite that has importance. An example would be acquiring another health system. Or starting a robotics program. Honestly? This is complicated stuff. 𝐀𝐧𝐝 𝐭𝐡𝐞 𝐍𝐞𝐰 𝐏𝐫𝐨𝐝𝐮𝐜𝐭 𝐑𝐞𝐪𝐮𝐞𝐬𝐭 𝐩𝐫𝐨𝐜𝐞𝐬𝐬 (𝐰𝐡𝐞𝐫𝐞 𝐦𝐨𝐬𝐭 𝐩𝐞𝐨𝐩𝐥𝐞 𝐜𝐚𝐥𝐥 𝐦𝐞)? That NPR isn't always the biggest priority, because VAC is already trying to make sure the health system or ASC isn't: 𝐅𝐚𝐢𝐥𝐢𝐧𝐠 𝐩𝐚𝐭𝐢𝐞𝐧𝐭𝐬, 𝐥𝐨𝐬𝐢𝐧𝐠 𝐦𝐨𝐧𝐞𝐲, 𝐦𝐢𝐬𝐬𝐢𝐧𝐠 𝐠𝐞𝐭𝐭𝐢𝐧𝐠 𝐩𝐚𝐢𝐝, 𝐥𝐨𝐬𝐢𝐧𝐠 𝐞𝐦𝐩𝐥𝐨𝐲𝐞𝐞𝐬, 𝐯𝐢𝐨𝐥𝐚𝐭𝐢𝐧𝐠 𝐭𝐡𝐞 𝐥𝐚𝐰, 𝐠𝐞𝐭𝐭𝐢𝐧𝐠 𝐜𝐢𝐭𝐞𝐝, 𝐛𝐫𝐞𝐚𝐤𝐢𝐧𝐠 𝐜𝐨𝐧𝐭𝐫𝐚𝐜𝐭𝐬 𝐚𝐜𝐜𝐢𝐝𝐞𝐧𝐭𝐚𝐥𝐥𝐲, 𝐠𝐞𝐭𝐭𝐢𝐧𝐠 𝐬𝐮𝐞𝐝 𝐚𝐧𝐝 𝐟𝐨𝐫𝐠𝐞𝐭𝐭𝐢𝐧𝐠 𝐭𝐨 𝐭𝐫𝐚𝐢𝐧 𝐭𝐡𝐞 𝐜𝐨𝐧𝐬𝐭𝐚𝐧𝐭 𝐜𝐡𝐮𝐫𝐧 𝐨𝐟 𝐧𝐞𝐰 𝐞𝐦𝐩𝐥𝐨𝐲𝐞𝐞𝐬... Man, it makes me want to talk molecular weights. So when your new product or service request comes in front of them... 𝐕𝐀𝐂 𝐧𝐞𝐞𝐝𝐬 𝐭𝐨 𝐮𝐧𝐝𝐞𝐫𝐬𝐭𝐚𝐧𝐝 𝐰𝐡𝐚𝐭 𝐭𝐡𝐞 𝐩𝐫𝐨𝐛𝐥𝐞𝐦 𝐢𝐬 𝐭𝐡𝐚𝐭 𝐲𝐨𝐮 𝐬𝐨𝐥𝐯𝐞. How much your product will cost them. What do they get in return. Does it affect any of the things that we listed earlier. If you hand them a new product request and it says (in essence) "Our product is cool and helps patients" Maybe we better understand how hard it is for the Value Analysis team to assess your product. 𝐓𝐡𝐞𝐲 𝐜𝐚𝐫𝐞 𝐚𝐛𝐨𝐮𝐭 𝐲𝐨𝐮𝐫 𝐬𝐜𝐫𝐞𝐰 𝐚𝐧𝐠𝐮𝐥𝐚𝐭𝐢𝐨𝐧 𝐚𝐬 𝐦𝐮𝐜𝐡 𝐚𝐬 𝐈 𝐜𝐚𝐫𝐞𝐝 𝐚𝐛𝐨𝐮𝐭 𝐂𝐨𝐯𝐚𝐥𝐞𝐧𝐭 𝐛𝐨𝐧𝐝𝐬. And withdraw as well. #sales #medicaldevices

8

What’s wrong with a copycat? 1. The 510(k) process is literally comparing yourself to a cleared product via the FDA (yes, clearance and approval are not the same because of the associated risk - approvals are riskier, however some think these two words are interchangeable). 2. How many copycats are out there for any products? Can’t count that high. 3. I used to copy my brother’s haircut back in the day but a mushroom/bowl cut was not my look 🤣… 4. No, my Dad does not have such pictures in an archival system. 5. Blueprints are fundamental foundations for success in ANY business = industry agnostic 6. My Mom has the picture but it’s hidden…please chill with such sensitive info! Cats do have 9 lives but you don’t need 9 investors all the time, unless they like to copy one another 🧲. The real question is: Which copycat is the best so the next copy machine can be developed 😝?

