MedTech Masters Q&A: Mark Gardner

As the Bell­mont Part­ners Health team con­tin­ues its 15th anniver­sary cel­e­bra­tion this month, we are high­light­ing our health clients and the medtech com­mu­ni­ty. Next up in our Medtech Mas­ters Q&A series, is a con­ver­sa­tion with Mark Gard­ner, founder and man­ag­ing part­ner of Gard­ner Law and Chrysalis Incu­ba­tor. 

Mark Gard­ner, MBA, Esq., is an attor­ney, pro­fes­sor, and entre­pre­neur with 25+ years in health­care. He found­ed Gard­ner Law and Chrysalis Incu­ba­tor, guid­ing FDA-reg­u­lat­ed com­pa­nies and inno­va­tors through legal and busi­ness chal­lenges. Mark teach­es at Mitchell Ham­line School of Law, the Carl­son School of Man­age­ment, and the Uni­ver­si­ty of Min­neso­ta Law School. He pre­vi­ous­ly held com­mer­cial roles in medtech and biotech and reg­u­lar­ly speaks on AI in health­care and FDA reg­u­la­tion. 

How did you get start­ed in the medtech indus­try? What is your back­ground? 

My start in health­care was in 1999 at Med­tox Lab­o­ra­to­ries where I focused on com­mer­cial­iza­tion of lab­o­ra­to­ry ser­vices and diag­nos­tic devices. While work­ing at the lab, I grad­u­at­ed from busi­ness school and start­ed attend­ing law school on nights and week­ends. From there I went on to work as a prod­uct man­ag­er at com­pa­nies in the wound care and car­di­ol­o­gy spaces. These days I work in health­care as an attor­ney, pro­fes­sor, and entre­pre­neur. I found­ed Gard­ner Law, which caters to FDA-reg­u­lat­ed com­pa­nies. I also found­ed Chrysalis Incu­ba­tor, where we guide inven­tors and med­ical device com­pa­nies through the com­plex­i­ties of bring­ing inno­v­a­tive med­ical tech­nol­o­gy to mar­ket.  

Tell us a lit­tle bit about Gard­ner Law — what areas do you spe­cial­ize in and what kinds of clients do you serve? 

At Gard­ner Law, all our clients are relat­ed by the FDA. That’s the com­mon denom­i­na­tor. We assist med­ical device, phar­ma­ceu­ti­cal, bio­log­ic, health tech, lab­o­ra­to­ry, food, cos­met­ic, and oth­er com­pa­nies reg­u­lat­ed by the agency, on reg­u­la­to­ry, health­care com­pli­ance, pri­va­cy, lit­i­ga­tion and busi­ness mat­ters.  

What are the trends you’re see­ing in the medtech indus­try now, in terms of the things com­pa­nies are com­ing to you for help with? How has this changed over the years?  

The biggest and most recent changes involve the inte­gra­tion of AI into med­ical tech­nol­o­gy, an explo­sion in the wear­ables and health tech sec­tor, more reg­u­la­tion on the state lev­el, and an increase in pri­va­cy and secu­ri­ty demands on our clients. These are all rel­a­tive­ly recent devel­op­ments. We con­tin­ue to see an inter­est by lead­er­ship at the DOJ and OIG in com­bat­ing fraud, abuse, and waste in the health­care indus­try. As well as an agency that places high demands on any­one sell­ing an FDA-reg­u­lat­ed prod­uct that impacts the Amer­i­can pub­lic. Reg­u­la­tion of the indus­try nev­er seems to go back­wards. At least I haven’t seen that hap­pen in my 26 years work­ing in the indus­try. 

What role does com­mu­ni­ca­tions play in some of the chal­lenges you help your med­ical device/tech clients nav­i­gate? 

FDA-reg­u­lat­ed indus­try is a high-stakes place to con­duct busi­ness. People’s lives are at stake. Vio­la­tors can go to jail and/or be exclud­ed from work­ing in the indus­try. There­fore, hav­ing clear com­mu­ni­ca­tion, espe­cial­ly when deal­ing with a cri­sis is crit­i­cal. Beyond that, firms reg­u­lat­ed by indus­try are com­pelled by reg­u­la­tors to be trans­par­ent and artic­u­late when it comes to dis­clos­ing safe­ty and effi­ca­cy infor­ma­tion about their prod­ucts. We work with pub­lic rela­tions experts to make sure our clients are com­mu­ni­cat­ing effec­tive­ly. 

We under­stand you also recent­ly co-found­ed an incu­ba­tor for medtech star­tups. Can you tell us a bit about that? 

Since launch­ing ear­li­er this year, my part­ners and I are hav­ing an absolute blast assist­ing inven­tors of new med­ical tech­nolo­gies whose goal it is to take an idea for a new med­ical tech­nol­o­gy and make it a real­i­ty. We found­ed Chrysalis Incu­ba­tor with the goal of help­ing peo­ple nav­i­gate the increas­ing­ly dif­fi­cult chore of get­ting new med­ical tech­nolo­gies into the hands of health­care providers. When found­ing the com­pa­ny, we expect­ed to hear most­ly from physi­cians. We’ve been delight­ed to find that engi­neers and laypeo­ple are com­ing to us with their ideas. My part­ners include Dar­ryl Barnes, MD, a Mayo-trained sur­geon, inven­tor, and medtech entre­pre­neur; Bren­dan Pittman, MBA, a tried-and-true medtech busi­ness exec­u­tive who spent time at Medtron­ic and Boston Sci­en­tif­ic, among oth­er com­pa­nies; and Ben Tramm, EE, Esq., a renowned intel­lec­tu­al prop­er­ty attor­ney who has got­ten hun­dreds of med­ical devices patent­ed and also spent time at Medtron­ic as an elec­tri­cal engi­neer. The com­mon theme among me and my col­leagues is that we’ve done the work that it takes to get a med­ical device from idea to stan­dard of care. We’re not just cuf­flinks and wingtips; we’re oper­a­tors that have spent our careers doing the hard work that we advise our clients on. This is what sets us apart. 

We are grate­ful to Mark for shar­ing his insights with us and for the impor­tant work that he and his part­ners do in help­ing their clients nav­i­gate and solve chal­lenges with­in the com­plex reg­u­la­to­ry world of medtech every day. 

ICYMI, check out our last Q&A with Frank Jaskulke, vice pres­i­dent of sales and busi­ness devel­op­ment at Avio Medtech Con­sult­ing and stay tuned for the next install­ment in our series! 

Do you have a life-chang­ing inno­va­tion and are look­ing for help to bring it mar­ket? We’d love to hear more about it! Con­tact us for a com­pli­men­ta­ry PR strat­e­gy ses­sion and brain­storm.