10

FDA is coming to Minnesota.! We are not Fly Over country this week!! Last Call and Last Chance to register for the FDA Road Show coming to Medical Alley! This session put on by FDA Experts is not just for Regulatory and Quality professionals, it also applies to R&D and Product Development teams so please share with your colleagues! #FDA #RAPS #Medicaldevice #Standards #Harmonization

12

2 Comments

Riddle me this, Mr. Customer: if the FDA found so many deficiencies in your supplier's facility that they wrote a warning letter about it, do you REALLY want to use their product in your device? 🙄 More Never Have I Ever shorts on YouTube: https://lnkd.in/gPHDgjx5 Read more about the importance of supplier audits here: https://lnkd.in/gEsEHsvk Or just put some time on my calendar and we can chat about it in person: https://leanraqa.com/time. #medicaldevices #qualitymanagement #compliance #regulatoryaffairs #medtech #biotech #europe #eumdr #europeancommission

22

1 Comment

Do you want to work with a vampire that only does regulatory consulting? Or do you want to get on the commercial jet that takes you from napkin sketch to commercialization? ————- VitaTek RD/Rapid Prototyping/Weekly in house Hydrophilic Coating in house Regulatory in house Die Mold Tooling in house Balloons (coming soon) in house Catheters (coming soon) in house Contract Manufacturing in house Sterilization in house Marketing shop in house Merchant Services in house Warehouse Distribution in house Medical Device Sales Team in house www.vitatek.io Medical Device Development Manufacturing Everything In House #prototyping #rapidprototyping #contractmanufacturing #manufacturing #medical #medicaldevices #sterilization #medicaldevicemanufacturing #researchanddevelopment #researchdevelopment #equity #privateequity #capital #hydrophilic #coatings #diemolds #meddevice #doctors #technology #future #creativity #entrepreneurship #startups #leanstartups

30

4 Comments

Mr Boojangles top questions to ask contract manufacturers. Medical Device Contract Manufacturers all claim they design and mfg in house. Top questions to ask your contract mfg. 1) Die Molds in house? Order from China and then upcharge me? Lead time? Mold flow analysis in house? 2) FDA regulatory on staff? Meet them weekly? 3) Is your team in the operating room weekly? Last time in the OR? 4) Sterilization in house? If no, who can I call to get sterilization validation lead times? 5) Office on site and work in your mfg clean room? Work on my product weekly, can we have weekly meetings? Can I use your QMS? Will you distribute my product to hospitals? 6) Can you provide weekly prototypes? Animation video? Investor one pager? Business plan? 7) Hydrophilic coating in house? Reformulation in house? Less than $900 per liter? Manufacture in house? Lead time less than 3 months? 8) Will you do marketing, social media, website? 9) Will you hire a medical sales team? Run the team? Hit quota? Sales strategy? Why not? Ask the questions! VitaTek RD/Rapid Prototyping/Weekly in house Hydrophilic Coating in house Regulatory in house Die Mold Tooling in house Contract Manufacturing in house Sterilization in house Marketing in house Sales Team in house www.vitatek.io Medical Device Development Manufacturing Everything In House #prototyping #rapidprototyping #contractmanufacturing #manufacturing #medical #medicaldevices #sterilization #medicaldevicemanufacturing #researchanddevelopment #researchdevelopment #equity #privateequity #capital #hydrophilic #coatings #diemolds #meddevice #doctors

14

1 Comment

𝐇𝐞𝐲 𝐦𝐞𝐝𝐢𝐜𝐚𝐥 𝐝𝐞𝐯𝐢𝐜𝐞 𝐫𝐞𝐩𝐬! When you reset trays and run them around? 𝐓𝐡𝐚𝐭 𝐭𝐢𝐦𝐞 𝐜𝐨𝐦𝐞𝐬 𝐨𝐮𝐭 𝐨𝐟 𝐲𝐨𝐮𝐫 𝐜𝐨𝐦𝐦𝐢𝐬𝐬𝐢𝐨𝐧𝐬. This isn't an opinion or an argument. 𝐈𝐭'𝐬 𝐚 𝐬𝐭𝐚𝐭𝐞𝐦𝐞𝐧𝐭 𝐨𝐟 𝐟𝐚𝐜𝐭. Plan accordingly. #medicaldevices

21

14 Comments

“Five days a week, for three and a half hours each session, I’m tethered to my home dialysis machine. During this time, I’m effectively incapacitated—unable to move freely or engage in anything beyond the simplest tasks. Though I receive treatment at home, the experience is still far from comfortable. The chair I sit in may not be a typical clinic chair, but it creates the same unrelenting pain. Now, imagine this scenario in a dialysis clinic. The chairs are often outdated, non-ergonomic relics that seem more suited for a waiting room than a medical facility where patients spend significant portions of their lives. The lack of proper support leads to additional joint and muscle pain, compounding the already significant discomfort of dialysis. This isn’t just a minor inconvenience; it’s a serious issue that exacerbates the stress and strain of an already grueling treatment. “ This image although exagerated really does reflect the issues facing many UK patients both in NHS, private sector satellites and Home HD patients being made to sit for over 6 hours in cheap furniture grade chairs rather than CE marked Medical Device MHRA registered custom made reclining chairs with critical features such as zero gravity and Trendelenburg positions.

13

2 Comments

"This change could significantly affect the safety or effectiveness of the device". 💥If you make changes to an approved/cleared device, and don't consider a new 510(k) or PMA, it can get you a warning letter. 👉Manufacturer of a thermodilution catheter removed heparin coating from a PVC tubing of an already cleared version, but did not submit a new 510(k). ❗The FDA finds these devices "adulterated" and "misbranded". Therefore, the warning letter (See link in comments below). 👉Why did they miss it? One possible reason is not involving their RA team when planning these design changes. 👉Another possible reason is not analyzing potential risks which would have triggered an assessment of safety and effectiveness. 🤔What do you think? What is the best way to avoid these issues? Please share your opinion in comments 👇 ========================================= Like this post? Like, comment & share with your network. Follow me Naveen Agarwal, Ph.D. and hit the 🔔icon to get notified when I post. #riskmanagement #letstalkrisk #medicaldevices

43

33 Comments

🏀𝐎𝐩𝐞𝐫𝐚𝐭𝐢𝐧𝐠 𝐌𝐚𝐫𝐠𝐢𝐧 - 𝐖𝐡𝐲 𝐬𝐡𝐨𝐮𝐥𝐝 𝐲𝐨𝐮 𝐜𝐚𝐫𝐞? Most health systems are running at a 1-2% operating margin right now. Which means if you save a facility $100,000 in costs? You just saved the health system $10,000,000 in Revenue they don't need to find. 𝐓𝐡𝐚𝐭'𝐬 𝐬𝐨𝐦𝐞 𝐓𝐰𝐢𝐧𝐤𝐢𝐞... $10,000,000 x 1% = $100,000*. Your clinical champ likely won't know this. But it's true. And matters. So if you can help your champ know how to describe it. 𝐘𝐨𝐮 𝐚𝐫𝐞 𝐝𝐨𝐢𝐧𝐠 𝐲𝐨𝐮𝐫 𝐣𝐨𝐛 𝐛𝐞𝐭𝐭𝐞𝐫. And helping your Champ. And the health system. You can do this.. I will help. 🏀🏀🏀🏀🏀 *This confused me for some time. But here's how it makes sense to most reps. If you are paid 1% on sales... For you to make $100,000, you would need to sell $10,000,000. Same idea here. To make $100,000 on an operating margin of 1%, they need to bill $10,000,000 in services. You both might need a better comp plan... #sales #medicaldevices

42

28 Comments

𝐍𝐨 𝐨𝐧𝐞 𝐤𝐧𝐞𝐰 𝐲𝐨𝐮𝐫 𝐩𝐫𝐨𝐝𝐮𝐜𝐭. 𝐔𝐧𝐭𝐢𝐥 𝐲𝐨𝐮 𝐛𝐫𝐨𝐮𝐠𝐡𝐭 𝐢𝐭 𝐭𝐨 𝐭𝐡𝐞𝐦. Now you can't get it approved. Tired of it yet? I hear ya. We can help. Link in the comments to talk about how. #sales #medicaldevices

19

5 Comments

Ways to get into a tough lab or OR if you’re a new med device rep (please comment other creative ways you set meetings with tough accounts): 1. Offer an in-service to new techs or nurses. This is very basic but there’s often additions and turnaround, so it’s in everyone’s best interest to get them trained asap. 2. Offer continuing education credits for techs. See if your company has presentations you can give to staff in order to give them credits. I used ASRT presentations for IR labs a lot post Covid when restrictions were tighter. 3. Connect with a Physician, Tech, Director, Nurse, etc via phone, email or LinkedIn and ask their advice for the best way to set up an in-service or office visit to share new products. Don’t give up after 1-2 tries. These people are all busier than you could imagine. 4. Network with other reps. Earlier in my career I was too focused on myself and viewed other reps as threats. Now I network as much as possible and have developed incredible relationships that have led to some BIG intros that I wouldn’t have had just by cold calling all the time. Shoutout to Matt Abrams, MBA for being selfless with intros when I first moved to Cali. 5. Ask your boss for help, ha. This is overlooked. I’ve been trying to set a meeting with someone for a while now and told my boss I’ve been having difficulty. Turns out she’s called on him for a decade and sent him a text. Meeting has been set. 6. Ask happy customers if they know anyone at the hospital you’re trying to get into. I’ve gotten cell phone numbers of lead techs, lab directors and Drs from happy customers with permission to say they sent me. If their friends are happy with you and trust you, this will increase the chance of someone meeting with you. Lake Odom any other advice you’d give or good stories of reps setting meetings in your lab?

67

24 Comments

𝐌𝐞𝐝 𝐃𝐞𝐯𝐢𝐜𝐞 (𝐋𝐞𝐚𝐝𝐞𝐫𝐬𝐡𝐢𝐩) 𝐢𝐬 𝐬𝐥𝐨𝐰 𝐭𝐨 𝐤𝐧𝐨𝐰! Those of you in the field need to bring your leadership teams into the 2020's.  Here's why your VP might be behind the times! #sales #medicaldevices 

40

16 Comments

Apologies for the blurry picture in advance... This picture is worth more than a thousand words. It pretty much explains how powerful the brain is when it listens rather than talks. This can be related to anything including music (singing a song versus listening to the song) or listening to a person talk. The electrical activity when listening to sound is considerably higher as you can see by the increased level of yellow zones at the bottom of the picture. What music do you listen to when connecting the dots? #theoryofeverything #universalenergy

7

Did you know why migratory birds fly in a V-shape? The answer is very wonderful: This method makes the birds cover the greatest possible distance by taking advantage of the total air flow formed by the entire flock, thus reducing the effort expended during flight ... This means that when each bird strikes the air with its wings, it generates energy that helps it fly and helps the bird that follows it, which enables all the birds in the flock to cooperate in the flight process .. Studies have shown that this formation in flight enables the entire flock to cover a distance of 71% more than if the bird flew alone ... Not only that, but researchers have found that the birds alternate their places in the flock in a strange way. When one of the birds feels tired, it returns back so that it can take advantage of the air current resulting from the flock as a whole, thus reducing the effort expended to the maximum degree, then after a while it returns to its place again, making way for another bird to rest

3

Sharing an interesting patient we had in MRI this week. Siemens Aera 1,5 T Dog, Irsk Setter, DOB 2017 History: Nasal discharge (bloody, serous, purulent) and sneezing for more than 3 months, seemingly acute onset. Rhinoscopy in June this year found mucus plug in the right nostril and irritated mucus membranes bilaterally, but no obvious lesions, fungal plaques or foreign body. The dog improved after flushing, but the symptoms returned a few weeks later. A tear duct flush was performed at another clinic ehich again improved symptoms for w few weeks before they returned. Intially the discharge seemed to be mostlly on the right side, but now the owner reports it might be more bilateral. Nevrologi us / Neurological examination: N/A Findings: MR images of the head are available for review. In the right nasal cavity, 3.3 cm caudal to the nares, there is a 7.2 cm long, T2 signal intense mass that causes lysis of the nasal turbinates. The mass occupies 90% of the right nasal cavity diameter with a small portion of the dorsal nasal cavity unaffected. The mass surrounds the apical tooth root of 107. The mass contains multiple cystic lesions within the parenchyma and has diffuse contrast medium enhancement. The mandibular lymph nodes are 0.7 cm thick. No lysis of the ethymoid labyrinth or cribriform plate is seen. There is no lysis of the nasal septum or extension into the left nasal cavity identified. No extension of the mass into the oral cavity is seen. The rostral aspect of the frontal sinuses are unremarkable. No abnormalities of the mandible are identified. The rostral eyes are unremarkable.   Conclusion: Right nasal mass - presumed neoplasia The MR appearance of the mass and the solid soft tissue nature of the lesion makes a neoplastic mass most likely. Differential diagnoses include lymphoma, squamous cell carcinoma and least likely adenocarcinoma, since generally adenocarcinomas are very destructive. Recommendations: A nasal biopsy of the mass can be performed to further characterize the lesion, but no other imaging of the head is needed at this time. Radiographs of the thorax can also be performed to look for evidence of metastatic disease. #veterinary #siemenshealthineers #MRI #diagnosticimaging #vetlabs #AdvancedMedicalImaging #VeterinaryInnovation #MRIRevolution #veterinaryneurology

39

2 Comments

Great to see that HPAEC-PAD-MS looks very promising for sensitive glycan analysis (separation and quantification).

23